[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]




                 DEPARTMENTS OF LABOR, HEALTH AND HUMAN

               SERVICES, EDUCATION, AND RELATED AGENCIES

                        APPROPRIATIONS FOR 2003

_______________________________________________________________________

                                HEARINGS

                                BEFORE A

                           SUBCOMMITTEE OF THE

                       COMMITTEE ON APPROPRIATIONS

                         HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS
                             SECOND SESSION
                                ________
  SUBCOMMITTEE ON THE DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, 
                    EDUCATION, AND RELATED AGENCIES
                      RALPH REGULA, Ohio, Chairman
 C. W. BILL YOUNG, Florida           DAVID R. OBEY, Wisconsin
 ERNEST J. ISTOOK, Jr., Oklahoma     STENY H. HOYER, Maryland
 DAN MILLER, Florida                 NANCY PELOSI, California
 ROGER F. WICKER, Mississippi        NITA M. LOWEY, New York
 ANNE M. NORTHUP, Kentucky           ROSA L. DeLAURO, Connecticut
 RANDY ``DUKE'' CUNNINGHAM,          JESSE L. JACKSON, Jr., Illinois
California                           PATRICK J. KENNEDY, Rhode Island
 KAY GRANGER, Texas
 JOHN E. PETERSON, Pennsylvania
 DON SHERWOOD, Pennsylvania         
                                    
                   
 NOTE: Under Committee Rules, Mr. Young, as Chairman of the Full 
Committee, and Mr. Obey, as Ranking Minority Member of the Full 
Committee, are authorized to sit as Members of all Subcommittees.
      Craig Higgins, Susan Quantius, Susan Ross Firth, Meg Snyder,
             and Francine Mack-Salvador, Subcommittee Staff
                                ________
                                 PART 4A

                      NATIONAL INSTITUTES OF HEALTH

                              

                                ________
         Printed for the use of the Committee on Appropriations
                                ________
                     U.S. GOVERNMENT PRINTING OFFICE
 80-980                     WASHINGTON : 2002

                                  COMMITTEE ON APPROPRIATIONS

                   C. W. BILL YOUNG, Florida, Chairman

 RALPH REGULA, Ohio                   DAVID R. OBEY, Wisconsin
 JERRY LEWIS, California              JOHN P. MURTHA, Pennsylvania
 HAROLD ROGERS, Kentucky              NORMAN D. DICKS, Washington
 JOE SKEEN, New Mexico                MARTIN OLAV SABO, Minnesota
 FRANK R. WOLF, Virginia              STENY H. HOYER, Maryland
 TOM DeLAY, Texas                     ALAN B. MOLLOHAN, West Virginia
 JIM KOLBE, Arizona                   MARCY KAPTUR, Ohio
 SONNY CALLAHAN, Alabama              NANCY PELOSI, California
 JAMES T. WALSH, New York             PETER J. VISCLOSKY, Indiana
 CHARLES H. TAYLOR, North Carolina    NITA M. LOWEY, New York
 DAVID L. HOBSON, Ohio                JOSE E. SERRANO, New York
 ERNEST J. ISTOOK, Jr., Oklahoma      ROSA L. DeLAURO, Connecticut
 HENRY BONILLA, Texas                 JAMES P. MORAN, Virginia
 JOE KNOLLENBERG, Michigan            JOHN W. OLVER, Massachusetts
 DAN MILLER, Florida                  ED PASTOR, Arizona
 JACK KINGSTON, Georgia               CARRIE P. MEEK, Florida
 RODNEY P. FRELINGHUYSEN, New Jersey  DAVID E. PRICE, North Carolina
 ROGER F. WICKER, Mississippi         CHET EDWARDS, Texas
 GEORGE R. NETHERCUTT, Jr.,           ROBERT E. ``BUD'' CRAMER, Jr., 
Washington                            Alabama
 RANDY ``DUKE'' CUNNINGHAM,           PATRICK J. KENNEDY, Rhode Island
California                            JAMES E. CLYBURN, South Carolina
 TODD TIAHRT, Kansas                  MAURICE D. HINCHEY, New York
 ZACH WAMP, Tennessee                 LUCILLE ROYBAL-ALLARD, California
 TOM LATHAM, Iowa                     SAM FARR, California
 ANNE M. NORTHUP, Kentucky            JESSE L. JACKSON, Jr., Illinois
 ROBERT B. ADERHOLT, Alabama          CAROLYN C. KILPATRICK, Michigan
 JO ANN EMERSON, Missouri             ALLEN BOYD, Florida
 JOHN E. SUNUNU, New Hampshire        CHAKA FATTAH, Pennsylvania
 KAY GRANGER, Texas                   STEVEN R. ROTHMAN, New Jersey    
 JOHN E. PETERSON, Pennsylvania
 JOHN T. DOOLITTLE, California
 RAY LaHOOD, Illinois
 JOHN E. SWEENEY, New York
 DAVID VITTER, Louisiana
 DON SHERWOOD, Pennsylvania
   
 VIRGIL H. GOODE, Jr., Virginia     
   
                 James W. Dyer, Clerk and Staff Director

                                  (ii)
                                                                      

                                                                      
                                     
                                     
                                     

             NATIONAL INSTITUTES OF HEALTH BUDGET OVERVIEW

Panel:  From Bench to Bedside and Beyond
            NIDDK, NCI, NIA, NINDS, and NIAID

Panel:  Biomedical Science in the Future
            NIBMS, NIDCD, CSR, NIMH, NIDA, NCRR and B&F

Panel:  Collaborations in Research
            NIAMS, NICHD, NIBIB, FIC, NCMHD, NCCAM

Panel:  Disease Prevention and Health Promotion
            NINR, NLM, NIEHS, NEI, NIDCR, NHLBI, NHGRI
                and NIAAA

                                 (iii)

 
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION AND RELATED 
                    AGENCIES APPROPRIATIONS FOR 2003

                              ----------                              

                                            Wednesday, May 1, 2002.

                EFFORTS TO PREPARE AGAINST BIOTERRORISM

                               WITNESSES 

CLAUDE ALLEN, DEPUTY SECRETARY
ELIZABETH JAMES DUKE, ADMINISTRATOR, HEALTH RESOURCES AND SERVICES 
    ADMINISTRATION
DAVID W. FLEMING, ACTING DIRECTOR, CENTERS FOR DISEASE CONTROL AND 
    PREVENTION
ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS 
    DISEASES
CHARLES CURIE, ADMINISTRATOR, SUBSTANCE ABUSE AND MENTAL HEALTH 
    SERVICES ADMINISTRATION

                          Chairman's Statement

    Mr. Regula. We'll get started this morning. We have an 
interesting morning and a very important panel to present the 
story of bioterrorism as it relates to the Federal Government.
    Mr. Allen, I understand that you're in charge, you'll kick 
it off then you'll call on your colleagues to give their 
reports, then we'll go to questions. So your statement will be 
made part of the record. We'll appreciate a summarization.

                      Deputy Secretary's Statement

    Deputy Secretary Allen. Thank you, Mr. Chairman, members of 
the Committee. Thank you for inviting the Department of Health 
and Human Services here today to discuss the President's fiscal 
year 2003 request for our bioterrorism preparedness efforts.
    I do want to take a moment and stress to you that being 
ready for a bioterrorist event is an important part of our 
homeland security. I want to thank each of you for being so 
supportive of the President and Secretary Thompson's efforts to 
build and enhance the necessary protections to ensure the 
safety and the public health of our Nation.
    I have several of our agency heads here with me today, and 
I would like to take a moment to introduce them to you. At my 
right, your left, is Dr. Elizabeth James Duke, Betty Duke as we 
affectionately refer to her, who is our Administrator for the 
Health Resources and Services Administration. Dr. David Fleming 
is the Acting Director for the Centers for Disease Control and 
Prevention. Dr. Tony Fauci is the Director of the National 
Institute of Allergy and Infectious Diseases at the National 
Institutes of Health. And Mr. Charles Curie is the 
Administrator for the Substance Abuse and Mental Health 
Services Administration.
    We're proposing a comprehensive and aggressive approach to 
improving our public health infrastructure to combat 
bioterrorism and other public health threats we may face. The 
fiscal year 2003 bioterrorism budget request for HHS is $4.3 
billion, which is an increase of $1.3 billion, or 45 percent 
over fiscal year 2002. Of this amount, $2.3 billion is 
requested in the public health and social services emergency 
fund $1.75 billion in the National Institutes of Health, and 
another $120 million in the health facilities construction and 
management fund for the Centers for Disease Control and 
Prevention facilities. And lastly, $159 million in the Food and 
Drug Administration.
    Our State and local public health preparedness system is 
our first line of defense against bioterrorism. In order to 
create a blanket of protection, the fiscal year 2003 budget 
provides $918 million in funding to State and local health 
departments to improve laboratory capacity, enhance 
epidemiological expertise in the identification and control of 
diseases caused by bioterrorism, and provide for better 
electronic communications and distance learning.
    This is in addition to the $1.1 billion provided this year 
for State and local health departments and their partners to 
equip and train themselves to respond to potential acts of 
bioterrorism and other public health threats and emergencies 
stemming from a terrorist attack. We want to make sure that 
State and local health departments are fully staffed and 
trained, have strengthened lab capacity and increased lab 
capacity, and have secure information systems and solid 
communication capabilities. These are some of the areas we'll 
be focusing on. You'll hear more about our health alert 
network, Dr. Fleming oversees that at the Centers for Disease 
Control. I'll let him speak to you about that as well.
    In addition, we'll talk about CDC, we'll also enhance their 
communication backbone for the next generation disease 
surveillance via the National Electronic Disease Surveillance 
System, which you can hear more about as well. These systems 
will assist but never replace the interaction of alert 
clinicians and well trained public health epidemiological 
response and outbreak control staff. We saw how the interaction 
and their interaction worked in Florida in identifying the 
first case of inhalational anthrax.
    We also know that our medical system must work hand in 
glove with the public health system in both the detection of 
bioterrorist attacks and in the treatment of its victims. So 
we're working closely with the States to ensure integration of 
our efforts at all levels, and they have been asked to develop 
their public health and hospital preparedness plans in tandem.
    A key ingredient of our strategy is ensuring that the 
Nation's hospitals are well prepared. A total of $518 million 
is requested for two programs. HRSA is responsible for leading 
this aspect of preparedness, and the agency will continue the 
hospital preparedness program begun in fiscal year 2002.
    Two hundred thirty-five million dollars, an increase of 
$100 million, is requested to continue cooperative agreements 
with health departments and States and other eligible entities 
to care for victims of bioterrorism by upgrading the capacity 
of hospitals, outpatient facilities, emergency medical service 
systems and poison control centers.
    Additionally, to address hospital infrastructure, 
development for laboratories, HRSA will use $283 million to 
ensure adequate hospital laboratory capacity to diagnose and 
report on potential biological and chemical agents that might 
be used by terrorists. They will also work to help hospitals 
improve their capabilities to control infections and assist 
hospitals with the purchase of personal protective 
equipment,which is so vitally important to them in providing first 
responder services. We will also focus on infectious disease 
containment systems, as well as other equipment for decontamination of 
biological and chemical agents.
    We also will be expanding the number of Epidemic 
Intelligence Service officers by providing a Federal 
epidemiologist officer in every State, complete the 25 new 
metropolitan medical response systems begun in fiscal year 
2002. We will also be reaching the planned total of 122 total 
MMRS systems around the country. And further, fund the 
readiness of our disaster medical assistance teams and the 
National Disaster Medical System assets.
    In addition, we can talk further about the additional 
investments in the national pharmaceutical stockpile. The 
Department's goal is to maintain a sufficient quantity of 
antibiotics to care for 20 million individuals exposed to 
anthrax, to procure up to 25 million doses of the next 
generation anthrax vaccine currently under development, and to 
have sufficient stockpiles of smallpox vaccine and treatment 
for vaccine side effects, what we call VIG, to immunize the 
entire population in the event of an attack, and rapid 
deployment at the Federal, State and local level to distribute 
the national pharmaceutical stockpile assets if deployed.
    I want to thank you again for the support of this Committee 
and your colleagues, Mr. Chairman, here in Congress, that 
you've provided in passing the fiscal year 2002 appropriation. 
There has been tremendous progress made. The day the 
appropriation was signed into law, we bought 100 million doses 
of Ciprofloxacin, you've given us the funding we need to order 
enough quantities of smallpox vaccine to protect every 
American.
    And with the recent donation of some 1950s smallpox vaccine 
by Aventis Pasteur, we can respond in an emergency even sooner 
than anticipated. We have also given States the first round of 
grants to prepare themselves to be able to use these resources 
in an emergency.
    Even with these advances that we've made, and this 
progress, we still have more work to do. Our budget includes 
$650 million for procurement of vaccines and pharmaceuticals, 
stockpile management and related preparedness activities. 
Again, I will talk finally about the National Institutes of 
Health and what's going on there.
    Our bioterrorism request for NIH is $1.75 billion, which is 
over a six-fold increase for NIH's bioterrorism spending over 
fiscal year 2002. It represents approximately 40 percent of the 
total NIH increase for 2003.
    NIH's bioterrorism research plan calls for expanded basic 
research on the physiology and genetics of potential 
bioterrorist agents, accelerated discovery, development and 
clinical research of next generation vaccines, therapies and 
diagnostic tests, and expanded research infrastructure at both 
the intramural and extramural levels in order to be able to 
conduct this research in safe and up to date facilities.
    In particular, the advancement of knowledge should have 
enormous positive impacts on our ability to diagnose, treat and 
prevent major killer diseases, such as malaria, tuberculosis, 
HIV-AIDS, and a spectrum of emerging and re-emerging diseases, 
such as West Nile fever, dengue, influenza, and multi-drug 
resistant microbes.
    We have to make sure that the Nation's mental health is 
also in order, and at the Secretary's request last November, 
SAMHSA convened a national summit to bring focus to the mental 
health problems arising from the bioterrorism or other 
traumatic events. The fiscal year 2003 budget includes $10 
million to assist State and local organizations in developing 
solutions and plans to meet the mental health needs that arise 
from bioterrorist incidents.
    Finally, the Department's request of $159 million for the 
Food and Drug Administration reflects the President's 
commitment to promote and protect the public health by assuring 
that safe and effective products reach the market in a timely 
way and to monitor products for continued safety after they are 
in use. I realize this request comes before the Agricultural, 
Rural Development, Food and Drug Administration and Related 
Agencies Subcommittee, but it is an important element in our 
defense against bioterrorism.
    As you see, we have made substantial progress to date in 
enhancing the Nation's capability to respond to biological or 
chemical attacks, or terrorism. I thank you for the resources 
you have made available this year, and look forward to working 
with you to further strengthen our defenses against 
bioterrorism.
    Mr. Chairman, that concludes my remarks, and I would now 
like for our other witnesses to present brief testimony on 
their specific agency's activities. Then we would be pleased to 
answer any questions you or the Committee members may have.
    [The information follows:]

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    Deputy Secretary Allen. We'll start with Dr. Fauci.

                      Director of NIAID Statement

    Dr. Fauci. Thank you, Mr. Chairman. It's a pleasure to be 
here again before the Committee, members of the Committee.
    I'm going to spend just a couple of minutes outlining for 
you the NIH's plan, strategic plan and research agenda, as it 
were, for the biodefense effort at the NIH. This first poster 
really addresses the underlying strategy and philosophy of the 
entire department, vis-a-vis biodefense. And it's titled 
Biowarfare versus Bioterrorism. Because it really underscores 
the important difference, although there are overlaps between 
what we do and what the Department of Defense does, in multiple 
agencies within the Department of Health and Human Services.
    First of all, the population that we need to protect is 
much more diverse with regard to age and health than the 
military population. We're responsible for infants, children, 
elderly, pregnant women, individuals who are on medications and 
individuals with immunosuppressive diseases. Therefore, the 
scope of what we need to deal with with regard to therapies and 
vaccines is highly complicated and certainly much more 
difficult.
    Also, the military plans would emphasize one strategy, 
namely vaccines. As you will hear, probably in the question 
period, we have vaccines as an important component of our 
armamentarium, but we also need the diagnostics and 
therapeutics.
    Finally, the agents that we need to deal with are much 
greater in number. Because although the attacks on the military 
would emphasize highly efficient killers, in the civilian 
population, any microbe that's unleased upon us that would 
cause a significant amount of terror, even if the biological 
impact is minimum, we've already experienced that with the 
anthrax situation here in Washington and in other cities in our 
country.
    So if I could have the next slide, Deputy Secretary Allen 
mentioned to you the budget request for the NIH within the 
scope of the Department. It's approximately $1.75 billion. The 
breakdown of that is illustrated here on this slide. As you can 
see, there is a significant amount on basic biomedical research 
into the physiology of the microbes as well as the host defense 
mechanisms, which as I'll get to in just a moment, are relevant 
for the other diseases that Deputy Secretary Allen mentioned, 
namely other emerging diseases. There will be a significant 
amount on research facilities, because unlike the war on cancer 
and the war on HIV-AIDS, there are certain facilities that are 
necessary to not only protect the researchers, but also the 
communities surrounding the research facilities.
    We have already, in anticipation of the defense of this 
budget, put together a comprehensive strategic plan for 
biodefense as well as a research agenda for the high priority 
agents, which we refer to as Category A agents, including 
smallpox, anthrax, Ebola, botulism, tularemia and others. In 
that regard, the plan that we are dealing with now and will 
project for the next several years is anchored in basic 
research with appropriate facilities, but also for that amount 
of money, would have to deliver to the American people 
definable milestones and end points in the form of vaccines, 
diagnostics and therapeutics.
    In that regard, I'm happy to report that with the 
supplement that we generously received from the Congress in 
2002, together with the plans for what we'll do in 2003, we 
have already made some significant accomplishments, some of 
which I've already mentioned to this Committee in the main NIH 
hearing. They have to do with the highly successful smallpox 
vaccination dilutional study that has now brought us already 
immediately to approximately 77 million doses. You already 
heard from Deputy Secretary Allen about the purchases and the 
Aventis Pasteur 1950's vaccine, which will again bring us to 
the point where we will have enough vaccine, if necessary, to 
vaccinate everyone in the country.
    There's also the important anthrax pathogenesis advances 
that have been made, together with the efforts that we have 
right now, of moving rapidly into a phase one clinical trial on 
the second generation of the anthrax. Finally, I'm happy to 
report that even in Ebola, we now have shown in an animal model 
that we can protect monkeys from challenge with Ebola vaccine, 
and we will be entering phase one clinical trials in humans 
before the end of this calendar year.
    Finally, as this headline from News Day shows, the worst 
bioterrorist may be nature itself. That refers to the comment 
just a moment ago by Deputy Secretary Allen about emerging and 
re-emerging diseases. Because in the Department, we look upon 
deliberate release of microbes in a bioterrorist event to be 
obviously important and something we need to address, and we 
are addressing that.
    But that really is part of the broader picture and the 
responsibility of the Department of addressing emerging and re-
emerging diseases, as shown on this final poster, where we had 
the flu pandemic, which really was truly a bioterror agent. Not 
deliberately, but naturally evolving, that killed 25 million 
people in 1918, 750,000 in the United States. The AIDS 
epidemic, you've heard from me many times before this 
Committee, 40 million people living with HIV, 23 million 
already dead.
    The bioterrorism events that we have faced and likely will 
face again is really part of that emerging and re-emerging 
disease phenomenon. Because of that, we are building a 
sustainable effort that will serve us well not only for the 
immediate threats of deliberately released microbes, but for 
the decades ahead of what we'll have to face in emerging and 
re-emerging diseases from natural causes.
    Thank you very much, Mr. Chairman.
    [The information follows:]

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                   Administrator of SAMHSA Statement

    Mr. Curie. Mr. Chairman, I'm Charles Curie, the 
Administrator of SAMHSA. First, let me thank the members of the 
Subcommittee for calling this important hearing. It's a 
privilege for me to sit before you with Deputy Secretary Claude 
Allen and my colleagues to discuss the Department's efforts to 
respond to threats of and actual acts of bioterrorism.
    As the Nation's lead voice for mental health and substance 
abuse, SAMHSA recognizes that we all have an unprecedented 
opportunity to face a challenge of the future. Being that any 
act of bioterrorism will inevitably create enormous mental 
health and other behavioral health consequences, we need to 
recognize that planning for and responding to acts of 
bioterrorism is different from anything we have known. This is 
simply uncharted territory.
    The fields of mental health and substance abuse are simply 
not prepared in terms of an adequate response and treatment 
capacity, evidence based intervention nor a properly trained 
work force. Immediately after I was confirmed as SAMHSA 
administrator, Secretary Thompson, as Deputy Secretary Allen 
indicated, asked me to convene a meeting with State 
representatives to focus on the mental health and substance 
abuse impacts of terrorism and bioterrorism. In November, 
Governors from 45 States and jurisdictions sent teams 
representing not only mental health and substance abuse 
authorities, but Departments of Health, Emergency Preparedness 
and Education, as well as local providers of mental health, 
substance abuse and faith-based providers and organizations, 
and other voluntary organizations to our national summit held 
in New York City.
    At that summit, we had expert plenary sessions in which we 
brought in the best thinkers in the country as we were actually 
creating the field of dealing with the mental health and 
substance abuse consequences of bioterrorism. The good news is 
that there had been work done in the previous years out of the 
Center for Mental Health Services in SAMHSA, under the 
leadership of Brian Flynn and in consultation and collaboration 
with the Centers for Disease Control and prevention and our 
other sister operating division, to frame a mental health 
response. We used that information and again, some of the best 
thinking in the country to give information to the State teams.
    We also devised a workbook, and those State teams, and 
there were 10 to 15 members from each State, including 
representatives from Governor's offices, met on their own at 
least three times during that three day period to begin to 
hammer out a plan that they could present back to their State 
to become part of that State's disaster response to 
bioterrorism. The good news is, several States indicated they 
could take our workbook and plug that in as a module to mental 
health and substance abuse. We're receiving the final draft of 
those plans and offering technical assistance to States at this 
point in time.
    We asked these State teams about their needs. The 
Department, the Secretary, and the President responded 
favorably by including the $10 million that Deputy Secretary 
Allen indicated in the President's budget to focus on mental 
health and bioterrorism. This will be the first time any 
Federal dollars have been designated at SAMHSA for this 
purpose.
    In response to these stated needs, our plans for the use of 
these funds include technical assistance to the States, to 
assist them in incorporating bioterrorism readiness and 
response into their State emergency preparedness planning, 
behavioral health triage in health care settings, especially 
hospital emergency rooms, so that hospital personnel can devote 
life saving interventions to deal with those exposed to 
biological agents and separate out what is a psychological 
response to what is an actual physical danger.
    Bioterrorist crisis intervention is another area, and will 
exist to serve people who become psychological victims of 
terrorist events. Then also disseminating knowledge to public 
officials to prepare them in averting widespread public fear 
and panic, overwhelming fear-induced utilization of hospital 
emergency rooms and other health care facilities and loss of 
confidence in public institutions. In other words, risk 
communications.
    We were also able to make available at that summit a draft 
publication of risk communications which is being finalized 
now, which public officials can use to help give them guidance 
in dealing with the aftermath of an emergency. What public 
officials say in the aftermath of a bioterrorist attack or 
perceived attack or any disaster is probably the most important 
mental health intervention for the public.
    There are vast unknowns when it comes to how our Nation 
will respond to acts of bioterrorism. We do know, however, that 
we have a rich history of overcoming adversity and emerging 
even stronger. We will be sure to continue this success by 
taking into account the Nation's mental health in times of 
terrorism. That is the only way we can truly take the terror 
out of terrorism.
    SAMHSA also responded by sending $1 million to New York 
City within the first week after September 11th to help with 
the mental health response. An additional $6 million was sent 
out through the Department of Health and Human Services to the 
other impacted areas over the next two weeks, and within the 
first month a total of $28 million. Those dollars were used in 
conjunction with approximately $150 million that had been 
issued by FEMA so far for crisis counseling.
    Secretary Thompson stated when he addressed the national 
summit, we must follow our short term responses with long term 
commitments. I look forward to working with you to achieve the 
promise of this mission. Thank you.
    [The information follows:]

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                    Acting Director of CDC Statement

    Dr. Fleming. Mr. Chairman and members of the Subcommittee, 
good morning. I'm Dr. David Fleming, the Acting Director of the 
Centers for Disease Control and Prevention. I'm honored to 
appear before you today on behalf of CDC, our country's agency 
that protects the American people by serving on the front lines 
of public health.
    I'll be brief, and try to complement what Deputy Secretary 
Allen has already told you. Our mind is that although this 
investment this Committee had the foresight to make before 
September 11th paid off, the horrible events of that day and 
the anthrax events that followed demonstrated the need for 
continued investment in our public health system. We need to be 
even better prepared to correct the weaknesses we identified 
and to build the capacities we don't yet have.
    So I'm pleased to be here today to testify in support of 
the President's request for $1.6 billion for CDC, to help guide 
our Nation's public health activities in this new era.
    Our request includes resources to improve CDC capacity, to 
maintain our national pharmaceutical stockpile and smallpox 
vaccine stocks, and to continue to improve State and local 
health department public health preparedness. Let me just 
briefly talk to you about each of those.
    First, for improving CDC preparedness, we're requesting 
$300 million. This includes a range of activities that improve 
our laboratories, our surveillance and epidemiologic 
capacities, our emergency operations ability and research 
activities. It also includes $100 million for a new laboratory 
at our Fort Collins facility in Colorado, and to begin to 
renovate our existing laboratories in Atlanta, which as many of 
you know, having visited there, are in some need of repair.
    During the anthrax attacks, our national pharmaceutical 
stockpile proved its value by delivering almost 4 million doses 
of antibiotics to prevent anthrax in 65 deployments to 10 
States, with an average time from receiving that request to 
delivering it in the field of 5 hours. To maintain this 
capacity for delivering antibiotics and vaccines, including 
smallpox, we are requesting $400 million. This is $750 million 
less than appropriated this year. And this decrease results 
from not having to repeat those large initial purchases of 
antibiotics and vaccines.
    Finally, for building State and local health department 
capacity, we are requesting $940 million. While only a few 
States dealt with anthrax illness, the anthrax crisis affected 
every single State. We saw dramatically how our State and local 
health departments are the core of our public health system, 
and how they must be ready to respond to all threats.
    The best way to protect against any health threat is to 
develop our already-existing public health system. That's what 
we're doing through training, and developing our public health 
work force, through improving our laboratory facilities, 
improving our epidemiologic capacity at the local level, by 
providing secure, up to date information systems and a robust 
health communications capacity that includes our health alert 
network functions and our electronic disease functions that 
Deputy Secretary Allen asked out.
    And I want to assure you, we're being smart with this 
investment. We're building in measures of accountability. We're 
preparing for unknown threats by enhancing those systems that 
deal with known, natural, day to day threats. And we're 
bolstering State and local health departments' infrastructure 
that strengthens every single one of our public health actions.
    Over the last three months, each of your States has 
developed a plan for these resources. Please, please talk with 
your health departments about the needed capacities these 
dollars are creating in your States today.
    In closing, our request represents this Administration's 
commitment to improving CDC and our Nation's capabilities in 
preparing for and responding to acts of bioterrorism and other 
public health emergencies. Make no mistake, this is a 
tremendously challenging time to be in public health. There has 
never been a more exciting time to be in this field. And not 
only at CDC, but throughout this country's front lines, we are 
ready to do what needs to be done. We are up to this challenge.
    In closing, I'd like to thank the Subcommittee for your 
continued support in protecting and improving our country's 
public health system. You are making a wise investment. Thank 
you very much.
    [The information follows:]

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                    Administrator of HRSA Statement

    Dr. Duke. Good morning, Mr. Chairman, members of the 
Committee. I am pleased to appear before you today to discuss 
the efforts of the Health Resources and Services Administration 
(HRSA) to further prepare the Nation's health care system and 
the public health system for possible bioterrorism attacks.
    As Deputy Secretary Allen has outlined, the focus of HRSA 
is to link the health care system with the public health 
system, so that together we can detect bioterrorist attacks and 
provide appropriate prevention and treatment. The President's 
2003 budget for HRSA proposes that the Agency will operate five 
programs at a level of $618 million.
    I'd like to comment briefly on the hospital preparedness 
program begun in 2002. For 2003, $235 million, an increase of 
$100 million, is requested to continue the cooperative 
agreements with health departments and States and other 
eligible entities. These cooperative agreements provide funds 
to States and to our three largest cities to plan and 
coordinate hospital preparedness. The States and cities are 
required to pass on 80 percent of the funds to hospitals to 
expand their capacity to care for victims of bioterrorism.
    We recently provided phase one funding, that's 20 percent 
of the total award, to 59 eligible entities. The grantees used 
those funds to prepare needs assessments for their areas and 
develop initial implementation plans. Out of the 59 eligible 
entities, 53 have already sent in their proposed implementation 
plans and the other 6 have asked for a short extension.
    Just last week, we had a team of reviewers going through 
those 53 plans, and following our review, the Office of Public 
Health Preparedness (OPHP) at the Department level will be 
coordinating a cross-cutting review of these plans as submitted 
to HRSA and to CDC and the Office of Emergency Preparedness 
(OEP), to ensure that these plans are coordinated and are 
mutually supportive, to ensure that we have a strong response 
capability at the State and local levels.
    Two new programs are proposed for HRSA for 2003, the first 
addresses hospital infrastructure. These are the needs for 
laboratories, infection control and decontamination and the 
funding level requested is $283 million. The second would allow 
HRSA to operate a new educational incentives for curriculum 
development and training program. That's requested at a level 
of $60 million.
    HRSA has extensive experience in working and collaborating 
with public and private health professional organizations and 
academic health centers to develop new and innovative training 
programs to meet emerging needs. HRSA will continue to operate 
the emergency medical services program for children at a level 
of $19 million, and will continue the poison control centers at 
a level of $21 million. With this set of programs, we believe 
that we are strengthening the ability of the Nation's public 
health system and hospitals to prepare for biological or 
chemical attacks.
    Mr. Chairman and members of the Committee, I'd be pleased 
to address any comments or questions you have on the specifics 
of any of these programs. I'm pleased to be here today.
    [The information follows:]

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
                     COORDINATION BETWEEN AGENCIES

    Mr. Regula. I want to thank all of you. Obviously you're in 
the front lines of all this. Mr. Allen, I assume you have 
somewhat of a master plan, if you will, that coordinates the 
activities of these sub-agencies?
    Deputy Secretary Allen. We actually do. As you may recall, 
Secretary Thompson has set up an office in the Department, in 
the Office of the Secretary, which is the Office of Public 
Health Preparedness. I know there's legislation going through 
seeking to request an assistant secretary for public health 
preparedness. That office is coordinating the activities of 
these agencies, in fact, Dr. D.A. Henderson is leading that 
office in the Department, in the Office of the Secretary.
    I work very closely with him, though I try to stay out of 
it as much as possible, but get pulled in often when there are 
issues that we need to resolve. But we are very coordinated in 
our work. In my experience in government, at the State level 
and here at the Federal level, there is an unprecedented level 
of cooperation within the Department, but also across 
departments. I think Dr. Fauci has already mentioned our 
working and addressing biowarfare, it's more than just HHS. It 
involves the Department of Defense, the Department of Justice 
and other agencies, in that effort. We're coordinating that as 
well across the Departments, across the various silos that 
often exist in Government.

                              VACCINATIONS

    Mr. Regula. A more practical question, last year we had a 
shortage of flu vaccines. Now would be the time you would be 
getting ready for it. Are we going to avoid that in the 
upcoming winter?
    Deputy Secretary Allen. We are certainly making every 
effort to do that. We've seen not only a shortage of flu 
vaccine, but there's been a shortage of vaccine for equine 
encephalitis vaccines and the like. This is an issue that we 
have to address. As a Department, we believe that monies that 
are being invested in bioterrorism actually serve a broader 
purpose, that is, as the monies you provided to us in 2002, to 
address the immediate effects of after September 11th actually 
served to induce pharmaceutical companies, heretofore who had 
represented that they did not want to get into this area, of 
this kind of activity any further, are now rethinking their 
activities and their efforts in this regard.
    So we think that there is an opportunity for us to try to 
stave off a shortage of flu vaccine and other necessary 
vaccines. But I'll let either Dr. Fleming or Dr. Fauci add to 
that.
    Dr. Fauci. Just very quickly, on the point of this 
impending flu season's vaccine. We are working very closely 
with the manufacturers. The problem with influenza is that the 
vaccine needs to be developed each year. The vaccinethat was 
available last year will not protect this year. There is a short 
timeline, therefore, that the manufacturers have, to determine what 
needs to be in the vaccine to produce it and to distribute it.
    All the indications we have thus far, though, is that the 
manufacturers are on target to produce at least as much, and 
probably more vaccine, than was available last year, and better 
yet, have it available earlier in the season, that is, in 
August, September, October, when people are ready to get the 
vaccine. We're working closely with our private provider 
network, most flu vaccine is delivered in the private sector, 
to ensure that they are ready. But we don't anticipate the 
shortage we had last year.

                            FUNDING FOR NIH

    Mr. Regula. Dr. Fauci, as you know, this is the fifth year 
of doubling the NIH budget. Obviously a portion of that 
doubling money will be diverted to research on bioterrorism, if 
I understand you correctly. This will then somewhat limit what 
can be done in some of the other areas, is that correct? And 
secondly, what kind of research will be focused on 
bioterrorism?
    Dr. Fauci. You are correct, obviously there is a finite 
amount of money. The doubling was very generous. A significant 
portion of the component of fiscal 2003 that went into the NIH 
doubling is devoted to biodefense, that is correct. As has been 
the case historically, at the NIH for many years, that when 
certain issues arise and certain emergencies as we did with the 
HIV-AIDS epidemic in the mid to late 1980s and through the 
1990s, the relative acceleration of one versus another really 
met not only the public health needs, but in some respects the 
scientific opportunities. I think we're seeing a bit of that 
now with the bioterrorism.
    In that regard, we fully predict and expect that the 
positive spinoffs that we have seen when we had 
disproportionately accelerated one area of research versus 
another for a variety of reasons, that there are indeed many 
positive spinoffs. And you know, I've given this Committee over 
the years many examples of that, not only with regard to the 
HIV-AIDS, but the various directors of the cancer institutes 
have shown you how cancer directed research has had 
extrapolations to other areas.
    We feel that the investment in biodefense that the NIH will 
be making, as somewhat disproportionate as it is, vis-a-vis 
other areas, will ultimately have positive impacts on 
everything from emerging infectious diseases that are not 
related to biodefense, to immune responses of the body to 
various cancers as well as autoimmune and hypersensitivity 
diseases.
    So you're correct on the numbers, but we think we're going 
to see the same sort of indirect benefits in other areas.

                             COMMUNICATIONS

    Mr. Regula. My last question is a two-part. Obviously we 
don't know where terrorism might strike. Do you have a 
communications network, because panic would be one of the 
concerns, so there's a quick response? And as a second part of 
that, Dr. Duke, you have the community health centers, which 
addresses the needs of a certain portion of our population. Are 
you taking steps to enable those agencies to be responsive in 
the event of a localized terrorist attack?
    Dr. Fauci. Let me address the communication issue. There's 
really two parts, I think, to your question. First is, in the 
event of a bioterrorist attack, we, the public health system, 
need to be able to communicate rapidly and effectively with 
local health departments, with community providers. The 
resources that have been allocated by this Committee to the 
health alert network and to NEDSS to the State and local 
infrastructure grants are enabling us to build that integrated, 
unified communication system that will allow us, using the same 
system, to deliver health alerts, to transmit data, to provide 
secure information.
    Second, though, an important part of communication is the 
ability to convey accurate, timely information to the public. 
We are upgrading our capacities at the Department to do that. 
In addition, a substantial amount of the resources that are 
going to the State and local level are going to assuring that 
they have individuals who are trained, with the messages that 
need to be delivered. All public health is local. In a crisis, 
people are going to be looking to national leadership, but 
they're also going to be looking to their State and local 
officials to deliver accurate, timely information. We're 
enabling that through the State bioterrorism cooperation.
    Mr. Regula. If you include the communications, i.e. TV, 
radio, press, print media, because that's where most of the 
people look to get their information.
    Dr. Fauci. Mr. Chairman, you're absolutely right. We at the 
Department level are making connections with the national 
media.
    But it's important that those same connections be made at 
the State and local level, so that people have pre-existing 
credibility with the public and with the TV reporters and with 
the news media. Thank you.

                        COMMUNITY HEALTH CENTERS

    Mr. Regula. Community health centers.
    Dr. Duke. Yes. In the guidance that we sent out on our 
grant program for hospital preparedness in 2002, we guided the 
selection of advisory committees, so that the community health 
centers would be involved with the development of the State 
implementation programs, and that is taking place.
    Additionally, we collected a searchable data base of all of 
our community health centers, by State, by zip 
code,alphabetical order, with all contexts associated with it. And 
we've also put out guidance to them as well. So we believe they are 
going to be an integral part of our response.
    Mr. Regula. Did you want to comment?
    Deputy Secretary Allen. Mr. Chairman, two points I was 
going to add to that. One, in the Office of the Secretary, 
there's $5 million that has been appropriated for 
communications as well. We have established in the Office of 
the Secretary a command center that will serve as a central 
point for gathering information from our departments, but also 
integrating with the rest of Government as well in time of 
emergency.
    As Dr. Fleming has pointed out, under the HAN system and 
the NEDSS system, one of the requirements of the grants that 
we're providing the States is that they have to be able to 
cover 90 percent of their population. And so we can say that 
with the money you have generously given and we hope and expect 
to get, we'll be able to cover 90 percent of the population of 
any State under those systems.
    Mr. Regula. Mr. Wicker.

                           INCREASED FUNDING

    Mr. Wicker. Thank you very much, Mr. Chairman.
    I have always been a proponent of increased funding for the 
agencies represented here. And I don't want to sound like the 
skunk at the garden party. But do you run into any criticism 
that this bioterrorism plan is simply a way for you to plus up 
your agency a little more? And let me tell you what makes me 
say that, based on the testimony today.
    For example, Dr. Fauci said natural causes, he mentioned 
the flu and AIDS. There's discussion of a broader purpose than 
just bioterrorism. Dr. Fauci also mentioned indirect benefits. 
Dr. Curie mentioned with regard to SAMHSA that $1 million was 
sent to New York City after the attack of 9/11, and yet the 
attack of 9/11 was a terrorism attack, to be sure, it was not a 
bioterrorism attack. And a total of only $28 million was sent 
from SAMHSA.
    So I just wonder if you would address that question of how 
the flu and how AIDS is part of all this. And then let me just 
throw in my second question, and then the panel can address 
that, too. What specific acts of bioterrorism are we planning 
for? And what specific examples in history do we have to go by? 
Of course, we all know about the anthrax. So you need not 
mention that.
    But domestically, what have we seen in the past, and also, 
in the whole history of terrorism worldwide, of which we've had 
a great deal, what specific acts are you looking at for us to 
go by in addressing these?
    Deputy Secretary Allen. Sure. To answer your first 
question, I think that's a very critical question. We would 
unabashedly say, yes, much of this money will go to plus up our 
public health system. The reason for that is that when we talk 
about bioterrorism, the way we look at it at the Department of 
Health and Human Services, and in our various agencies, is that 
we're talking about the ability to respond to an outbreak.
    In this situation, we talked about the anthrax attacks or a 
potential smallpox attack or a release of a biological, 
chemical, nuclear or radiological agent, we look at it in two 
ways. One, many of these occur naturally. Yet if we're not able 
to deal with those incidents that occur naturally, it's rare 
that we will be able to deal with those that occur 
intentionally. Anthrax was released in this country as an 
intentional act. It was not an accident. And if we were not 
able in the most rural parts of this country to address the 
basic public health infrastructure, allowing them to help 
survey, to detect and to respond to such an attack, whether it 
be natural or intentional, we're not serving the purposes of 
this country and protecting ourselves from what would be a 
larger, more deliberate act.
    So we would not shy away from saying that yes, this money 
will go to serve in many ways building basic public health 
infrastructure. But that basic public health infrastructure is 
the building block upon which our bioterrorism activities are 
based.
    As Dr. Fauci has mentioned, much of the research that is 
ordinarily being done at the NIH in these areas is going to be 
enhanced because of the focus on bioterrorism. But it has 
direct benefits in our attempts to address other infectious 
diseases and outbreaks that occur.
    So we would not be shy about saying that this money is 
going to address a number of issues that have to seriously be 
addressed. One being, in the event of a bioterrorist attack, 
what are we going to be able to do. We would not be able to 
address that event if we do not have the basic infrastructure.
    I'll give you one particular example, and I cite this as 
the area of how we focus so much on our metropolitan medical 
response systems are serving our largest cities, 122 major 
areas. But if we had an event, if we had an agent release in a 
rural area, we would be very challenged, for the very reason 
that oftentimes individuals living in rural areas do not have 
access to primary health care. They do not have transportation, 
they oftentimes delay seeking care. Thereby, it allows someone 
who wants to deliberately attack this country to have an 
opportunity to release it.
    Therefore, the weakest links of our system have to become 
the strongest links of our system. That is what we believe much 
of this money will go to deal with. But the goal again is to be 
able to address the bioterrorism event. We could not do that 
separate and apart from addressing the emergingand re-emerging 
infectious diseases that we're having to confront.
    To address your second question, and I'll ask others to 
respond to both of these, one example that I can give you is 
not a domestic example of a deliberate release of an agent, but 
I do know internationally we've seen this happen. The sarin gas 
situations in Japan, that would be one that comes to mind very 
quickly. The fact that we know that Al-Qaeda and other 
terrorist organizations have trained very deliberately, 
efficiently, effectively, and at length, in use of biological, 
chemical, nuclear and radiological agents, while we may not 
have seen that on our domestic soil here, we do know that it 
has happened, and we do know that it exists. Therefore, we are 
trying to be prepared to address whatever that event might be.
    Dr. Fauci. You asked about what threats we are considering. 
I think one that I mentioned in my discussion that we really 
need to address is, although it is part of a continuum of 
emerging and re-emerging diseases, it would never naturally 
occur. For example, smallpox. It would never naturally occur. 
And it would be foolish for us not to be prepared for that. We 
must be prepared for something to be deliberately released on 
our society here in the United States or someplace else in the 
world, which would then trigger the necessity for our own 
response.
    And already, as I mentioned in my remarks, the money from 
the supplement from 2002 has addressed, for example, the 
dilutional study. Just a few months ago, the United States of 
America had 15 million doses of smallpox. If we had a multi-
focal attack in many cities, which is entirely conceivable, we 
would have had a very, very serious problem.
    Right now, today, we have 77 million doses all ready 
because of the dilutional study. We have, with the contract 
with Acambas Baxter, an additional potential likely by the end 
of this year 155 million doses, and then the Aventis Pasteur 
additional 75 million doses would put us in a position that by 
the end of this year, we will have enough, if necessary, to 
vaccinate each and every American in this country.
    So that is a very important accelerated program that 
resulted from the resources that we were given. That's a very 
cogent example of one of the questions that you asked about 
what would be a feasible threat.

                          SMALLPOX VACCINATION

    Mr. Wicker. I know Dr. Curie may want to respond, because I 
called his name specifically, but what's the downside to 
smallpox vaccination in terms of that percentage of the 
population that will have an adverse reaction, perhaps, and 
contract the disease?
    Dr. Fauci. Absolutely. The downside of the known toxicities 
of the currently available candidates that we have, vaccines 
that we have decades of experience with, for every million 
persons who are vaccinated, there will be one to two deaths per 
million, and significant numbers of individuals who might have 
serious toxicities that require treatment that don't result in 
death. And that's the balance of risk benefit that we have been 
and are considering and will continue to consider in any policy 
decisions that are made of vaccinating first responders and/or 
making vaccine available for those, for example, who would 
choose to be vaccinated.
    Right now the policy, based on solid foundation, is to have 
what's called a ring vaccination approach, of identifying and 
isolating cases, and then vaccinating contacts and the contacts 
of the contacts. That's something that we continually re-
examine at the Department, the strategy that we have.
    But in answer to your question, the downside obviously of 
the toxicities, which brings us to the Secretary's long term 
plan for smallpox, if we had a vaccine now that had virtually 
no toxicities, I don't think there would be any debate that we 
would vaccinate everybody in the country with that right now, 
just because it would be a vaccine that would be easy to 
vaccinate with very little toxicity. It's the probability and 
the likelihood of a certain percentage of toxicities that 
causes us to be very circumspect about a policy decision of 
preemptively vaccinating.
    In fact, we are at the NIH and at the CDC pursuing the 
research on potential candidates that might not have the 
toxicities that the classic live vaccinia vaccine has. And when 
we do have that, I think we'll bring our country much closer to 
essentially eliminating an important threat of bioterrorism, 
namely smallpox.
    Mr. Regula. Mr. Sherwood.
    Mr. Sherwood. Thank you, Mr. Chairman.
    On the smallpox, Dr. Fauci and Secretary Allen, you just 
discussed quite well the ideal situation of what we would do 
with smallpox if we had the vaccine. But because of the crisis 
that we all felt after 9/11, I understand that Aventis Pasteur 
from Pennsylvania donated 70 million doses to the Department of 
Health and Human Services. This was vaccine that they had 
produced several years ago, and it was produced really before 
some of the advances that we know today. And yet that gave us a 
great deal of security, to have that at our disposal.
    I wanted to know why you haven't offered to indemnify 
Aventis Pasteur with the possibility of your using this old 
vaccine that they donated to you.
    Deputy Secretary Allen. Certainly. The vaccine that Aventis 
Pasteur has donated, of course, would not be used except for an 
emergency situation. It is 50 year old vaccine. So we'revery 
grateful that they had it. And in times of emergency, we would be 
willing to use that.
    At this point, our legal counsel are working with Aventis 
Pasteur in terms of the indemnification issues. We're 
surrounding that. So I'm not prepared to give you an answer 
specifically as to whether or not that will ultimately occur. 
But I'll be glad to get a response back to you after having 
consulted with our general counsel's office that is working 
with them on this.
    This has been an issue, however, in general the issue of 
indemnification for smallpox vaccine has been an issue that we 
have been dealing with since and prior to 9/11. It's been an 
issue that we've been working with the companies, Acambas 
Baxter, the company that we're working with to produce the 200 
million doses, it was an issue then. You may recall the 
President issued an executive order that included 
indemnification for allowing the Department to offer 
indemnification as a means for curing vaccines. So we are 
looking at that.
    But in Aventis Pasteur's specific situation, I can't give 
you an answer right now.
    Mr. Sherwood. Mr. Chairman, is that an answer that we could 
ask to get?
    Deputy Secretary Allen. I'll be glad to provide that to 
you.
    [The information follows:]

    Answer. According to the Federal Acquisition Regulation 
(FAR), a contractor providing the Government with supplies or 
services for which it wishes to be indemnified must first 
submit a formal request for indemnification to the Government. 
The request must address the nature of the risks for which the 
contractor seeks indemnification and explain the contractor's 
exposure to such risks, and must include information on the 
contractor's existing insurance coverage and the cost and 
availability of additional insurance. No such request has been 
submitted by Aventis Pasteur at this time. However, CDC 
procurement officials and attorneys in the Department's Office 
of the General Counsel have had preliminary discussions with 
Aventis Pasteur about the indemnification process.

    Mr. Sherwood. Fine. Thank you. Thank you very much.
    I'll give it back to you, Mr. Chairman.
    Mr. Regula. Okay. Mr. Miller.

                 ANTHRAX AND OTHER BIOTERRORIST THREATS

    Mr. Miller. Good morning.
    When the anthrax things occurred back in October, we read 
that there was a very limited, first of all it took a lot of 
technical expertise and specialized knowledge to produce that 
anthrax. And that there was a finite number of places or people 
that could handle that. And I know it may cover other agencies, 
because it's Agriculture and other, FBI and all those.
    Are we doing a better job of controlling or keeping track, 
not only of anthrax, of other potentially bioterror items that 
could be, because we found out that we thought we had this 
finite number for anthrax, and it turned out it had been spread 
around other agencies. And we still haven't solved that 
problem. But what is being done to keep track of that?
    Deputy Secretary Allen. I will attempt to answer, and ask 
Dr. Fleming to further elaborate on it. Under current law, CDC 
is required to regulate the transfer of certain select agents. 
There's a select agent list that exists that Congress passed 
that we would have to monitor. Under the present legislation, 
the bioterrorism bill, there is additional language that would 
require us not only to regulate the transfer of select agents, 
but also to regulate the possession and use of those agents. It 
goes beyond HHS in terms of CDC and FDA and others in our 
Department, but also reaches to the Department of Agriculture 
as well.
    In addition, I know the Department of Defense is also 
looking at working with that select agent list and how they 
will track the transfer or the use and possession of their 
select agents also that exist on that list. I'll let Dr. 
Fleming address in greater detail that issue.

                             SELECT AGENTS

    Dr. Fleming. Yes, thank you. We take very seriously our 
responsibility under the current select agent law to try to 
regulate as best as possible the transferring of these select 
agents among laboratories, and look forward at the new 
legislation as enacted to expanding that scope to try to 
regulate these agents at laboratories that are using them.
    There is more that can be done, and we're anxious to work 
with our partners in the Department and with other agencies to 
make sure that it happens. The bottom line, though, is that 
many of these agents are naturally occurring, and the 
regulation can go a long way to preventing access to these 
agents by people who shouldn't have them. But we all need to be 
especially vigilant in that. A regulatory program cannot 
guarantee with 100 percent assurance that these agents will 
remain only in the hands of people who are authorized to have 
them.

                              CONSTRUCTION

    Mr. Miller. But we are in the process of starting totighten 
down some, right. After Oklahoma City, you find it doesn't take always 
a great deal of sophistication.
    Let me switch to another question, Dr. Fauci. The chart 
over there showed $521 million in construction. Would you talk 
about that construction money and how that's going to be used, 
and how much of the total money is really kind of a one time 
expense and will be available for other programs the next time 
around?
    Dr. Fauci. Very good question. The facilities in 
construction are going to be several projects. One is the 
building of new what we call BSL-4 facilities, which is the 
highest available containment. There are a very limited number 
of those facilities in the United States. Currently one in 
Atlanta, one in Fort Detrick, one at the NIH which is 
restricted to multiple drug-resistant tuberculosis, one in San 
Antonio and one that is being built in Galveston.
    We are planning to put an additional BSL-4 facility in 
Hamilton, Montana, which is NIAID departmental-owned 
laboratory. One in Fort Detrick, in association with our 
collaboration with the Department of Defense, as well as a 
variety of regional centers of excellence in biodefense and 
emerging infections, that will have BSL-3 facilities in them, 
and where appropriate, perhaps one or two additional BSL-4.
    So it will be the construction, but also it would be the 
training of individuals who will be part of that process, 
because you will have to train an additional generation of 
individuals who are skilled in working in these very special 
circumstances.
    With regard to one time money, indeed, for the building 
itself it would be, but a substantial amount of money, for 
example, that one year would be allocated to the building 
itself, and a relatively smaller amount for actual research to 
be conducted in that building, because the research can't be 
conducted until the building is up, that the subsequent out 
years, money that was put in for the building would then be 
money that would actually be put toward the research to be 
conducted.
    So although there may be part of the money that could be 
``freed up'' because it's one year money, the plans, the three 
and four and five year plans that we have, will in fact utilize 
some of the original one year money to actually be money to 
support the research. So at the end of a four or five year 
period, you actually would have money that would be continued 
from one to the other. So although there's the possibility of 
some of it being freed up, I don't think it's going to be a 
substantial amount that will be freed up.
    Mr. Miller. Thank you.
    Mr. Regula. Mr. Cunningham. I'm sorry, Ms. Pelosi.

                                SMALLPOX

    Ms. Pelosi. You know what the system was, Mr. Chairman. 
We're under the 10 minute rule, right?
    Thank you very much, Mr. Chairman. I really want to commend 
you for having this very, very important hearing. It's a very 
special one, in that it is cross-cutting, across so many 
different agencies, as you so wisely planned. And I think very 
valuable.
    I of course am very interested, from the standpoint of this 
Subcommittee, but also as the ranking member on the 
Intelligence Committee. I'm very pleased with what I heard, but 
I have some questions as well, that have arisen from my other 
work beyond this Committee. And I want to follow the line of 
questioning that Mr. Wicker was pursuing about the smallpox 
vaccine. I understand the answers that were given, and 
clarifications Mr. Sherwood had sought.
    But I wanted to ask you, I was interested, Dr. Fauci, that 
you said that one in a million people could die. I mean, God 
forbid that one person should die, but that's a small number 
compared to, I've heard one in 25,000.
    Dr. Fauci. No, it's not that much.
    Ms. Pelosi. But a large number could have symptoms?
    Dr. Fauci. Right.
    Ms. Pelosi. I've heard encephalitis, or other bad 
consequences from the live vaccine, smallpox vaccine.
    Dr. Fauci. Correct.
    Ms. Pelosi. I wondered if you are doing any research or, if 
you had the money would you want to do the research, for a dead 
smallpox vaccine which I understand is less harmful?
    Dr. Fauci. Yes, Ms. Pelosi, thank you for asking the 
question. This is an important part of what we call the third 
generation smallpox. The first generation is what we have, that 
dry vaccine that we got from calf lymph, that we diluted, the 
study that I referred to. The second generation is the same 
microbe, but developed in tissue culture and not in calf lymph.
    The third generation is exactly what you're referring to, 
and that is part of our intermediate to long range plan to 
examine either highly attenuated or killed versions of the 
smallpox, there's one candidate that seems promising called 
modified vaccinia ankara, MVA, we refer to it as. Modified 
vaccine ankara, like in Ankara, Turkey, MVA.
    It is actually promising because it has been used as a 
vector, it's a virus as a vector to carry the genes of other 
viruses, and has been used, for example, in certain studies in 
cancer patients where you vaccinate cancer patients against 
certain of the antigens of their own tumors. So the cancer 
people have a lot of experience in that regard.
    But the one thing that they've learned which is of keen 
interest to us in the infectious diseases field is that there 
have been very little, if any, of the toxicities that we have 
seen with vaccinia. We have not seen that with MVA.
    So now we need to prove, and we are in the process 
ofaddressing that now, that if you vaccinate someone with MVA, A, is it 
safe, and I can tell you right now that it is, because we've done a lot 
with people who are not being vaccinated for smallpox. But the other, 
does it induce the potency of an immune response that we just recently 
showed over the past few months when we did the dilutional study with 
vaccinia?
    If both of the answers to those questions are yes, then 
we're going to very aggressively pursue that. That's the point 
that I made in answer to one of the other questions. If we had 
in our hands now a complete safe, effective vaccine against 
smallpox, the whole dynamics about when and who you would 
vaccinate would change very rapidly.
    Ms. Pelosi. And do you have the resources to move to this 
third generation?
    Dr. Fauci. Yes, in the plan, and again, this gets back to 
the question that Mr. Miller asked, in the three and four year 
plan that we have about the resources that we have been given 
now, and we will use in subsequent years, we would have the 
money to do that.
    Ms. Pelosi. But if there's scientific opportunity now and 
the toxicity is less, why aren't we moving right into it?
    Dr. Fauci. We are. But the studies will take a couple of 
years to do.
    Ms. Pelosi. Let me just follow up on that, and I appreciate 
everything you're saying. Now, would this, how would this be 
different for people with compromised immune systems already?
    Dr. Fauci. They are the main people, one of the main groups 
that we're concerned about. So if you have a non-live vaccine, 
that it is virtually impossible for that microbe to get out of 
control in someone who is immunosuppressed, the big problem 
with vaccinia is that if I were immunosuppressed and you 
vaccinated me, my body's normal defenses, which would respond 
to the vaccine, make a good immune response and then protect 
me, might not even be able to suppress the actual vaccination 
itself, which would then cause a disseminated reaction in me.
    That would essentially be a non-issue in a vaccine----
    Ms. Pelosi. Dead vaccine.
    Dr. Fauci. Yes.

                EMERGENCY MEDICAL SERVICES FOR CHILDREN

    Ms. Pelosi. Thank you. I have one quick question, and I'm 
going to address it to Secretary Allen, and thank you all very 
much for your very excellent presentations. I wish I had time 
to ask you all my questions.
    Last year with the cooperation of our great chairman, I was 
able to get $10 million in our bill to assist communities 
implementing emergency response evacuation, parental 
notification plans for schools and other community facilities 
where children gather. We were told in our community, whether 
we talked to the police, the fire, first responders, they all 
said the same thing, protect the children. We have to have a 
component to protect the children first.
    And I wondered what role the emergency medical services for 
children played in the effort to protect schools. Is HHS 
collaborating with the Department of Education in this effort?
    Deputy Secretary Allen. We are collaborating with the 
Department of Education in this effort. To give you another 
idea of where some of the other monies that are going to serve 
this purpose, back in, I guess it was January, I had the 
privilege of going to Colorado, I was in Colorado Springs where 
some of our metropolitan medical response systems, they were 
actually conducting an exercise. At this particular exercise, 
they had the broad range of the types of first responders 
there, but they also had the media included, public utilities 
and education, they had the Department of Education represented 
there.
    So these are the sorts of exercises that we need to 
continue doing, and the monies that have been appropriated have 
served for that purpose, of making sure that Health and 
Education are working together to address the needs and 
concerns, particularly as they relate to children.
    Ms. Pelosi. I appreciate that, and I look forward to 
working with you on it. Thank you all very much. Thank you, Mr. 
Chairman.
    Mr. Regula. Mr. Cunningham.

                        ANTHRAX EFFECTS/STUDIES

    Mr. Cunningham. Thank you, Mr. Chairman.
    I, like Ms. Pelosi, sit on the Select Committee on 
Intelligence. So we know exactly what the threat is now, but 
what in many, many different countries on recent briefs that 
we've had, on a gearing up of Al-Qaeda in bio and chemical, 
biological warfare that could be eminent, there is a rapid 
movement even as we speak today in a real global threat. So I 
laud your efforts in what you're doing, as Ms. Pelosi does.
    One of the concerns I have, I also sit on the Defense 
Appropriations Committee--busy guy. But one of my concerns was, 
say, with anthrax vaccinations in the military, is that there 
wasn't enough studies being done. For example, we have more and 
more women in the military. What were the effects of anthrax 
vaccinations if the woman should become pregnant? And those 
kinds of studies, this Nation put a lot of men and women on the 
front line with an A-bomb and you see the results.
    When you look at Agent Orange and the results that our 
Nation did to a lot of our veterans, if you look at Desert 
syndrome and where they denied that there was anything, when we 
have all of the evidence that there is something wrong with 
these folks, my concern is that as we move forward, sometimes--
I want to move fast, like you do--but we don'thave the 
safeguards to protect our men and women with these new biological 
retreats that we have, such as anthrax, such as smallpox, such as these 
things that go forward.
    Second concern, and which I'm glad, you gave a good example 
with smallpox, my concern, the military is charged with 
fighting two fronts. But if I was a bio and chemical terrorist, 
I would load a load of marijuana or heroin, and can you imagine 
the influx in our inner cities, and maybe loading it with 
hepatitis-C or with Ebola, those kinds of things, where you not 
only vaccinate those people but just the exponential expansion 
of the disease would be bad.
    I've seen software that right now focuses in directing 
fire, police, Centers for Disease Control, all of those things, 
and you did talk about how that you're working together, but I 
think we still have a long way to go in that. I guess my real 
question is, are we looking, with these new technologies, to 
safeguard that we're not actually doing more harm in 
vaccinating and taking care of the public in these threats?
    Deputy Secretary Allen. A couple of responses, and I'll ask 
both Dr. Fleming and Dr. Fauci to respond. That is certainly a 
concern that we have, first of all, from human subject 
protections, as a Department, we're very concerned about that 
issue, ensuring that whatever we would do, whether it's in a 
time of emergency or in a non-emergency situation, that we 
protect humans, their health and safety. That's the utmost goal 
of the Department.
    So in doing that, particularly in this regard since we're 
looking at vaccines, the reason why we've requested funding for 
the NIH and for CDC is to actually conduct those types of 
studies. The reason why we've got the Aventis Pasteur gifts 
that they've given us in terms of the 50 year old vaccine, we 
know how that was created, we know that it has certain 
impurities in it, and therefore, we reserve that for only an 
emergency situation, yet we're still conducting tests to make 
sure of the efficacy of it.

                       PUBLIC HEALTH PREPAREDNESS

    Mr. Cunningham. If I could interrupt you just one second, 
that little yellow light goes on and my time is up.
    Another question is, where my colleague said, does it 
appear that you're trying to beef up, I had a brief, and are 
aware that you've actually sent teams to Asia where the flu 
starts. Many scientists feel that 1918 is going to emerge 
within the United States and the world again. I would think 
that if anybody criticizes you for the efforts of this 
Committee, trying to keep in line the requirements that you 
have, then I think the alternative is very deadly.
    Deputy Secretary Allen. Point well taken. And again, we 
would not be bashful about saying, yes, we're beefing up, 
because we know that again, the basic public health 
preparedness is what is going to protect us in the time of an 
event.
    I do want to finish and give Dr. Fauci and Dr. Fleming a 
chance. But I will say, you've raised a question about DOD. We 
work very closely with the Department of Defense in 
coordinating and looking at these issues, much more closely now 
than perhaps we did in the past. There is coordination and 
cooperation on these sorts of efforts in terms of having tests 
performed, research done before we actually vaccinate anyone.

                          ANTHRAX VACCINATIONS

    Mr. Cunningham. If you could just look into anthrax 
vaccinations for especially the military to see if there is 
effects with women that may become pregnant. It's a real 
concern.
    Dr. Fauci. Just an extension of that, Mr. Cunningham, the 
agenda for research for development of vaccines is not only for 
vaccines for diseases for which we don't have an existing 
vaccine, but improvements for the vaccines that we already 
have. Two good examples, one you mentioned, one that was in 
response to a question by Ms. Pelosi, and that is the smallpox 
vaccine that would be as effective but not attenuated, 
essentially, so attenuated that it just wouldn't cause any 
problems.
    So if we would have a vaccine that would be safe, we would 
eliminate all the concern about that. With regard to anthrax, 
the currently used vaccine is called AVA, for anthrax vaccine 
absorbed. That is one that's made from the supernatant of a 
culture that has a lot of elements in it, some of which might 
not even be needed to induce immunity.
    The currently tested one that we're in the process of right 
now testing for the next generation of anthrax is what we call 
a recombinant protein, a recombinant protective antigen, which 
is just one of the elements of the original, more crude vaccine 
for anthrax. When we prove that to be safe and immunogenic, you 
can almost guarantee that toxicities of that more highly 
purified vaccine will be less than what we've seen in the more 
crude ones.
    So a lot of the effort that we're talking about, all of us 
today, are geared towards improving vaccines for the purpose 
that you mentioned, to make them safer.
    Dr. Fleming. Just one last quick comment, is that while 
we're awaiting this new generation of anthrax vaccine, there 
are dollars being requested today to allow us to specifically 
address the questions that you're asking regarding safety of 
the existing vaccine. Those studies are going on.
    Mr. Cunningham. Thank you, Mr. Chairman.
    Mr. Regula. Thank you. Mrs. Lowey.

                         HOSPITAL PREPAREDNESS

    Mrs. Lowey. Thank you, Mr. Chairman. And I want to thank 
our presenters for your testimony today.
    My first question is about hospitals. Hospitals will 
undoubtedly be the first impacted in a bioterrorism event. But 
as we saw with the anthrax outbreak in New York City, 
ourhospitals are simply unprepared. Emergency rooms could not handle 
the amount of people who came in convinced they were exposed to 
anthrax.
    Right now in New York, most hospitals are running at full 
capacity. One hospital's CEO reportedly gave up his office 
recently to provide space for patients.
    Now, you can't chalk this up to poor management, it's the 
result of HMOs and ever-shrinking Medicare reimbursements, 
forcing hospitals to eliminate excess capacity. Other States 
face the same situation. Hospitals simply cannot afford to keep 
beds open or stockpile supplies in case of a bioterrorism 
event. And I can assure you that $618 million is not enough to 
help our hospitals prepare.
    The estimated costs, as I understand them, to hospitals, to 
fully prepare for bioterrorism, is over $10 billion. I'm glad 
to see that head shaking and agreeing with us. So my question 
is, is the Administration interested in a long term solution? 
Is this a short term fix? Is the Administration looking at the 
larger issues facing hospitals? Has it asked them to take on 
responsibility? Just to Secretary Allen, thank you.
    Deputy Secretary Allen. Yes, no, yes. [Laughter.]
    The Administration is interested in this issue. In fact, 
the reason I nodded is that we are too aware of what the 
hospitals are saying that it would take for them to be 
prepared, $10 billion. And we're not arguing with that figure.
    What we are saying though, is that in the interim, what 
we're doing is the $618 million, we have $518 million, is what 
I have, is a significant investment in what we need to do 
immediately to help work with and to address these issues.
    We are going to be working with them very closely, and I 
want to ask Dr. Duke to address specifically how the $518 
million is trying to go and focus on building capacity, 
building regional cooperation and helping to bring training to 
those who are really going to be on the front lines in the 
hospital systems to address that. I do want to say at the very 
end of that that we also would say that we think it's important 
that the HMOs and health plans are also a part of our 
preparedness as a Nation, as opposed to them being a part of 
the problem, that they will also be a part of the solution.
    Dr. Duke. Thank you. In our proposal for this year, we have 
two programs. One is the hospital preparedness program itself, 
which asks for the States to put together a comprehensive 
program working with their hospital associations, working with 
their offices of rural health, working with a broad scope of 
providers of health care, including for example, the health 
centers as well.
    We've asked them to work on a regional approach, rather 
than simply the ``lonely bandito'' approach of one hospital at 
a time, but rather to work in a coordinated fashion. We've also 
put in a program for capital investment to improve emergency 
rooms, to improve the capacity of hospitals to meet emergencies 
involving 500 patients or more. So with the regional approach 
and with an educational approach, we are looking also at 
investing in our training capacity, so that the new diagnostics 
that are coming up, the new treatment modalities that are 
coming up, are available to the first line folks in the 
hospital setting.
    So we believe we're making the appropriate investment as a 
beginning step here to get up to speed. Next, the capital 
investment plus the hospital preparedness program, we believe, 
will make a tremendous contribution toward improving our 
capacity to respond.

                         STATE AND LOCAL PLANS

    Mrs. Lowey. Did I hear you say that you're working with the 
States to put together plans?
    Dr. Duke. Yes.
    Mrs. Lowey. And are you, maybe you can expand on that. Are 
you working with the States in ensuring that the States are 
coordinating with local governments? Because I know, I attended 
a meeting with my local hospitals, for example, and I'm working 
closely with my local government in trying to make sure we're 
prepared. Boy, there's a lot of work that has to be done. So I 
just wondered if you could elaborate on that.
    Dr. Duke. Yes. The approach we've taken is that the funding 
is going through States with a responsibility to ensure that 
all of the relevant actors are involved, hospitals. The 
requirement in our guidance is that 80 percent of the funding 
will be immediately passed through to the hospitals who will 
then work with their partners on the local level and on the 
regional level. We at the Department level will be working with 
our colleagues to ensure that the money that is provided to CDC 
is coordinated with what's available through the emergency 
preparedness that's available through HRSA.
    So we believe that we are getting synergy out of the funds 
that you've provided to make these big steps forward. So the 
States are absolutely crucial, because health is a locally 
provided service.
    Mrs. Lowey. Is there a time frame within which they're 
supposed to be reporting back? And then is there an evaluation 
of these plans?
    Dr. Duke. The plans have been coming in, the first set of 
plans was due on April 15th, and 53 of the 59 eligible entities 
have provided initial plans. We're in the process of reviewing 
those plans right now. And each agency will review them from 
the point of view of the guidance relativeto the program they 
have. But in order to ensure the kind of coordination at the national 
and the State and local level, those plans, as reviewed by, for 
example, HRSA, under the hospital preparedness program, will then be 
reviewed yet again by a cross-cutting committee headed by D.A. 
Henderson's office of Public Health Preparedness. Those plans then will 
be coordinated to make sure that we're getting the maximum impact for 
our investment. That's happening right now.

                   FUNDING FOR STATE AND LOCAL PLANS

    Mrs. Lowey. I see the red light blinking, so just one other 
quick one, Mr. Chairman. After you review the plans, will there 
be additional money going to respond to the needs in the plan?
    Dr. Duke. Yes. Twenty percent of the funds were made 
available for planning and immediate implementation. The other 
80 percent will be going out by early summer.
    Mrs. Lowey. Thank you. Thank you, Mr. Chairman.
    Mr. Regula. I want to advise the members that I think we'll 
have time, Mr. Istook has yet to take his time, but we'll have 
enough time that each member could have at least one additional 
question, if you would like, before we adjourn. So, Mr. Istook.

                          SMALLPOX VACCINATION

    Mr. Istook. Thank you, Mr. Chairman.
    I really just have one simple question, with a little bit 
of a prelude. I understand, of course, the ring method for 
eradication of smallpox and similar strategy with other 
diseases. I understand also of course that our society is much 
more mobile than the third world societies where the final 
round of eradication occurred. We of course have had 
significant vaccination programs as far as the suppression of 
the disease in earlier years.
    I am still concerned about the potential success of the 
ring approach to a mobile society such as ours if we were to 
have some sort of terrorist induced outbreak such as smallpox. 
I'm concerned that the ring theory would not be near as 
successful without a potential high mortality rate in a society 
with as much mobility as we would have. I therefore question 
whether we should rely upon that to the extent that I'm 
hearing.
    With that in mind, knowing that we have vaccine stockpiles, 
understanding the concern with toxicity levels, especially 
among those that have a depressed immune system, and therefore 
people may not wish to start a national inoculation program 
such as we haven't seen for many years, I guess the last 
national major one was maybe, was it swine flu in the Ford 
Administration? But what is wrong with the approach of making 
the stockpile that we have available to those who wish to have 
inoculation, to let members of the American public who want to 
have the inoculation for themselves and their family, not as a 
massive program trying to make sure that everyone is, but at 
least diminishing what the potential impact might be, on a 
voluntary basis, but making our supplies of vaccine available 
for that?
    Deputy Secretary Allen. As an initial start, and I'm going 
to ask Dr. Fleming and Dr. Fauci to address it, the first issue 
is, we need to have ample supply before any discussion about 
that would ever occur.
    Mr. Istook. That's a hundred million and the others that 
are being expanded?
    Deputy Secretary Allen. Correct. We have 300 million 
citizens, so therefore you start down that path, who gets it, 
how you ration it. It creates the very issue of risk 
communications that we've been trying to address.
    Mr. Istook. Presupposing that everybody wanted to 
affirmatively seek it.
    Deputy Secretary Allen. Correct. Then beyond that, I think 
there are other issues that we need to address, and I'll ask 
them to address them, but there are some international issues 
that we need to address as well, is that of course, as the 
United States would begin a process of that, we have certain 
obligations to allies. And it raises some other issues that we 
have yet to address.
    In fact, the week after next, the World Health Organization 
will be meeting, the World Health Assembly, and this issue is 
on the agenda to discuss. So I think there are issues that go 
beyond simply having the supply available, first and foremost, 
and then making that decision as to whether to have voluntary 
or involuntary strategies, that both have certain risks and 
benefits associated with them.
    Mr. Istook. But basically you're saying the stockpile that 
most Americans have been told is intended for our protection, 
that we can't make those decisions unless we decide whether 
other nations in the world want to draw upon our stockpile?
    Deputy Secretary Allen. Absolutely not. That is not what 
I've suggested nor is that what I've said. What I have said, 
though, is that we have to balance the benefits and risks 
associated with a decision such as that. Because for example, 
we do, as you've already stated, we live in a global community, 
and largely the mobility is a major issue. Therefore, an 
outbreak of smallpox anywhere is an outbreak of smallpox 
everywhere. So we have to be prepared to address that.
    But to get more specifically to your concerns about the 
addressing of the strategy, the ring strategy and where we go 
from that, I'm going to ask Dr. Fleming.
    Mr. Istook. In that mobile society, correct.
    Dr. Fleming. A couple of points. First, I wanted to assure 
you that we recognize that this is a controversial issue, and 
one that needs further discussion. So we are going to be 
embarking, over the next three to six months, insome national 
dialogue on this, using our immunization experts and involving 
appropriate community providers as well, so we can come to a solution.
    But let me comment specifically on ring vaccination. In 
fact, smallpox was eradicated from Europe well before it was 
eradicated in Africa. There were multiple instances in the 
1970s and 1980s where it was reintroduced into the European 
population, that is reasonably mobile. And in that setting ring 
vaccination was able to effectively contain the epidemic.
    Mr. Istook. But it was still among a population that had 
had a lot of inoculation?
    Dr. Fleming. Yes, although inoculation in any of those 
instances had been discontinued. So a fair proportion of the 
population was naive.
    Having said that, we do believe that the first approach to 
containment does need to be ring vaccination. We are preparing 
our State and local health departments around the country to 
recognize and respond, to deal with the mobility issue. That's 
not to say that in a worst case event, if ring vaccination was 
failing, that we would not quickly move to an additional 
strategy.
    One last point. The issue around choice, and shouldn't 
people be allowed to get the vaccination if they want it, is it 
an important one. And as I say, we are going to be having this 
national dialogue on that. I would point out, though, that the 
risk of vaccination is not just to the individual who receives 
it. Because it is a live vaccination, someone who has been 
vaccinated is capable of transmitting that to individuals 
around them.
    So in the setting of vaccination, we would expect 
transmission of the vaccine strain to others around vaccinated 
people, including immunocompromised individuals. And in that 
context, we do need to weigh in that it's not purely an 
individual decision, whether to be vaccinated, but rather in 
part a societal decision as well, taking into account the risks 
to people who did not want to be vaccinated but who were 
inadvertently exposed to someone during the time that they were 
infectious after receiving vaccine.

                           HOMELAND SECURITY

    Mr. Istook. I appreciate the information, and I certainly 
just want to finally stress that a major aspect of all of 
homeland security is expecting people to assume burdens and 
responsibilities for security rather than expecting it to be 
simply a government agent at the airport or whatever it may be. 
The private sector is having to assume a lot of responsibility, 
individuals expect that they have to assume a lot of 
responsibility.
    And as I mentioned, I think that one thing we need to 
factor in intensively in this is, are we just going to have 
homeland security that is a Government program saying, 
everybody should/must do this as far as an inoculation, for 
example? Or do we say, we want to be enablers for people that 
do want to heighten the security levels for themselves and 
their family, and therefore deal with, and I don't know if the 
inoculation has to be a live strain as opposed to a dead 
strain, the technical part of that I don't know.
    But I think there are serious questions here about the 
overall approach to homeland security, to what extent is it 
going to be Government driven and to what extent do we expect 
the average American citizen to be accepting responsibilities?
    Deputy Secretary Allen. Those issues are being discussed 
very vigorously within the Executive Branch, not only within 
the agencies working with the scientific community, but also I 
know on the homeland security council we are discussing those 
issues as well. So I do want to make sure you understand that 
we are very much trying to get our hands around these issues.
    Mr. Istook. Certainly.
    Deputy Secretary Allen. Because they do have serious 
implications. And in many ways, I think your point is well 
taken, that it's not always a Government solution. That's 
certainly what we've learned in trying to respond to 
innovating. And that's very much of the reason why we're asking 
for the funding we're asking for, is both for intramural 
programs and extramural programs. Much of that also revolves 
around these sort of questions of what is the most appropriate 
strategy to adopt in terms of how we deal with an outbreak.
    I was in London the earlier part of April at a G7 
conference where we gathered together with some of the G7 
states, in addition to Mexico, to talk about these issues, 
again, how we're going to approach it in terms of approaching 
the World Health Organization as well. So these issues are 
going on at all different levels, because we have great 
concerns and a need to be concerned. So they will be weighted 
very seriously.
    Mr. Istook. Thank you. Thank you, Mr. Chairman.

                              PREPAREDNESS

    Mr. Regula. Mr. Allen, just a summary. Are we much better 
prepared today than we were on September 10th to deal with all 
of these possible impacts of terrorism? And secondly, will a 
lot of this work that's being done, i.e., communications, 
improving the public health system, have a benefit to society 
in addressing other things that result from natural causes, 
result from, like in our instance, in our area we had a 
meningitis outbreak, they had Legionnaire's disease in 
Cleveland. Will we be as a society much better prepared, even 
if it isn't terrorism? And if there is, do you think we're in 
pretty good shape?
    Deputy Secretary Allen. I would say in terms of being 
preparedvis-a-vis September 10th or 11th, I would say 
absolutely. We have worked together, because of your efforts here in 
Congress in providing funding for us, and we've worked across 
Government both at the Federal, State and local levels, with the 
private sector, and with communities. I would say yes, we're much 
better prepared.
    Are we absolutely prepared? No. There's much work still to 
be done, particularly, for example, as we talked about earlier 
in terms of making sure that the weakest links of our systems 
are the strongest links of our systems. We need to be reaching 
into communities to make sure that they understand the 
significance and how they can be prepared in addressing these 
sorts of issues.
    In terms of where we are, the spillover benefits are great, 
as we've already talked about, the fact that we will have a BL-
3 lab and a BL-4 lab in Montana. I was in Hawaii last week 
visiting some of our folks there. They will be having a BL-3 
lab in Hawaii to be able to address, as offshore. Some of the 
issues they're dealing with are dengue fever, tuberculosis, 
leprosy, something that we don't even think about on the 
mainland. These are issues they're confronting.
    And because of the investments that have been made, using 
bioterrorism as the impetus to get money into the system, we 
will improve the ability to provide public health care, 
population based public health, research and coordination 
across the board. There's no doubt that this money has served 
and will serve a very valuable purpose to better prepare the 
American people for whether it's a terrorist attack or a 
natural outbreak of disease. These are issues that we must be 
prepared for and we're grateful for the monies.
    Mr. Regula. A good investment.
    Deputy Secretary Allen. Absolutely.
    Mr. Regula. I would advise the members of the Committee, we 
do have another panel. We have the Agency for Health Care and 
Research Quality. However, I'm still going to give our members 
any additional questions they would like to ask. Because what 
you're doing is extremely important. This is very significant.
    Deputy Secretary Allen. And I don't want to discount, if I 
can, Mr. Chairman, because you do have the Agency for Health 
Care Research Quality coming up, I want you to understand that 
they're involved in this effort as well. As the private sector 
has been coming to the Department with technology, with 
experience, with knowledge, we have had to be a conduit to link 
the public and HHS as a whole with what they're doing. So I 
want to make sure that link is there as well as you talk with 
them on this issue.
    Mr. Regula. Mr. Sherwood, anything additional?

                              HEALTH CARE

    Mr. Sherwood. Yes. I'd like to make one little comment. Dr. 
Fleming, in World War II when the country was really 
concentrated on what we had to do to get through that, we made 
some technology jumps and some organizational jumps that have 
served us very well in the ensuing 60 years.
    Now that we are very concentrated on bioterrorism, is there 
going to be some serendipity there? Can we use that to increase 
the linkage between our new knowledge, our research like NIH 
and CDC, to health care delivery? Example, an article in the 
Post this morning about beta blockers and how important they 
are, and yet so often they're not prescribed. Are we going to 
make some jumps out of this that are going to do us some good 
in the long run, where our efforts to fight bioterrorism, are 
we going to get some serendipity out of this?
    Dr. Fleming. I'd like to comment as well, I sure hope it 
won't be serendipity, but yes, is the short answer, that we are 
consciously trying to make those things happen. Without going 
into a lot of detail, just one example in health care delivery, 
one of the major problems we're facing is the delivery of 
preventive services to adults. That's something that is hard in 
our clinical system to make happen.
    One of the benefits of these dollars is to increase the 
existing linkages between health departments who have that as a 
priority and the medical community. So certainly, one of the 
intended outcomes here is not only to make those connections so 
that providers will be better able to respond to a bioterrorist 
event, but to increase the credibility in the linkages between 
the public health system and the medical community, which will 
result in, for example, better delivery of adult preventive 
services, immunizations, influenza vaccine, pneumococcal 
vaccine, a whole host of secondary benefits.
    Mr. Sherwood. Thank you.
    Mr. Regula. Mr. Miller.
    Mr. Miller. No questions, Mr. Chairman.
    Mr. Regula. Mr. Cunningham?

                               RESOURCES

    Mr. Cunningham. Just one statement. One of the things 
that's overlooked in coordination of the different groups, to 
be able to help in case of a national emergency, some of the 
members on the Floor tried to eliminate the Selective Service 
System. They don't believe in Selective Service or the draft. 
The draft would only come in case of national emergency, like a 
world war. But one of the things that the Selective Service 
does do, it coordinates and has lists of all of those 
individuals that have specialties to help in case of national 
emergency, like bio and chemical warfare.
    I would hope that you would work with those groups as much 
as you can, because it's a resource for you that many people 
overlook.
    Thank you, Mr. Chairman.
    Mr. Regula. Mr. Istook.
    Mr. Istook. No further questions, thank you.

                               PUSH PACKS

    Mr. Regula. On push packs, are they out in place now?
    Dr. Fleming. Yes, the national pharmaceutical stockpile has 
12 locations around the country where those push packs reside.
    Mr. Regula. Within them, they have a lot of what would be 
needed in any given locality in emergency?
    Dr. Fleming. Fifty tons of equipment in each, and then in 
addition, there's a backup or reserve to supplement, after the 
first 12 to 24 hours. We can get push packs to any place in the 
continental U.S. within five hours of receiving the request, 
excuse me, six hours.
    Mr. Regula. So that would be an enormous advantage in the 
event of a crisis, either terrorist or otherwise.
    Dr. Fleming. Absolutely.

                       INTER AGENCY COORDINATION

    Mr. Regula. Second question. Does the military, and the 
work they're doing, you mentioned anthrax, do you coordinate so 
we're not reinventing the wheel? Because you have a broader 
range of challenges, but nevertheless, a lot of what the 
military's probably doing has a value in the civilian side.
    Dr. Fauci. The current project on the development of a 
second generation anthrax is being done in total collaboration 
with the Department of Defense currently and in the future.
    Deputy Secretary Allen. In addition, as you are aware, in 
case of a national disaster, under the National Disaster 
Medical System, the military, that would be DOD, the Veterans 
Administration and FEMA, report to the Secretary of Health and 
Human Services. So on September 11th, we enacted a public 
health emergency under Section 319 of the Public Health 
Services Act. They reported up under to the Secretary.
    In fact, two weeks ago, Secretary Thompson met with all the 
surgeons general of the various branches of the military to 
again discuss this coordination across Government. So that's a 
key element, that in times of need, their resources would come 
to bear if they weren't fighting on a second front. So those 
are issues that would be very important in times of national 
emergencies.
    Mr. Regula. And lastly, I assume you coordinate with 
Governor Ridge?
    Deputy Secretary Allen. I'll be meeting with him later on--
regularly.
    Mr. Regula. Okay. Thank you very much. You've been very 
informative, very instructive, a lot of information this 
morning.

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



                                         Wednesday, March 13, 2002.

                     NATIONAL INSTITUTES OF HEALTH

                               WITNESSES

DR. RUTH L. KIRSCHSTEIN, M.D., ACTING DIRECTOR, NIH
WENDY BALDWIN, DEPUTY DIRECTOR FOR EXTRAMURAL RESEARCH
MICHAEL GOTTESMAN, DEPUTY DIRECTOR FOR INTRAMURAL RESEARCH
CHARLES LEASURE, DEPUTY DIRECTOR FOR MANAGEMENT
WILLIAM BELDON, DEPARTMENT OF HEALTH AND HUMAN SERVICES
ANDREW VON ESCHENBACH, DIRECTOR, NATIONAL CANCER INSTITUTE
CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG AND BLOOD INSTITUTE
LAWRENCE A. TABAK, DIRECTOR, NATIONAL INSTITUTE OF DENTAL AND 
    CRANIOFACIAL RESEARCH
ALLEN M. SPIEGEL, NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND 
    KIDNEY DISEASES
AUDREY S. PENN, ACTING DIRECTOR, NATIONAL INSTITUTE OF NEUROLOGICAL 
    DISORDERS AND STROKE
ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND 
    INFECTIOUS DISEASES
MARVIN CASSMAN, DIRECTOR, NATIONAL INSTITUTE OF GENERAL MEDICAL 
    SCIENCES
DUANE ALEXANDER, DIRECTOR, NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN 
    DEVELOPMENT
PAUL A. SIEVING, DIRECTOR, NATIONAL EYE INSTITUTE
KENNETH OLDEN, DIRECTOR, NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH 
    SCIENCES
RICHARD J. HODES, DIRECTOR, NATIONAL INSTITUTE ON AGING
STEPHEN I. KATZ, DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS AND 
    MUSCULOSKELETAL AND SKIN DISEASES
JAMES F. BATTEY, JR., DIRECTOR, NATIONAL INSTITUTE ON DEAFNESS AND 
    OTHER COMMUNICATION DISORDERS
RICHARD NAKAMURA, ACTING DIRECTOR, NATIONAL INSTITUTE OF MENTAL HEALTH
GLEN R. HANSON, ACTING DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE
RAYNARD KINGTON, ACTING DIRECTOR, NATIONAL INSTITUTE ON ALCOHOL ABUSE 
    AND ALCOHOLISM
PATRICIA A. GRADY, DIRECTOR, NATIONAL INSTITUTE OF NURSING RESEARCH
DONNA DEAN, ACTING DIRECTOR, NATIONAL INSTITUTE OF BIOMEDICAL IMAGING 
    AND BIOENGINEERING
JUDITH L. VAITUKAITIS, DIRECTOR, NATIONAL CENTER FOR RESEARCH RESOURCES
STEPHEN E. STRAUS, DIRECTOR, NATIONAL CENTER FOR COMPLEMENTARY AND 
    ALTERNATIVE MEDICINE
JOHN RUFFIN, DIRECTOR, NATIONAL CENTER ON MINORITY HEALTH AND HEALTH 
    DISPARITIES
GERALD T. KEUSCH, DIRECTOR, FOGARTY INTERNATIONAL CENTER
DONALD A.B. LINDBERG, DIRECTOR, NATIONAL LIBRARY OF MEDICINE
YVONNE T. MADDOX, ACTING DEPUTY DIRECTOR, OFFICE OF THE DIRECTOR
JACK WHITESCARVER, ACTING DIRECTOR, OFFICE OF AIDS RESEARCH
STEPHEN A. FICCA, ASSOCIATE DIRECTOR FOR RESEARCH SERVICES
SUSAN QUANTIUS, ASSOCIATE DIRECTOR FOR BUDGET
KERRY WEEMS, ACTING DEPUTY ASSISTANT FOR BUDGET, DHHS
    Mr. Regula. Okay, we will get started. We are happy to 
welcome the NIH team here this morning. On behalf of all the 
people of America, we are especially pleased to welcome you, 
because they depend on you a great deal for their well being in 
the future.
    Dr. Kirschstein, if I believe the press reports, this may 
be your last appearance before this Committee--not your last 
appearance, but before this Committee. [Laughter.]
    Have to be careful with the semantics here.
    I just want to express the appreciation of millions of 
Americans for your wonderful service at NIH. You and your 
husband have been dedicated Americans, 46 years I believe that 
you've been out there. Think of the millions of lives that have 
been improved because you have done, both as a researcher and a 
leader, you have touched their lives.
    I told the Committee last year when we started, I said, the 
Bible says there are two great commandments, love the Lord and 
love your neighbor. This is the love your neighbor Committee. 
We love our neighbors through the activities of institutions 
like NIH. As I understand it, there were nine institutes and 
it's under $100 million when you came there. That's why they 
call them the good old days. [Laughter.]
    Today there are 27 institutes and $23 billion 
appropriations. Not many that can lay claim to that many years 
of really great service to the people of this Nation. I just 
think it is wonderful what you have been able to do. We will 
miss you whenever you decide you will leave out there, and we 
certainly wish you well in everything you do. What you leave in 
this world are few things, legacies. I have an interesting 
thing happening in our office, and I am sure David, you and 
Roger have the same thing, that is veterans of World War II 
want their medals. They write to us and ask, will you get my 
medals. When they left the service, they did not want any part 
of it. Now suddenly they are getting closer to the end and they 
want their grandchildren to have their medals.
    We all like a legacy. You have been especially blessed, 
because you have had an opportunity to leave a great legacy. It 
must make you feel very good to be able to do that.
    Dr. Kirschstein. Thank you. I appreciate everything you 
have said.
    Mr. Regula. Mr. Obey, would you like to make some comments?
    Mr. Obey. I understand you've been maligning the past? 
[Laughter.]
    Mr. Regula. When it was a $100 million budget for NIH, you 
cannot malign it.
    Mr. Obey. Amen.
    Let me simply say, Dr. Kirschstein, that I think you are a 
precious national asset. I do not think very many people 
understand what NIH is. They certainly do not in my district. 
Yet, they all understand what medical research is all about and 
they understand what medical progress is all about.
    I think your career has been really remarkable. There are a 
lot of people in Congress and in this town in other capacities 
who get a lot of attention and a lot of press. And there are a 
lot of other people in those same institutions who do a lot of 
the work and solve a lot of the problems. You fall in that 
latter category in my book.
    You have now been what, twice acting director of the NIH?
    Dr. Kirschstein. Yes, sir.
    Mr. Obey. And in my view, despite your indication that you 
are not interested in being the permanent director, I think any 
President would have been smart to nominate you any time there 
was an opening to run that shop.
    But I also want to mention the almost 20 years that you 
spent running the Institute of General Medical Sciences. You 
know, there was a time when it looked like people were going to 
earmark funds for this disease or that disease, people posing 
for holy pictures, trying to show who was most against cancer 
and most against heart disease or most against diabetes or some 
other disease, so they wanted to earmark funds for the Cancer 
Institute, for the Heart Institute. But nobody ever wanted to 
earmark funds for the General Medical Sciences Institute, 
because who the hell ever died of general medical----
    [Laughter.]
    Mr. Obey. It was tough to get people to understand that a 
lot of the very basic research took place at that Institute. 
But you have served that institution so very well, and you have 
served the country so very well. The public, even though 99 
percent of them will never know your name, have all benefitted 
from your service. I know I am grateful, and if they knew about 
it, they would be, too.
    Dr. Kirschstein. Thank you very much, Mr. Obey.
    Mr. Regula. Mr. Wicker, do you want to make a brief comment 
here?
    Mr. Wicker. I think I will wait for questions.
    Mr. Regula. Okay. You'll be number one.
    Steny.
    Mr. Hoyer. Thank you very much, Mr. Chairman.
    For those of us who have served on this Committee for a 
number of years, Dr. Kirschstein, and frankly all the directors 
of the Institute, but Dr. Kirschstein has been an extraordinary 
asset, as David Obey said. Mr. Chairman, I missed most of your 
comments. Sorry for being late.
    But she is and has been a national asset. More than that, 
she has been a personal asset, I think, for each of us on the 
Committee. Always open to answer questions, to work with us on 
problems that we had in figuring out what we needed to be 
doing, working with us on the political problems that confront 
a committee like this, as Mr. Obey mentioned, where there is 
the inclination to want to earmark and to focus on a particular 
disease or ailment research project.
    And that is a real asset for NIH, I think. So many of the 
directors have that same skill, which I think their medical 
colleagues may not appreciate as much as they appreciate their 
intellectual and professional skills, which are obviously very, 
very high. But I wanted to join both Mr. Regula and Mr. Obey. 
Frankly, our Chairman has not had as long an experience, he is 
by the way, doing an outstanding job chairing this Committee, 
and we're very lucky to have him. And of course, he's had very 
long experience on the full Committee.
    But I know Mr. Obey and I, I suppose, have been on this 
Committee longer than anybody else on the Committee. Both of us 
consider Dr. Kirschstein to be one of the extraordinary talents 
of the Federal Government and of our country. We thank her for 
her service.
    Dr. Kirschstein. Thank you, Mr. Hoyer.
    Mr. Regula. Mr. Miller.
    Mr. Miller. Let me make a brief comment, echoing the 
comments of my colleagues. We were fortunate for over two years 
to be without a director that you were able to step in with the 
depth of knowledge and experience there, but also your husband. 
He stepped in at the Cancer Institute and did a very fine job. 
It's always difficult to take an acting position, because you 
do not have the complete command of everything. During these 
times of great growth in the budget, you both have done a good 
job. Your husband has done a good job, too.
    Dr. Kirschstein. Thank you.
    Mr. Hoyer. I know the gentleman didn't mean that. We've had 
a director. It's had ``acting'' in front of her name. But that 
didn't, in my opinion, make any difference, either how the, and 
to the credit of the Institute directors, how they responded to 
her leadership or the leader, the quality of the leadership she 
gave.
    I know you didn't mean that, but----
    Mr. Miller. It makes it a more difficult challenge when you 
have acting in front of your name.
    Mr. Hoyer. It does make a difference, but she did an 
extraordinary job.

                            Opening Remarks

    Mr. Regula. Okay. We look forward to hearing from you and 
your testimony. We will make the entire testimony a matter of 
record, in the record, and if you'll summarize, we will 
appreciate it. Again, welcome, and thank you on behalf of 
America.
    Dr. Kirschstein. Thank you very much, Mr. Regula. I am 
overwhelmed, and hope I can perform again for this time.
    Let me introduce the people at the table. To my left is the 
Acting Deputy Director of NIH, who has done an extraordinary 
job of helping me through these two plus years, Dr. Yvonne 
Maddox. To her left is Dr. Wendy Baldwin, who is the Deputy 
Director for Extramural Research, and to her left, Dr. Michael 
Gottesman, the Deputy Director for Intramural Research.
    To my immediate right is Ms. Sue Quantius, who I think 
almost needs no introduction to the members of this Committee 
and who is currently the Director of the Office of Budget. We 
want to welcome to the table for the first time Mr. Charles 
Leasure, who is the Deputy Director for Management and 
immediately to his right is Mr. William Beldon from the 
Department.
    With that, Mr. Chairman, I want to tell you how very 
honored I am to appear before the Committee and to represent 
the 27 directors, colleagues without whom I could have not done 
the job, the directors of the 27 institutes and centers, each 
of whom has presented to you a written statement related to the 
President's budget proposal for fiscal year 2003. I shall now 
present the overview of the total Administration budget for the 
National Institutes of Health for 2003.
    The Congress, the Administration and the American public 
have been committed to doubling the funding of NIH by the end 
of 2003. Although scientific accomplishments often take years 
to produce new treatments or diagnoses, a confluence of the 
generous budgets and the extraordinary scientific opportunities 
has already begun to yield amazing results. The current budget 
proposal is $27.3 billion, an increase of 15.7 percent over 
fiscal year 2002. It completes the original commitment, enables 
the NIH to continue to take advantage of the broader and deeper 
opportunities now at hand to understand diseases and to improve 
health, and it opens the way for future progress in medical 
research.
    Opportunities truly are at hand. Some of them are general, 
benefiting research in many areas, and others are specific and 
deal with particular diseases and disorders. Among the general 
opportunities the complete draft of the DNA sequence of the 
human genome is the best known of the new tools. It is helping 
scientists in so many ways from so many disciplines to 
understand how the human body works and what causes disease.
    But there are several other areas of investigation that are 
changing the way biomedical research is being done. They 
include proteomics, the computer-aided analysis of the patterns 
present in large sets of proteins, proteins being the products 
of our genes. They will help with the goal of understanding the 
function of those proteins.
    They include combinatorial chemistry, a new way to generate 
large libraries of molecules that can be screened for use as 
drugs. And they include new, advanced imaging techniques that 
enable scientists to see not only within the human body but 
within its cells as various functions are being carried out.
    There are of course new and expanded opportunities in 
therapeutics and prevention that we will be undertaking. These 
efforts do not eclipse the research in specific diseases and 
disorders, but actually complement them and enable us to 
acquire new knowledge to more fully understand and ultimately 
to control or defeat cancer, Parkinson's disease, diabetes, 
Alzheimer's, asthma, heart disease and many, many others, as 
well as to prepare for incidents of bioterrorism. The 
President's budget for 2003 provides the NIH and its institutes 
and centers with funding to deliver the results on these 
promises.
    Mr. Chairman, my written statement has a number of 
important examples of NIH's accomplishments, many of which will 
be discussed over the next several days, particularly regarding 
cancer, Parkinson's and Alzheimer's disease. But there are so 
many others that I want to highlight a few new ones.
    For example, we used to think that the heart muscle, 
damaged as a result of heart attack, could not be repaired. But 
recent studies have shown that heart cells can indeed 
regenerate and if the proper materials and sustenance are given 
to them, they can be stimulated to regenerate. This repair 
process can be enhanced, thus increasing not only survival but 
the health of the previously damaged heart.
    The area of fundamental research, solving the three 
dimensional structures of essential molecules, is very 
important. After 20 years of work, scientists have determined 
the structure of an enzyme which is responsible for the first 
step in making the building blocks of life, proteins. This 
structure suggests that each and every one of its dozen sub-
units must properly fit together so that such proteins can be 
made.
    Understanding how this fit occurs and how it differs 
between lower organisms such as bacteria and humans may allow a 
very practical approach to the design of antibiotics 
specifically tailored to those bacteria, helping us with 
infections.
    We have learned an enormous amount from genome sequencing. 
We have learned that the genetic sequence between any two 
people is about 99.9 or more percent the same. But we do know 
that in common diseases, among them asthma, there are complex 
interactions between multiple genes as well as other factors 
such as the environment. Genetic links associated with asthma 
are now found in chromosomes 5, 8, 12, 14 and 15.
    But in addition, linkage to a gene on chromosome 11 is 
unique in African-Americans, while genes on chromosome 1 and 6 
are unique in Hispanics and whites. Since minority populations 
have substantially higher rates of hospital admissions and 
emergency room visits associated with asthma, identifying such 
genetic factors, even if they each have a small effect, may 
improve therapeutic options for all patients.
    I have presented, therefore, in my written and verbal 
statements, a brief summary of the scientific areas we are 
studying. Our research portfolio is so broad, so deep and so 
complex, that even if I went on for a long time, I would not be 
able to give you a complete picture. Yet I am confident that 
the fiscal year 2003 budget request enables NIH to sustain the 
momentum of research already in progress, to open the way to 
new research opportunities in the coming fiscal year and the 
years to come, and to augment both our research infrastructure 
and our human capital.
    Some practical things about the fiscal year 2003 budget: 
The request would fund a total of 9,854 new and competing 
research grants and a total of all research grants of 38,038, 
the highest annual total ever. The intramural research program 
increases by 15 percent over the 2002 estimate, and most 
institutes and centers will increase by 9 percent while the 
National Institute of Allergy and Infectious Diseases and the 
National Cancer Institute increase by 62 percent and 11 percent 
respectively, as a result of the large increases in 
bioterrorism and cancer research.
    The research management and support, RM&S funds, are vital 
if the NIH is to manage its programs and resources efficiently 
and effectively. These funds are used by the NIH to sustain, 
guide and monitor the extramural and intramural research 
activities. The funding increase is about 17 percent in total. 
Several of the institutes are higher than that because of new 
responsibilities.
    Mr. Chairman, I am sure that you will recall that at these 
hearings last year, I promised to provide you with an update on 
the Clinical Research Center construction project. At that 
time, I apprised you of the fact that the General Services 
Administration, as the contracting agent for NIH, and in 
consultation with the Office of the General Counsel, Department 
of Health and Human Services, had decided to terminate the 
contract with the then-construction manager of the project, due 
to certain unresolved issues that had occurred between that 
contractor and the development manager.
    I can tell you now that we have selected a new construction 
manager, which has recently presented to us a proposed 
guaranteed maximum price. This price is a great deal more than 
was expected to complete the building. We are working with the 
Department and OMB to validate both the GMP and a new schedule 
and having discussions with all the appropriate parties 
regarding budget options for covering the additional costs.
    Mr. Chairman, this concludes my opening statement. I and my 
colleagues will be pleased to respond to any questions.
    [The prepared statement of Dr. Kirschstein follows:]

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    Mr. Regula. I will withhold my questions, because I know 
members have other commitments.
    Mr. Obey--he's on the Floor. Then we will go to Mr. Wicker.
    Mr. Wicker. Thank you, Mr. Chairman.
    Dr. Kirschstein, let me echo the laudatory remarks of my 
colleagues and just observe that in listening to them here and 
hearing my Chairman talk about the two great commandments, it 
occurs to me that you are somewhat like Moses----
    [Laughter.]

                         GREATEST SUCCESS STORY

    Mr. Wicker [continuing]. Looking out over the promised land 
and speaking to the children of Israel about what to expect in 
the future.
    Let me just ask you, what is your greatest success story? 
You mentioned these amazing results in the first page of your 
testimony. Mr. Obey mentioned the fact that even back in our 
constituencies, the words National Institutes of Health are not 
very familiar, and people really still do not understand the 
NIH. If I go back to some civic club in my constituency and 
want to talk about the greatest achievement of the last two 
years of your directorship, what would be the first thing I 
should mention?
    Dr. Kirschstein. There are so many that it is hard to 
really single any one out. But I think it is the fruition of so 
many activities related recently to the basic science that has 
been performed by all the institutes, both as Mr. Obey said in 
general, and in basic activities of all related to diseases, 
the fruition of the fact that those findings and the clinical 
applications for them are somehow coming together and enabling 
us to really see a number of things that will be able to very 
directly benefit the health and well-being of the American 
public, both in prevention, in diagnosis, in treatment and in 
many cases in cure.
    And the fact that while we used to talk in periods of 20 
years before a discovery came to fruition in terms of something 
that could be applicable to the patient that time has begun to 
narrow. So now you will hear from my colleagues, and maybe each 
one of them at some point during their four days here will be 
able to tell you what they think of this. Because they may have 
a different view than I do.
    But we will be able to tell you what has allowed this 
enormous opportunity to keep on providing more for the well-
being of the public.
    Mr. Wicker. Let me just observe to my colleagues on the 
Subcommittee, I have 24 mostly rural counties in North 
Mississippi. I write a weekly column that appears in most of 
the weekly papers. I think maybe for all of us on the 
Committee, it might be a good opportunity to take the fifth 
year of our doubling project and the occasion of your announced 
retirement as an opportunity to write a column for----
    [Laughter.]
    Mr. Miller. She hasn't announced it yet.
    Dr. Kirschstein. I'll answer that in a moment. [Laughter.]
    Mr. Wicker. Well, you're moving to another area of service 
for the NIH. As an opportunity to inform our constituents of 
some of the really, really excellent accomplishments that we 
have made on behalf of science and health.
    Dr. Kirschstein. We would be pleased to. I think each of my 
colleagues attempts, and we have wonderful staff who help us, 
to translate what we have accomplished into what the public can 
understand. We have done that through many means, and we look 
for opportunities to talk to people, to have visitors come, Mr. 
Regula has had a number of visitors come and visit us. We hoped 
to have some people from the Chamber of Commerce, it didn't 
quite work out.
    But we would be delighted to do all of that.

                           MUSCULAR DYSTROPHY

    Mr. Wicker. Thank you also for your help with regard to the 
legislation which I sponsored, H.R. 717, concerning muscular 
dystrophy, particularly children and Duchenne muscular 
dystrophy. As you know, that bill has been enacted, signed into 
law by the President. I just wondered if you could let the 
Subcommittee know if you have been able to formulate, since it 
was signed December 18th of last year, if you have been able to 
formulate any plans as to how you might implement those centers 
of excellence and the things called for in that legislation.
    Dr. Kirschstein. Indeed we have. And we had arranged this 
session to be one in which I made this opening statement, and 
when questions were asked that were specific to diseases that 
are being studied in the Institutes, that we have a chair at 
the table and the Chairman very kindly agreed to have the 
institute director of that in charge of activity come forward. 
So if Dr. Penn would come up and answer that question, working 
in concert, the Neurological Disorders and Stroke Institute and 
the Arthritis and Musculoskeletal Diseases Institute, Dr. Katz, 
have begun to implement that.
    Dr. Penn. Good morning. We indeed have had a major meeting 
in January of this year to begin to formulate and work on the 
new Act and the provisions of the new Act. So this involves Dr. 
Katz and the Arthritis Institute as well as the Child Health 
Institute. We met with representatives from the Parent Project 
for Muscular Dystrophy, with the Fascio-Scapulohumeral group, 
who actually were on the phone, and with the Muscular Dystrophy 
Association, MDA, who were at the table. We've agreed that we 
will definitely all work together, that we will formulate new 
research plans, that we will try to develop centers orsomething 
that will fulfill the mandate of centers, so that we get resources that 
everybody shares, we have registries of our patients, and we can move 
forward toward pulling back normal functioning genes.
    I have to say that all of the groups at the table are 
together on this. We have since gone out to the Muscular 
Dystrophy Association meeting, their latest meeting on stem 
cells. One of our people was there. Muscle is a little 
different, so it may not be the usual stem cells that we worry 
about. But they are very interested in that. We are still 
waiting to facilitate gene therapy.
    So we are very encouraged, and we are going to commit 
appropriate resources to this.
    Dr. Kirschstein. Let me add to that, Mr. Wicker, in fiscal 
year 2002 we estimate that we will be spending $23 million and 
we estimate $25 million for the muscular dystrophies for fiscal 
year 2003.
    Mr. Wicker. Thank you, Mr. Chairman. If I could just 
conclude, I want to thank you for your staff coming into my 
office and discussing this issue in laymen's terms that even a 
Congressman can understand, and helping us amend the bill in 
such a way that you all felt that it could be more workable. 
It's a great result, and I thank all my colleagues who helped 
me with that legislation, particularly you and your staff.
    Dr. Kirschstein. We thank you, Mr. Wicker.
    Mr. Regula. Mr. Obey, you're up.

                        SCIENTIFIC OPPORTUNITIES

    Mr. Obey. Thank you, Mr. Chairman.
    Doctor, I would just like to ask about three or four 
basically boilerplate questions, because I think some of them 
need repeating again and again. The most difficult job this 
Subcommittee faces in dealing with your budget, outside of 
assuring enough resources for it, is to deal with every well-
meaning group in the land that wants to come in and have 
Congress specify a specific amount of funding for a specific 
disease. When you have people in your office who are suffering 
from Parkinson's or suffering from cancer or Lou Gehrig's 
disease or you name it, it's very difficult to explain. Because 
they do not want to hear generalities. They want to know what 
you are going to do about their problem. I understand that.
    Nonetheless, if you were sitting with those folks, what 
would you say to them to make them understand that they do no 
one any long term favors if they insist that we start 
earmarking funds for specific diseases at specific levels? How 
would you explain to them that scientifically that's the wrong 
thing to do if you really want to solve the problems they are 
concerned about?
    Dr. Kirschstein. They come to my office, too, Mr. Obey. And 
it is the most difficult problem. It is heart wrenching to see 
these patients, there is no question about that. We listen to 
them carefully. And we consider the status of where we are in 
regard to that particular disease or the broader field of 
science that is encompassed by studies in that disease. We also 
know that as we have progressed in our knowledge, it is not any 
longer really as possible to compartmentalize that research 
done on Parkinson's disease is solely for Parkinson's disease 
or research done on neurobiology, neurosciences will not be 
important in many other areas.
    We seek opportunities by calling together, the scientific 
experts as well as the people who represent either themselves, 
because they are ill, or family members who are ill. We did 
that most recently on two separate occasions, as recently as 
December if I am not mistaken, or early this year, I cannot 
remember exactly, the Parkinson's people. We sat together and 
talked about what were the scientific opportunities that could 
be directly related to that disease, what are the therapeutic 
possibilities, what do we not know, what can we learn if we 
study something very basic. And we put together a plan of how 
we can accomplish it. We try to be very honest with the people 
and say, if we do not think that the scientific opportunities 
are ripe to make something happen, we feel that we must move 
further, we would not be promising you something we cannot 
accomplish.

                        DOUBLING THE NIH BUDGET

    Mr. Obey. On your budget, again, both parties pose for holy 
pictures about the doubling of NIH over five years, or roughly 
doubling. But one of my concerns is what happens when the five 
year window is over. If you take a look at the out-year 
situation, my understanding is that the President's budget 
envisions an increase for fiscal year 2004 of just $576 
million, or 2.1 percent, in contrast with the huge increase we 
have this year. And for 2005 and 2006, the projected increases 
are the same.
    What would be the impact on NIH if you only got a $576 
million or 2 percent increase in fiscal year 2004?
    Dr. Kirschstein. Mr. Obey, we have thought about that, and 
we are very aware also that the President's budget has a 2.1 
percent increase. We will study the situation very carefully, 
and by appropriately looking at where those funds should be 
used and constraining some areas and thinking carefully how 
about to go about it, we believe that it will be possible to 
maintain in that budget, a reasonable number, not very 
different, in fact approximately the same as the number of new 
and competing research grants as we have been doing this year.
    Mr. Obey. Let me ask about that. Is it not true that the 
cost of just providing year to year renewals of ongoing 
research grants totaled about $1.2 billion last year andabout 
$800 million this year?
    Dr. Kirschstein. Yes, sir.
    Mr. Obey. In both cases, considerably more than the entire 
NIH-wide increase the Administration is proposing for 2004?
    Dr. Kirschstein. Yes. But there will be some cycling. Some 
of those costs were due to very large grants. And we may have 
to look at ways to do something about this. We will try our 
very best to maintain whatever momentum there is.
    One thing I think we have to say is that it is very clear 
that one way or another, biomedical research will progress. It 
may take longer, but it will progress.
    Mr. Obey. But you cannot, can you, assure us that a $576 
million increase next year would allow you to fund renewals or 
that you would not have to be cutting grants for existing 
projects?
    Dr. Kirschstein. I cannot assure it, but I will try.
    Mr. Obey. I am sure you will try. But I think the important 
part of that sentence is that you cannot assure it. I mean, I 
frankly do not think the Administration set out to produce this 
result. I think those small increases are all that they can 
afford if they are trying to fit into the budget area the ever-
increasing costs of their tax cuts. I do not expect you to 
comment on it, but I feel free to. Because I think what we are 
seeing is that as the costs of those tax cuts ramp up a lot of 
things that we know shouldn't happen have to be included in the 
budget in order to make room for it.
    Mr. Chairman, I have another question for the record, but 
I'll submit it. My time is up. I have another question 
concerning the National Institute for Environmental Health 
Sciences.
    Mr. Regula. Mr. Hoyer.

                             SUCCESS RATES

    Mr. Hoyer. Thank you very much, Mr. Chairman. I share, as 
you will not be surprised, Mr. Obey's concerns.
    I remember back to a colleague of ours who I mention often, 
because I was so impressed with the tenacious focus he had for 
NIH, and that's Joe Early. You remember Congressman Early from 
Massachusetts, who made extraordinary contributions to this 
effort, and very frankly, Congressman Early, in the doubling of 
the budget of NIH with the rhetorical support of Mr. Natcher, 
would have said, that's fine, but it's not enough. Because the 
opportunities to effectively apply more resources to overcome 
illness and disease and have such a big economic payoff in 
terms of the invested money.
    I've mentioned Dr. Lowe, the dental, his report. Tony, you 
ought to have this report as well. In terms of the investment 
in dental research, Susan, you'll probably remember this, 
investment in dental research, over all of the time that we had 
been appropriating money for NIH, and this was maybe ten years 
ago that he made this analogy, over all the time that we had 
been funding NIH, were paid off four or five times over in one 
year's savings, in the dental field.
    And obviously, it would be multiplied many times over, for 
instance, in terms of AIDS, in terms of the lives that we have 
extended, the quality of life that we have extended, the 
workers that we have kept on the job, the families we have 
kept. That applies to all the institutes, as was mentioned. It 
was Dr. Fauci's focus, but it is the focus of all of us as 
well.
    In any event, we are going to have to be pretty tenacious 
in making sure that we do not back up. Let me ask you, in that 
context, what is our pay line projected to be in 2003?
    Dr. Kirschstein. About 30 percent success rate.
    Mr. Hoyer. That's an average, I take it. Do you know what 
our lowest pay line will be in the institutes? Because we've 
been down in the middle teens, as you know, from time to time.
    Dr. Kirschstein. Several of the institutes are very low. 
But they are institutes that have been traditionally not paying 
as many individual research grants but have been building their 
portfolios with large groups, particularly the National Center 
for Complementary and Alternative Medicine. So I do think that 
that counts. There are a couple that are in the 14 and 15. But 
the vast majority are 30, 29, some of them are higher than 
that. We think that is a very good pay line.
    Now, the other thing about that and about what you've been 
saying is, many of us have been consciously concerned about, 
and I believe I spent some time talking about this at last 
year's hearing, about making sure that we do not have a sudden 
drop. So we've been talking about one time investments in large 
instrumentation, in data bases, in repositories of cells and 
chemicals. So some of this will be flattened out as a result.
    Mr. Hoyer. Mr. Chairman, you weren't on the Subcommittee 
when Joe Early was here. You were here with him on the 
committee. But one of the things that Congressman Early was 
concerned about, and Dr. Kirschstein is now speaking about, the 
fluctuation of pay lines not only adversely impacts current 
research, but what it really does, it discourages very talented 
people from going into basic biomedical research because of the 
inconsistency of resources available for basic research.
    So that's what David Obey was speaking about. I think we 
all need to be concerned about keeping that pay line up over 
the 25 or 30 and particularly now, because the opportunities 
are even greater than they were 10 years ago. I would imagine 
now the level of so-called good research that peer review has 
shown is a significantly higher level than it was even 10, 15 
years ago.
    Dr. Kirschstein. Absolutely.

                         LOAN REPAYMENT PROGRAM

    Mr. Hoyer. Let me ask you two quick questions. I was going 
to ask about security and what money was spent on it. I'll do 
that for the record. I was a sponsor of the ClinicalResearch 
legislation and I have some comments about it. But let me just ask the 
question. When will the NIH move forward and initiate the graduate 
training in clinical investigation awards? That was something that we 
had anticipated. What's the status?
    Dr. Kirschstein. The National Center for Research Resources 
is implementing that program now through the program that it 
has to enhance clinical research activities, so that there will 
be ability to train and get stipends and tuition. And loan 
forgiveness, which is probably the most important thing that 
came out in some ways for the general issues related to the 
clinical research enhancement. Dr. Vaitukaitis can expand on 
that if you would like to.
    Mr. Hoyer. My time is very limited, and I would like to get 
that. But one of the concerns I know that the advocates and 
those who expected this to have a broader impact are concerned 
about the budget of one institute being able to accomplish the 
objectives on that. Are we going to apply it more broadly?
    Dr. Kirschstein. The institutes are starting off by 
applying the loan repayment program very broadly. At the 
moment, the National Center for Research Resources has taken up 
the graduate education activities. This is post-M.D., graduate 
education post-M.D. I think as this progresses we will evaluate 
it and see whether we want to go more broadly.
    Mr. Hoyer. I know my time has expired. I have another 
question on that which I will submit. And I apologize, but my 
time has expired. Not only that, like Mr. Obey, I have a 
commitment at a quarter of twelve. This is the time when I 
think all of us ought to probably just have one subcommittee. 
[Laughter.]
    But that's not the case.
    Dr. Kirschstein. Thank you, Mr. Hoyer.
    Mr. Hoyer. Thank you, Doctor.
    Mr. Regula. Mr. Miller.

                        APPOINTMENT OF DIRECTORS

    Mr. Miller. Good morning. John Porter used to talk about 
this as being the crown jewel of the Government. Unfortunately, 
not too many people know about some of the things that take 
place within this great Institute. Mr. Hoyer actually and Mr. 
Wicker both talked about what's been done in dental. Mr. Wicker 
asked what are you proud about. The problem is, so much is hard 
to focus in the credit. Yet when we're talking about this kind 
of dollars we just need to try to do a better job of really 
communicating the great successes we have here.
    One area I always think is that we should encourage every 
medical institution that gets grants to invite their local 
member of Congress to come in. I do not have one in my 
district, but I have one not far away, and I have visited the 
University of South Florida, the Moffett Cancer and the medical 
school and such. It's so impressive, not just to visit out at 
your facilities in Maryland.
    So anything we can do to encourage that, because that just 
helps people educate that this $27 billion is not all spent out 
in Bethesda, Maryland.
    Let me ask a clarification question. Dr. Zaroni has been 
nominated, he has to be approved by the Senate, is that right?
    Dr. Kirschstein. The position of Director of NIH is a 
Presidential appointment, subject to Senate confirmation.
    Mr. Miller. Sometimes that can take months and months and 
months. Do you have any idea of a time?
    Dr. Kirschstein. No, sir.
    Mr. Miller. Is that the only one? The other acting 
directors can be appointed, I see the new Director of the 
Cancer Institute was appointed directly by the President. But 
he's the only one appointed directly?
    Dr. Kirschstein. The Director of NIH is the only one that 
requires Senate confirmation.
    Mr. Miller. Can any of the other acting directorships be 
addressed before Doctor--I do not want to----
    Dr. Kirschstein. Mr. Miller, I have in place search 
committees to be looking for the directors of all the 
institutes which have acting directors at the moment. Those 
search committees are moving ahead very rapidly. We have almost 
finished the search for two out of the group. Names will be 
submitted as soon as possible to the Secretary who makes the 
appointments.
    I think probably the Secretary will want to discuss with 
others how he should move forward in regard to the fact that I 
am doing that as an acting director. In the time I have been 
Acting Director, however, we have had three or four important 
positions open. Two of them are directorships of institutes. I 
recommended to the then-Secretary two of our institute 
directors who have been on board for at least a year and one of 
them for almost two.

                          CLINICAL ACTIVITIES

    Mr. Miller. The focus of NIH has been basic research. Now 
we are talking about more clinical research. Mr. Hoyer brought 
it up, and you are talking about translational research. I know 
it's hard to define, I know it's a not a definite line between 
clinical and basic research, but whether it is the human genome 
project, basic, is there a focus as far as a change or a shift 
in emphasis?
    Dr. Kirschstein. Yes, I think so. First of all, I would say 
that the focus of NIH is on health research, biomedical 
research. It is not to do research in the basic sciences in a 
vacuum. It is to do research that will in one way or another be 
applicable to either preventing, diagnosing, curing, treating 
or ameliorating the ills, the diseases, from which the public 
suffers.
    Now, very often, in order to do that work, it requires the 
use of the most fundamental model systems, organisms like 
bacteria and viruses, animal models all the way through to 
clinical studies. But it is a continuum which would not be 
possible if our goal was not continuously to realize the health 
mission. That's why we're called the National Institutes of 
Health. We are not called the National Institutes of Biomedical 
Research. Ithink that is a real differentiation.
    Mr. Miller. As far as resources, shifting a little bit more 
towards percentage-wise, as far as clinical rather than basic?
    Dr. Kirschstein. We are beginning to move definitely more 
toward this.
    Mr. Miller. Can you really define which is clinical or 
basic?
    Dr. Kirschstein. We put figures together every year on what 
we spend on basic research and what we spend on what's called 
more applied research. And the numbers are changing. They've 
gone from 60 percent basic down to 57 percent in 2003, and up 
from 39 and a half percent to 43 percent on applied, which is 
clinical. So the emphasis that I have presented in the last two 
years, two of the three times that I have been testifying, and 
as I said today, has been on clinical activities.

                           STEM CELL REGISTRY

    Mr. Miller. Can I ask one more question? This could be a 
long question, but we will keep it real short, on stem cell. 
Would you give us an update of the situation on stem cell 
research and how many lines are available, how many grants have 
been made? Is it slower or faster than expected? What is the 
expectation?
    I do not want to make this a long answer.
    Dr. Kirschstein. Dr. Baldwin has been following the 
details. I could probably try, but she will give you a quicker 
answer.
    Dr. Baldwin. There are 78 lines available now. We have 
added some lines since the stem cell registry was first posted. 
That was a very important step, because anyone who wanted to do 
research in human embryonic stem cells has to be able to pick a 
line off that registry. We are very pleased to have added lines 
to that registry.
    Mr. Miller. How many are there now?
    Dr. Baldwin. Seventy-eight.
    Mr. Miller. How many were you expecting when you announced?
    Dr. Baldwin. About 64. We have also extended the receipt 
date for the fall applications. If someone were really ready to 
do research right away, we made accommodations to be able to 
receive these applications. And we in fact got a number of 
applications in. We got the nine on that receipt date. We have 
had more come in for February 1st receipt date. They are in 
review now.
    We are also accepting administrative supplements. We have 
received about a half dozen of them. And you might ask why 
haven't we actually made awards. This is a new area of 
research. Applicants and scientists want to take time to 
prepare their applications, and they may want to develop some 
preliminary data. They want to make sure that when they come in 
with an application, they have a really sound one.
    So I have not been surprised by the pace of this. It would 
be very unusual if the scientific community just stopped what 
they were doing and suddenly picked up an area that they had 
not been able to work in with Federal funding before and 
flooded us with applications. We see the rate of submissions 
increasing over time. We are working at all the pieces that 
have to be in place. We have infrastructure awards ready to go 
to make sure that the people who have the stem cells are able 
to supply the investigators who want them.
    Dr. Kirschstein. Many of the institutes have put out, after 
the President's announcement, requests for applications. So we 
are moving apace.
    Mr. Miller. Do you feel you are behind schedule or about on 
schedule? I guess it's hard because it is so new.
    Dr. Kirschstein. It is hard to say.
    Dr. Baldwin. Those of us who have been doing this for a 
long time have a sense of the pace at which the community will 
respond. I would say we are about on target.
    Mr. Miller. Thank you. Thank you, Mr. Chairman.
    Mr. Regula. Mr. Cunningham.

                   ACKNOWLEDGEMENT OF DR. KIRSCHSTEIN

    Mr. Cunningham. Thank you, Mr. Chairman.
    I want to also thank you, Dr. Kirschstein, and when they 
asked you about your accomplishments, you were a little remiss 
in talking about your own accomplishments. Let me note just a 
few that I saw.
    I was concerned when John Porter left as Chairman, I was 
concerned on who would take over Chairman of this Committee, I 
didn't recognize someone that I thought could do as good a job. 
I am happy to say, I think Chairman Regula has done a good job. 
I do not like one vote he cast on the House Floor, but in this 
Committee, he did pretty good. [Laughter.]
    Mr. Regula. I like all of yours. [Laughter.]
    Mr. Cunningham. But I want to thank you first for the 
availability of your department. I found that sometimes you 
comment to a doctor that hey, can you come and see me, I want 
to talk about this. They literally tree you until you do meet 
with them. The availability has been, and the responsiveness, 
unlike any other Department, I think, and that includes the 
Department of Defense. You have been responsive.
    When I was over there in a visit, watching the film on 
Phyllis and meeting Phyllis, what an opportunity, that young 
lady with Parkinson's and the advancements. She had been given 
back her children and her grandchildren, they had a grandmother 
and a mom. The oncology, my daughter interned over there in the 
oncology lab and also the cardiology lab. By the way, she has a 
sub-med in, she's gone liberal on me, she wants a women's 
health studies over there this year. [Laughter.]
    But she's got an application in, and I support it. 
[Laughter.]

                            OCULAR ALBINISM

    Who happens to be the gentlelady who has agreed to give a 
talk to my daughter's group at Yale, I offered to talk and she 
wouldn't let me. She let the gentlelady. And I want to thank 
you for that as well.
    But also, the outreach. Dr. Varmus was the head of cancer 
research, and now Dr. von Eschenbach. The only bad thing about 
him is he's not Irish. But we've already met. When you talk 
about another accomplishment, the outreach of the Department, 
the highest rate of prostate cancer is in African-Americans. 
You know, D.C. has never had a town hall meeting in that. And 
Doc has volunteered to do that, as well as UCSD. Those kinds of 
things out in our communities to let people know what you are 
doing I think is monumental in health.
    I have a dream that you can help me with, and we have 
talked about it, not only making permanent the Office of 
Women's Health, but also an office of Men's Health, not to be 
competitive, but to work in collaboration and coordination,to 
get the information out of all the things we find, of what the advances 
are. There is a report due that you can help me with on ocular 
albinism. My adopted son, my son was adopted, and when I adopted him 
they told me he may have dyslexia. Fortunately, it didn't happen, 
didn't come to fruition. But ocular albinism is a hereditary disease 
that affects vision in children that can be distorted. If you could 
give me a report on that, our language asks that, I would appreciate 
it.
    Dr. Kirschstein. I am sure that Dr. Sieving, the Director 
of the Eye Institute, would be pleased to do that. Dr. Sieving.
    Dr. Sieving. I am pleased to be here. I am one of the new 
institute directors who came on board this last year through 
the efforts of Dr. Kirschstein. I am pleased to be here.
    The request to address some activity on ocular albinism is 
very important. Ocular albinism is a developmental issue for 
vision. It affects a number of young people, and it gives us 
the opportunity to look both at the genetics of the disease, 
how one might ameliorate this ultimately, and the interactions 
of the genes with the development of the eye. We have a 
mechanism to solicit grants and expect to be funding about $3 
million worth during fiscal year 2002.

                          EARMARKING DISEASES

    Mr. Cunningham. Thank you. One last question. I have been 
against earmarks. I do not believe members of Congress should 
say that the Department should go in this direction or that 
direction. You all are the professionals. I notice, and listen, 
I am a cancer survivor and I want research in cancer. But I 
notice the President has earmarked money for cancer, prostate 
cancer. I do not think it's enough.
    But at the same time, I always want to give the Department 
the flexibility to act, whether it's with Dr. Sieving or with 
Parkinson's or Alzheimer's or those diseases. Can you give me a 
brief explanation of how you see this earmark? Is it positive, 
negative?
    Dr. Kirschstein. The discussion of what should be the right 
number for any disease entity is one that we could have very 
broadly. The President has a deep commitment not only to 
biomedical research, which he made evident by presenting, for 
the past two years, the yearly increment for the doubling, but 
also a deep and abiding commitment to cancer research. He and 
we are aware that very broadly, the National Institutes of 
Health supports cancer research in one way or another.
    About 85 percent of that is supported by the National 
Cancer Institute. But the remaining is supported by the other 
institutes doing studies, not only of a basic nature, but 
perhaps on an organ system which is very susceptible to cancer, 
prostate being one of those. Therefore, we can all gain through 
this inter-institute effort, including interdisciplinary 
effort. There is much to be done by many, many institutes. I 
think we all gain and learn a great deal about other diseases 
by doing cancer research as well as cancer related research. 
That is the statement.
    Mr. Cunningham. Thank you. I yield back, Mr. Chairman.
    Mr. Regula. Ms. DeLauro. We have only one vote on, I think. 
So if we could keep going.

                  RECOUPMENT OF FEDERAL RESEARCH FUNDS

    Ms. DeLauro. I will do that. Thank you very, very much, Mr. 
Chairman. I will try to move quickly and I will enter some 
questions into the record.
    Welcome. It is wonderful to see you all here this morning. 
I have a question that has to do with recoupment of Federal 
research funding. You know, I am a very, very strong proponent, 
as you all know, of NIH research and the whole issue of 
doubling the budget has been very important to me.
    But I am also concerned about the amount of money, the 
public money, that gets invested, and in cooperation, if you 
will, with private companies, whether they be pharmaceutical 
companies or others in the broad range of companies in which we 
work together. When I first came 12 years ago, I testified on 
behalf of the opportunity to work together with Bristol Meyers 
Squibb with a CRADA on Taxol, etc. We moved forward in those 
developments.
    But again, what I want to do is begin to ask some questions 
about, when these things move along, and they are in the public 
domain, how in fact do we recoup any of the profits, if you 
will, that then go back into the NIH to help to do the kinds of 
things that we need to continue to do and to extend that 
budget, if you will? It's in essence trying to get the most 
from federally-funded research.
    Can you let me know, and if these questions are too long 
and you can get back to me on this, I am perfectly fine, given 
that we have to go to vote. I want to outline how basic 
research we fund at the NIH leads to the creation of new drugs, 
do we have a mechanism at NIH for recouping funding or some of 
the funding, and if so, how much of that funding do we recoup.
    Would you, in light of the biotechnology revolution, will 
you support a more in-depth study which would analyze how NIH's 
research money results in a new drug? For example, the study 
might look at various organizations that are involve din the 
process, how they interact, who incurs the risk in drug 
development and how much and who makes the profit. I think this 
kind of an analysis could serve as a kind of baseline for 
further study of how much the Federal Government recoups from 
its research and a road map, if you will, of how we can make 
improvements.
    We are again always interested in trying to stretch that 
research dollar. We do this, and I am not sure of what we are 
getting back in order to help us increase and multiply, if you 
will. Maybe I should just do that and leave this for the 
record. It is a lengthy question.
    Mr. Regula. When we get the transcript with the question, 
we can get it for the record.
    Ms. DeLauro. I can get it to you.
    Dr. Kirschstein. We have data, and we have mechanisms for 
doing that, both in place within the NIH intramural program and 
in some other areas. But it is a very long question and we will 
provide the data.
    Ms. DeLauro. Please. What I would very, very much like to 
do is work with all of you on this issue. It is an issue which 
I am very, very concerned about, and one I think we need to 
really examine thoroughly. I think it would be helpful for the 
rest of the Committee as well. And I will submit my other 
questions for the record as well.
    Thank you very, very much.
    [The information follows:]

                 Recoupment of Federal Research Funding

    There is no standard pattern or process for the development 
of discoveries from basic research. New discoveries may arise 
out of a large research project but often are ancillary to the 
main objective of the research. The findings can come from 
working around obstacles or through serendipitous discovery.
    Most basic research discoveries are early-stage including 
proofs of concept, mechanisms of action, and basic 
interactions. They can include new compounds or chemicals. 
However, these discoveries require further research and 
development to demonstrate proof of principle and bring them to 
practical applicability.
    We should make it clear that the NIH is not in the drug 
development business. We do not develop new therapeutics and 
simply hand them over to companies to manufacture and 
distribute. The NIH needs partners, licensees, to invest 
significant resources to conduct the further development 
required. This is a high risk venture for those who wish to 
pursue the development of these technologies.
    Typically, technologies need to be further developed with 
the combination of other technologies to eventually create a 
product that can have the anticipated effect without side 
effects that would deter their use. That process of development 
of new products is long and expensive. It can take years of 
development and many of these promising new discoveries fail to 
become efficacious and safe drugs.

                    Mechanism for Recouping Funding

    The NIH licenses technologies that originate from 
laboratories at the NIH. In exchange for licenses, the NIH 
receives royalty income which includes payments even before a 
technology comes to the marketplace. If and when an NIH 
technology becomes a part of a product that reaches the market, 
the NIH receives a portion of the sales as royalty income. By 
law, the income is used to provide inventors with a share of 
the royalties, pay for patent and other technology transfer 
related costs, with most of the funds being returned to the 
laboratory to support further research. Last year, the NIH 
generated more than $46 million in royalty income. Over the 
past 7 years, we have generated more than $260 million in 
royalty income. The last report from the Department of Commerce 
indicated that the NIH is responsible for two-thirds of the 
royalty income generated by the entire federal government.
    Recipients of NIH funds operate in essentially the same 
manner as the internal NIH inventors. They license technologies 
for further research and development and receive royalty income 
that is used in a manner similar to that used by the NIH. The 
NIH does not receive a share of income generated by recipients 
from licensing of their government-funded discoveries.

                        Recoup Research Funding

    We believe that a recent report may address a number of the 
questions you have raised. The NIH submitted a report to the 
Congress in July 2001 in response to its request in 
Congressional Conference Report for a plan to ensure that 
taxpayers' interests are protected. That report concluded that 
the taxpayers have greatly benefitted from new diagnostic, 
therapeutic and vaccine products that were developed and have 
extended life and improved health. In addition, the study cites 
a report by the Congressional Joint Economic Committee issued 
in May 2000 entitled ``The Benefits of Medical Research and the 
Role of the NIH.'' That report concluded that the taxpayer 
receives the economic benefit of a return of $15 for every $1 
invested in the NIH. A copy of the report has been provided to 
the Committee and is available on the NIH website, http://
www.nih.gov/news.
    The report does not provide specific information on the 
amount of risk and profit of the various parties to the drug 
development process. That type of study would require the full 
cooperation of industry and access to business confidential 
information that is not available to the NIH.

    Mr. Regula. The Committee will be in recess. Mr. Sherwood 
will be back and he will preside for his questions. So if you 
will bear with us.
    Dr. Kirschstein. Certainly, sir.
    [Recess.]

                   EPIDEMICS OF DIABETES AND OBESITY

    Mr. Sherwood [assuming chair]. Well, after our short break, 
I am sure the Chairman will be back in a hurry. But we will 
just proceed a little bit, if that is all right with everyone.
    Doctor, I wanted to ask you about diabetes. Everything we 
have heard from both CDC and from Secretary Thompson has 
identified diabetes as an epidemic, and that they have changed 
the name from adult onset because of obesity in young folks and 
the huge, huge increase that we are having. But can you help me 
with the fact that in light of this drastic increase, the 
percentage of NIH budget devoted to diabetes since 1987, if I 
am correct, has decreased? I wondered if you would comment on 
that or if you have some ideas for us.
    Dr. Kirschstein. Mr. Sherwood, we have made enormous 
progress and have been providing resources for diabetes 
research in what I consider to be a very significant manner. As 
you look at percentages, that may be true, but the growth of 
the field has exploded. Dr. Allen Spiegel, who is the Director 
of the National Institute of Diabetes and Digestive and Kidney 
Diseases, would be pleased to expand on that.
    Dr. Spiegel. Thank you. You are indeed correct that all the 
CDC epidemiologic data, show that both obesity and type 2 
diabetes are continuing epidemics. The public health problems 
have increased dramatically even between 1990 and 2000, which 
is the period of their most recent data. As you astutely 
pointed out, the fact is kids and adolescents, are now showing 
up with type 2 diabetes. This will be emphasized in a New 
England Journal of Medicine paper from Yale researchers that we 
are going to see published this week. So it is highly 
prevalent, both obesity and even now, impaired glucose 
tolerance, a pre-diabetic state.
    However, as Dr. Kirschstein implied, we are attacking this 
problem vigorously. There is cause for hope and the possibility 
of reversing the epidemic. Specifically, for type 2 in kids, we 
together with other institutes such as the National Institute 
of Child Health and Human Development, are funding centers 
around the country for research on both prevention, as well as 
treatment. We are testing school-based, community-based and 
family-based interventions to prevent this problem and to treat 
it in those already affected.
    The greatest cause for hope, though, is the result of the 
NIDDK's major multi-center trial that the Secretary announced 
in a press conference August 8th of last year. This is a 3,200 
individual multi-center trial called the Diabetes Prevention 
Program, which showed that in individuals at high risk for 
development of type 2 diabetes, this disease could be 
prevented. We achieved a 31 percent reduction in the 
development of type 2 diabetes using a drug, Metformin, and a 
58 percent reduction using a lifestyle intervention involving 
modest changes in diet and exercise.
    Our challenge now, as a Nation, is to translate the results 
of this landmark clinical trial, so we can reverse these grim 
statistics.
    Dr. Kirschstein. Let me add, Mr. Sherwood, that in the 
session we will have tomorrow called From Bench to Bedside, we 
will have a number of the institute directors talking in more 
detail about how they have gone from research to the bedside of 
the patient and beyond. Diabetes will be one of the subjects.

           TRANSLATING DIABETES AND OBESITY RESEARCH FUNDING

    Mr. Sherwood. What you have just told us leads into my next 
question, in which you talked about early in your testimony. 
What we have heard from SAMHSA and the National Academy of 
Sciences, Institute of Medicine, is that as you said earlier, 
there is a 15 to 20 year lag between the discovery of effective 
forms of treatment and the translation into routine patient 
care.
    Isn't that exactly where we are with diabetes? Is it 
acceptable in this country that our delivery system, that it 
takes us so long to get the good work and the new knowledge 
that we have out into practice? I think diabetes maybe is a 
wonderful example of that. You have told us that obesity in 
children is such a problem of diabetes. Yet we do not seem, I 
do not see the links between behavior and our research. Where 
do you reach more young people than in public school?
    We have always had some physical training classes, or 
physical exercise classes in school. They have become a little 
bit passe lately, sort of out of touch, people think. I think 
we have to get something out in the public that reduces this 
obesity among the kids. I am interested in your comment on 
that, as well as the general lag.
    Dr. Kirschstein. We totally agree with you. Probably 
altering behavior, research on altering behavior is something 
that needs a great deal of attention. It is so easy for 
children to sit in front of a television set as opposed to 
getting out and exercising. Dr. Spiegel probably wants to talk 
about some other studies in that regard.
    Dr. Spiegel. The effort to combat this epidemic of obesity 
and diabetes is really a trans-NIH effort. In fact, it is a 
trans-Department effort. The Secretary himself is clearly 
passionate about it. I know this from hearing him speak about 
obesity and its association with type 2 diabetes on multiple 
occasions.
    In 1999, many of the institutes supported innovative pilot 
projects for obesity prevention. These were targeted at all age 
ranges. For example, women during pregnancy gain significant 
amounts of weight and then findthat very difficult to lose. 
Pregnancy is a high-risk period. Dr. Kirschstein has already mentioned 
TV watching. In one study kids were not allowed to watch TV unless they 
pedaled a stationary bike. During that period of time, they lost weight 
and watched less TV. [Laughter.]
    Mr. Sherwood. That's a win-win.
    Dr. Spiegel. Absolutely. As a Nation, we have to realize 
that obesity is not a cosmetic problem. It is a health problem. 
A Rand study just indicated greater health care costs from 
obesity than from either smoking or drinking alcohol.
    We have to mobilize against the environmental factors that 
pre-dispose to obesity.
    Mr. Sherwood. That might not be the way we want to sell 
that. [Laughter.]
    Dr. Spiegel. Through positive approaches and messages, we 
can make the environment more conducive to exercise and less 
conducive to eating the wrong foods and to eating excessively. 
This requires not just an NIH effort, but a national effort.
    Mr. Sherwood. Thank you very much. Mr. Miller.
    Mr. Miller. I think Mr. Jackson wants to go now.
    Mr. Jackson. I have a small emergency, I will be right 
back.

                                EARMARKS

    Mr. Miller. I have a chance to ask a couple more questions. 
Thank you, I am delighted.
    First I want to follow up on a question Mr. Cunningham 
asked. That was about this issue of earmarking, and it is a 
slippery slope that I think you all are concerned about, as we 
are. You read in the paper about Mississippi wants to earmark 
some money and you hear the Senate wants to earmark some money. 
But actually, when the Administration's budget request has an 
earmark for cancer, I mean, my wife had breast cancer, my 
father died of lung cancer, I fully support it.
    But it is an earmark, is it not? So I am not opposed to it, 
but if we are going to be opposing earmarks that Mr. Sherwood 
would have earmarked X number of dollars specifically for a 
diabetes program in his district in Pennsylvania, that's what 
we want to basically avoid to give you all to have a chance to 
have peer reviewed research. But it starts off when you all do 
an earmark of your own for us to avoid earmarking.
    Dr. Kirschstein. There is no question that a decision was 
made to specify a specific amount for cancer related research. 
I want to emphasize that, because research related to cancer 
also is of an enormous benefit to research, in other areas as 
well. And we do have an interdisciplinary field in which we 
feel that what is learned about one disease and one entity is 
important to the other.
    Dr. Fauci can give you examples of why we were able to move 
forward so rapidly when AIDS emerged as a disease, because of 
what we had learned about some cancer viruses which are related 
to the AIDS virus in certain ways. So I think we have to be 
very aware of the breadth of the science.
    Mr. Miller. I understand. I am just saying, you make our 
job more difficult on this issue of earmarking. Some people 
have analyzed the way money for cancer, for example, and divide 
it by the population, the number of people impacted by cancer 
versus the number of people impacted by AIDS. They say, look at 
the huge disparity. That is not the way we should look at it, 
either.
    So I understand. Let me switch to a slightly related issue. 
I have gotten a little more sympathetic to this issue about 
earmarking. My two colleagues on either side of me are not 
here, both good friends, but it concerns the geographic spread 
of the money. Both Mr. Istook from Oklahoma and Mr. Wicker from 
Mississippi make a case, their States have not gotten--not that 
they should have a fair share, I mean, I do not know where 
Florida rates, and that is not the critical thing, but we have 
some fine medical institutions that compete. I am sure Boston 
gets a very nice share because of all their institutions, or 
New York City.
    And there is a program to help bring States up. Again, we 
should not earmark just for Pennsylvania, which has a great 
school, but Mississippi, or those on the lower end of the 
scale. How are we addressing that issue without getting--there 
is some earmarking, I guess, in a separate program. But how are 
we addressing that? They should be asking the question, not me.
    Dr. Kirschstein. Mr. Miller, 23 States and the Commonwealth 
of Puerto Rico probably share less in the funding that is 
received from NIH than do the remaining States. We have been 
concerned about that for a number of years, because there are 
possibilities and there are biomedical research institutions 
within those States which are doing fine research.
    So in order to provide the opportunity for the biomedical 
researchers in those States, or individuals who would like to 
join their faculties, because there is something about a 
critical mass of scientists that leads to the ability to have a 
broad portfolio, we have provided a sum of money to each of the 
States to begin to develop programs. We are developing 
activities. We will continue to do that. That money will be 
increased in the President's 2003 
budget.
    We will work----
    Mr. Miller. How much money is that? How big a program 
isthat?
    Dr. Kirschstein. It is going to be $185 million in fiscal 
year 2003.
    This is not earmarked for an entity, it is not earmarked 
for a disease. It is to allow a State which, because of one 
fact or another, has been unable to develop the program it 
needs. It starts with asking that the State educational 
institutions, develop either one or two consortium efforts in 
which any school of higher education, junior college, college, 
professional school in the biomedical sciences, allied 
sciences, graduate schools, universities, work together to find 
some facet of activity in that State or develop some facet of 
activity in that State which can be brought to fruition. We 
will give them support for a defined amount of money to be 
divided equally among those 24 entities for three years, 
possibly renewal for three more.
    Mr. Miller. Just getting the broad support, because that's 
the very original question I asked, that we need for NIH, and 
understanding of it, I think it is important that we do not 
have a mandated division of how the money is spent. But I have 
seen it with other programs. I remember the National Endowment 
for the Arts, a controversial issue, but part of the problem 
was, most of the money went to a few cities, Washington, New 
York, Chicago, San Francisco, Boston. So other areas did not 
get very much of the money.
    That affects the support of that program. I saw that with 
Title I money. So now they mandate Title I money for rich 
school districts to get money, too. It does not really target 
economically disadvantaged. But I have been converted a little 
bit on this issue, that in order to get that support we need to 
help.
    I have time, I guess, for one more question. You just 
briefly touched on it, and that is the new building. Would you 
give us an update? Is that under our budget, the new building? 
We have to appropriate the money? That's what I thought. It's 
an amazing development, but where do we stand? I know the costs 
have gone up, the time line.
    Dr. Kirschstein. The funds for what will probably be an 
increase are not noted in the budget for fiscal year 2002 or 
2003. There are funds which have been appropriated already for 
2002 and construction is continuing.
    We are working with the Department and the Office of 
Management and Budget to find solutions for that. As soon as 
they have been found, we will come to the Committee.
    Mr. Miller. Has the completion been delayed because of it?
    Dr. Kirschstein. There will be some delay.
    Mr. Miller. When do you expect to move in it?
    Dr. Kirschstein. Probably in the late spring of 2004.
    Mr. Miller. Thank you very much.
    Mr. Regula [resuming chair]. Mr. Jackson.
    Mr. Jackson. Thank you, Mr. Chairman.

             NATIONAL CENTER ON MINORITY HEALTH DISPARITIES

    Welcome, Dr. Kirschstein, and thank you for your testimony.
    I have a series of questions, Mr. Chairman, that I am going 
to submit for the record. But I do want to ask four of Dr. 
Kirschstein this afternoon. Dr. Kirschstein, I was extremely 
pleased to note that the new National Center on Minority Health 
and Health Disparities made its initial awards for research 
endowments to several minority health professions institutions 
last year. I look forward to working with you and Dr. Ruffin to 
ensure that the research endowment program is formally 
established as a multi-year initiative.
    I am, however, concerned that other provisions of the 
legislation authorizing the new national center have not yet 
been addressed. As you know, and I hope that all the directors 
who are present are listening to this very clearly, because I 
am going to be, over the course of their testimonies before 
this Committee, asking them a series of questions about their 
understanding of this legislation. As you know, the authorizing 
legislation provided comprehensive authority for the Director 
of the National Center to coordinate health disparities 
research at NIH. The law also calls for the establishment of an 
advisory council on minority health and health disparities.
    In addition, the law provides for development of a 
comprehensive plan and budget for all NIH minority health 
research, that is, all of it, which is to be coordinated and 
approved by the Director of the National Center. I am hoping, 
Dr. Kirschstein, that today or soon you can provide the 
Subcommittee with an update on the progress that has been made 
in these areas. I guess that's my first question.
    My second question, in recent budget documents, NIH has 
identified a total of $2.4 billion that was directed towards 
health disparities research at the various institutes in fiscal 
year 2001. This amount included $74 million dedicated to the 
Office of the Director. It is my understanding that none of 
these additional dollars, $74 million, were provided to the 
National Center for Minority Health and Health Disparities. I 
am hoping that you could answer this question as well.
    Given that the primary responsibility for health 
disparities at NIH lies with the National Center, do you think 
that the Center could have benefitted from some of those 
dollars? Moreover, do you believe that the National Center 
could benefit from any future funds provided by your office for 
health disparities research at NIH? And lastly, Dr. 
Kirschstein, the fiscal year 2002 budget justification for NIH 
contained a chart which is supposed to be attached to 
something--oh, it's attached to my document, I'll share it with 
you shortly--which showed that NIH is spending about $2.4 
billion annually, or roughly 10 percent of its budget, on 
health disparities research. I am hoping you can provide a 
detailed breakdown of these dollars for the hearing and for the 
record.
    Thank you, Dr. Kirschstein, and thank you, Mr. Chairman.
    [The information follows:]

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Dr. Kirschstein. Thank you, Mr. Jackson. I will provide 
things in detail for the record.
    There are two things that might be discussed. I believe the 
legislation calls for there to be oversight and coordination by 
the Director of the National Center in cooperation with the 
Director of the National Institutes of Health. Secondly, in 
terms of the $74 million you were talking about, when that 
money was allocated by me, $20 million of it went to the then-
Office of Research on Minority Health. I think, if you will, 
I'd like to ask Dr. Ruffin to expand a bit on some of those 
answers, and particularly on the endowments.
    Dr. Ruffin. Thank you, Dr. Kirschstein, and thank you, Mr. 
Jackson.
    As you know, P.L. 106-525, which established the Center, 
the National Center on Minority Health and Health Disparities, 
had a number of statutory mandates that were listed. Prominent 
among those was a strategic plan, the endowment, the 
establishment of a loan repayment program, and also health 
disparities centers of excellence.
    On January 16th, I think, the Center celebrated its first 
year as a national center. I am very pleased to say to you that 
in each one of those categories that were listed, each one of 
the statutory mandates that were listed, that the Center, along 
with all of the ICs at NIH and certainly with the help of Dr. 
Kirschstein, have now established each of those programs.
    The strategic plan is now in place and has been turned over 
to Dr. Kirschstein for her review and subsequent review by all 
of the ICs, and then submitted to the Secretary for his 
approval and review. Then from there of course to the Congress.
    The endowment program particularly includes the 736 
institutions, institutions that were statutorily mandated by 
HRSA. We are working collaboratively with HRSA to establish the 
endowment program in those institutions. In fiscal year 2001, 
twenty institutions around the country were officially 
designated as 736 institutions. Of those twenty, about sixteen 
of them actually applied for the endowment program. Of that 
number, I think about five of those institutions received 
awards. There is a possibility that two other institutions may 
be awarded as well.

                         NCMHD ADVISORY COUNCIL

    Mr. Jackson. Dr. Ruffin, let me back up for a moment. I 
know my time is going to draw near.
    I remember questioning Dr. Varmus before this Committee 
several years ago. Dr. Varmus, I guess by the Cancer 
Institute's advisory committee, was given some advice for which 
he accepted the advice and moved forward. My understanding, 
after having questioned Dr. Varmus, that the history of 
advisory councils when they offer the director advice, they 
take the advice and then essentially accept the advice.
    But when the advisory council offers advice on the 
establishment of the Center, which I provided documents to this 
Committee, Dr. Varmus rejected the advice. Dr. Varmus--well, he 
rejected the advice.
    So when I asked the question about the advisory council and 
the establishment of it beyond the comprehensive strategic plan 
and the creation of that advisory panel, that if that advisory 
panel gives the director or the acting director of the NIH 
specific information or advice regarding minority health and 
health disparities, that the director relies heavily upon the 
advice of that advisory council, pan-NIH, across the entire 
spectrum of NIH.
    So what is the status of the creation of that advisory 
council that is supposed to advise the director of NIH 
specifically about health disparities and health research 
disparities across NIH? And that's an important question, 
because there is precedent for directors and acting directors 
of NIH to follow the advice of their council.
    Dr. Ruffin. As I understand it, the membership of the 
advisory council is now being finalized. We are certainly 
planning and hoping that that advisory council will be in place 
by May, and that the National Center will have its first 
advisory council meeting during that time.
    Mr. Jackson. Thank you, Mr. Ruffin. Thank you, Dr. 
Kirschstein, Mr. Chairman.

                              ORAL CANCER

    Mr. Regula. A few questions. First, one for Chairman Bill 
Young, who is sorry he could not be here.
    Chairman Young met in Florida with several dentists last 
week, and the topic of oral cancer came up. He was surprised to 
learn that one death occurs every hour in the United States due 
to oral cancer. He wondered if you could tell us what NIH is 
doing to work on early diagnosis and prevention of oral cancer.
    Dr. Kirschstein. The NIH, and particularly the National 
Institute on Dental and Craniofacial Research, is expanding its 
program. Dr. Larry Tabak, the Director, would like to answer 
that question.
    Dr. Tabak. Thank you, Mr. Chairman, for the opportunity to 
outline for you some of NIDCR's efforts. Head and neck cancer 
remains a disfiguring disease associated with a high mortality 
rate, as you have noted. Each year about 30,000 new cases are 
diagnosed.
    Mr. Regula. If I can interrupt, is it usually associated 
with tobacco? Either snuff or pipe or whatever?
    Dr. Tabak. Yes. Certainly two factors have been noted, 
tobacco being one, and alcohol use being the other. As a 
result, about 8,000 Americans will die each year from these 
diseases.
    About 90 percent of these cancers are so-called squamous 
cell carcinomas. These are cancers of the cells that line the 
inside of your cheeks, the floor of your mouth, your pharynx, 
your lips and the tongue. The incident rates for African-
American males are about 40 percent higher than white males. 
Yet the rates for African-American and white women are 
comparable. The overall survival rate is very much dependent 
upon the time of detection. So when detected at the earliest 
stages of the disease, the survival rate is about 80 percent. 
But if you are detected in the late stages, the survival rate 
drops to 22 percent.
    NIDCR has made significant investments in research in this 
area. In particular, the step wise progression of these types 
of cancer has been intensely studied. At each stage, the 
affected cells take on a unique signature. By recognizing what 
that signature is, you will begin to have the ability to detect 
the earliest stages of this disease at a time when the cell 
seemingly appears normal.
    As a result, investigators supported by NIDCR have been 
able to develop a test using the genetic material from cheek 
cells that have sloughed off into your saliva. It turns out 
that those cells have a signature identical to the cancer. So 
what this provides is a basis for reliable non-invasive tests 
using saliva as the medium to analyze.
    Obviously we are working very hard toward enhancing the 
translation of the fundamental scientific discoveries. Together 
with the NCI, we will be funding specialized programs of 
research excellence in head and neck cancer this fiscal year. 
We also currently support five state model programs for oral 
cancer prevention and early detection. These are located in 
Florida, Illinois, Michigan, New York and North Carolina. These 
are community based programs in which incidence and mortality 
rates are being defined for each state. Risk factor knowledge 
is being examined, both by practitioners as well as the 
subjects in the community, and health professional practices 
will also be determined.
    It is our hope that these types of studies will provide the 
basis for the interventions that will be necessary and can be 
uniquely tailored for the individual states that are 
represented.
    Mr. Regula. With a little bit of luck, can you get early 
detection and is it treatable?
    Dr. Tabak. Yes. In fact, if you detect this disease at its 
earliest stage, the survival rates are over 80 percent.
    Dr. Kirschstein. Mr. Chairman, I might add, for what Mr. 
Miller was talking about before, that this is a very clear 
example of research being done on cancer and its related 
activities in the Dental Institute and the collaboration that 
you heard about is a very important part of it.

                       GRANT APPLICATION PROCESS

    Mr. Regula. It seems to me, something else, procedurally to 
do the research, a university or a college or like Sloan 
Kettering or whatever, they submit a proposal to you to do 
research in a field, am I correct?
    Dr. Kirschstein. Yes, sir.
    Mr. Regula. And they will define the ways in which they 
hope to do this and what result they might achieve?
    Dr. Kirschstein. They will predict what might be the 
result, or they will pose a question about what might be the 
options of what they are finding. Sometimes if the area is 
ready for an expansion of research activity, rather than 
relying completely on investigators proposing to us what to do, 
the institute involved will issue a request for a grant 
application or in some cases, contract proposals inviting a 
series of applications to be submitted in that area. Then we 
will choose among them, based on the peer review system.
    The institute has then in that case probably decided about 
how much funds should be available for that particular area of 
research. I am sure this may have been something that Dr. Tabak 
did in the case of the Dental Institute. So they are 
anticipating a group of applications coming.
    Mr. Regula. And to determine what kind of an application 
you are going to seek, have you identified something that would 
benefit from research in, let's say, cancer or Parkinson's, 
whatever the case might be?
    Dr. Kirschstein. It depends on the stage at which you issue 
this. If it is clear that what is the need is to study the 
basic cancer cells and how you can develop a test to allow 
detection sooner, then that is what the request for 
applications will outline. If the institute feels that the 
field is further along and would benefit most by the 
development of a therapy, then it will issue something about 
that. If it thinks it requires increasing the need for being 
able to do images of the area involved, it will work on that. 
So it very much depends on the stage of the research.
    Mr. Regula. What kind of an institution initiates, let's 
say that Mayo Clinic decides it would be real profitable to do 
some research on juvenile diabetes. Could the institutes, 
clinics suggest to NIH, we think that there ought go be 
research in this field, and this is why?
    Dr. Kirschstein. Absolutely. Sometimes an investigator-
initiated research effort, or sometimes because they come 
together with others in a conference room or are discussing the 
issue from which arises a series of recommendations that the 
various institutions out there pick up, or the institute picks 
up and says to a large number of institutions, we think this is 
a fruitful area. If you wish to work in this, let us know.
    Mr. Regula. Can research lead you down a path you 
hadn'teven anticipated when you started out?
    Dr. Kirschstein. Absolutely. Yes. I can give you one very 
beautiful example. I have used this for many, many years. But 
it is a very nice, simple example. An investigator who asked 
the question as to whether or not the growth of bacteria would 
be inhibited by electrical fields. So he set up a series of 
petri dishes with bacteria growing on them, and put electrodes 
on and sent electricity through the dish. In only one dish was 
there inhibition. What was the difference?
    As he looked into it, that dish had a platinum electrode in 
it. The others were other metals. There was enormous inhibition 
of the growth of bacteria. He repeated it until he found it was 
really true. Immediately, serendipitously, he decided maybe 
this is really more than just bacteria being inhibited. That 
led fairly rapidly to the most important new anti-cancer drug, 
cisplatin.
    Mr. Regula. Well, I guess that proves the value of 
research. [Laughter.]
    Dr. Kirschstein. Yes, sir.

                            RESEARCH GRANTS

    Mr. Regula. Is a normal project about three years?
    Dr. Kirschstein. The average length of a research grant 
these days, is four years. They can submit requests for 
anywhere from three to five years, and the average is four 
years. That was actually something that has been true since we 
had a discussion with this Committee back in 1993, as I recall, 
when there was concern that there were a number of grant 
applications that were going on for five years and there were 
young people who could not get into the system.
    It was suggested by this Committee in its report to us that 
the average length be about four years.
    Mr. Regula. When you make a grant, you know it is going to 
be over four years, I assume you make the payout over a four 
year period to the grantee.
    Dr. Kirschstein. That is correct.
    Mr. Regula. Do you have obligated funds that you grant 
Institution X, a four year research project, do you obligate 
funds in case we don't appropriate enough new money?
    Dr. Kirschstein. No, sir. We obligate funds for one year, 
but we make a commitment to that institution and that 
investigator that there are funds provided in the budget for 
the next years. So you will see in the mechanism table that we 
submit for NIH as a whole and that each institute submits under 
research grants, you will see a line item for the total number 
of grants we anticipate paying for the year.
    That is divided into several parts, but the two major ones 
are the new and competing grants; that is new money that we are 
requesting and the Administration is requesting for that 
particular year. Then there is money that we are requesting in 
a commitment base that has carried over from the previous year 
for those grants to which we have assured the investigator, 
that because he or she has met the requirements of peer review 
and the importance of the work and has passed through council 
review, that we will pay as non-competing grants.
    Mr. Regula. I don't want to create any shock waves, but if 
we were to say, flat fund after the five year commitment, flat 
fund, would you be able to meet those obligations, for grants 
that are already in process?
    Dr. Kirschstein. In flat funding, yes, because the 
commitment would be almost enough. Now, Mr. Obey raised the 
issue of perhaps it would not quite be enough. But I believe it 
would be, and I think my budget people have told me that.
    Mr. Regula. So you would be comfortable?
    Dr. Kirschstein. There might not be any money for new 
grants but we actually were doing a modeling which said there 
would be funds.
    Mr. Regula. In other words, obviously you couldn't go to 
new ones.
    Dr. Kirschstein. We might be able to, depending on what one 
means by flat funding. Because the competing grants go for four 
years. So the ones that come to the four year end will turn 
into the non-competing grants for four years. They will create 
new money which is generated, so flat funding will have a 
certain amount of new money in it.
    Mr. Regula. Do your directors work with the grantees during 
the process of the work they are doing?
    Dr. Kirschstein. The staff do work closely with them, it's 
an ongoing dialogue.

                            CLINICAL TRIALS

    Mr. Regula. When you get a grant completed, and the results 
are back, is that information published?
    Dr. Kirschstein. Almost always.
    Mr. Regula. So the general public, the scientific community 
and the medical community, has access to all this?
    Dr. Kirschstein. First of all, they have access to all 
funded, information about funded grants through a web base that 
we have. It's called CRISP. If I'm not mistaken, the abstract 
and what is going on and the progress, for every grant that is 
funded, is available to anybody who wishes it.
    A lot of it is in scientific terms and it is most useful to 
the scientists. But scientists make progress in their work as 
they go through the period of the four years. And they will 
publish scientific papers along the way. If there is a 
discovery that is important, that will be translated into 
language that ends up in the press or ends up in a story that 
is accessible to the public.
    Mr. Regula. So a four year grant would have a flow of 
information during the period of time which would be on your 
web site?
    Dr. Kirschstein. Exactly.
    Dr. Baldwin. At the moment, it is the abstract of the 
project.
    Dr. Kirschstein. Yes, but that's fine.
    Dr. Baldwin. It would also include updated information.
    Mr. Regula. But the information is available?
    Dr. Kirschstein. Yes, absolutely.
    Mr. Regula. So if somebody is following the progress of 
this particular project, they could do so.
    Dr. Kirschstein. Furthermore, all of the clinical studies 
that are being performed with NIH money and perhaps with other 
money as well, are available to the public through a data base 
that NIH has up on the web called clinicaltrials.gov. Anybody 
who is seeking information about the most up to date treatment 
of certain diseases, (it is funded through the National Library 
of Medicine), can go to that data base.

                   GOVERNMENT PERFORMANCE REVIEW ACT

    Mr. Regula. I understand that OMB is working on the 
development of some basic research metrics. Tell the members of 
the Committee more about this. Translate that into layman's 
language.
    Dr. Kirschstein. The Government Performance Review Act 
requires that all Federal agencies develop a performance basis 
for determining how efficient and effective they may be. That 
is required on a yearly basis. Doing this for research which is 
not done in increments of one year, but is done over four, 
five, maybe more years, because it is a continuum, is a 
daunting task. But there are some aspects of it that can be 
done, and we are working with the Office of Management and 
Budget in development of a plan that might be able to do 
something about this, somewhat better than perhaps we might 
think.
    Mr. Regula. So this is ongoing. Will it be ready for the 
2003 grant proposals?
    Dr. Kirschstein. We have already done an assessment of 2001 
and 2002 by looking at our entire research portfolio and 
dividing it into areas such as those that are related to 
prevention and those that are related to therapeutics and so 
forth. We have had two such reviews performed by outside 
groups, members of the advisory committee to the director, as 
well as members of a second advisory group that we have, the 
Council of Public Representatives. We send them a number of 
books that are about this high describing all the 
accomplishments that the institute directors have selected them 
for that particular year. Usually it is not just--one can't 
divide it up into exactly what was done in one year. But there 
is a history. They go through them.
    The groups that have done this for the past two years have 
been enormously impressed by the accomplishments.
    Now, for 2003, we will be working with the OMB on some 
changes.

                      CHANGE IN MEDICAL EDUCATION

    Mr. Regula. Last question. Obviously you graduated from 
medical school a couple of years ago. How has medical education 
changed? You have seen it over a pretty long period of time. 
And a follow-up question to that is, do the NIH activities 
impact on medical education in the universities, colleges and 
so on across the Nation?
    Dr. Kirschstein. I think medical education has changed, 
because the science has changed. It was a much less complicated 
curriculum, I think, back in 1947 when I started medical 
school.
    I think there has been an attempt by the medical schools to 
change that curriculum. They are always thinking about how to 
make it better. There are some things I know they feel they 
need to change in ways that they have not yet done. There 
certainly is more education in the basic sciences, because 
there is more to learn. There are medical schools now as the 
one that you have in Rootstown that are based in community-
based hospitals as opposed to the large, more academically 
oriented hospitals. I think there is an emphasis on doing some 
things that allow doctors to treat patients more at the 
bedside.
    There are some things that are not taught in medical school 
that we feel researchers need to know. For that reason, we at 
NIH have developed a curriculum award for people who have gone 
through medical school who are in academic settings, want to do 
research, to learn about the ways one does clinical research, 
how to do a statistical analysis of a clinical trial, how to 
provide information that is needed the Food and Drug 
Administration, for an investigational new drug application, in 
order to be allowed to do the study. How to obtain, if needed, 
informed consent from a patient. How institutional review 
boards for clinical research do their work.
    So this is a field that is constantly evolving.
    Mr. Regula. Your activities at NIH do spill out into the 
medical education community.
    Dr. Kirschstein. In indirect ways as well, Mr. Chairman. 
Because of the importance of research in those medical school 
environments, NIH staff go and lecture and talk at those 
schools. Many of them have adjunct appointments.
    Mr. Regula. They go to the schools to lecture?
    Dr. Kirschstein. Yes.
    Mr. Regula. That's great.
    Dr. Kirschstein. We are not permitted, except in 
oneinstance which I will come to in a moment, to provide for support of 
the education of physicians who are training solely to be 
practitioners. We have one program where we are training people to be 
physicians and also researchers, the medical student training program, 
MSTP, for the double M.D.-Ph.D degree, which can support tuition. We 
can train and we do do a good deal of training of post-M.D. individuals 
in learning the craft of research in the specialties. We can even 
support funds for their tuition for special courses.
    Mr. Regula. Well, thank you. This has been a great hearing. 
You have all been excellent. I want to thank you for your 
wonderful service to the Nation.
    Dr. Kirschstein. Thank you, sir.
    Mr. Regula. And I want to tell you, you are a powerful 
argument against early retirement. [Laughter.]
    Dr. Kirschstein. Mr. Wicker said earlier, I think you were 
not here, Mr. Chairman, that he thought I had announced my 
retirement. I have not. [Laughter.]
    Mr. Regula. Whenever.
    Dr. Kirschstein. I am going to go back, I think, the job 
that I have rightfully held and is being held by the acting, 
the Deputy Director, unless the Director does not want me. 
Thank you very much.
    Mr. Regula. Thank you. The Committee is adjourned.
    [The following questions were submitted to be answered for 
the record:]

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                                          Thursday, March 14, 2002.

                     NATIONAL INSTITUTES OF HEALTH

                               WITNESSES

DR. RUTH L. KIRSCHSTEIN, M.D., DIRECTOR, NATIONAL INSTITUTES OF HEALTH
DR. ANDREW VON ESCHENBACH, M.D., DIRECTOR, NATIONAL CANCER INSTITUTE
DR. ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND 
    INFECTIOUS DISEASES
DR. ALLEN SPIEGEL, M.D., DIRECTOR, NATIONAL INSTITUTE OF DIABETES AND 
    DIGESTIVE AND KIDNEY DISEASES
DR. RICHARD HODES, M.D., DIRECTOR, NATIONAL INSTITUTE ON AGING
DR. AUDREY PENN, M.D., ACTING DIRECTOR, NATIONAL INSTITUTE ON 
    NEUROLOGICAL DISORDERS AND STROKE
SUSAN QUANTIUS, ASSOCIATE DIRECTOR FOR BUDGET
KERRY WEEMS, DEPUTY ASSISTANT SECRETARY FOR BUDGET, DHHS
    Mr. Regula. We will get started here. Thursday is going 
home day for members, so we have to get moving or we will lose 
them. Members commute, many, many even to California every 
week. I don't know how they handle the time change but they do. 
I would judge that probably two-thirds of the body pretty much 
commutes regularly. I haven't spent a week in here for years 
and haven't missed it either.
    We are happy to welcome you back, Dr. Kirschstein. I met 
your nice husband. Together, you two have been a wonderful 
asset to this Nation. We appreciate what you mean to him. You 
will leave a legacy that will go far beyond your life or mine. 
Not everyone has that kind of privilege in this Nation, to 
leave something of lasting value that helps people for long 
term benefits.
    Thank you all for coming. Dr. Kirschstein, you will make a 
brief statement for us and then introduce the members of your 
panel for their statements. We will be pleased to hear from 
you.

                            Opening Remarks

    Dr. Kirschstein. Thank you, Mr. Chairman.
    Indeed, I do feel privileged to have served this country.
    The Institute and Center directors of the individual units 
collectively constitute the National Institutes of Health and 
are pleased to have the opportunity over the next month or so 
to expand on these activities beyond the overview that you 
received yesterday. This will be accomplished through a series 
of panel discussions. Although each panel will only have a 
small number of participants, the area that will be covered at 
each session is of interest to, within the missions of, and 
broadly supported by all the Institutes and centers.
    The clinical research advances listed in my opening 
statement are but a few selected to be representative of and to 
frame the theme for today's hearing, ``From Bench to Bedside 
and Beyond.'' Such translational research illustrates progress 
from a basic discovery, usually at the laboratory level but not 
necessarily, to the patient's bedside and indeed in some areas 
beyond to the public as a whole.
    As I said, I have provided in the written statement, 
several examples of that. My colleagues will now each present a 
small opening statement, I will introduce.

              GENESIS OF THE NATIONAL INSTITUTES OF HEALTH

    Mr. Regula. When was the NIH started?
    Dr. Kirschstein. 1887.
    Mr. Regula. What was the genesis of it? I know CDC was a 
result of the Civil War. How did it come about?
    Dr. Kirschstein. The genesis of the National Institutes of 
Health was that in that period of time, post-Civil War, there 
was a great influx of immigrants to the United States, there 
was also a great deal of trade being carried on by our Merchant 
Seaman Service, both across the Pacific and from Asia and in 
the East Coast from Europe.
    The people who took care of the merchant seamen when they 
were ill were in the commissioned corps of the United States 
Public Health Service, one of the uniformed services. Those 
merchant seamen were bringing into this country, as were the 
immigrants, large numbers of very, very serious infectious 
diseases, cholera, plague, smallpox, tuberculosis also malaria 
but it came another way. There was deep concern that we in this 
country had very little research going on. It was decided that 
a physician at the United States Marine Hospital on Staten 
Island would be sent to Europe to study in the great European 
laboratories of Koch and Pasteur to become a researcher able to 
handle that.
    He came back after a year or so and established a one-room 
laboratory on the top floor of that hospital that was called 
the Laboratory of Hygiene.
    Mr. Regula. This was in New York?
    Dr. Kirschstein. In New York on Staten Island.
    Early in the 1900s, that was expanded and the group moved 
to Washington, downtown, to the Butler Building I believe it 
was called. At that point, it became known as the National 
Institute of Health, singular, indeed continuing to study the 
scourges of the day that were killing vast numbers of people. 
The headline in the New York Times almost every day was ``New 
Epidemic Hitting,'' yellow fever or something of the sort.
    Then in 1937, a group of researchers and physicians at 
Harvard decided that the United States Government needed a 
cancer program. They wrote the President and a separate 
laboratory was set up at Harvard that became the National 
Cancer Institute, moved down and joined the single Institute 
which was the Hygienic Institute or the Microbiology Institute, 
the Institute that Dr. Fauci is now director of, and then new 
institutes were formed. The next one was the Heart Institute, 
then Mental Health and then Neurology and collectively then the 
name was changed to the National Institutes, plural, of Health. 
It moved out to the Bethesda campus in 1940.
    Mr. Regula. So there is no single founder in a sense?
    Dr. Kirschstein. The public founded, the Congress founded 
the National Institutes of Health.
    Mr. Regula. What a wonderful legacy that the people at that 
time had the vision to do this. I guess it is our 
responsibility to carry on.

                            Opening Remarks

    Dr. Kirschstein. Yes, sir.
    The panel members will now present. Dr. Andrew von 
Eschenbach, the newly appointed Director of the National Cancer 
Institute, will present his statement, followed by Dr. Anthony 
Fauci, the Director of the National Institute of Allergy and 
Infectious Diseases; then Dr. Allen Spiegel, Director of the 
National Institute of Diabetes and Digestive and Kidney 
Diseases who will discuss primarily diabetes. Dr. Fauci will 
discuss primarily vaccines. Then we will have Dr. Richard 
Hodes, Director of the National Institute on Aging who will 
discuss primarily Alzheimer's Disease; and Dr. Audrey Penn, 
Acting Director of the National Institute of Neurological 
Disorders and Stroke will discuss primarily Parkinson's 
Disease.
    [The information follows:]

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    Dr. von Eschenbach. Thank you.
    Mr. Chairman and members of the subcommittee, I am Dr. 
Andrew von Eschenbach, Director, National Cancer Institute.
    If I can begin with a small editorial comment, I want to 
thank you for your kindness and graciousness in recognizing Dr. 
Kirschstein yesterday morning for her 46 years of service to 
this country and to her husband, Dr. Rabson this morning for 
his 46 years of service to the National Cancer Institute. He 
was the Acting Director before I arrived. I can assure you that 
if you see how hard they both work, you can actually double 
those years in contribution.
    I am very pleased for the first time to join my 
distinguished colleagues from NIH to discuss translational 
research and other activities supported by the NCI. The budget 
increases you have made possible over the past several years 
have allowed NCI to pursue an aggressive path of discovery in 
cancer research. While our journey is far from over, we 
continue to see promising results from these efforts. The 
latest statistics from our soon-to-be-released report to the 
Nation show that overall cancer mortality continues to decline. 
During the period 1990 to 1999, cancer death rates decreased by 
almost 6 percent, approximately 134,000 lives saved over that 
period.
    The mysteries of cancer are yielding ground to our 
relentless and substantial commitment to research and the 
knowledge we gain in the laboratory is being translated into 
new interventions in the clinic to prevent and treat this 
disease. This is bench to bedside. While there are many 
chapters being written in this story, I would like to focus on 
one of the most recent advances that is represented on this 
poster.
    [The information follows:]

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                           CANCER METASTASIS

    How cancer cells metastasize or spread to other parts of 
the body and kill and what we are going to do to stop this 
process is the focus of the poster. For decades in the clinic, 
physicians have recognized that cancer cells from certain 
organs have a characteristic propensity to spread to specific 
parts of the body. For example, lung cancers typically spread 
to the brain; prostate and breast cancers preferentially 
metastasize to bones. The question has been why. How do cancer 
cells know where to go?
    Mr. Regula. If you put a cancer cell on a slide and another 
cell, what would be the difference?
    Dr. von Eschenbach. The cancer cell would be abnormal both 
in its shape and its configuration and would have an abnormal 
appearance that a pathologist could recognize as being 
distinctly different from the normal.
    Mr. Regula. Do you know what makes that happen?
    Dr. von Eschenbach. We are beginning to understand that 
process at the genetic level. We know that there are certain 
genes that are abnormal that result in abnormal proteins that 
alter the structure and the function of that cancer cell such 
that it behaves in a malignant fashion.
    Mr. Regula. Does a cancer cell start out as a good cell?
    Dr. von Eschenbach. There are cells that start out as good 
cells that are then subsequently altered or damaged by a 
variety of mechanisms that then give rise to this malignant 
cascade of abnormal cells.
    Mr. Regula. Do we all have some cancer cells in our bodies?
    Dr. von Eschenbach. It is understood that at some point in 
time in our lives all of our cells are damaged to the extent 
that they could become cancer but our bodies have ways of 
repairing that damage. Ultimately, in one of two men and one of 
three women in this country, that process will emerge to an 
actual cancer. So it threatens all of us.
    Mr. Regula. So your mission is to try to alter the cancer 
cell so it doesn't misbehave or to keep it from happening?
    Dr. von Eschenbach. Both, sir. In the past, our strategy 
had been to just hopefully find the cancer and destroy it. Now, 
today, with this research, we are able to hopefully find it, 
alter it and change its behavior, control it and even prevent 
it.
    Mr. Regula. So the new therapy is not to excise it but to 
control it?
    Dr. von Eschenbach. That is correct, to complement what we 
have done before by also being able to control cancer much like 
we can control other diseases like high blood pressure. We may 
not be able to cure it but if we can control it and keep it 
from killing or destroying someone's life and creating the pain 
and suffering, then we will have succeeded.
    Mr. Regula. The killing mechanism is that it crowds out, it 
grows rapidly and crowds out healthy tissue?
    Dr. von Eschenbach. That is one of the processes. In fact, 
the reason to use this particular example of metastasis is that 
metastasis that spreads to other parts of the body is usually 
associated with the lethal or killing form of cancer. If we can 
prevent spread and metastasis, we may be able to stop the 
killing type of cancer that we encounter.

                               ZIP CODES

    Mr. Regula. Thank you. I am sorry to interrupt.
    Dr. von Eschenbach. Not at all. So in this attack on 
metastasis and understanding how and why these cancer cells 
spread to other parts of the body, we have taken that question 
from the clinic to the laboratory to explore. NCI funded 
researchers have now determined that there are unique proteins 
on the surface of the cancer cell and that these proteins act 
like zip codes. When the cancer cell gets into the bloodstream, 
these zip codes on the cell can direct it only to specific 
locations or mailboxes that have that address.
    For example, within the bone, there are unique receptors 
for the zip code protein that is present on prostate cancer 
cells. Your research dollars have made these discoveries 
possible and future research dollars will support taking this 
knowledge from the laboratory back to the clinic by developing 
interventions that could erase the zip codes so that the cancer 
cell can never get to its destination or use the zip codes to 
address cancer killing smart bomb therapies that will go only 
to the tumor site.
    These and many other exciting chapters in our story of 
scientific discovery are yet to be fully realized but are well 
on the way to being written. Mr. Chairman and members of the 
subcommittee, the goal of the National Cancer Institute is to 
wisely spend the dollars proposed in the President's budget for 
further scientific discovery such as these and then to 
translate that discovery into methods that will detect, treat 
and prevent cancer. Only when we have saved lives and restored 
the quality of life in the one of two men and one of three 
women who will develop cancer, will our mission be complete.
    I thank you for the opportunity to testify about this 
important aspect of cancer research and I will be pleased to 
answer your questions.
    Mr. Regula. Thank you.
    Dr. Kirschstein. Dr. Fauci.

                 CONCEPTION AND DEVELOPMENT OF VACCINES

    Dr. Fauci. Mr. Chairman, Mr. Miller and Mr. Peterson, it is 
a pleasure to be here with you again.
    In the two to three minutes allocated to me, I am going to 
talk a bit about the conception and development of vaccines and 
the role of the NIH in vaccine development, which really stands 
as one of the important prototypes of the true bench-to-bedside 
concept we are discussing here this morning.
    I have outlined on this slide, the fundamental basis for 
the development of vaccines which is really anchored on the 
concept of basic research for which the NIH takes a major 
responsibility in the collaborative effort between industry, 
academia and the NIH.
    [The information follows:]

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    If one looks at the steps, I have done this schematically 
in a metaphorical way here, looking at the development 
ultimately of a vaccine, we learn about the pathogenesis of 
microbes, look at ways to enhance the immune response, there is 
clinical evaluation and ultimately one develops a vaccine.
    If you were to pick out what the top economically important 
components of what the NIH does in cost benefit in health to 
the Nation, without a doubt vaccines has to be on everyone's 
short list in that regard. Let me give you some very brief 
examples.
    These are just four representative examples of vaccines 
that have been developed at the NIH together with our 
industrial partners, concepts that were formulated either at 
the NIH or by NIH-funded grantees and contractors. On the 
righthand side of the slide are the potential lives saved each 
year from the proper execution of these vaccine programs.
    [The information follows:]

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    As you can see, four key examples--Hepatitis B, Haemophilus 
influenzae type b, acellular pertussis, and pneumococcal 
conjugate. If I take this one, Haemophilus influenzae type b, 
which was developed in collaboration with the Child Health 
Institute, in just a few short years, we have taken a disease 
that had been the primary cause of microbial-induced deafness 
and mental retardation in children in the United States and 
worldwide, and essentially are on the brink now of eliminating 
that infection in much the same way as we have eliminated 
smallpox and are well on our way to eliminating polio, both of 
which were done through vaccinology.
    This last poster tells us about the challenges for the 
future because although the victories have been most 
extraordinary over the past several decades, we still have a 
lot to do. These are some of the challenges that we will be 
facing and hopefully I will have the opportunity to discuss 
before this committee in years to come. That is, the challenges 
for an AIDS, malaria and tuberculosis vaccine, the three great 
killers in developing nations, and the threat we find ourselves 
in unfortunately in our Nation today, the threat of 
bioterrorism. Vaccines will be one of the major tools, 
particularly those new and improved vaccines against smallpox, 
anthrax and other frightening diseases such as ebola. These are 
going to be the goals and the milestones for which we will aim 
over the next few years.
    As I mentioned, hopefully we will have some important 
results for you over the next few years.
    Thank you very much for giving me this opportunity and I 
would be happy to answer any questions.

                           DIABETES RESEARCH

    Mr. Regula. Thank you. Dr. Allen Spiegel.
    Dr. Spiegel. Thank you, Mr. Chairman.
    The research mission of the National Institute of Diabetes 
and Digestive and Kidney Diseases encompasses a wide array of 
chronic disabling diseases. Today, I have been asked to focus 
my remarks on diabetes, but I would be pleased to take 
questions on all of our programs.
    Diabetes research is an excellent example of how 
fundamental discoveries in the laboratory are translated into 
clinical research, and then beyond, to improved public health.
    The poster illustrates what research has taught us about 
the stages in the natural history of diabetes. People with 
diabetes progress from being able to maintain a normal blood 
sugar or glucose level to a pre-diabetic state termed IGT, then 
to overt diabetes. In both major forms of the disease, type 1 
and type 2 diabetes, poor control of blood sugar leads to 
abnormal blood vessels in the eyes, kidneys and nerves. If 
unchecked, these blood vessel complications of diabetes can 
progress to blindness, amputations, and kidney failure, and to 
death most often from heart disease.
    NIH supported research has shown that prevention is 
possible at each stage of the disease: preventing disability 
and death from the complications, preventing the complications 
themselves, and perhaps most importantly from a public health 
point of view, even preventing the development of diabetes. 
Given time constraints, I will just give a few examples of how 
research at NIH has made prevention possible.
    Basic research has shown that elevated blood glucose 
activates a protein termed PKC, leading to the diabetic 
complications. Specific inhibitors of PKC were shown to block 
development of the complications in animal models of diabetes. 
Currently, these inhibitors are being tested to prevent 
diabetic complications in humans in advanced clinical trials.
    Type 1 diabetes affects nearly a million Americans, mostly 
children. Fundamental research has illuminated how a 
malfunctioning immune system destroys the insulin-producing 
beta cells of the pancreas causing this disease. This knowledge 
has led to several approaches for re-educating the immune 
system, with the goal of preventing type 1 diabetes in those at 
risk. These approaches are being rapidly tested in NIH-
supported clinical trials.
    In parallel, we have a vigorous program aimed at more 
effective treatment, and indeed, complete cure of type 1 
diabetes in those already affected. New hope emanates from 
successful preliminary studies in which transplantation of beta 
cell clusters known as islets has restored natural insulin-
producing capacity to type 1 diabetes patients.
    Turning to type 2 diabetes, which affects approximately 15 
million Americans, we see a disease that is reaching epidemic 
proportions in the U.S.--rising in incidence by nearly 50 
percent just from 1990 to 2000. Basic research has identified 
new targets for more effective treatment of type 2 diabetes.
    Clinical trials have shown that, with effective treatment, 
the complications of both forms of diabetes can be prevented.
    NIH-supported research also shows that primary prevention 
of type 2 diabetes, a critical public health goal, is possible. 
Last August, we announced impressive results from a major 
multicenter clinical trial, the Diabetes Prevention Program or 
DPP. Modest improvements in diet and exercise decreased the 
development of type 2 diabetes by a remarkable 58 percent in 
high-risk individuals in the trial. Now, we are working on 
methods for cost-effective translation of the DPP results to 
the estimated 20 million Americans with IGT who are at high-
risk for type 2 diabetes. Prevention efforts offer our best 
hope of stemming the tide of this diabetes epidemic and 
averting the huge burden of suffering and health care costs.
    Thank you for your attention.
    [The information follows:]

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    Dr. Kirschstein. As we turn to the members sitting to the 
right, I also would like to introduce Mr. Kerry Weems who is 
from the Department.

                          ALZHEIMER'S DISEASE

    Mr. Regula. We are beginning to get to know him well.
    Dr. Kirschstein. Dr. Hodes from the Aging Institute.
    Dr. Hodes. Thank you. It is a privilege to be here 
testifying before the subcommittee again.
    The National Institute on Aging has as its mandate efforts 
to improve the quality of life for older men and women through 
addressing a variety of conditions.
    Mr. Regula. What is the definition of older?
    Dr. Hodes. It is generally 10 to 20 years older than 
oneself. [Laughter.]
    Mr. Regula. Touche.
    Dr. Hodes. Among those many conditions, it is my 
opportunity this morning to talk about Alzheimer's disease, 
amajor cause of dementia that affects some 4 million Americans 
currently, with devastating effects on those affected, as well as loved 
ones, caretakers, and ultimately society. This in the context of an 
aging American demography, projects a risk of several times this number 
of Americans will have Alzheimers Disease in decades to come.
    It is hard now to remember that as recently as 30 years ago 
there was really not an appreciation of the fact that 
Alzheimer's existed as a discrete condition. It is on that 
background, that it is a real pleasure to talk about the 
progress that has been made and the experimental laboratory 
bench to bedside approach that has been taken to understanding 
and approaching this disease.
    Basic research in the area of epidemiology has identified a 
number of risk factors, meaning factors that put people at high 
risk for developing Alzheimer's disease. Among these is the 
identification of several genes which can when mutated, 
actually cause the disease. This has led to an understanding of 
the biochemistry, the cellular events that underlie the 
Alzheimer's disease process and has allowed for the first time 
in recent years the development of animal models so that one is 
now capable of taking the genes that can cause Alzheimer's 
disease in humans, incorporating them into mice and seeing in 
those mice some of the brain lesions characteristic of 
Alzheimer's disease, as well as some of the memory and learning 
deficits.
    For the first time as illustrated here, this means one can 
now take drug development through stages that involve animal 
models, preclinical research looking for those interventions 
which are most promising, and then taking them on to clinical 
trials.
    [The information follows:]

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                   PREVENTION OF ALZHEIMER'S DISEASE

    There is as yet no effective prevention or curative 
treatment for Alzheimer's disease, but again through the budget 
that has been made available to NIH and the National Institute 
on Aging over the past years, we have been able to take these 
dramatic advances in basic science and translate them into 
current clinical trials numbering some 18,007 of which are 
large scale prevention trials.
    Prevention trials in the case of Alzheimer's disease are 
particularly important since it is far more likely that we will 
be able to succeed in preventing damage than to reverse cell 
death and dysfunction of the brain once it has occurred.
    The second poster illustrates an example of the specificity 
with which we now understand some of the processes that 
underlie Alzheimer's disease. It is an illustration on the top 
right of the beta amyloid plaque. This is the plaque lesion 
that is seen in the brains of individuals with Alzheimer's 
disease. As a result of research over the past several years, 
we have learned that plaques consist of material called amyloid 
peptide which in turn is the product of the beta amyloid 
precursor, that red bar you see in the surface of all normal 
cells. We now understand that to translate that normal protein 
into the plaque typical of Alzheimer's disease requires the 
activity of a number of enzymes, beta and gamma secratase. It 
is only when these scissors work together to cut the normal 
protein in such a way that they produce this amyloid peptide 
that causes plaques and may lead to memory loss in animal 
models and in at least some human genetically determined cases 
of Alzheimer's disease.
    Armed with such information, we are now capable for the 
first time of designing interventions to remove or prevent the 
formation of amyloid plaques, to interfere with the enzymes 
that cause the disease. We face a situation in which although 
the cure is not yet in hand, scientists, investigators and all 
of us, I think, have reason to be hopeful this improved 
understanding will translate to effective treatment and 
ultimately prevention.
    Mr. Regula. Where they could take the cell out and take out 
the gene that creates Alzheimer's and then put it back in? 
There was a story recently.
    Dr. Hodes. Yes. About 10 to 15 percent of Alzheimer's 
disease is early onset, familial, genetic. In those cases, 
there is a mutation in a single gene which causes Alzheimer's 
disease. It is inherited so one can predict by looking at the 
cells passed on from mother or father to offspring whether that 
individual will be at risk for Alzheimer's or not.
    The article referred to the ability to look at a fertilized 
egg from a mother or father who carries the disease and ask 
whether a given egg is one of the 50 percent that will carry 
that Alzheimer's gene or is one of the 50 percent that will 
not. Clearly the ethical and societal implications of this are 
enormous, but in terms of the ability to translate science to 
knowledge, it is possible by that sort of test to identify 
whether in that instance a mother or father has or has not 
passed on the gene for Alzheimer's disease to a child.
    This is now possible in that minority, 10 to 15 percent, of 
Alzheimer's cases that are of known genetic origin, but is not 
true of the bulk of late onset Alzheimer disease.
    I thank you for the opportunity to present these examples 
and look forward to a chance to discuss with you further any 
issues of interest to the committee.
    Dr. Kirschstein. Dr. Audrey Penn, the Acting Director of 
the Neurological Disorders and Stroke Institute.
    Dr. Penn. Good morning.

                          PARKINSON'S DISEASE

    Important developments from several types of basic 
neuroscience are coming together to reveal the causes of 
Parkinson's disease and to identify treatments.
    Parkinson's is a debilitating neurodegenerative disease 
which results from loss of dopamine nerve cells in specific 
clusters deep in the brain. Thirty years ago, scientists at the 
bench found the signaling molecule dopamine was concentrated in 
these basal ganglia. You can see the white region on the left, 
and what is lost in Parkinson's brains as you see on the right.
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    This resulted in the first effective medical therapy, L-
dopa, which replaces the dopamine. Neurosurgeons had for years 
tried unsuccessfully to control the abnormal movements of 
Parkinson's by making small wounds or lesions in the main motor 
pathways from the brain to the spinal cord.
    In 1954, during such a surgery, the inadvertent 
interruption of a small artery which supplied the key basal 
ganglia, strikingly improved a Parkinson's patient, and surgery 
aimed at the basal ganglia was a major therapeutic strategy 
until the advent of L-dopa, when it was abandoned. However, we 
all know that L-dopa is not a perfect therapy.
    Years of neurophysiological investigations of control of 
movements using microelectrodes to measure the electrical 
activity emanating from the cells in the basal ganglia, the 
large complex there, have now permitted specific targeting of 
surgery in Parkinson's. Even more importantly, simply 
stimulating key targets, a small area no bigger than a green 
olive deep in the brain, is really strikingly improving 
patients.
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    Deep brain stimulation is providing benefit while 
extraordinary investigative efforts are providing new 
information as to the mechanisms of this disease.
    The availability of families with multiple members affected 
with Parkinson's allowed identification of defective genes, and 
then the defective proteins, now known to be important to 
mechanisms of degeneration, since they are involved in the 
production of the characteristic pathology, in this case Lewy 
Bodies. In turn, understanding the cellular roles of these 
proteins suggests new therapies. Detective work at the bench 
showed the ``frozen'' heroin addicts recognized to have severe 
Parkinsonian rigidity had been damaged by a byproduct of heroin 
called MPTP, and now we expose animal models to this MPTP and 
we have great models to examine mechanisms, and to test our new 
therapies.
    Our investigators are very enthusiastic about all of this 
new information and are working together ensuring resources to 
pursue all clues. Some of this cooperation has developed as the 
scientists of the 11 Udall Centers meet regularly and focus on 
Parkinson's disease. The scientists agree that the rate of 
progress is impressive.
    All current therapeutic strategies arose from fundamental 
bench research, which was furthered by cross fertilization from 
applied research and other neurodegenerative diseases. At 
multiple stages, clinical studies have generated, and continue 
to generate, new questions for the basic scientist to address. 
As the interrelationships between the likely mechanisms of 
damage become clearer, we come even closer not only to 
therapies, but also to prevention.
    I would be pleased to answer any questions.
    Mr. Regula. I want to say at the outset, I admire all of 
you and the work you do. I don't think people fully appreciate 
how important your work is to their well being. We just sort of 
take these things for granted but all of you do the work of the 
Lord.
    Mr. Miller.

                            CANCER RESEARCH

    Mr. Miller. Dr. von Eschenbach, congratulations on your 
appointment.
    As the Chairman said, it is always an honor to have you all 
here. I always feel guilty that you only get two to three 
minutes to talk. I feel bad that we have so many conflicts of 
meetings at this time that we don't get a chance to be able to 
participate. I also feel at times that you are just so over our 
heads as lay people here.
    You keep using John Porter's comment as the crown jewel and 
unfortunately not as many people realize what we have. I think 
it is unfortunate.
    I remember at a county commission meeting in my hometown. 
My wife is very active in the library system and they were 
asking for more money for the library. The county commissioner 
asked the director of the library, have you read every book in 
the library and he said no. He said, well, why do you need more 
books. Sometimes politicians don't realize what we have. I 
think we need to do more to toot our own horn.
    There was a story on television the other day about a big 
book store in Northern Virginia on Soviet studies that is going 
out of business, the largest one in the western world. They 
went bankrupt and went out of business. All of us remember the 
Cold War and actually Russian studies, Soviet studies was a big 
issue at universities with big programs. Now there is not much 
interest in that, it has changed dramatically. Russian studies, 
the Russian language is no longer at the forefront of our 
interest because of the collapse of the Berlin Wall and what 
has happened since then.
    Do you see those type breakthroughs that your successors 
will be like? Will you or your successors in 2012 be talking 
about the same things? How will it change and be different in 
2012 or 2017? There is so much in the pipeline. You see a lot 
of the studies going on. Are you going to be out of business in 
12 years?
    Dr. von Eschenbach. God, I hope so. I think your point is 
an important one. What I have seen is we are beginning to 
change our approach to cancer so that by understanding it at 
the biologic level, one, we will change it to a chronic disease 
that we can manage; two, hopefully completely eliminate it but 
much of the knowledge we gain could be then applied to many 
other diseases. So although we will go out of business, the 
yield will be more widely applicable.
    For example, research done in cancer to understand how 
cancer cells induce the development of blood vessels to get 
food and oxygen, that research has led to treatments now being 
applied to problems like macular degeneration and diabetic 
retinopathy in the eye. We hope to put ourselves out of the 
cancer business but at the same time able to use the products 
and benefits of our research that will then benefit other 
diseases over time.
    Mr. Miller. Do you think you will be treating prostate 
cancer? I was told there was a chance anybody who was old 
enough would get prostate cancer. It is extremely slow growing 
so maybe you don't need to do much about it. Are we still going 
to be worrying about prostate cancer or breast cancer 12 years 
from now?
    Dr. von Eschenbach. I think both of them are particular 
examples of this new concept. With prostate cancer, we know 
many men develop prostate cancer, it remains relatively 
innocuous and they live their entire lives and die with it 
rather than from it.
    On the other hand, there is a subset of men who have a very 
virulent form of the disease and prostate cancer is the second 
leading cause of death in men. So one of the purposes of this 
kind of research is to understand the differencebetween the 
two. Why are some prostate cancers innocuous, why are others virulent 
and more importantly, once we know that, can we change the virulent 
ones into the innocuous ones and then men can live perfectly normal, 
healthy lives with us controlling their cancer and not having to put 
them through the radical kinds of treatments that we have had to use to 
this point in time?

                           CONQUERING DISEASE

    Dr. Fauci. Speaking about going out of business, I remember 
in 1968 when I was driving down from my residency at the New 
York Hospital on my way to take an infectious disease 
fellowship at the NIH. At that time, literally as I was driving 
down the New Jersey Turnpike, there was an announcement that 
then Surgeon General William Stewart had announced that now 
with antibiotics and vaccines, the problems of the world with 
infectious diseases are over and we should be concentrating on 
chronic diseases.
    When I got to the Baltimore Harbor Tunnel, I wanted to turn 
around and go back to New York because I didn't need to take an 
infectious diseases fellowship. As we know, since then, we have 
had the HIV epidemic, emerging and reemerging diseases and now 
we have the threat of bioterrorism.
    From the standpoint of infectious diseases that delicate 
balance between microbes and the human host is one that we must 
continue to stay ahead of. That has to do with understanding 
the microbes better. What I foresee in years to come is having 
the sequences, the genomic sequences of essentially all of the 
pathogens and being able to identify targets for diagnostics, 
for therapeutics and for vaccines so that as new diseases 
emerge, the human species will in fact stay very much ahead of 
the curve as opposed to chasing epidemics.
    I think we have a lot of work ahead of us but only by 
continuing the intensity of the research are we going to stay 
ahead of that curve.
    There will be a never-ending interaction between microbes 
and the human species. I believe we will conquer HIV/AIDS with 
a vaccine and with even better therapies but other diseases 
will come along, the same way the flu pandemic came along in 
1918 and wreaked such havoc on the population. I think it is 
naive to think that we are not going to see other microbes in 
the future do the same thing.

                              HIV VACCINES

    Mr. Regula. What is in the pipeline now at the different 
phases of testing for AIDS, for HIV?
    Dr. Fauci. Actually this has been a very important year 
with regard to the concepts of HIV vaccines. At the national 
conference in Seattle just last month, there were a couple of 
concepts, one that we are doing in collaboration with the Merck 
Company in a vaccine that incorporates putting together genes 
from different viruses so that you can vaccinate someone with 
an adenovirus which is a common virus that infects man but that 
has the genes of HIV inserted into the adenovirus so that it 
can act in a way that stimulates a very potent immune response.
    We are going to be going into advanced phase studies in the 
next couple of years. We are already in Phase I studies. So the 
news is starting to look much better. We have been before this 
committee many years in the past talking about caution in 
thinking that we are going to win this war in the next year or 
so. It is going to be a long way but I am very optimistic about 
what has gone on over the past couple of years in the area of 
HIV vaccines.

                         HUMAN GENOME SEQUENCE

    Dr. Spiegel. Your tremendous support has allowed us to 
obtain the ``book'' of the human genome sequence. This resource 
now is critical in terms of our being able to read and 
understand that sequence and apply that knowledge. One example 
from NIDDK is polycystic kidney disease (PDK), one of the most 
common genetic diseases, an important cause of end stage kidney 
failure, which costs $18 billion a year in this country. We now 
know the genes that cause this disease.
    In the case of Crohn's disease, a severe inflammatory bowel 
disease, our investigators have just identified a gene in the 
last year that increases the risk for getting this disease by 
as much as 40-fold.
    In type 1 diabetes, we know several of the genes that 
provide increased risk. Our investigators are working on taking 
that genetic knowledge and turning it into therapies and 
prevention. I believe that is what is in the pipeline. 
Continued investment will allow that knowledge to be applied in 
practical terms.
    It isn't all the genes. If we come back to the type 2 
diabetes example, it is critical that individuals who are 
susceptible learn what it is in the environment--the 
combinations of dietary changes and environmental changes in 
terms of exercise that can prevent the development of diabetes. 
The study I alluded to in my statement shows this can be done. 
It was done in 3,200 individuals of all races and ethnicities, 
45 percent of whom were minority individuals.

                        TRANSLATING DISCOVERIES

    Mr. Peterson. I always find it stimulating to listen to you 
folks. I have a question. As the Congress and the 
Administration have made a push to fund research adequately and 
to give you the ability to move forward, do we have any 
operations that measures how these discoveries get implemented 
to the public. As I looked at your sign, it ought to say bench 
to prevent the need of a bed. I don't look forward to a 
treatment being bedridden.
    You are coming up with wonderful new data and information 
and immunizations but at the same time, are we a healthier 
population in this country? The answer is no. There is a 
disconnect between what you are learning and what theAmerican 
people are doing in their utilization of what you are learning. For 
some reason, this country is less healthy than it was five or ten years 
ago by personal choices and lack of things we could be doing to be 
healthy.
    With all this great success, I am concerned that there is 
somehow a disconnect.
    Dr. Spiegel. That is a tough question. I agree with you, 
but let me elaborate.
    Let's come back to the type 1 diabetes, that affects about 
a million Americans, which used to be called the juvenile form. 
Just over the last two decades, the life expectancy of 
individuals with type 1 diabetes has gone up by between 10 to 
15 years. That is a measurable, real, improved outcome. It is 
really because of advances in the therapy of those individuals 
that life expectancy has increased.
    A clinical trial that was done at NIH, the Diabetes Control 
and Complications Trial, which ended in 1993 showed that tight 
control of blood sugar can prevent the blindness, kidney 
disease and amputations from this disease. This advance has led 
to a decline in blood sugar measured by the hemoglobin A1c test 
in type 1 diabetes patient. So there are positive performance 
measures.
    However, you are absolutely right in terms of the role of 
environment in type 2 diabetes--the choices in terms of healthy 
lifestyle. This is in part why we need to decrease the time 
between a clinical trial result, like the one we announced in 
August, and how we translate that to the public.
    We have science-based information on websites and in 
booklets that we distribute around the country through our 
National Diabetes Education Program. People can see if they are 
at risk for type 2 diabetes. They can self-identify whether 
they need to go in and be screened. It isn't futile; you can 
actually do something about it. We know individuals with type 2 
diabetes have a fourfold increase of heart attacks. Women who 
are protected from heart attacks if they don't have diabetes 
lose that protection with diabetes. That is why we have a new 
National Diabetes Education Program, ``ABCs'' campaign. This 
campaign emphasizes controlling not only the blood sugar, but 
also blood pressure and cholesterol.
    I totally agree with you that it is useless to just 
generate the knowledge. We and all the Institutes are committed 
to translating this knowledge. That is why our goal is ``bench-
to-bedside and beyond.''
    Dr. Fauci. Let me give you a couple of very brief examples 
of why things are better off now. If you take a very important 
disease in the United States, HIV/AIDS, in which there are 
still 950,000 people infected, the deaths from HIV/AIDS over 
the last several years have decreased by 75 percent because of 
the bench-to-bedside development and conception of drugs, and 
the application and distribution of now very effective 
antiretroviral therapies. The deaths in 1996 were 50,000, in 
the year 2001 it was 13,000. That is with a constant infection 
rate. I believe that is a very good example.
    Another example is the one I gave in the vaccine study, 
when you are at Haemophilus influenza b in which thousands of 
children each year became mentally retarded or deaf due to 
influenza b, but because of a bench-to-bedside approach of 
vaccine development and the execution of the vaccine trials, 
that disease has essentially disappeared from the United 
States.
    Those are two examples of how things are being translated.

                           DISABILITY DECLINE

    Dr. Kirschstein. Dr. Hodes.
    Dr. Hodes. I would like to begin by stepping back to broad 
statistics. There has been concern as the nation and the world 
face an aging demography in its population that as we extended 
life we would see a population in which more and more older 
individuals survive but survive with great disability and where 
quality of life would be compromised.
    In that respect, there has been some extremely heartening 
and positive data over the past years that have shown 
significant changes since 1982 when approximately 25 percent of 
older Americans, defined as age 65 and older, were disabled. 
Data through the present estimate have shown this disability 
rate to have decreased steadily over that interval to 
approximately 19.6 percent, a very substantial decrease in age-
adjusted disability.
    This means that there is no irrevocable destiny that as 
people grow old, they will be infirm and disabled. The causes 
that contribute to this are many. When one looks at factors 
that correlate with survival without disability, perhaps the 
best correlation is with education. Education is manifesting 
itself in many ways. It may involve some direct biological 
event such as the conditioning of the brain to prevent 
dementia. It may be that with education one is better able to 
take advantage of medical and public health advances. There is 
no question it is among the best correlates or predictors of 
this decreasing disability.
    In terms of specific examples of research that has been 
translated into practice, one that was alluded to by Dr. 
Spiegel was the area of hypertension. For a long time, people 
were accustomed to paying attention only to diastolic 
hypertension. Blood pressure is always expressed as a high 
number over low number. That low number, the diastolic blood 
pressure, is what we were traditionally taught was the most 
dangerous and needed to be controlled. Older people, as a 
population, statistically tend to increase their systolic blood 
pressure and this was most often ignored as just a side affect 
of aging to be accepted.
    Over the past years in collaboration with the Heart, Lung 
andBlood Institute, the National Institute on Aging has been a 
part of a study which examined what could be accomplished by treating 
systolic hypertension in older people with a drug, a diuretic that 
costs literally pennies a day. The outcomes have been quite incredible.
    This therapy has been successful in reducing the incidence 
of congestive heart failure years later by 50 percent. If one 
looks at those individuals who already have a history of 
cardiac disease, the likelihood of their developing congestive 
heart failure has been decreased by 80 percent.
    So research has without question, led to interventions 
which are increasingly known to the public and to the medical 
care providing establishment, but to reemphasize what you have 
heard, a large part of the challenge that remains is 
implementing these, communicating to the public in an effective 
way, and finding ways to have as many people as possible take 
advantage of what can be offered as proof of research based 
investigation.

                       INFORMATION DISSEMINATION

    Mr. Peterson. I have an aunt and uncle who are 94 and 95. 
He is 94, still drives a car, does most everything. She is 95 
and she still makes a mean apple pie. They have utilized 
everything that you people are doing. He was in the health care 
business. He ran Blue Cross of Illinois years ago, so they live 
healthy lifestyles. They exercise, eat their fruits and 
vegetables, do all the things right, but most Americans aren't 
doing that.
    Those who are plugged in and are listening and paying 
attention to health are benefitting from what you are doing, 
but a large percentage of our population has disconnected that 
what they do has anything to do with how healthy they are going 
to be.
    Dr. Hodes. No question, and I think all of us realize part 
of the mission of NIH in addition to carrying out research is 
in the dissemination of information. Regarding the area you 
mentioned of exercise, for older people it wasn't so long ago 
that a doctor's advice was take it easy, you are old, don't 
hurt yourself. A large body of exercise intervention research 
has now indicated that for older people, strength training or 
aerobic training can have enormously positive effects.
    In terms of communicating to the public, after the weight 
of these research accomplishments became overwhelming, NIA 
developed a publication, an exercise manual for older people. 
As evidence of the fact that there is a public willing to take 
advantage and listen, this exercise guide was made available 
free to the public, one copy at a time in response to requests. 
It has now been distributed to over 430,000 older Americans, 
and now accompanied by a video that is distributed for cost 
recovery. We hope this trend is going to increase. We are in 
the process now of studying the next important question. For 
those who have asked for the book, how many people are 
exercising and what will be the outcome in their overall 
health?
    Dr. Kirschstein. Dr. Penn.
    Dr. Penn. One of our other major diseases has placed us 
right here and that is stroke. In stroke, we are really finding 
that we had better address prevention and intervention issues 
along with the research. They inform each other, as we said 
before but we are engaged, with the help of Madison Avenue pro 
bono and many of our voluntary organizations--actually have a 
memorandum of understanding with the American Heart Association 
and with the Heart, Lung and Blood Institute and with the 
Surgeon General--we are trying to get out there and instruct 
people on the signs of stroke and what they can do to prevent 
it.
    As you might have heard, all the risk factors for diabetes 
and a lot of the risk factors for heart disease are right there 
for stroke. It is even more important, or just as important, in 
our minority populations who are, in many cases, having more 
strokes. We are trying to work on the elderly because the 
elderly have this propensity for abnormal heart rhythm where 
you throw pieces of clot into the brain.
    We have found that neurologists can't disengage themselves 
from this. We have a lot of therapies--probably all of us 
should be taking one aspirin a day--and we had better get on 
with the implementation of what we have learned so far.
    Dr. von Eschenbach. One additional comment. I think your 
point is extremely well taken. One of the things we are paying 
a great deal of attention to at the National Cancer Institute 
is to do research on how to get the message across and why 
patients or people are not accepting the kind of healthy 
lifestyles we know would prevent or offset the kind of problems 
you alluded to.
    Next year, we anticipate over $324 million of our budget 
will be directed just to health behavior research so we can 
break those barriers down, make certain that we are 
appropriately getting the kind of response from the American 
people that we need. That is particularly true in minority and 
underserved communities.
    Mr. Peterson. One of my suggestions would be to somehow 
engage the health care community. I visit 18 hospitals in my 
district. Obesity abounds in the hospitals. That is not a good 
example. I live across the street from a very busy family 
physician. The vast majority of the seniors that visit him, the 
major part of his patient base, are obese. It is the majority 
that come in there. I can't believe he is not talking about 
that because, I have one man that is 57 years old and I said 
does he talk to you about being obese and he said no.
    If the health care community isn't going to tell the 
population they are dealing with about healthy lifestyles, who 
is going to?
    Mr. Regula. I think you have touched on a tough subject. 
When we finish with questions, I would like each of you to say 
how you disseminate the information you gained to 280 million 
Americans.
    Ms. Pelosi.
    Ms. Pelosi. Thank you. I appreciate the concern raised by 
Mr. Peterson and the response he received thus far. I look 
forward to further responses from our distinguished panel. It 
is a great day for us when you all come in. We are so proud of 
you and thank you for what you do.
    I think another part of the problem is many Americans don't 
have access to health care and there is a disparity when we 
talk about the minority population and those with less 
education, and those who are economically disadvantaged. They 
simply are not in the loop, they don't even have a chance to 
talk to the doctor about obesity because they don't go to one.
    I think we will be a healthier country and I appreciate 
your question, Mr. Peterson, that those who are in the loop are 
not all availing themselves sufficiently of the information. I 
am very concerned about those who are not in the health care 
loop, who don't have access to health care.
    We say to children that they should not abuse 
substances,alcohol, drugs or smoke because it is not good for their 
health and yet they don't have access to health care. So we place no 
value on it and then we tell them it should be important to them. We 
have a mixed message in terms of our public policy.
    Very recently in the President's budget a large cut in the 
CDC's chronic disease prevention and health promotion programs, 
appropriations would be reduced by $57 million or 8 percent. It 
seems to me a foolish cut because prevention is our least 
costly approach to a healthier America and contributes to the 
quality of life at the same time as it saves money.
    I think if we want a healthy country, we have to make that 
a priority across the board and have reasonable prospects for 
access to quality health care for all Americans. What 
information we do have should be disseminated and promulgated, 
but many of us have family members who would never have known 
they needed special care if they had not gone in for their 
checkup. If you don't go in for the checkup, then how can you 
be healthy? It is a vicious circle in my view.
    For our seniors, if they had access to prescription drug 
benefits where they could predictably have access to the 
therapies they need without question as to whether they are 
going to be able to afford them, I think we would have a 
healthier older population as well.
    I appreciate the concern my colleague raised, it is a 
legitimate one but the answer is, I think, multifaceted.
    I have a couple of specific questions for our witnesses. 
For Dr. von Eschenbach, I may submit a question for the record 
when I have more information available to me because I came 
directly from another meeting. Could you say something about 
what you are doing at the Cancer Institute on brain tumors? Is 
there some new initiative there you could speak to?

                         TRANSLATIONAL RESEARCH

    Dr. von Eschenbach. We have been particularly interested in 
fostering a program that relates to today's topic of bench to 
bedside, i.e., translational research and the creation of SPORE 
programs which are specialized programs of research excellence 
that will enable us to bring basic scientists as well as 
clinicians together to not only investigate the causes with 
regard to brain cancer but also be able to translate that into 
opportunities for therapy. The translational piece of that 
would be accomplished through our cancer centers and SPORE 
programs.
    Dr. Kirschstein. I would like to ask Dr. Penn from the 
Neurological Disorders and Stroke Institute to expand on that.
    Dr. Penn. With the National Cancer Institute, we are 
working on a little more at the basic end, so we have a program 
to identify the brand new genes present in brain tumors. In a 
single type of brain tumor, unfortunately the most devastating, 
the glioblastoma, there have been found over 1,500 brand new 
genes. We are displaying these on a chip, a small arrangement 
where you can look at the DNA in these genes. We expect to find 
what they really produce in terms of proteins.
    Meanwhile, our field out there is ahead of us, and several 
of the investigators have used this sort of information to say 
this tumor is ready for surgery and radiation and this one is 
going to be terrible to treat--same tumor, but different genes.
    Finally, we have a program with the National Cancer 
Institute in our intramural programs at the Clinical Center 
which are using this information and trying brand new therapies 
that we think may work. A glioblastoma has about a year and a 
half total survival, and some of the childhood ones are just as 
bad or worse. I am very grateful that we can collaborate with 
the National Cancer Institute on this.

                              BIOTERRORISM

    Ms. Pelosi. Dr. Fauci, as you know, we all stand with the 
President in the fight against terrorism and support his 
initiatives on funding for bioterrorism. In your research in 
your statement, are you getting additional funding to do that 
or is that money you have to take from other research?
    Dr. Fauci. No. As a matter of fact, it is all new money. It 
is a rather large increase in our budget designated for work on 
bioterrorism. There is actually a $1.5 billion increase. We are 
not diverting anything from the other issues, not from HIV/AIDS 
or from emerging diseases or from our immunology and immune-
mediated diseases portfolio.
    Ms. Pelosi. You have been able to absorb this additional 
money?
    Dr. Fauci. Yes. We have already put together a rather 
comprehensive strategic plan as well as a research agenda that 
will guide us towards the effective spending of the money over 
the next year. I have a copy of the research agenda that we 
have developed for the fiscal year 2003 resources we are 
getting.

                                HIV/AIDS

    Ms. Pelosi. That is great. Could you comment briefly. 
Although the new infections in HIV and AIDS has plateaued, 
there is disturbing data that HIV infections have increased in 
inner city minority populations and in young gay men. What more 
do we need to do to prevent new infections?
    Dr. Fauci. I think it absolutely critical and as a Nation, 
we are making steps in that direction, to address in a very 
open and transparent way, what is happening particularly in the 
inner-city areas. Although the 40,000 new infections each year 
are constant and disturbingly so, we get into a complacency 
where we have plateaued but we have plateaued for the last 11 
years and it has not come down. What has happened is it has 
gone away from the generally white gay population in which the 
infections initially predominated now to an ever-increasing 
relative proportion of inner-city, minorities, African-
Americans and Hispanics, associated initially with injection 
drug use, but then secondary to that, heterosexual transmission 
particularly among adolescents.
    The other issue that we are trying to address and we are 
partnering not only with the leaders of the African-American 
community but particularly with the clergy of the African-
American community is the fact that gay African-American men 
need to be better accepted not only for their homosexuality so 
they can come out and get access to the care you are talking 
about but also for the dissemination of information in a way 
that gets to them and does not allow them to feel marginalized.
    We have a lot of societal issues that are responsible for 
the disproportionate turn of infections towards the inner-city, 
towards minorities and particularly young minorities.

                              HIV VACCINE

    Ms. Pelosi. Dr. Fauci, I was pleased at your reference to 
the new HIV vaccine, the progress. I think you mentioned the 
prospects for that new vaccine?
    Dr. Fauci. We have as a field been looking at different 
concepts to induce as potent an immune response as possible 
before moving on to the larger Phase 3 efficacy trial. Some of 
the concepts I actually mentioned to this committee last year 
and the year before were just in what we called thepre-clinical 
phase. As we had hoped, they have moved from the pre-clinical to the 
animal phase and now are in humans. One approach is taking a common 
virus to use as what we call a vector, we work well with this virus, it 
has been in the population and we have vaccines against it, a common 
virus called adenovirus.
    You insert the genes of HIV into the adenovirus and then 
vaccinate the individual against this common virus which is now 
mimicking the HIV virus without any of the dangers of HIV 
infection. The results that were reported in Seattle a couple 
of months ago indicate the level of immunity, the depth and 
breadth of the immune response with that candidate vaccine is 
better than anything we have seen with any of our other 
candidates.

                       CANCER AND THE ENVIRONMENT

    Ms. Pelosi. Dr. Spiegel, I am well aware of your great work 
and the turf you cover. I am very proud of your work and it is 
so exciting seeing what you have done.
    Dr. von Eschenbach, if I could ask a brief question about 
cancer and the environment. In Marin County in an area near San 
Francisco, you have heard the story before on Long Island and 
Cape Cod and in San Francisco, there seems to be more than a 
coincidence of breast cancer that seems to be unaccounted for. 
We can understand some of the level but some of it seems to be 
related to the environment.
    Can you talk about anything that you are doing at the NCI 
to see what the connection is?
    Dr. von Eschenbach. One of the most important initiatives 
that has been underway and will continue to be promoted is the 
understanding of the gene environmental interaction so that how 
these environmental factors actually cause the genetic 
alterations that give rise to cancer, in addition to continuing 
to do our population based studies to identify what those 
factors are in the environment that are specific for individual 
types of cancer. It is a multi-pronged effort.
    Ms. Pelosi. In Marin County, it is not an environmental 
justice issue but in some parts of our country, it is, in areas 
where there are chemicals in the air. For one reason or another 
in San Francisco, it is certainly an environmental justice 
issue because it is in the poor neighborhoods, minority 
neighborhoods. I would encourage you in that direction because 
the bench of course is essential to our success but I think 
beyond the bench and looking at the environment may have some 
answers for us.
    Thank you all very much. Dr. Kirschstein, always an honor 
for us when you are here. Thank you for your excellent work. I 
hope we will continue to see you along the way.
    Dr. Hodes, I neglected you today but I will catch up later. 
This aging question is very sensitive with some of us.
    Thank you.
    Mr. Regula. Mr. Jackson.

                   PREVENTION-INTERVENTION COMPONENTS

    Mr. Jackson. Thank you.
    Let me begin by thanking the various directors for their 
outstanding work they continue to do.
    I have four questions and I am going to ask one of Dr. 
Penn, one of Dr. Spiegel and two of Dr. von Eschenbach.
    Dr. Penn, stroke, America's number three killer and leading 
cause of permanent disability, disproportionately strikes 
African-Americans. As I understand it, African-Americans have a 
38 percent greater risk of first strokes than whites. Compared 
with whites, young African-Americans have a two to three times 
risk of clot caused strokes and African-American men and women 
are more likely to die from stroke.
    Can you please tell us how NINDS is addressing health 
disparities in stroke?
    Dr. Penn. I started before, but I will really flesh it out 
this time. We are very concerned and are working through our 
specialized neuroscience research programs to develop what we 
are calling ``prevention-intervention'' components. We have 
engaged our investigators, because we have five or six grants 
out there for the studies of stroke in African-American 
populations both in Chicago and Baltimore, and our flagship, 
which we are trying to launch right now, is at Morehouse School 
of Medicine in Atlanta where we are in the middle, as we said 
last year, of the ``buckle'' of the stroke belt. We are looking 
at both populations, minority and majority.
    That is coming along very well. We have a lot of help from 
stroke investigators, from Dr. Sullivan who is the President at 
Morehouse, and a lot of help from the Surgeon General. What we 
are trying to do is not only work on prevention- and there we 
will have help from the National Public Radio people in 
Atlanta, on all the risk factors, but also on intervention. 
African-Americans have a somewhat different profile and don't 
have clots in the neck as often as they do in the head, so we 
have to work on why. There are a lot of things we have to 
address.
    We work as closely as we can, and have from the beginning, 
with Dr. Ruffin and his group and also with Dr. Judy 
Vaitukaitis in the National Center for Research Resources, 
because she provides a lot of infrastructure in all of our 
programs.

                    DIABETES RESEARCH WORKING GROUP

    Mr. Jackson. I am going to read the final three questions 
so the respective heads can respond. Dr. Spiegel, it seems the 
Diabetes Research Working Group has provided an important road 
map for diabetes research since it was released in 1999. I am 
interested in what plans you have to update this report in the 
future.
    Dr. von Eschenbach, as you know, medically underserved 
communities and minorities are disproportionately affected by 
cancer. To begin to effectively address this problem, it seems 
important to develop expertise from within the community. 
Recently, I read that you had spoken to your advisory board 
about your plans to revamp the National Cancer Institute's 
Cancer Center Program and focus on minority and underserved 
communities.
    Currently, are there any cancer centers at minority serving 
institutions?
    Secondly, when you headed the Integration Panel for the 
Department of Defense Peer Review Prostate Cancer Research 
Program, you recognized the need to accelerate research and 
training at institutions serving minority populations. The DOD 
Prostate Cancer Program has designed interesting initiatives 
that would create partnerships for historically black colleges 
and universities in order to enhance the research capital 
within the institutions serving the black community.
    During the past two years, I regularly noted the slow pace 
at which the NCI Center to Reduce Health Disparities has 
undertaken new initiatives. I am wondering what specifically 
are NCI's plans to reduce the burden of prostate cancer in the 
black community? Will NCI support increased training and 
research initiatives for minority researchers and historically 
black colleges and universities?
    Dr. Spiegel.
    Dr. Spiegel. In 1999 the Diabetes Research Working Group 
issued a congressionally mandated report in which it identified 
five extraordinary areas of opportunity: the genetics of 
diabetes, autoimmunity and the beta cell, cell signaling, 
obesity, and clinical trials. All the Institutes of NIH, and 
the Diabetes Mellitus Interagency Coordinating Committee that I 
chair, have been addressing these five extraordinary 
opportunities with all the resources we have.
    Congressional language we have in this fiscal year asked us 
to do an update of this very important report to define the 
progress since the report which was issued in 1999, to define 
the initiatives we have put in place, and also the new 
opportunities.
    To do this report, due August 31 of this year, we have 
consulted widely with the community, both by bringing in 
outside experts from around the country with whom we will be 
meeting on May 16, and by interacting closely with our 
constituencies, the American Diabetes Association, the Juvenile 
Diabetes Research Foundation, and with patients and their 
families as well.
    I and my staff clearly need to hear directly from the 
patients. With the synthesis of all this input, we expect to 
have a very complete progress report for the Congress.

                      CANCER CENTERS AND TRAINING

    Mr. Jackson. Dr. von Eschenbach.
    Dr. von Eschenbach. With regard to the issue of training, I 
think you touched on an extremely important issue that I am 
very pleased to have Harold Freeman within the National Cancer 
Institute to head up our Center for Minorities and Health 
Disparities. In recent conversations I have had with Dr. 
Ruffin, what we really are very much looking forward to is the 
opportunity to enhance the pipeline that will bring young 
investigators at the college level into the biomedical and 
medical research arena and to provide a pathway in addition to 
continuing to support their career development once they have 
received their degrees. I think the training issue that you 
allude to is an extremely important one.
    With regard to Centers and SPORES, we have within the 
prerequisites for the designation of centers and SPORES the 
expectation and review process to be certain that within those 
programs there are outreach to minority communities so they are 
included and incorporated into those centers' efforts. With 
regard to the centers and the training, both of those are 
initiatives that need to be further enhanced.
    Mr. Jackson. Dr. von Eschenbach, I look forward to working 
with you and coming up with some creative ideas on how to 
enhance those.
    Dr. von Eschenbach. I think the point that you have alluded 
to is an extremely important one in that one of the personal 
particular philosophies that I have is that we need to do this 
in a partnership with the community so that we are working 
collaboratively together because I don't believe we can simply 
impose or superimpose solutions. These need to be collaborative 
strategies that we will develop together.
    Mr. Jackson. Thank you.

                       INFORMATION DISSEMINATION

    Mr. Regula. Dr. Kirschstein, I would like an idea of how 
you disseminate this information? There is a lot of 
constructive information available here. How do 280 million 
Americans access it?
    Dr. Kirschstein. Each of the Institutes and Centers at NIH 
as well as centrally through my office has an Office of 
Communications of health information. A great deal of that 
information is communicated to the public through documents 
that are specifically prepared for public usage. Let me give 
you a quick example not among the Institutes that is here and 
ask each of them to address it.
    In the Heart Institute, they have books on healthy diets 
for people to prevent heart disease and to prevent or 
ameliorate heart disease and the booklets are published in 
English in laymen's terms as well as in Spanish.
    Mr. Regula. How are they distributed?
    Dr. Kirschstein. They are distributed broadly to radio 
stations, television stations, public libraries, schools, 
community centers and in addition, we have mandated programs in 
hypertension education and cholesterol education, that go out 
to the public generally. I would like to let the Institute 
directors describe how they do that.
    Dr. von Eschenbach. With regard to the Cancer Institute, it 
really is a multifaceted strategy that begins with our internal 
process of communication with regard to the creation of a 
website so that patients and professionals have the opportunity 
to immediately access information.
    We have also funded a very important initiative over time 
called the Cancer Information Services which provides a network 
in various institutions so that there can be opportunities for 
patients to call in and get information about specific concerns 
and issues that they have.
    I understand within the past year there were 1.9 million of 
those kinds of requests for information.
    Then there is the wide dissemination in print and visual 
media of cancer information publications. There were 10 million 
of those publications that were distributed. So it is a 
multifaceted strategy.
    In addition to that, as I indicated earlier, we also are 
spending a great deal of effort in trying to do the research to 
understand how to most effectively communicate with all levels 
of our society so that we formulate messages that are 
appropriate to each of the segments affected by cancer.
    Dr. Fauci. We have somewhat similar mechanisms to 
disseminate information that range from written material to a 
very comprehensive and updated website that is accessible to 
the general public.
    Mr. Regula. What troubles me is a lot of Americans don't 
have a website.
    Dr. Fauci. I got you. For those who don't, we have a series 
of well orchestrated outreach approaches, particularly the town 
meeting format that we utilize a lot. Some examples of that, 
Ms. Pelosi remembers how we did that together in the San 
Francisco area when we were trying to get out information vis a 
vis HIV/AIDS, not only in the early years but as the therapies 
became available.
    We recently had a town hall meeting type approach here in 
Washington at the 19th Street Baptist Church in which we 
addressed many of the issues that we were talking about and how 
to engage the minority community about embracing the African-
American clergy. This was a sponsored town meeting by the 
clergy in the District of Columbia.
    So we do everything from the sophisticated thing that not 
everybody has access to, to actually going out in the community 
and talking about these issues. We have done it with everything 
from HIV/AIDS to asthma, we have a number ofoutreach programs 
not only in NIAID but also with the National Heart, Lung and Blood 
Institute and the National Institute of Environmental Health Sciences, 
a number of outreach programs vis a vis education of asthma and 
interventional components of asthma that have been an important part of 
our inner-city asthma programs. So it is everything from websites to 
going out into the community.
    Dr. Penn. We pursue all the avenues that you have already 
heard. I should mention that we work pretty closely with our 
professional societies, who are into this also. We are all 
available, all of us staff who are physicians and not 
physicians, to go out with our voluntary organizations and go 
to various chapter meetings and national meetings and talk 
about what we can disseminate in terms of prevention 
information or what we are doing.
    Stroke is an excellent example of that because we had 
recently the ``Nightline'' program, which some of you may have 
seen, where the producer actually had a stroke, and through the 
new information on the plasticity of the nervous system, he 
worked his way, literally exercised his way, back to being 
essentially normal. This is something that is going to come in 
the next 10 years, I hope, when we know more about why that 
happens.
    We had a ``Stroke Sunday'' which was very effective; we 
have to go into the churches like this.
    Dr. Kirschstein. Let me add a few comments. First of all, 
we work very hard at this. We are all available as the 
directors have already described to come to any place in the 
country that wishes to have us and we will volunteer. Mr. Obey 
had a number of us on four different weekends. Dr. Varmus was 
Director, I was there as the Deputy Director and so many of us 
have been to those districts. In addition, in the local area 
which includes Virginia, Maryland, Pennsylvania and the 
District, most of the institutes have adopted elementary, 
middle schools and occasionally high schools and go into those 
schools to teach the children. This gives us an opportunity 
particularly for diverse populations, in Virginia, for example, 
a very diverse population, of the largest growing immigrant 
group of Vietnamese to talk about what they can do to be 
healthy.
    Dr. Hodes. If I could just add, in addition to Dr. 
Kirschstein's statement of our willingness to help, there is 
also an enormous resource in the large cadre of physicians and 
scientists who are supported by the Institutes and who are in 
institutions across the country. Working with you, we are happy 
to and often do direct attention to them as wonderful resources 
in various areas of the nation.
    Dr. Spiegel. Let me give you an example of another unique 
kind of program we are just starting because this problem of 
type 2 diabetes disproportionately affects Native Americans. We 
have launched a program in partnership with tribal colleges and 
universities where we have a dual goal. We are trying to create 
a science curriculum for tribal middle schools and high schools 
in which science education will be focused on diabetes. On the 
one hand, participants will receive health care information 
they can use. As Dr. von Eschenbach implied, we are partnering 
with the tribal colleges and universities, so we are not just 
superimposing this information from the outside. By partnering 
with them in a culturally sensitive way, we hope that we will 
inspire some of these students to themselves become researchers 
and ameliorate the diabetes affecting their tribes.
    Dr. Kirschstein. All of this said, we need to keep working 
at it. It is something we have to continually emphasize because 
people have short memories and if we don't go out and continue 
to do this, the messages will not remain with them.
    Mr. Regula. If you had a publication that lists what you 
have available and the Administration on Aging could distribute 
these with meals on wheels to the area aging centers so a 
senior could pick up this pamphlet if they are interested in 
stroke and see where to send to get the pamphlet, stroke, 
diabetes, whatever they check off, mail it in and they would 
get it return mail. Would that work?
    Dr. Kirschstein. I think it would and we will start on it 
right away, Mr. Regula. I really do think it is a good idea.
    Mr. Regula. You hear so much super excellent information in 
these hearings and I keep thinking how do we get it to the 
people because that is our primary concern.
    Dr. Hodes. It is a wonderful idea. The National Institute 
on Aging interacts closely with the Administration on Aging 
precisely for the reasons you indicate. They are an avenue to 
communicate with a large number of older Americans. This is an 
excellent suggestion which we will certainly incorporate into 
our interactions with them.
    Mr. Regula. Mr. Miller.

                      BASIC VS. CLINICAL RESEARCH

    Mr. Miller. I thoroughly enjoy the opportunity to hear you 
all talk.
    You mentioned websites. I enjoy them. I remember just over 
a year ago I had this liver concern, we had to have a 
transplant with our daughter who donated. I went to your 
website, Library of Medicine, and Dr. Lindbergh is not here 
today but there is so much available, so much that goes over my 
head and some of it you can't get to. When you go to the New 
England Journal of Medicine, you have to be a subscriber to it, 
so you don't always have access to it and I can't always 
understand it but you do have good web pages. You are right, a 
lot of people don't have access to it but their friends do. I 
think that is a great way to make that information available.
    I have a concern with basic research versus clinical 
research. You mentioned Dr. Hodes you need to educate the 
medical community, the physicians and such that basic research, 
we have seen a decline in the amount of money for basic 
research versus clinical.
    Nancy Pelosi talked about who takes charge of the education 
of lay people. We visited the CDC a few years ago and talked 
about diabetes. Our former Speaker, Newt Gingrich, was really 
concerned about that. There was a question about education to 
prevent diabetes, diet and such. I wish we could spend more on 
that area. You could prevent so much by education. How do you 
get out that message? Whose responsibility is it? Is it CDC's? 
You have an education role but your primary role should be 
research and sharing that research information. Who is 
responsible and how do you keep yourself still focused before 
you become a major teaching institution?
    Dr. Kirschstein. It is a fine line but we feel it is a 
responsibility. Actually, we have an inherent responsibility 
because the American public has so much interest in research 
and the Congress has provided us with so much wherewithal to do 
this that I feel, and I think all my colleagues do, it is an 
inherent responsibility on our part, in addition to 
concentrating on the areas that you are mentioning, Mr. Miller, 
to go the next step.
    Incidentally, we try very hard to make this understandable. 
One of the things that has happened is thatthe media has been 
superb at this. The most important findings in the New England Journal 
of Medicine are translated most often into newspaper articles the day 
before they are published in the Journal.
    Dr. Hodes. To comment further, this balance between basic 
and translated clinical or applied research, I think today's 
theme is an excellent way to address that. We all continue to 
have the obligation to determine the appropriate balance 
between basic and applied research and to make that tailored to 
the circumstance.
    At an extreme, if we dealt only with application and 
neglected basic research, we would mortgage our future in terms 
of developing new generations of interventions. If we were to 
do the opposite and focus solely on basic research and not 
translate it, that would also be irresponsible.
    I think when we report to you or you see published a 
percentage in basic or clinical research, this is really an 
outcome determined by scientific opportunities and public 
health imperatives. If there is a finding in an area of basic 
science that has a compelling potential for translation to 
clinical research, then you will see a shift in that area 
towards more clinical research. If there is an area in which 
the basic understanding doesn't yet allow translation it is 
predominantly basic. I think we are constantly examining the 
profile broadly but also in each particular area to make it 
best serve both the long and balanced short term obligations we 
have.
    Dr. Spiegel. I would just point out also that one shouldn't 
make too large a distinction between basic research and 
clinical research. Although we are emphasizing ``bench-to-
bedside,'' it goes in the other direction as well. Let's look 
at the Crohn's disease discovery that I mentioned. This new 
susceptibility gene as been determined, that was found through 
clinical research focused on identifying people with Crohn's 
disease, studying their families and then being able to do the 
genetic analysis. Now that the new gene has been discovered, 
one needs to go back to the laboratory bench, because it had 
never been understood or even appreciated before. This genetic 
discovery offers a whole new pathway for which critical drugs 
may be developed for either prevention or treatment. Research 
needs to be a seamless interaction, a bidirectional 
interaction. That is the vision we really have.
    Dr. von Eschenbach. I was just going to add, Mr. Miller, 
that your point about the dissemination issue, I think one of 
the important lessons I learned early on as a surgical 
oncologist was I could not solve the problem of cancer alone. 
It had to require collaboration and integration with others. I 
think that is particularly true today of us as an institution, 
that we need to be collaborating not only among ourselves for 
this exchange of information but also outside. The national 
dialogue on cancer, for example, recognized that cancer is a 
societal problem and we need to come together with the CDC, 
with other Federal agencies, and with the States in order to 
really be able to approach this problem comprehensively.
    I think the National Cancer Institute has to contribute its 
unique piece but we also have to collaborate and work 
effectively with others to make sure we are certain the entire 
agenda is being addressed.

                         HIV/AIDS THERAPEUTICS

    Mr. Miller. We have to communicate to the American people 
what a great, crown jewel we have and part of it is to see how 
they relate. What Dr. Collins has done is great but it is hard 
for others to comprehend what that really means.
    I have one other question. I want to switch back to Dr. 
Fauci. I am sorry Ms. Pelosi is not here because it is a 
continuation of her question about HIV issues. When you go 
through Phase I, II, III trials and then it is available 
basically. Tell me about how long it takes to go through these 
trials? I guess there is no rule of thumb and some go pretty 
fast. The last big breakthrough was Protease which was quite a 
few years ago. I don't know when Protease came out or got 
approved but it was six or seven years ago.
    What is in Phase III? You said the latest was a Phase I 
issue which could take years.
    Dr. Fauci. I was referring to vaccine, you are referring 
specifically to therapy now. Let me address that. As a concept, 
the protease inhibitors were tested in 1995, became available 
in 1996, so we have had about 5\1/2\ years of the concept of 
protease inhibitors being used in our regimens for HIV together 
with the nucleoside analogs and the non-nucleoside analogs. 
Typical examples of a nucleoside analog is AZT or DDI or DDC.
    Right now, the two exciting areas of concept breakthroughs 
are the other two vulnerable sites of the virus, vis a vis its 
replication. One is its binding to the surface of the cell and 
there are a number of drugs that are called fusion or entry 
inhibitors. They prevent the fusion of the virus to the cell. 
The way HIV gets into the cell, it binds to a receptor the way 
most viruses enter cells. There is a receptor that they capture 
or co-opt, then HIV enters the cell.
    These agents are already past Phase I, well into Phase II, 
and now we are planning to collaborate with some of the 
companies involved in going into Phase III trials for a class 
of fusion inhibitors. One that is the furthest ahead is from a 
company called Trimeris from Research Triangle Park in North 
Carolina. The agent is called T-20 for Trimeris 20. It will get 
a name when it gets licensed by the FDA.
    The other concept is the integrase inhibitors. They are 
just going from pre-clinical into Phase I trials. The integrase 
inhibitor prevents the virus, when it converts to its DNA form, 
from inserting itself or ``integrating itself'' into the 
chromosomes of the cell.
    With those two concepts, you have the spectrum of what you 
are referring to, Mr. Miller. You have the fusion inhibitors 
that are already going into Phase III which means that in a 
period of one to two-and-a-half years, they will be ready for 
licensure if they are accepted. Then you have the integration 
inhibitors which are just going into Phase I.
    In a normal, accelerated format which is what we have been 
using successfully with HIV, it generally takes from the time 
you do it in pre- clinical studies to the time you get licensed 
anywhere from four to five years, in comparison to 12 years the 
way it was decades ago. So it has cut the time frames by more 
than half.
    Mr. Miller. Two new areas have the potential to be the next 
generation of drugs?
    Dr. Fauci. The next generation of drugs for HIV, yes.
    Mr. Miller. Thank you.

                     INTRAMURAL STRUCTURAL BIOLOGY

    Mr. Regula. One of you used the word intramural. Do you 
move information back and forth at NIH, so that you might 
discover something that has a relationship to what you do? Is 
there a cross-cutting, maybe that is the word?
    Dr. Kirschstein. I will let the Institute directors 
describe that but I think the most remarkable way is they 
alltalk to each other and their scientists talk to each other all the 
time, the informal communication in addition to the formal scientific 
seminars and so forth. I will let them expand on that.
    Dr. Spiegel. I have asked Dr. Fauci's permission and he 
says it is okay. He just mentioned the integrase. We have in 
the Intramural Program, which represents roughly 10 percent of 
the budget that is expended on research in Bethesda and some 
outlying campuses, some of the best structural biologists. 
These are the people who determine the three-dimensional 
structure of different proteins. It was actually individuals in 
the National Cancer Institute who were some of the first to 
determine the three-dimensional structure of the protease of 
HIV. In the early 1990s, scientists in the NIDDK Intramural 
Program determined the three-dimensional structure of HIV 
integrase. There is an AIDS-targeted program in the Intramural 
Program and it is a very collaborative program. That three-
dimensional structure allowed drug development of the kind you 
now see moving forward appropriately in the Extramural Program. 
Tremendous collaboration and interaction at many levels move 
the research agenda.

                         HORMONE RELATED STRESS

    Mr. Regula. That is interesting. Incidentally, talking 
about this pamphlet, you ought to get those into doctors' 
offices too. They would be more interesting than most of their 
magazines. The way you have to wait in these places these days, 
it would be a great opportunity to disseminate.
    I was a speaker on a panel in Phoenix for the Steel 
Institute. I was waiting on the fellow speaking ahead of me. He 
had been the Director of the Medical School at the University 
of Nebraska. He had a heart attack at 43, no family history and 
he finally concluded it was stress induced. He decided to spend 
the rest of his time focusing on stress. He had an institute in 
Phoenix, wrote a book, ``It's not Worth Dying for.'' Maybe some 
of you are familiar with it.
    I would be interested to hear from each of you what role 
stress plays in health because obviously it has to get your 
system out of whack if you are stressed. What do you think?
    Dr. Spiegel. First, one needs to be a little cautious about 
invoking stress as a cause of disease. Undoubtedly, it is 
important, but for historic reasons, one should be cautious. In 
the 19th century before the discovery that a particular 
bacterium caused syphilis, stress was attributed as the cause. 
Peptic ulcer disease was thought to be caused by stress and 
then investigators determined that a bacterium, Helicobacter 
pylori is the cause. This is another example of collaboration 
and interaction between our Institute which supports 
gastroenterologists, and Dr. Fauci's Institute, the National 
Institute of Allergy and Infectious Diseases, working. We 
actually co-supported study of infectious etiologies of chronic 
diseases of unknown cause.
    On the other hand, there certainly is an adverse effect of 
stress and, as an endocrinologist, I know that it comes through 
the hormone system. Specifically, the steroid hormones, the so-
called glucocorticoids, have a very adverse effect in terms of 
breaking down protein and increasing obesity, particularly 
central obesity. There are some plausible notions that stress 
may have an impact in terms of obesity in the general 
population. We should always investigate these concepts with 
careful research and scientifically, before attributing 
conditions to stress.
    Dr. Fauci. I second that and it really gets back to the 
causal etiology of a disease versus what we call co-factors 
that might either predispose or impede someone's capability of 
dealing with the true primary cause of disease. We often see 
that in situations and it relates to what Dr. Spiegel said vis 
a vis glucocorticoids which also have a rather profound 
suppressing effect on the immune response. So when you are 
dealing with infectious diseases which require an appropriate 
response of the host to the microbe, if you don't have a 
microbial infection, if you don't have a microbe there, you 
could have all the stress you want and you are not going to get 
an infection. It is the same as saying does going out in the 
cold give you a cold? You could freeze to death before you get 
a viral illness if there is not a virus there.
    When you do come into contact with a microbe, the host 
response is not infrequently tempered by the state of your 
ability of your immune response. If you are under severe stress 
or severe exhaustion, some of the natural body's defenses that 
would allow an otherwise normal person to very easily clear 
that infection might be impeded so that an infection you would 
otherwise handle well wreaks havoc with you because you have a 
suppressed immune system on the basis of the mechanisms that 
Dr. Spiegel mentioned.
    Dr. von Eschenbach. One of the amazing comments is that the 
story in cancer is almost exactly the same story Dr. Fauci just 
told you. We know there are certain things that cause a cell to 
become a malignant cancer cell but the behavior of that 
malignant cancer cell is dependent upon the environment it 
finds itself in. The body that cancer is in has an effect on 
that cancer. Stress, nutrition, a variety of other things may 
be affecting the person and that then influences the behavior 
of the cancer. So stress doesn't cause cancer, but it can very 
much play a role in how the cancer may behave.

                                 STRESS

    Dr. Hodes. In terms of the effect of stress on the nervous 
system, I think there are lessons learned from research and Dr. 
Penn may well want to comment too. One has to be careful not to 
regard stress a linear determinant, saying stress is bad or 
stress is good. In terms of stress response, it is not 
surprising when one thinks about the way in which our species 
evolved, acute stress responses to specific circumstances are 
very adaptive. If you need to flee under an emerging situation, 
then a stress response is appropriate and that sort of acute 
stress response in the nervous system does not appear to have 
harmful effects. However, chronic stress has a quite measurable 
adverse effect on brain structures that can now be detected.
    Moving from that basic neuroscience example to a case of 
practicality, one of the chronic stresses that is of increasing 
importance in the aging community is that which caregivers 
experience, caregivers for individuals with Alzheimer's or 
other disabilities. An extensive series of studies now have 
shown that those individuals undergoing that kind of stress 
have measurable changes in their immune response system and 
importantly, interventions including respite or physical 
exercise programs in populations of these caregivers appear to 
measurably reverse that stress.
    Stress can be good in the right situation, often in excess 
is bad, but importantly, there are ways it can be addressed 
therapeutically.
    Dr. Penn. Just a couple of corollaries. What is called the 
``flight or fight'' situation, when you really are atwhat you 
would call maximum stress, involves a very important part of the 
nervous system called the autonomic nervous system, which makes you 
perspire, makes your pupils dilate and so on. This is one of the places 
the nervous system interacts with the immune system, because it isn't 
just the circulating hormones of the adrenal gland, it is also the 
autonomic nervous system that may trigger that reaction and certainly 
regulate with it up and down.
    Again, all of us are working together.
    Dr. Kirschstein. Mr. Regula, we have five Institute 
directors. I am sure every one of the others could give you an 
example and the important one when he comes next week or the 
week after in heart. Dr. L'Enfant, I am sure will want to 
address that.
    Mr. Regula. The Speaker at 43 had a heart attack, no family 
history, his parents in their 80s. Then he realized he was 
fighting with the board of trustees, trying to raise money, 
jumping on airplanes and he felt that his heart attack had been 
stress induced.
    Dr. Kirschstein. I think it is probably more complex than 
that. Dr. L'Enfant might want to explain that to you because it 
has similar situations to what have been described, I am sure. 
I think it is an important phenomenon that we all must take 
into consideration.
    Mr. Regula. I will never forget he gave us the three rules. 
He said, one, don't sweat the small stuff; two, most things in 
life are small stuff; and three, if you can't fight and you 
can't flee, flow. Pretty good advice.
    Dr. Kirschstein. Very true.

                            GLOBAL RESEARCH

    Mr. Regula. I must say I watched President Reagan and he 
practiced that. He may not have known he was doing it but I 
remember his famous quote, ``Doc, are you a Republican`` when 
he was sitting there, grating with a bullet, so he was flowing, 
I think.
    Dr. Fauci, you have a tough job of translating research 
globally because infectious diseases are everywhere and it is 
the leading death around the world for those under age 45. What 
are the barriers associated with the translation of research on 
a global level and how do you overcome them? You are the 
institution for the world. I don't think 5 billion people 
appreciate it but you really are.
    Dr. Fauci. One of the arenas you are referring to, and as 
you said, each of the Institutes could probably give their own 
example, is because of the global-nature of infectious 
diseases, given our responsibility for infectious diseases, we 
often find ourselves in interactions at the international 
level.
    One of the things we have learned over the years, and I 
think there has been a good lesson, that if you are going to 
translate the kinds of advances that we make in the United 
States that would be most applicable and relevant to developing 
nations, particularly the work we do in vaccines and therapies, 
when you engage developing nations, you have to engage in true 
partnerships where you don't just as we say practice parachute 
science where you parachute in, do your thing and you leave. 
You have to build as we have, particularly in the research 
arena, what we call sustainable infrastructure so that when you 
leave the country, you will have trained the in-country 
investigators, you will have put into place the opportunity for 
them to continue without you and not to essentially dissipate 
when you leave.
    That has been the fundamental philosophy that has driven 
our networks of prevention trial networks, vaccine trials 
networks, our centers for interdisciplinary research 
internationally in infectious diseases. We have a wide array of 
networks, and are driven by the fundamental philosophy of 
collaboration and building sustainable infrastructure. It is 
really starting to show to be quite successful.

                        RESEARCH COLLABORATIONS

    Mr. Regula. Do all of you have contacts with institutions 
beyond our borders and do you get a pretty good partnership 
type response?
    Dr. Kirschstein. Yes, indeed.
    Dr. Hodes. Absolutely, and there are many such examples. 
Some of them involve specific research institutions, others are 
with national organizations. For example, in the area of aging 
research, there is a lot to learn as well as disseminate by 
comparisons of what the practices and consequences are 
internationally, both in developed and developing nations. So 
there are extensive networks in which NIH participates as a 
partner.
    Mr. Regula. Do you gain ideas from other parts of the 
world?
    Dr. Hodes. Without question. For example, mentioning the 
trend toward decreased disability in the older population in 
this country, we are extremely interested in learning how those 
trends compare with what goes on in other countries and what 
factors may be responsible for those differences. Not all 
research can be done easily in a controlled, randomized clinic 
trial setting. So the natural experiments, comparisons that go 
on, as well as addressing the diverse needs of a heterogenous 
world also inform us about issues that are as important to this 
Nation as they are to the rest of the world.
    Dr. Spiegel. A lot of this depends on specific disease 
examples. We deal mostly with non-infectious diseases; however, 
type 1 or what used to be called juvenile diabetes is very 
prevalent in the Scandinavian countries. Finland, for example, 
has the highest incidence. Therefore, it is very important for 
us as a Nation to partner with those countries that have really 
terrific health care systems and registries. Also, 
organizations in the private sector, the Juvenile Diabetes 
Research Foundation, are able to fund international research 
much more readily than we are. We can then partner with those 
investigators.
    In fact, our type 1 diabetes Trial Network here in the 
United States is trying to match up and partner with those 
outstanding institutions in Europe to speed these trials. That 
way we can have more patients and get results more quickly. 
That is just one example.
    Mr. Regula. So you have a relatively free flow of 
information back and forth with other nations?
    Dr. Kirschstein. Yes, very. Let me add one thing that has 
not been mentioned.
    All these Institutes and all the others, there is also a 
Fogarty International Center, one of the 27 centers and 
institutes and it will be in one of these sessions sometime 
soon.
    Mr. Regula. Somebody asked me the question yesterday, do 
you develop drugs or is this done by the industry? We get a 
whole plethora of new drugs almost weekly. Is that the role of 
the NIH? I don't know?
    Dr. Kirschstein. It is complex because there are things NIH 
does and things the industry does and the Institutedirectors 
can describe it.
    Dr. Fauci. A typical example, Dr. Spiegel alluded to. It is 
sort of a case history that answers your question. The original 
crystallization of the protease molecule took place at the NIH. 
That was done in partnership and then the material, the 
information was transferred to industry. The industry then 
helped develop the inhibitor of that protease molecule which 
now we refer to as the protease inhibitor which is a major 
anti-HIV drug.
    The drug companies that did the development of that drug 
then utilized the NIH's clinical trial networks to prove the 
drug was safe and effective and ultimately got approved. What 
you had was the concept was developed within the Intramural 
Program at NIH, the actual development of the drug took place 
by the drug company and the proving of the drug's efficacy was 
a collaboration between the NIH and the industry.
    Mr. Regula. Very interesting.
    Mr. Miller, do you have any other questions?

                           STEM CELL RESEARCH

    Mr. Miller. One more. The issue we talked about briefly 
yesterday is stem cell and therapeutic cloning. We are getting 
into a subject you may not want to have to discuss because of 
the political.
    There was an article in this morning's paper about two 
papers coming out that adult stem cells may not be as useful as 
some thought or would have hoped. We still don't know. I am one 
of a minority within my party and I voted against the bill, 
banning cloning, banned therapeutic cloning.
    Would you all comment about where you stand on grants in 
the area of stem cell research? We talked about it briefly 
yesterday, therapeutic cloning potential, trying to block it 
and ban it in the United States, we don't know where it is 
leading yet but comment both on where you stand on stem cell 
research and therapeutic cloning.
    Dr. Kirschstein. You heard from Dr. Baldwin yesterday that 
the lines that have been approved, which were there prior to 
the President's announcement on August 9 and are now listed on 
our registry. As she told you, we have mechanisms ready and 
able to put forward funds to continue research on that. She 
described to you what was going on.
    The two papers on adult stem cells which were described in 
the newspaper this morning are two of many studies that are 
being done. I think Dr. Spiegel probably has more knowledge of 
those than anybody else. He may want to comment and then we 
will move to the next part of it.
    Dr. Spiegel. The papers are right here from the journal, 
Nature. It is a very controversial area and a very rapidly 
evolving area of science. The question is: What is the 
potentiality of adult stem cells to turn into the many 
different types of cells in the body? Plasticity is another 
term that has been applied to it.
    Papers in the New England Journal looking at recipients of 
bone marrow donors, from a brother into a woman, gave some 
evidence of adult stem cell plasticity. They showed you can 
just look for the Y chromosome, which the woman won't have, in 
the liver, in the gut, in other areas that the bone marrow 
cells from the donor had populated these other areas. That 
suggests plasticity, but has no implications therapeutically.
    These papers are contrasting that view. They are suggesting 
that some of the apparent plasticity of these adult stem cells 
is really due to a strange phenomenon where they fuse with 
other cells. I won't go into it, I am not a stem cell biologist 
so this is over my head to some extent. What I can tell you is 
it just reflects the scientific uncertainty, why the research 
is involved and evolving in terms of the potential plasticity 
of the adult stem cells versus the unequivocal potentiality of 
the embryonic stem cells.
    Mr. Miller. The other part of the question was therapeutic 
stem cells.
    Dr. Kirschstein. I wanted to make sure no one else wanted 
to make a comment.
    In terms of therapeutic cloning, the Administration has 
made its position very clear and we support the 
Administration's position. In terms of scientific potential, 
the National Academy of Sciences has recently issued a report 
in which many scientists joined together to study the issues 
and came up with the recommendation that there is enough 
scientific potential to go forward on that work. The Academy of 
Sciences report equally mentioned the fact that the moral and 
ethical issues need to be discussed widely as this work might, 
in its view, be started.
    It is my feeling at least that needs to be discussed much 
further.
    Mr. Miller. What is the potential of therapeutic cloning? 
Where could it theoretically lead? Are we driving researchers 
off to England where they allow this? We have the potential, 
the economics of biomedical research has an impact on our 
economy. Luckily the Senate is not going to pass anything but 
they don't pass anything anyway. I don't want to put you on the 
spot because you report to the President.

                      RESEARCH WITH DRUG COMPANIES

    Mr. Regula. Report to the Administration. One question, Dr. 
Fauci, on the drug issue.
    Do you have contractual arrangements with these drug 
companies? We spend a lot of taxpayer money on research through 
the grants and so on. The drug companies pick up from there. Is 
this based on contracts?
    Dr. Fauci. It really is on a case-by-case basis. One ofthe 
mechanisms of interaction and collaboration is by what we call a 
collaborative research and development agreement. When you engage in a 
CRADA agreement, resources are put in by both sides, and what usually 
spins off is if there is intellectual property, for example if a patent 
is issued, is a shared patent depending on the contribution of each. 
Then the companies can get exclusive licensure if they are very much 
involved.
    Dr. von Eschenbach. In addition to the mechanisms Dr. Fauci 
already alluded to, that the NCI is involved in as well, we are 
also exploring at this point collaborative relationships with 
the pharmaceutical industry to co-fund clinical trials so that 
they would contribute half of the cost for a series of 
programs. That mechanism will hopefully be able to be 
implemented through the Foundation for the National Institutes 
of Health. We are looking at these collaborative public-private 
partnerships at a variety of places along that continuum from 
discovery to delivery.
    Dr. Hodes. Just to comment further. Exactly that 
arrangement through the Foundation is already in place in one 
series of collaborative research in which a number of the 
Institutes, the Arthritis Institute and Aging taking the lead, 
have partnered with four major pharmaceutical companies who are 
investing millions of dollars to co-fund clinical studies in 
this case in the area of osteoarthritis and interestingly are 
doing so under circumstances where they were willing to 
contribute in the absence of any intellectual property 
advantage to themselves.
    This may not be the rule, being realistic, but there are 
occasions in which such partnerships agree in what is perceived 
to be the common good without contractual assignment of 
intellectual property rights.
    Mr. Regula. We will have questions for the record. You all 
have been terrific. I wish all of America could sit in on this. 
It would make them feel good about what is happening with their 
tax dollars at NIH. We could go on much longer because it 
raises a lot of interesting questions but I looked at my 
schedule and I think if we don't terminate, we will all get 
stressed. [Laughter.]
    Mr. Regula. The committee is adjourned.
    [The following questions were submitted to be answered for 
the record:]

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                                           Tuesday, March 19, 2002.

        FUNDAMENTAL RESEARCH: BIOMEDICAL RESEARCH IN THE FUTURE

                               WITNESSES

DR. RUTH L. KIRSCHSTEIN, M.D., ACTING DIRECTOR, NIH
DR. MARVIN CASSMAN, DIRECTOR, NATIONAL INSTITUTE OF GENERAL MEDICAL 
    SCIENCES
DR. JAMES F. BATTEY, JR., DIRECTOR, NATIONAL INSTITUTE ON DEAFNESS AND 
    OTHER COMMUNICATION DISORDERS
DR. RICHARD NAKAMURA, ACTING DIRECTOR, NATIONAL INSTITUTE OF MENTAL 
    HEALTH
DR. GLEN R. HANSON, ACTING DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE
DR. JUDITH L. VAITUKAITIS, DIRECTOR, NATIONAL CENTER FOR RESEARCH 
    RESOURCES
DR. ELLI EHRENFELD, DIRECTOR, CENTER FOR SCIENTIFIC REVIEW
KERRY WEEMS, ACTING DEPUTY ASSISTANT FOR BUDGET, DHHS

                            Opening Remarks

    Mr. Regula. Okay, we will get started. We have a lot of 
witnesses that are going to need some time.
    Dr. Kirschstein, we're happy to welcome you back. You're 
getting to be a regular here. We're always happy to have you 
and your team. We'll let you introduce your team as they each 
speak, we'll try to do the whole panel. Maybe Mr. Obey and I 
may have a couple of interruptions, if we have questions. 
Otherwise we'll have questions when they're finished.
    Dr. Kirschstein. Mr. Chairman, Mr. Obey, we're pleased to 
be here for this panel, which will expand on what was discussed 
the other day. To allow biomedical research to make progress 
toward the prevention, diagnosis and cure of diseases that 
assuredly will continue to afflict mankind for years to come, 
we must acknowledge that considerable resources are needed.
    These include modern day laboratories and equipment, 
especially expensive and large instruments, the latest 
information technology, repositories of chemicals, cells, 
tissues and genes, animal models of disease, as well as highly 
creative, highly motivated and well prepared researchers who 
have been trained to have the requisite up-to-date research 
skills to recognize important biomedical problems and the ways 
to solve them.
    I discuss these issues in my written testimony which has 
been submitted for the record. The panel today will address 
these needs, which are limited to not just those of the 
institutes and centers they represent, but are required for 
future studies by the biomedical research enterprise in 
general.

                             Introductions

    Today's panel members are Dr. Marvin Cassman, to my 
immediate left, the Director of the National Institute of 
General Medical Sciences, who will discuss research training of 
young scientists. Dr. James Battey, Director, National 
Institute of Deafness and Other Communications Disorders, who 
will expand on the career development programs for researchers, 
and also discuss animal model systems.
    Dr. Richard Nakamura, to the far left, the Acting Director 
of the National Institute of Mental Health, whose topic is 
multidisciplinary neurosciences research. Dr. Glen Hanson, to 
my immediate right, the Acting Director of the National 
Institute on Drug Abuse, who will discuss clinical trials. Dr. 
Judith Vaitukaitis, to his right, the Director of the National 
Center for Research Resources, who will expand further on 
clinical trials and also discuss the need for research 
facilities and extramural construction as well as modern day 
laboratory equipment and instrumentation.
    Finally, on my far right, Dr. Elli Ehrenfeld, the Director 
of the Center for Scientific Review, who will discuss the peer 
review system. We are joined by Mr. Kerry Weems from the 
Department.
    In addition, I will provide information, if requested, on 
the infrastructure on the NIH campuses themselves, namely the 
buildings and facilities program and the intramural research 
training activities.
    Dr. Cassman.

                           RESEARCH TRAINING

    Dr. Cassman. Thank you, Dr. Kirschstein.
    Good afternoon, Mr. Chairman, Mr. Obey. The mission of the 
National Institutes of Health is both to support research that 
will lead to an improvement in the Nation's health and to 
ensure that there is an adequate supply of trained researchers 
to aid in the pursuit of this goal. The two efforts are tightly 
linked in the United States by the fact that most of the basic 
research in this country is conducted in academic laboratories. 
As has been often noted, one of the great strengths of American 
science is that new discovery in the training of the next 
generation of discoverers takes place in the same locations.
    Research training has been part of the NIH mission since 
its earliest days. Many, actually most of the current training 
programs derive from the National Research Service Act, which 
was established in 1974. In fiscal year 2001, the NIH research 
training budget for pre- and post-doctoral students equaled 
$576 million.
    In addition, there is a still larger number of students and 
post-doctoral fellows that are supported through their 
employment on research grants. While contributing to the goals 
of the research program being supported, the students also 
complete an essential part of their apprenticeship in research. 
The training grant mechanism also allows NIH to target areas of 
emerging interest, such as biotechnology and bioinformatics. 
They also serve the purpose of addressing broader NIH goals 
such as bringing under-represented minorities into the research 
work force and providing training in scientific ethics.
    Additionally, the NIH uses research career development 
awards for specialized training. These are targeted to 
investigators at the post-doctoral level and beyond. In recent 
years, NIH has used the RCDA to address the shortage of 
clinical investigators. There is also a specialized program 
called the Medical Scientist Training Program, the MSTP 
program, that generates students with dual degrees M.D.s and 
Ph.D.s. These people are very highly sought after; they tend to 
be on the frontier in translating basic biological research 
into clinical practice. Almost all the training programs are 
interdisciplinary in their function.
    In summary, research training is a critical part of the NIH 
mission. In the words of a 1988 report from the Office of 
Technology Assessment, ``Policy makers should seek to prepare a 
cadre of versatile scientists and engineers for research and 
teaching careers, invest in an educational system that creates 
a reservoir of flexible talent for the work force and ensure 
opportunities for the participation of all groups.'' This is 
precisely what the NIH training programs have attempted to do 
and have done, with considerable success. That's been attested 
to by many reports over the years, and in particular, some 
recent reports from the National Academy of Sciences and an 
internal NIH study that tracked career progression.
    The training programs are not simply ancillary to our 
research efforts; they are integral to it and they operate 
together with the research programs in a highly coordinated 
fashion. Thank you. I will be happy to answer any questions you 
may have.
    [The justification follows:]

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                CAREER DEVELOPMENT AND RESEARCH TRAINING

    Dr. Kirschstein. Dr. Battey.
    Dr. Battey. Mr. Chairman, Mr. Obey, it's a pleasure to be 
here. I'd like to begin my remarks by thanking the NIGMS for 
supporting me in their MD-PhD program a little over 25 years 
ago. That was how I got my start in research. I'm grateful to 
this day for that support.
    The NIDCD, and I believe all the NIH institutes, 
understands clearly that if we're going to spend the budgetary 
resources that we are so generously given each year in the best 
way possible, we need to continually replenish our cadre of 
investigators with bright, young, well trained scientists. The 
best and the brightest of American youth need to be attracted 
into the biomedical research endeavor, or we will not 
completely fulfill the potential that we have to realize--this 
enormous biomedical research opportunity that is before us.
    Several years ago, the NIDCD convened a work group on 
career development and research training, where we brought in a 
number of our investigators and members of our scientific 
community to advise us on how we could do a better job of 
training and developing the careers of young investigators. We 
received a whole list of recommendations, many of which were 
directed towards, in particular, getting clinician scientists 
into the research arena.
    If you like, I can go into the specifics of all of these. 
But suffice it to say that we have implemented all of those 
recommendations and we already have early indicators that we're 
getting better, brighter young people into the research 
endeavor. That's extremely satisfying.
    We're also doing a better job of keeping clinician 
scientists in the research endeavor, rather than having them 
drift off into clinical practice, which has been one of the 
things that's often happened in the past.

                         TRANS-NIH INITIATIVES

    So maybe I'll move along to speak just for a few minutes 
about animal models, as Ruth had promised I would. This topic 
really falls into the category of infrastructure. I'm going to 
talk about two trans-NIH initiatives, one of which was an 
initiative to accelerate the pace at which the mouse genome was 
sequenced. This initiative was guided by the leadership of 
Francis Collins, the Director of the National Human Genome 
Research Institute, and you might ask me why sequence the mouse 
genome.
    The mouse is really unique among mammalian models. It is 
unique in the sense that we have very good control of the 
genetic background. What do I mean by that? What I mean is that 
within a given in-bred strain of mice, all members of that in-
bred strain are basically genetically identical. There are no 
differences, which allows very clean consistent experiments to 
be done. Scientists are able to specifically manipulate the 
genome of the mouse, and to determine the consequences. It's a 
wonderful tool for allowing us to understand gene function.
    Many of the organ systems in the mouse are very similar to 
that in the human. So what we learn about the fundamental 
biology and diseases and disorders of those organ systems in 
the mouse can be readily translated into the human. Finally, 
maybe the most powerful argument for sequencing the mouse 
genome quickly is that there is no better tool than a similar 
but not identical mammalian genome for annotating the human 
genome.
    What I mean by annotating is determining where the 
boundaries of the genes are and the numbers of the genes. By 
aligning the mouse and the human genome, one can find the 
beginnings and the ends of genes in the area of the human 
genome where we suspect there is a gene, but because this is 
the first time it's ever been seen, we don't know exactly where 
it begins and ends.
    A second trans-NIH initiative involves a number of 
institutes interested in making the mouse a more powerful model 
system. The way that they are going about that is by funding 
centers. Within these centers, scientists are systematically 
creating random mutations throughout the genome of the mouse 
and then subjecting those mice to phenotypic studies. They look 
for elevated seizure threshold, they might look for a dumb 
mouse that has a hard time running the maze. They might look 
for a deaf mouse that can't hear, they might look for a blind 
mouse.
    Then scientists can take these animal models and go back 
and find the mutation in the gene that causes the abnormality. 
Very often, it turns out that these are the same genes that 
underlie diseases and disorders in humans that are analogous to 
those that are found in the mouse. These are just two examples 
of infrastructure resources, both trans-NIH initiatives, both 
voluntary contributions on the part of the institutes. I think 
both initiatives will accelerate greatly the discovery of the 
genes involved in various diseases and disorders of human 
beings as well as contribute to a fundamental understanding of 
how those organ systems work.

                      REVOLUTION IN BRAIN SCIENCE

    Dr. Kirschstein. Dr. Nakamura.
    Dr. Nakamura. Thank you.
    When I was going to graduate school in the 1970s, we 
thought that genes were instructions for creating proteins that 
determined completely the structure of the brain. Not only 
that, we thought that that structure was fixed by the time you 
were about 20 years old, and from then on, it was only 
downhill, the only thing you could do is lose neurons.
    Today, we have a vastly different picture of what's going 
on in the brain. We now know that our brains are actively 
constructed by an interaction between the genes and our 
experience and our environment. What we learn, in fact, affects 
the structure of the human brain. This poses as a problem for 
us something very different than what we thought early on.
    Not only that, we had thought there were no new neurons 
growing in the brain after the age of, let's say, 20. But now 
we know that neural stem cells in the brain, these are natural 
stem cells in the brain, are constantly producing new neurons. 
These new neurons keep going, and we see new neurons in adults 
through the age of 77. That means through at least eight 
decades of life, we are constantly renewing our brains. These 
neurons are coming into place and helping us, among other 
things, remember things.
    These discoveries were fundamental to understanding a 
revision of what's going on in the brain and we also know that 
things like stress reduce the number of new neurons and things 
like exercise increase the number of new neurons. That study 
was done in rodents, so I can't promise you that it happens to 
human beings. But after I heard this result, I went out and 
bought a treadmill. [Laughter.]

                       ADVANCES IN BRAIN IMAGING

    Dr. Nakamura. So I wanted to show you, though, that in 
order to get these results, we needed to have a lot of new 
technology, new infrastructure, and we also needed to have 
scientists of all stripes working together. Here's just an 
example of what we knew 10 years ago and what we knew yesterday 
in two sets of results.
    The top image is one that many of you have seen before, 
this picture from two twins with schizophrenia, one with the 
disease and one without. The one with bigger holes in the 
brain, bigger ventricles, is the one with schizophrenia. This 
was taken as an example of how schizophrenia is a real brain 
disease. But it was a pretty primitive example. The definition 
is weak, the change in ventricle size is something that 
occurred over a lifetime, and we couldn't really say that this 
was due to schizophrenia itself.
    However, the pictures below show much more detail and they 
show pictures of the brain taken at two different points during 
development of those who are at risk for early onset 
schizophrenia. The individuals on the right are those patients 
who developed schizophrenia. It shows that those who develop 
schizophrenia lost a significant number of neurons. The red 
portion are those areas of the brain in which they lost neurons 
during development.
    This shows for the first time that schizophrenia is an 
active process that definitely affects the brain. This required 
animal models, molecular biology, neuroimaging physicists, 
behavioral scientists, clinicians and basic scientists.
    Thank you.
    [The information follows:]

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                 RESEARCH AND TECHNOLOGY INFRASTRUCTURE

    Dr. Kirschstein. Dr. Hanson.
    Dr. Hanson. Mr. Chairman and other members of the 
Subcommittee, it's a pleasure to be here and talk to you about 
how NIDA uses research and technology and infrastructure to 
work with the Nation to deal with the serious problems of 
substance abuse, including the problems of tobacco abuse. These 
are issues that cost this Nation approximately $300 billion a 
year as well as destroy countless numbers of families and 
individual lives.
    We have been employing recent neuroscience technology to 
elucidate the underlying mechanisms of drug addiction. Just as 
an example, you can see on this chart the representation of two 
different brain systems. The system in red is the underlying 
system that seems to be responsible for initiation of substance 
use. It tends to be a system that's very reward driven.
    After persistent or continuing use, drug administration 
becomes more compulsive and seems to be driven by the systems 
seen in purple. There's actually a shift in brain circuitry 
that's responsible for what we know to be a rewarding or 
initiating response and what occurs in addiction or a 
compulsive, more of a motoric system. This new perspective of 
shifting brain mechanisms allows us to develop more effective 
prevention and treatment approaches that will help people at 
various stages of the addiction process.
    It's important that we have in place an infrastructure that 
will allow us to take these kinds of breakthrough discoveries 
and apply them in such a way that they will be practical and be 
able to be applied in clinical settings. NIDA's clinical trial 
network is such an infrastructure. It consists of 14 nodes and 
90 community clinics spread across the country, as you can see 
in this graphic.
    The pink asterisks are those nodes that are in place. The 
white ones are nodes that we anticipate or that we hope we will 
be able to bring into that system. Currently, this network is 
testing more than a dozen science based treatment protocols, 
and identifying how to adapt these therapeutic strategies for 
community use.
    As I said, we're anticipating expanding the network, trying 
to go into under-served populations such as diverse minority 
groups and rural communities.
    Finally, it's important for NIDA to take this information 
and these discoveries and facilitate their dissemination into 
general practice. I recently returned from a blending clinical 
practice and research conference in New York City where nearly 
1,000 people from academia and treatment communities came 
together to discuss how new research findings could be applied. 
At this meeting, Dr. David Vlahov, a NIDA grantee, reported on 
the effects of stress on substance abuse after the 9/11 event. 
His data showed that there has been an increase in tobacco use, 
marijuana use and alcohol in much of Manhattan.
    These kinds of results help NIDA to identify where it needs 
to place its emphasis as far as research is concerned and some 
recent discoveries looking at the mechanisms of stress have 
actually provided some ideas and some potential strategies to 
deal with stress in the clinical realm that will help us 
prevent and treat these kinds of drug abuse issues.
    Because of your support, these are exciting, unprecedented 
times of opportunity. With your continued help, I'm sure that 
we and other members of NIH will be able to continue to make a 
difference in the health and the lives of the people of this 
country. Thank you.

                            INSTRUMENTATION

    Dr. Kirschstein. Dr. Vaitukaitis.
    Dr. Vaitukaitis. Mr. Regula, members of the Subcommittee, I 
am pleased to have this opportunity to discuss the key role 
instrumentation plays in modern research.
    Research is changing. The paradigm is moving toward an 
integrative or systems approach, rather than a reductionist 
approach. Instead of studying things down to the molecular and 
atomic level, we study them in an intact cell or an intact 
system. It's akin to putting Humpty Dumpty back together again 
to study how the parts interact, as we measure them with a 
variety of instruments.
    Why are we using this integrative or systems approach? 
Research questions have become much more complex. Consequently, 
they need a team of investigators, who range from experts in 
technology, like physicists, bioinformaticists, and 
bioengineers, to well-trained physician investigators and basic 
scientists. The makeup of the team will vary over time 
depending on the kinds of questions being asked.
    The systems approach is heavily dependent on research 
instrumentation and on bioinformatics. It requires what we term 
high throughput. We gather a lot of technical information in a 
short period of time. We have to analyze it, which requires 
high end computation, and experts in developing programs that 
will actually allow investigators to visualize the data, to 
predict where they should go next and what experiments should 
be done next.
    Equipment needed includes tools like cell sorters, confocal 
microscopes that cost several hundred thousand dollars. 
Investigators can apply to NIH for that type of equipment 
through the shared instrumentation grant program.
    Recently, we became aware of a need for higher end 
equipment costing more than $750,000. Some items may actually 
cost up to several million dollars, for example, cryoelectron 
microscopes and NMRs.
    We published a program announcement last fall for the high-
end instrumentation program, and expected just a few dozen 
applications. We were wrong. We received considerably more, 
underscoring the need for this high-end equipment. I have 
approached my colleagues from other institutes and they have 
pledged to help pay for some of this high end equipment that's 
absolutely essential for modern day research.

                              SYNCHROTRONS

    We have another way of providing access to instrumentation. 
We support a network of biomedical technology centers 
throughout the country, including centers that do 
crystallography using synchrotron radiation. It costs about $10 
million to build a synchrotron beam line. These kindsof 
equipment need to be shared by many investigators through a centralized 
resource. We are able to do that and support almost half of all the 
crystallographic beam lines that are available in this country.
    We wanted to increase the throughput of crystal studies at 
these synchotrons. We asked one of the sites to develop a 
technique to do that, because it is cheaper to increase the 
throughput than build new beam lines. We thought that if they 
improved the technique by about 20 percent, it would help 
immensely. In short, they used robotics to place a crystal on 
the beam line and found a new way of making crystals. They not 
only met our 20 percent mark, they increased through put a 
thousand-fold. We think, in reality, bench testing will show 
something on the order of a 10 to 20 fold increase in 
throughput. This will greatly facilitate studies of 
macromolecules from the various genomes that are almost 
completed including human and many others.

                          VIRTUAL LABORATORIES

    There is another way that one can access that 
instrumentation through what we call virtual laboratories. 
Separate investigators can work with someone else at a distance 
over the internet. For example, at the synchrotron I was 
describing, if someone wants to send their samples there to be 
uploaded by robot, they can control them with their own 
computer in their office.
    We can create a virtual laboratory in a scientist's office. 
It contacts the Stanford synchrotron site, the robot is 
instructed to load the crystal. The researcher controls the 
synchrotron and gathers the desired data. It's then sent to the 
San Diego supercomputer center and comes back with coordinates 
and a mockup of what the macromolecule may look like.
    Then, the researcher can use another program over the 
internet to define where a substance may bind to more than one 
place within that molecule. Using another data set, potential 
molecules that can fit into that binding site can be 
identified.
    What I've described is basically a way of doing structure 
based design for new drugs. One can also use these tools for 
other purposes.
    In summary, modern research is increasingly complex, and 
requires a multidisciplinary team, modern laboratories and a 
systems or integrative approach. Because this approach is very 
heavily data dependent, we need to provide access to teraflop 
computing, which we have begun to do through the internet, 
using a biomedical informatics research network that we are 
building with the National Science Foundation and several 
universities across the country.
    Thank you.

                          PEER REVIEW PROCESS

    Dr. Kirschstein. Dr. Ehrenfeld.
    Dr. Ehrenfeld. Mr. Chairman, members of the Subcommittee. 
Several of my colleagues around the table have described new 
scientific findings, resource needs and training needs in the 
country. I listened to all that is happening in the biomedical 
research world with pride and pleasure.
    I now want to focus on how we identify and select the 
research projects that NIH grantees are working on. So I will 
take just a few minutes to briefly outline how the NIH peer 
review process works and describe some of our current 
challenges and solutions. Then of course will be happy to 
answer questions.
    There are two levels to the peer review process at NIH. The 
first is the initial review, which is a review of grant 
applications for scientific and technical merit. It is 
conducted by panels of outside scientific experts predominantly 
from the research community. They come to what we call a study 
section meeting three times a year. The Center for Scientific 
Review conducts this initial review of about 70 to 75 percent 
of the applications submitted to NIH. Each institute or center 
conducts its own review of a subset of the remaining 
applications.
    The second level of review is done by the funding institute 
itself, which by law has a national advisory council that is 
designed for that purpose. A council unlike a study section, 
includes a much broader spectrum of individuals. It certainly 
has scientists in the field, but it also has members of the 
interested lay community; representatives of advocacy groups, 
health care providers, ethicists; and a much broader spectrum 
of people. Council members weigh very heavily the scientific 
evaluations that are provided by the initial review groups. But 
they also consider the need to fund certain areas of research 
because of public health needs or because scientific 
opportunities have opened up in the field.
    In the end, it is the institute that makes the funding 
decision based on both advice, from the initial review for the 
scientific merit and the second review for programmatic 
relevance to the science, the field, and the area that need to 
be supported.
    Many will agree that the peer review system is the major 
determinant of the success of the biomedical research 
enterprise in the United States. And the study section itself 
is probably the most critical part of thepeer review process. 
It is dependent upon two very critical elements.
    The first is to have the right people sitting around the 
table making the evaluations. Having the right scientific 
expertise to evaluate applications is what allows the most 
promising and the most meritorious applications to be 
identified. Our staff in the Center for Scientific Review and 
in the institutes solicits reviewer nominations very broadly, 
then identifies and recruits appropriate reviewers with diverse 
scientific outlook, and ethnic, gender, geographic 
distribution. We also seek representatives from small and large 
institutions and public and private institutions. In the case 
of small business applications, it is essential to have 
business and industry represented as well as academia.
    It is very important that members of the scientific 
community perceive that their applications are reviewed fairly 
by people whom they recognize as being knowledgeable to the 
field and whom they respect as scientific contributors in that 
field. It is also important to ensure that we have an 
appropriately diverse spectrum of people.
    The second critical element is how the study sections are 
organized: how they are put together and what research topics 
are reviewed in them. Science is changing very rapidly at this 
time. New tools are being developed and are being very rapidly 
applied to many different areas of biomedicine. Our study 
sections therefore have to be maintained and kept up to date 
with the entier landscape of modern scientific research. We 
also have to accommodate newly emerging fields and new ways of 
doing scientific research.
    To accomplish this, the Center for Scientific Review 
several years ago began a major initiative for systematically 
assessing and reorganizing our study section structure. We are 
slightly less than halfway through this process. It is being 
done with very broad input from the external research 
community. This effort has provided a very beneficial side 
effect of greatly improving interactions between NIH and the 
outside research world.
    While reorganizing and updating our study section, the 
numbers and complexity of the applications we receive have 
increased enormously in the last few years. In order to handle 
this growth more efficiently, NIH has invested very heavily in 
new technologies. We are geared towards handling applications 
electronically, providing reviewers with CD-ROMs instead of 
boxes of paper and providing Internet-assisted review tools 
that we have developed and implemented.
    Thank you for giving me the opportunity to present this 
information. I would be happy to answer any questions.

                           RESEARCH PROJECTS

    Mr. Regula. Thank you.
    Is research generic? How do you decide which projects 
you're going to research? Is research for research's sake, or 
do you do research on specified medical conditions?
    Dr. Kirschstein. Each of the institutes has a mission which 
prescribes----
    Mr. Regula. So each of these individuals head an institute?
    Dr. Kirschstein. That's right.
    Mr. Regula. And within the confines of that institute, what 
they are researching is described or laid out?
    Dr. Kirschstein. Dr. Hanson, for example, is the Acting 
Director of the National Institute on Drug Abuse. This is to 
study substance abuse and addictive behavior, as he described.
    We have another institute which you will hear from next 
week or the week after, on alcoholism and alcohol abuse. There 
is clearly an overlap.
    In addition, as Dr. Nakamura from the National Institute on 
Mental Health tried to explain, such studies are in the 
neuroscience research area as well as pharmacology and 
chemistry. So there is overlap. But each of them has a defined 
mission. And each of them talks about the boundaries of that 
mission, and Dr. Ehrenfeld has described the boundaries of the 
study sections that will review them. They don't always have a 
one to one correlation between all the study sections and the 
Institutes.
    So it's a very complex program that has grown up over the 
years. Because as I told you the other day, we started with one 
institute, gradually expanded and now we're up to 27.

                             NIGMS MISSION

    Mr. Regula. Dr. Cassman, what would be your area?
    Dr. Cassman. The General Medical Sciences Institute looks 
at the fundamental molecular and cellular bases of biological 
processes. We do this primarily by looking at model systems, 
non-human systems for the most part.
    So we're interested in the function of enzymes; we're 
interested in the mechanisms underlying cellular processes such 
as motility, the way cells move, as well as fundamental 
chemistry, biochemistry, and cell biology.
    Mr. Regula. How does that translate into action that 
affects everybody in this room?
    Dr. Cassman. Let me see if I can give you an example. We 
have an investigator who has been looking at the mating of 
yeast.
    Mr. Regula. Yeast?
    Dr. Cassman. Yes, yeast cells. Doesn't sound like it's 
going to be terribly important for anybody sitting around the 
table here--yeast cells, that's right. Just plain yeast cells. 
Mating behavior, of course, in yeast, is not at allsimilar to 
mating behavior in humans, so you can't use that as an analogy.
    But it turns out that the signals that yeast cells receive 
when they undergo mating are translated into signal 
transduction processes, that is, into networks of intra-
cellular behavior that are actually quite similar in all 
organisms, or at least all higher organisms.
    But the interesting thing is that in the process of doing 
this study, he was looking into how cells transform, how yeast 
cells change from a benign form to a highly infectious form, 
such as yeast infections, which are very hard to deal with. He 
was able to identify a gene that was critical for the 
transformation and will, I hope, be able to lead ultimately to 
a diagnosis initially, and then ultimately for a therapy for 
these rather intractable fungal diseases.
    Once this gets to the point of looking at the disease 
entity, we usually don't support it any longer. It's much more 
likely then in this case to be in the National Institute of 
Allergy and Infectious Diseases. The grant will move.
    Mr. Regula. The base of information?
    Dr. Cassman. Yes, absolutely. And grants will move from our 
venue into some other institute's interest when they start 
being much more closely tied to a specific condition or 
disease.
    Mr. Regula. You could give a grant to Ohio State University 
to pursue the same research you are, or something comparable.
    Dr. Cassman. Yes. All of this research is being conducted 
extramurally, that is, in the universities.
    Mr. Regula. You're just the manager of it.
    Dr. Cassman. That's right. We manage the direction and the 
award of the grants.
    Mr. Regula. Make the selection of the applications that 
come your way, pick the 30 percent that are successful.
    Dr. Cassman. Right. We do that together with the peer 
review process, of course. We also try to identify those areas 
that are on the boundaries of research and provide specific 
stimulus for those.
    Mr. Regula. Let's take the yeast. Was that initiated by 
your department or was it initiated by an outside group that 
said, we think this ought to be done?
    Dr. Cassman. That's right. This is investigator-initiated 
research.
    Mr. Regula. Your department?
    Dr. Cassman. Someone in the university who decided this was 
an interesting project. The peer review process validated that, 
said this was a good investigator, a good program and a good 
direction. And we supported and continued supporting it.
    Mr. Regula. Do all of you do some in-house research?
    Dr. Cassman. Almost every institute except ours. The rest 
of them I think without exception, if I'm not mistaken.
    Dr. Kirschstein. And the National Center for Research 
Resources.
    Dr. Cassman. Right. The two of us do not have intramural 
laboratories.
    Mr. Regula. You get your ideas from agencies or 
institutions that suggest we have, we meaning the institution, 
have an idea that we think could be beneficial to mankind?
    Dr. Cassman. Right. And approximately 90 percent of all of 
the research that NIH supports is from outside investigators. 
It's not internal research.
    Mr. Regula. So you have a sizeable job just to manage these 
projects, I would suggest. How many projects would you have in 
your institute? How many research projects have you got working 
out across the country?
    Dr. Kirschstein. A total of 38,000 individual research 
grants.
    Dr. Cassman. Not for us, but for all of NIH.
    Dr. Kirschstein. Yes.
    Mr. Regula. But collectively, the 27 directors----
    Dr. Cassman. Twenty-seven institutes, right.
    Mr. Regula [continuing]. Manage these 38,000?
    Dr. Cassman. Right.
    Dr. Kirschstein. The important thing about that management 
is that it is not purely administrative management. It is done 
by scientists who have chosen to become administrators who have 
really excellent scientific knowledge of these projects, so 
they can, as the project progresses, first of all, decide when 
it is important enough to something else to move to another 
institute, and secondly, to assess the science and whether it's 
going well and whether the budget throughout is consonant with 
the science.
    Dr. Cassman. And we periodically, with the help of advisory 
committees, establish so-called RFAs, that is, requests for 
applications. We identify areas that are of high importance and 
where additional research is needed to try to stimulate areas, 
usually at the boundaries of the science.
    Mr. Regula. Mr. Obey.

              IMPORTANCE OF PHYSICAL SCIENCES TO RESEARCH

    Mr. Obey. Thank you, Mr. Chairman.
    Dr. Kirschstein, let me just ask you a series of questions 
and you can direct them to whomever you think ought to answer 
them. As biomedical research gets more and more complicated, 
it's obviously more and more dependent upon research done in 
other fields. Yet if you take a look at the President's budget 
this year, we have about a 16 percent increase for NIH versus 
about a 3 and a half percent increase for the National Science 
Foundation and the same story roughly for other scientific 
agencies.
    I certainly don't expect you to argue against your own 
increase, but I do think it's appropriate for this Committee to 
be concerned, not just the Subcommittee, but the full 
Committee, to be concerned about the balance in our allocation 
of resources to different scientific agencies. Will you comment 
on some of the linkages that you have between NIH and some of 
these other agencies and give us some illustrations of why it's 
important not to neglect those other agencies if we want to 
have an adequate foundation for what it is that you do at NIH?
    Dr. Kirschstein. Mr. Obey, we could not agree with you 
more, that, as the science in general has become more complex, 
biomedical research is dependent on physics, chemistry, 
mathematics, biophysics, etc. There are enormous linkages, and 
we work as closely as we can with our colleagues in the other 
agencies. I think Dr. Cassman would be the appropriate person 
to address that.
    Dr. Cassman. Yes, thank you. Yes, Mr. Obey, you're 
absolutely correct. The contribution of the physical sciences 
to biology has been immense, and it's been that way for many, 
many years, many decades, in fact. The most obvious way, of 
course, is through instrumentation, and Dr. Vaitukaitis 
mentioned a few examples. But there are many other forms of 
instrumentation with which I'm sure you're familiar, CT 
scanners, PET scanners,magnetic resonance imaging. All of those 
emerged out of fundamental research in the physical sciences.
    In the basic research areas, there are equally a large 
number of examples. In fact, this is a good time to ask me, 
just yesterday I was at the Argonne National Laboratory for a 
signing ceremony where we, together with the National Cancer 
Institute, are establishing a facility at the Argonne 
synchrotron. That's a very large accelerator.
    The interesting thing about this accelerator is that it is 
managed and built by the Department of Energy. There are six of 
those in this country, five out of the six are managed by the 
Department of Energy, one by the National Science Foundation. 
The interesting thing about the synchrotron is that when it was 
built, it was not at all with the intention of having anything 
to do with biology. It was for particle physicists who like to 
spin things around, little particles around at very high 
speeds.
    Mr. Obey. I like to do that with a martini. [Laughter.]
    Dr. Cassman. Well, these go close to the speed of light, 
which is probably a little more than you're interested in.
    And there is an interesting phenomenon, when you get close 
to the speed of light, these particles emit bursts of energy in 
the x-ray region, very highly focused, very powerful bursts of 
energy. In the 1970s, some clever people began to realize that 
these energy bursts, now, as far as the physicists were 
concerned, were a total waste. Because they were pouring energy 
into this machine to get things moving around, and the 
particles were just throwing it off.
    This excess, really waste material as far as the physicists 
were concerned, was of fundamental interest to biologists and 
material scientists who could use it to do x-ray diffraction of 
the kind Judy was talking about.
    So the technology borne of physics has been a critical 
element in the development of science. There are people who 
will say that the major scientific advances have always emerged 
when a new technology is born.
    But there is another aspect which probably will be more 
valuable in the future than in the past. We need physicists, 
mathematicians and engineers to do the mathematical modeling of 
complex systems, again, Judy mentioned that earlier, that most 
biologists are not trained in. These are highly complex areas. 
They require a great deal of specialized knowledge of 
mathematics and statistics.
    For example, you asked about collaborations. Well, the 
Department of Energy is one example. Our institute has just 
established another collaboration with the mathematics division 
of the National Science Foundation. We're requesting 
applications in the application of mathematics to basic 
biological studies. We did this with the math division because 
they know mathematics. It's like Willie Sutton and the banks; 
you rob banks because that's where the money is. We went to the 
National Science Foundation because that's where the 
mathematicians are. We don't have that kind of contact and 
interaction with mathematicians that they do. And the 
collaboration helps both them and us.
    That's just one example.
    Mr. Obey. So in other words, it would not be wise, if we 
want to further the long term development of biomedical 
research, if we focused only on funding NIH to the exclusion of 
the other agencies?
    Dr. Cassman. In my opinion, I think it is essential that we 
provide significant funding for other agencies.
    Dr. Kirschstein. I think all of us feel that way. Dr. 
Vaitukaitis might like to respond.

                          OUTCOMES OF RESEARCH

    Mr. Obey. I've got a limited amount of time, so I'll take 
the first shot that each of you have. I want to keep it 
compressed if I can.
    Outcomes research. The Agency for Health Care Research and 
Quality is cut 16 percent below the current year in the budget, 
with most of those reductions coming in the research on health 
costs, quality and outcomes program. Would you explain what the 
relationship is between NIH's mission and their mission? Where 
do you overlap? Where do you differ? Why is it important that 
they be funded, rather than just NIH?
    Dr. Kirschstein. It's extremely important to study the 
outcomes of, particularly, the clinical research that NIH has 
supported as it translates to the bedside, as we were talking 
about the other day, and then into the community. Our 
relationships with the Agency for Health Care Research and 
Quality are very close. In fact, as you probably realize, 75 
percent of budget comes from the NIH evaluation, money.
    We work closely with them. The Office of Medical 
Applications for Research relies on the Agency for Health Care 
Quality and Research to do the evidence-based literature 
searches that are necessary for us to draw on for our consensus 
meetings. Many of the institutes have projects which are 
collaborative. The National Heart Institute has for a long time 
worked with AHRQ in regard to studying whether a procedure 
which was used for years by the surgeons, to take patients with 
severe emphysema, that is, the lungs expanding, and whether by 
simply removing, surgically removing parts of the lungs you 
could give them relief. Because the alveoli are expanding, 
people don't get as much air as they should.
    Well, nobody had ever done a study to determine that. 
Between the Heart Institute and the other agencies there has 
been a very close relationship, collaborative funding and so 
forth. It is a very important thing to be doing.

                    RESEARCH MANAGEMENT AND SUPPORT

    Mr. Obey. I recall back in the early 1970s, we were rapidly 
expanding the funding for the Cancer Institute, but we were 
having a terrible time expanding the number of program officers 
to oversee the individual grants. Has your budget growth been 
translated into adequate resources for grant review and 
management? Example, has the number of grants handled by each 
program officer been increasing or decreasing? Has the number 
of NIH staff coordinating the peer review process been keeping 
up with the volume of the work? Or are we running into the same 
problem we ran into then?
    Dr. Kirschstein. We certainly have found that recently, as 
we have talked more about the need for the research management 
and support areas, with both the Department and with this 
Committee and the Senate Committee, that there has been an 
understanding that we need more individuals in those areas. So 
the increases have been generous.
    Now, as Dr. Ehrenfeld points out, this is moving so rapidly 
that we really have to titrate it each year. But we are doing--
--
    Mr. Obey. I misunderstand something. You said the increases 
have been generous.
    Dr. Kirschstein. Yes.
    Mr. Obey. Which increases are you talking about?
    Dr. Kirschstein. In the research management and support for 
the various institutes and for then in turn, the Center for 
Scientific Review. That is in that RMS line that you put in the 
budget.
    Mr. Obey. So are you saying that in your estimation, the 
number of program officers have been increasing by an adequate 
amount?
    Dr. Kirschstein. Yes. I think we will have to titrate this 
as we go, in order to be sure that it is keeping up with our 
needs. Dr. Ehrenfeld described to you how rapidly things are 
progressing, and when she has those scientific review 
administrators, they have to do more and she may need more. 
They have to have new disciplines.
    Dr. Ehrenfeld. If I could just add to that, I think a very 
timely example is the new, very large initiative that we will 
be activating on bioterrorism. There is not sufficient 
infrastructure for reviewing these applications that are going 
to come in for managing the new applications that will be 
funded and implemented. It's an area that's going to require a 
great deal of regulation and oversight, because these are 
research projects and issues that have severe potential public 
health and public defense consequences and so on.
    Dr. Kirschstein. We have differentially increased the area 
of support for both the National Institute of Allergy and 
Infectious Disease and the National Cancer Institute, because 
both of them got very substantial increases this year. 
Primarily in the bioterrorism area which has, as you know, been 
increased remarkably and needed help.

                          LEVEL FOUR FACILITY

    Mr. Obey. I have a number of other questions but my time is 
virtually out. Let me just ask you one last question on this 
round.
    The budget this year, as I understand, contains $105 
million to construct the new level four facility at Fort 
Detrick. That is done to deal with severe biohazard problems. 
We had significant argument with the White House last year 
about whether or not that funding should be provided 
immediately. We were on the yes side.
    I'd like you to lay out what is the status of existing NIH 
facilities with respect to their being able to handle 
bioterrorism related infectious agents and why it is necessary 
to build this new facility. I just want the record to have it 
clear as to why it's necessary.
    Dr. Kirschstein. Do you want me to do it now or put it in 
the record?
    Mr. Obey. Do it now, very briefly. I just want the record 
to show why that building is necessary.
    Dr. Kirschstein. There is an area at Fort Detrick where it 
will be possible to put this structure up. It is absolutely 
necessary. As new vaccines are developed for a new generation 
of smallpox vaccines and new generations of anthrax vaccine 
that there be the ability to do testing in animals as well as 
at the bench in order to be assured that challenges can't be 
handled, that we must have the protection of those facilities 
to do that.
    Mr. Obey. Would you explain also and expand for the record 
what is a level four facility?
    Dr. Kirschstein. Yes.
    [The information follows:]

          Explanation of Biosafety Level 4 (BSL-4) Facilities

    Biosafety level 4 (BSL-4) facilities are designed to handle 
the most deadly agents and have exceptional engineering 
controls. BSL-4 facilities are highly specialized and are only 
operated in a few locations.
    A BSL-4 facility is required for working with dangerous and 
exotic agents that pose a high individual risk of aerosol-
transmitted laboratory infections and life-threatening disease. 
Agents with a close or identical antigenic relationship to 
Biosafety Level 4 agents are handled at this level until 
sufficient data are obtained either to confirm continued work 
at this level, or to work with them at a lower level. Members 
of the laboratory staff have specific and thorough training in 
handling extremely hazardous infectious agents and they 
understand the primary and secondary containment functions of 
the standard and special practices, the containment equipment, 
and the laboratory design characteristics. They are supervised 
by competent scientists who are trained and experienced in 
working with these agents. Access to the laboratory is strictly 
controlled by the laboratory director. The facility is either 
in a separate building or in a controlled area within a 
building, which is completely isolated from all other areas of 
the building. A specific facility operations manual is prepared 
or adopted. More information is available on the NIH web site. 
The address is: http://bmbl.od.nih.gov/sect3bsl4.htm.

    Mr. Obey. Thank you, Mr. Chairman.
    Mr. Regula. Just to follow up on Mr. Obey, does this have 
an element of involvement of the Defense Department?
    Dr. Kirschstein. Fort Detrick was once a facility that was 
run by the Department of the Army. Mr. Obey will remember that 
in 1971, a good portion of the Fort Detrick area was 
transferred to the Department for work by the National Cancer 
Institute, with the idea that we would no longer use it for the 
kinds of things they were doing at Fort Detrick.
    However, the Army has kept some part of its activity 
related to organisms and toxins like anthrax, botulism, plague 
and ebola out at Fort Detrick. The National Institute for 
Allergy and Infectious Diseases will collaborate with them, and 
in this facility, the work will be done in collaboration.
    Mr. Regula. Will they pay part of the cost?
    Dr. Kirschstein. They have been paying the maintenance. I 
do not know what the details are. Dr. Fauci knows that. He can 
answer that for the record.
    Mr. Regula. They would not necessarily help pay for the new 
construction.
    Dr. Kirschstein. No. The new construction would not be paid 
for by them. We will pay for that.
    Mr. Regula. It would seem logical, if they're getting 
benefit, they should.
    Dr. Kirschstein. Yes. We will be working that out, and 
arrangements have been made. I will give you information for 
the record.
    [The information follows:]

                  Biosafety Level 4 (BSL-4) Facilities

    Lack of specialized, high containment labs, like the one 
proposed for Ft. Detrick, is the most critical factor that 
limits research on the most dangerous and highly-infectious 
pathogens. The Army currently has a BSL-4 lab on Ft. Detrick--
it is one of only three operating BDL-4 labs in the nation.
    The NIH lab to be built on Ft. Detrick is to address NIH's 
mission-critical requirements, which, although complementary, 
differs significantly from the requirements of the U.S. 
military. Protecting the civilian population requires a much 
broader range of research and the NIH lab will support research 
for all segments of the civilian population, including the 
elderly, children, infants, and people with suppressed immune 
systems caused by disease, therapeutic drugs or other reasons. 
Building this lab on Ft. Detrick, as compared to building it 
elsewhere, brings two distinctive advantages--it will 
facilitate cross-transfer of scientific knowledge and expertise 
between the scientific staff at NIH and the Army because of the 
co-location of the two BSL-4 labs: and the physical security of 
the lab will be enhanced because the lab will be on a secured 
military installation.

    Mr. Regula. Well, you tell them the Committee urges that 
the Defense Department contribute substantially to the cost.
    Dr. Kirschstein. Yes, sir.
    Mr. Regula. Mr. Hoyer.

                             SUCCESS RATES

    Mr. Hoyer. Thank you, I appreciate that.
    Dr. Kirschstein, as you know, I have asked questions about 
pay line before, and we talked about review and how we get to 
the pay lines. My questions are, in a general sense, as we 
increase the funding substantially, first of all, is the 
science increasing in terms of the opportunities? In other 
words, is the quality of science applications from researchers 
around the country or around the world increasing at a 
significant level? And as we increase the pay line, what are we 
leaving on the table?
    You might reference, I know there's still a, I guess you 
generally, in your first appearance, said between a 15 or 
thereabouts percent, and as high as 31, 32 percent pay line?
    Dr. Kirschstein. Even a little bit higher.
    Mr. Hoyer. You might want to reference that.
    Dr. Kirschstein. The science is increasing, as you heard 
from my colleagues, as you heard the other day, so rapidly. A 
great deal of it is due to this infrastructure we've been 
providing for years, both the instrumentation, general clinical 
research centers, the research training of beautifully 
developed scientists who all have remarkably wonderful ideas. 
So yes, the science is there to support the work and beyond.
    Last year you may remember that although over previous 
years we had always talked about the fact that about one-third 
of the applications were what we wanted the success rate to be. 
Several of the institute directors, Dr. Fauci among them, said 
he would say that the science at a level percent of 45 percent 
could be supported.
    Now, I don't think we anticipate that that is possible, nor 
should you under the circumstances that Mr. Obey has been 
raising. But certainly the science is there, and I think Dr. 
Ehrenfeld can tell you that her reviewers are making comments 
about the fact that the science is really excellent.
    Mr. Hoyer. I'd be interested in Dr. Ehrenfeld's 
observations, particularly as to how much science we're leaving 
on the table that peer review says would be very worthwhile to 
pursue.
    Dr. Ehrenfeld. It's hard to get hard data to support that. 
These are kind of subjective feelings. What we have seen, for 
example, are situations in which our reviewers are generally 
asked to try to identify the bottom half of theapplications 
that they review. Those are in general not discussed in as much detail 
as the top half, because they're not likely to be funded.
    It is getting more and more difficult to make any study 
section eliminate 50 percent----
    Mr. Hoyer. Distinction between the top half and the second?
    Dr. Ehrenfeld. They won't do it. Basically, the reviewers 
will rebel and say, I can put maybe 25 percent of these 
applications, sometimes 30, and say, these are okay to say, 
we're not going to discuss them in detail.
    Mr. Hoyer. How long have you been in your position, Doctor?
    Dr. Ehrenfeld. Five-and-a-half years.
    Mr. Hoyer. That's a relatively short time for some of us on 
this Committee, for a young timer. But in that time frame, have 
you seen the number that peer reviewers felt comfortable 
leaving on the table diminishing substantially? Even in that 
short period of time?
    Dr. Ehrenfeld. Even in that short period of time. It's 
anecdotal data, I don't have a good way to document that. But 
there is a clear perception in the community that the level of 
science that is being done and that is possible to do at this 
time has gone up enormously and is screaming for an 
opportunity. Having to turn back two out of three applications, 
because in the best of cases, if we have a 33 percent, two out 
of three applications will be rejected, that is hard.
    Mr. Hoyer. So it's pretty safe, from what you say, as a 
ball park, obviously, anecdotal, but a third, a third and a 
third. That is to say, about a third probably shouldn't be 
funded, a third has a good possibility and a third we fund. You 
said 25 percent, but I would just----
    Dr. Ehrenfeld. I would accept those numbers, they are as 
good as mine, yes.
    Mr. Hoyer. I would say to the Committee members, 
particularly who are new, that is a very substantially higher 
percentage of, that essentially is about two-thirds that are 
worthy of funding, which is way over the 40 to 45 percent that 
we historically say, so we think we've only been 10, 15, 20 
percent on the table.
    Dr. Kirschstein. Actually, we historically thought getting 
a third was remarkably good. What we're seeing is that 
institute directors who have been here for a long time, Dr. 
Cassman, I, Dr. Fauci, are seeing significant increase in the 
quality and are saying, whereas we would have said a third, 45 
percent is not out of line. That's halfway toward that second 
third.

                        DOUBLING THE NIH BUDGET

    Mr. Hoyer. I think the answer to the next question, then is 
self-evident. Obviously one of the issues is, we have now, 
assuming we adopt this budget, doubled in five years the NIH 
budget. The question that we've raised over the years that 
we've been doing this, are we able to digest this sum of money 
effectively?
    Dr. Kirschstein. Yes, sir.
    Mr. Hoyer. That's a pretty simple answer. None of us are 
shocked on this side of the table. Do you have concerns about 
that, though? I presume you have had concerns about that, and 
therefore that's been one of the issues, that we're not just 
shoving out money because it happens to be there.
    Dr. Kirschstein. We are not just shoving it out, and 
indeed, are making sure that what we are giving will be used 
well, that is, what the job is of each of the people at this 
table and those of their colleagues whom they have chosen very 
carefully to work with them, to be able to assure themselves 
that not only have the study sections and the councils done the 
appropriate job, but that monitoring and oversight is done 
well.

                     NEURONAL LOSS IN SCHIZOPHRENIA

    Mr. Hoyer. Dr. Nakamura, let me ask you a couple of 
questions. I'm always fascinated with these visuals. Obviously 
the objective of these visuals in this research is to prevent, 
ameliorate or cure. I was fascinated by the extraordinarily 
better diagnostic ability we have now in schizophrenia. What's 
the consequence of that? You mentioned that, I think, to some 
degree. Like that curing or ameliorating schizophrenia.
    Dr. Nakamura. That is the goal. However, the results of 
this information will not allow us immediately to better either 
diagnose or treat schizophrenia. What it does is gives us a 
more profound understanding of how schizophrenia comes about. 
By knowing----
    Mr. Hoyer. What you're saying to me then is that with the 
color that occurs in the change in the diagnostic, I'm not sure 
whether that's a color or heat or what is that?
    Dr. Nakamura. It's a color to represent a loss of neurons. 
The red represents a loss.
    Mr. Hoyer. There is no way to predict loss of neurons 
before it happens, only now to, in effect, see it?
    Dr. Nakamura. Yes. Now we know, for schizophrenia, where 
neurons are lost in the brain and over what time period. So 
that gives us a signature that we can work from. It turns out 
that this may have diagnostic utility. We don't know that yet 
for sure, because these are average data over a number of 
patients. But the number of these patients who showed the exact 
same phenomenon as individuals was striking.
    So this may give us for the first time a signature, a 
physiological signature of the development of schizophrenia, 
which would make for a much better diagnosis than we've had.

                 RESEARCH ON CHILDHOOD MENTAL DISORDERS

    Mr. Hoyer. All of our time is limited, I want to go 
quickly. My colleague and I, in particular, Rosa DeLauro 
fromConnecticut, have been very interested, as you may know, in post-
traumatic stress disorder, particularly for children. We've talked to 
SAMHSA about it.
    It is our premise that research on children's mental 
illness, obsessive compulsive disorders and others, bipolar, 
still lags behind in NIMH. Is that accurate?
    Dr. Nakamura. Yes. The reason it lags behind is that 
children's behavior changes at such a rate, as we all know, 
that it has become very difficult to understand. For instance, 
we have a disease, diseases of misconduct or conduct disorder, 
for instance. We often get laughed at, because everyone knows 
who's raised children, there's going to be periods of 
misconduct.
    We're talking about diseases in which these behaviors go on 
much longer than usual, and they're disrupting the development 
of those children. But because everybody has experienced 
periods of time when children are out of control, it becomes 
much more difficult to do an accurate diagnosis that this is a 
chronic condition in that child. And parents don't like to hear 
that these are chronic conditions in their children.
    But as we have done longitudinal studies to know what are 
the outcomes for children with these kinds of conditions, we 
now know that the outcomes are very bad. But if we can 
intervene early enough, we can change the course of those 
children's outcomes into ones which are pro-social and useful 
for those families, so that they don't ultimately show 
depression, bipolar illness, etc.

                NEED FOR CHILD MENTAL HEALTH RESEARCHERS

    Mr. Hoyer. Given that, does NIMH have a plan to strengthen 
this focus?
    Dr. Nakamura. Absolutely. We have been working intensively 
with the pediatric and child psychiatry communities to try to 
train new clinicians who will do the research; to try and get 
psychologists who are interested in these areas to come over 
with new training programs. A new loan repayment program has 
been put into place with a particular emphasis on those working 
with children.
    So we are working very hard to establish this, and we are 
trying to get researchers to work with particular groups of 
children, for instance, bipolar illness in children, to try and 
confirm those diagnoses, learn what the long term outcomes are. 
Most importantly, learn what treatments are most effective.
    Mr. Hoyer. Thank you. Mr. Chairman, do I have a chance for 
one more question?
    Mr. Regula. Sure.

                    CLINICAL LOAN REPAYMENT PROGRAM

    Mr. Hoyer. Dr. Vaitukaitis, I'm going to ask you a 
question, because you got cut off before. I really was going to 
ask you the question anyway. I was very interested in the 
Clinical Research Enhancement Act, or sponsoring it. I'm 
pleased to see that we're moving forward with the loan 
repayment program.
    But my question is this. In the first year, as I understand 
it, only NIH researchers, researchers with NIH support, were 
eligible to apply. I don't believe that was our full intent. 
Can you comment on that? Do we intend to expand it? And what's 
the time frame of that?
    Dr. Vaitukaitis. This fiscal year, applicants were limited 
to those with support from NIH. Next year we will move into a 
more widely based approach that would include applicants with 
funding from other Federal agencies, the private sector, and 
probably even private donors. As long as the source of support 
for clinical research is peer reviewed, it can come from 
various sources. The loan repayment program would be 
considerably broadened next year.
    Dr. Kirschstein may want to comment.
    Dr. Kirschstein. We're going to double the number of loan 
repayment contracts we give in fiscal year 2003. First of all, 
when the legislation was passed, it was a time in the budget 
cycle that we had to determine to use the money from other 
things, research programs, clinical research programs.
    Secondly, except for a very small experience in the 
intramural program, we've never run a program like this. It 
involves having an individual contract between each one of the 
people who will receive the loan forgiveness, essentially. 
That's very labor intensive. It means you have to follow the 
people for years to make sure everything goes well.
    We thought we ought to do it as a pilot program, carve out 
and do about 250 loan repayments the first year.
    The second year, which is what we're asking for in 2003, we 
will double to 500, a little bit more, and----
    Mr. Hoyer. Expand the universe.
    Dr. Kirschstein. Yes.
    Mr. Hoyer. Thank you very much. Mr. Chairman, thank you, 
and Mr. Kennedy, thank you for yielding the time.
    Mr. Kennedy. My pleasure.

                 COURSE AND PROGNOSIS IN SCHIZOPHRENIA

    Mr. Regula. About losing neurons, that's in schizophrenia, 
right?
    Dr. Nakamura. In schizophrenia, yes.
    Mr. Regula. If you watch the show, A Beautiful Mind, they 
come and go. So if they're gone, how do you get them back?
    Dr. Nakamura. This is a particular form of schizophrenia. 
This is a form of schizophrenia that's childhood onset. This 
has a much worse course.
    A Beautiful Mind is a great film, and portrays 
schizophrenia in a way which is much more realistic than in the 
tradition of movie making. However----
    Mr. Hoyer. Very diplomatic, Dr. Nakamura. [Laughter.]
    Dr. Nakamura. It is not, it really isn't a typical case. 
You don't start out usually with a Nobel prize brain and come 
out of it as well as this individual has.
    So it's fairly clear that this individual did not lose a 
massive number of neurons in the process. So we are talking 
about a special form of schizophrenia, it doesn't apply to all 
of them.
    Mr. Regula. So if you had a substantial loss, the hope for 
recovery would be very----
    Dr. Nakamura. The prognosis for these individuals is very 
bad.
    Mr. Regula. I saw Dr. Nash interviewed the other day, and 
he seemed pretty much with it. He must have not lost too many 
to begin with.
    Dr. Nakamura. There is a group of those with schizophrenia 
who undergo pretty substantial recovery and can work and can 
return to their families, if appropriately treated.
    Mr. Regula. Mr. Kennedy.

                  MENTAL ILLNESS AND HEALTH INSURANCE

    Mr. Kennedy. Thank you, Mr. Chairman.
    A beautiful segue into my questions. If we know all of 
this, why don't we treat it like every other physical disease 
in terms of insurance coverage? Is it plain discrimination? Can 
any of you answer that for me?
    Dr. Kirschstein. Those decisions are not based on what we 
have determined. We provide the knowledge and we expect to and 
will work with the people who have to make those decisions. We 
work closely with the Center for Medical Services, the old 
HCFA. We have had discussions with health insurance companies. 
But that is not a decision that we can make, as individual 
scientists or as an agency.
    Dr. Battey. But I think it is fair to say that psychiatric 
and behavioral disorders, have an underlying biological basis, 
just as deafness has an underlying biological basis, just as 
infectious disease has an underlying biological basis. So we do 
not believe that fundamentally these diseases are different 
than many other diseases that are covered by insurance.
    Dr. Nakamura. Let me also say, the National Advisory Mental 
Health Council has indicated that there is no medically 
justified reason for differentiating between mental and other 
physical illnesses.

                  PROMOTING RESEARCH ON MENTAL ILLNESS

    Mr. Kennedy. Well, I appreciate your saying that. I think 
that we need to get about making sure that it's covered, then 
if it's a question of cost, then that ought to be a question of 
insurance, not a question of whether this is physical or not. 
Because they're blurring the two when they're discussing 
parity. I appreciate your comments and would invite you to give 
me any more when and if you ever get the inspiration to.
    I'd like to say one other thing, though, about that. All of 
you here at the NIH are amongst the brightest, forward thinking 
folks. Yet, despite the evidence that four in ten of the top 
causes of disability worldwide, are mental illnesses, and when 
you measure the effective investment that NIH makes in mental 
illnesses as opposed to other physical illnesses, for example, 
by using a recent estimate from the NIH, one finds that one 
dollar invested in mental health research for every six dollars 
that's invested in AIDS. So $1 for mental illnesses, $6 for 
AIDS, $1 for mental illnesses, $65 for cancer. One dollar for 
mental illness is the equivalent of $161.
    So the fact of the matter is, we're not getting equal 
billing, even at the NIMH, or it's grown at a slower rate of 
growth than every other agency within the NIH. It seems to me, 
when we have the World Health Organization say mental illnesses 
are among the single greatest causes of disability worldwide, 
we ought to get more progressive leadership from the people 
that know the most. It's not going to happen from out in the 
hinterland. They don't appreciate what you appreciate. They 
don't have the education, the experience to know.
    So we need it from you guys. And we're not getting it. I'm 
afraid to tell you, we're not getting it. The reason I don't 
think insurance companies are going to jump at the chance for 
parity, and this country is not going to jump at the chance is 
because the very people who know the most aren't doing what 
they need to do. You all may be restricted because you're part 
of an Administration, you can't speak out of turn.
    But the fact of the matter is, if you don't speak, no one 
is going to speak. Because you all know that the stigma still 
rests around this country that mental illnesses are not 
physical illnesses. And you know that people are out there, who 
are not going to be pushing for this. Thank God for the movie, 
Beautiful Mind. It's the one popular culture movie that's now 
going to help penetrate people's consciousness about mental 
illnesses.
    But you know what? We need more from you. And I'm really 
distressed to see that the NIMH does grow at a slower rate than 
all the others. I'm distressed that there's a fraction, that 
one of every hundred dollars that's spent on research goes to 
mental illnesses. I'm disturbed by the fact that we've got an 
elderly population that's going to boom and we have little to 
nothing invested in research for senior mental illnesses.
    We just got a great presentation about how, when you grow 
old, it doesn't necessarily mean you lose all your neurons. Yet 
in spite of that testimony, we have inadequate funding for 
senior mental illness. It's not keeping pace at all, even 
within NIMH.
    So NIMH is slower than every other agency, and then even 
within NIMH, senior mental illnesses are growing, the research 
into that is so slow. So I don't know whether it's a question 
of whether there's enough geriatric folks in this peer review 
group, but the grants aren't going out. I don't know if you 
could answer for me why there aren't enough grants being chosen 
in these areas, made in these areas in terms of peer review.
    Dr. Ehrenfeld. I don't know where to start. I can say a few 
words and I think Richard also wants to say a few words.
    The solution sometimes to problems, even the most pressing 
problems, is not just to put money into it if the scientific 
opportunities are not there to make progress. Applications come 
in, the majority of applications that come in are investigator 
initiated. They come in from the scientific community, who get 
ideas and thoughts about ways to solve certain problems. That 
happens at a time when there is a sufficient base of 
understanding of the illness or the disease or the problem, 
then we see applications coming in.
    The peer review system can only review what applications it 
gets. And it's not so much there. That's the review side.
    The institute side, I think Richard needs to address.
    Dr. Nakamura. Yes. I accept your overall indictment that we 
have not been doing enough research in this area. This year, I 
have been very actively working to try and see what we can do. 
A key feature is that we don't have enough researchers in this 
area. So a couple of months ago, I met with the American 
Association for Geriatric Psychiatry and committed to renewed 
efforts in this area. We have started a number of initiatives, 
including a clinical trial to address psychotic illnesses. It's 
a major clinical trial with hundreds of enrollees to understand 
psychotic episodes in those who are older.
    We have another effort too, on the loan repayment side, 
we're going to use some of our loan repayment money. More 
importantly, we've reconstituted the Aging Consortium to try 
and ensure that there is work across the institute and across 
agencies to try and address the problem of psychiatric 
illnesses in the aging.

                          BEHAVIORAL RESEARCH

    Mr. Kennedy. I appreciate that, Dr. Nakamura. I look 
forward to working with you on that. I'm sure this Committee 
does, too, because it seems to me that the baby boom generation 
is becoming a senior boom, and the highest rate of suicide is 
among seniors. We don't fully understand the complexity of 
evaluating and diagnosing the various mental illnesses that go 
hand in hand with growing old.
    And just as you said, with children, it's hard for us to 
know, because kids are kids, how you're going to be able to 
determine what is bipolar or what is going to be obsessive 
compulsive or disorderly conduct. You can use the same excuse 
for seniors and say, well, they're old, and of course, they're 
supposed to be like that, just like children are supposed to be 
like that. And we both know both are false. Children do not 
have to be so ill, and we cannot relegate that to them just 
because they are children. Seniors don't have to be so 
depressed and ill, and then people just relegate that to a 
function of age.
    So in both cases, I hope we work hard to continue to 
progress. But I know that's not going to happen unless we get a 
better--Secretary Thompson came here, didn't mention one word 
about mental health. And I know he cares about it. But it's 
clearly not coming from within NIH as a priority. Because the 
World Health Organization says it's the number one disabling, 
outside of cardiovascular disease, it affects every other 
aspect of the body, and we're not doing it. We're just not 
making the grade.
    We know that behavioral health affects every other disease, 
we have them come up here and talk repeatedly about the need to 
address obesity and how we all need to get into healthier 
lifestyles and behaviors. Well, let's start addressing it.
    That would be my last question, what are you doing in terms 
of the National Institute of General Medical Sciences to 
address behavioral science research within the different 
institutes?
    Dr. Cassman. In an earlier question from Mr. Regula, it was 
pointed out that each of the 27 institutes and centers has a 
specific mission. The mission of the National Institute of 
General Medical Sciences is to understand the fundamental 
biological processes at the molecular and cellular level. And 
that's the level at which we are involved in behavioral 
science. We use primarily model systems to examine the genetic 
and biochemical mechanisms underlying behavioral phenotypes.
    And I would point out that this is also true in a number of 
other institutes, the National Institute of Mental Health has 
programs in this area, the Neurology Institute----
    Mr. Kennedy. What are you doing, though, at NIGMS?
    Dr. Cassman. We are looking at, for example, cellular 
processes that regulate uptake of antidepressants and 
antipsychotics. We look at drug-drug and drug-nutrient 
interactions that may lead to alterations in behavior, at 
specific enzymes and transporters in the brain that metabolize 
drugs and steroids and regulate their biological activity. This 
is the molecular level at which we investigate these things, 
like circadian rhythms, learning and memory and so on.
    So we have a number of programs in each of these areas. 
Again, we look very carefully at what all of the institutes are 
doing. We try not to duplicate efforts in other institutes. And 
we look for regions in which we have specific expertise.
    For example, the effect of anesthetics on memory and 
cognition. That's an area for which we have a specific program 
in anesthesiology. We focus on that within that area.
    Mr. Kennedy. I know this has been a legislative charge of 
both this Committee and the Senate, so I'd be interested in 
getting a more detailed description of what you've been doing.
    Dr. Cassman. Sure.
    [The information follows:]

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Kennedy. And I thank you all for your great work to 
advance science in this country and help treat illnesses of our 
people. Thank you all very much.
    Mr. Regula. Mr. Sherwood would defer to you, Mr. Obey, you 
said you had a question.

              EDUCATING THE PUBLIC ABOUT MENTAL DISORDERS

    Mr. Obey. Thank you very much. I just have two very brief 
questions I'd like to ask, one following up on what Mr. Kennedy 
has raised.
    I am personally very disturbed about what we've seen happen 
in that Texas case just a couple of days ago with the woman who 
killed her children. I'm frankly appalled by the fact that a 
woman like that who obviously needed help as much as she needed 
it is going to wind up having to spend her entire life in jail. 
I guess as someone born in Oklahoma, that's something I've come 
to expect from Texas.
    But nonetheless, I'm wondering what on earth we're going to 
do to overcome the primitive, ignorant indifference that this 
society has when it comes to mental illness. What I'm wondering 
essentially is, how can we do a better job of disseminating 
information about mental illness across the country in time to 
help people who actually need it, before you have tragedies 
like that? How can you get the information out that makes 
people understand that if you have this problem, it can be 
dealt with? What kind of work is NIMH doing with SAMHSA or on 
your own to try to get some of this information out?
    Dr. Nakamura. We've been working very hard on this problem. 
I cannot comment on the particulars of the individual case.
    Mr. Obey. Of course not.
    Dr. Nakamura. But our education outreach has been very, 
very vigorous. Getting the public's attention on any one issue, 
given all the problems that we have, has been very difficult. 
Perhaps the one silver lining to September 11th was the almost 
instantaneous recognition by all parts of the population that 
anyone could come up with a mental illness when put under that 
kind of strain and stress.
    So we have been working very hard to put out publications, 
and I have a couple of examples here. We brought a number of 
packages. We had hoped to bring enough for everyone, however, I 
understand that getting packages into this building is 
extremely difficult right now. We brought what we could carry. 
There are two units here.
    They show how we make available a number of different 
pamphlets on different kinds of mental illness. Here is a 
package with one page sheets, so that for individuals who want 
a quick summary of different kinds of disease conditions and 
resources for getting help, might be made more readily 
available.
    We are also working very closely with the Substance Abuse 
and Mental Health Administration to try and bridge from the 
research side to the services side. Next week, in fact, a 
number of institute directors, Alcohol, Drug Abuse and NIMH, 
will be meeting with Mr. Charles Curie the Administrator of 
SAMHSA to talk about how we can bridge this gap between us even 
better. I think we want to work hard on this and the American 
people deserve that kind of communication.
    Mr. Obey. Thank you. Just one last question--
    Dr. Kirschstein. We have enough of these packets to give to 
members of the Committee, if they'd like.

                   RESTRUCTURE OF PEER REVIEW GROUPS

    Mr. Obey. Thank you. One last question for Dr. Ehrenfeld. I 
understand that the Center for Scientific Review has been 
working to reorganize the structure of its peer review groups, 
and that you're looking at jurisdictions and boundaries of 
individual study sections. What are you trying to get done with 
this? Are you going to wind up with something that results in a 
more disease specific approach? Or are you trying to create 
more cross-cutting focus?
    Dr. Ehrenfeld. The first phase of this reorganization 
effort was really to decide on the best way to create broad 
clusters of review, really the macro level question that you 
ask. And the decision was made that we should have clusters of 
study sections that are based primarily on disease and organ 
system and the diseases associated with those organ systems, 
plus of course a set of study sections for fundamental 
discovery that potentially will apply to all possible diseases 
and organ systems, so the level of kind of understanding 
cellular processes.
    That being said, each one of these clusters is now 
undergoing essentially an expert design of individual study 
sections that will populate that cluster. So if for example 
there is a cluster of study sections that will be related to 
cardiovascular science, experts from the research community in 
the broadest sense, dealing with all aspects, including 
behavioral science, now related to cardiovascular disease, 
basic science, and clinical efforts and so on are convened to 
sit down, look at the applications of today, hopefully with 
some insight about what's likely to be for tomorrow, and to 
design a set of appropriate study sections focused on 
cardiovascular sciences that will be able to handle with 
expertise and with fairness and with rigor the review of all 
the kinds of applications that come into the NIH dealing with 
various aspects of cardiovascular sciences.
    This kind of organization is designed, you ask, what do we 
hope to accomplish by this. It's designed to acknowledge the 
fact that a time has arrived of molecular medicine, that is, a 
time when genetics, biochemistry, molecular cell biology, are 
tools that are being applied to virtually every area of 
biomedicine. It is designed to foster and support the review of 
new opportunities in newly emerging areas, bioinformatics, for 
example, bioengineering, new kinds of processes that we don't 
have study sections currently designed to review those 
applications, because those fields didn't exist five years ago.
    But the science is changing so rapidly and the scope is 
increasing, that we want to make sure that we design a set of 
study sections that will be poised to review with fairness all 
aspects of science, all kinds of both hypothesis driven and 
most importantly, the multidisciplinary kinds of projects that 
are coming in to approach, to move things forward in the 
cardiovascular sciences area now requires research that 
integrates sometimes very basic research, sometimes the design 
of drugs to deal with the results of that, the application to 
patient population to see the effects, to analyze the behavior 
aspects of whether it can work.
    These are broad, multidisciplinary approaches and we need 
to have peer review groups that can handle that kind of scope.
    So there were a number of concerns that people had about 
the way our current study sections were limited in review of 
applications for the future, and we want to make sure that we 
are poised, really, to look forward for research.
    Mr. Obey. What's the time frame and when will it be 
implemented?
    Dr. Ehrenfeld. It's progressing deliberately a bit slowly, 
because we rely on an iterative process and dialogue with the 
outside research communities. We're doing it in phases.
    So I would say that the first new sets of study sections 
are likely to appear one year from May. All of these proposals 
have to be approved by the CSR advisory council and the next 
meeting is in May, and we will do the approvals for the first 
set of these IRGs. We give ourselves one year from that time to 
actually get it implemented in the study sections, formed and 
the reviewers appointed and so on.
    And after that, it will continue for another two to three 
years.
    Mr. Obey. Thank you, Mr. Chairman.
    Mr. Sherwood.

                            PUBLIC AWARENESS

    Mr. Sherwood. Thank you very much. I'm enormously impressed 
with NIH, but I have a question that's going to be similar to 
my question of a few days ago. Dr. Kerry at the Institute of 
Medicine told us that they reported about a 15 or 20 year lag 
between the discovery of effective forms of drug treatment and 
their translation into routine patient care. As a businessman 
and a person that likes to get things done right now and see 
results, I think that's unacceptable. And I think you're doing 
all this wonderful research, but it seems needlessly long.
    I want to know what we're doing to promote awareness of the 
findings of federally funded clinical research into effective 
drug abuse treatments. Dr. Hanson, would you chat with me about 
that?
    Dr. Hanson. Certainly. You're very correct in terms of 
there having been substantial discoveries in neurobiology, 
underpinnings of addiction and the abuse process. We would like 
to see some of those discoveries translated into practice in 
terms of developing new pharmacological strategies and/or 
behavioral strategies for treatment.
    There does seem to be this problem, and it's not just a 
drug abuse issue. It's a general neuroscience issue from some 
of these targets. We really are not positioned very well to 
develop drugs. We're not pharmaceutical companies. That's a 
very, very expensive proposition.
    What we need to do is partner with institutions such as 
pharmaceutical companies and convince them that these are good 
targets to go after, that we need to develop new molecules that 
will actively interact with these biological systems. Then once 
we develop those molecules, we can take them back to our 
institutes, such as Drug Abuse or Mental Health or Neurology 
and apply them to our specific issues.
    We talked a lot about the neuroscience or neurobiological 
basis of mental health. That also applies to drug abuse, 
because drug abuse is in many cases a mental health issue. The 
substances interact with the same neurobiological systems that 
you see in schizophrenia, you see in depression, you see in 
anxiety. When we talk about stress, stress not only helps to 
precipitate mental illness, it helps to precipitate drug abuse.
    As we identify these targets, if we can get this 
partnership going, we can develop drugs that will be useful 
across the span of neuroscience and neurobiology. That's where 
we are. We need to find ways to encourage these partnerships 
with the pharmaceutical companies.
    Mr. Sherwood. Thank you. I'd like if I may to extend my 
question to the rest of the table. Because I don't think that 
it is only in drug treatment. I think it's in general medical 
advances.
    As Mr. Kennedy said, with the baby boom population aging, 
there are other things, other than mental illness, that this 
becomes so important. We talked about diabetes and various. I 
just think that if we could stretch what you do a little bit, 
the delivery, we have to get your work and your knowledge down 
to Main Street. I think the system in this country is pretty 
slow at that.
    I'd like your comments, and I'd like to see if I could 
start us thinking about what we can do about that. As a layman 
who understands very little of what you do, I think that's the 
issue that would be important.
    Dr. Kirschstein. We agree. Actually, we discussed this the 
other day with Chairman Regula, who gave us a very good idea, 
which we're going to implement almost immediately, about how we 
can get good diets out to people who are in need of that 
information who are elderly. The Chairman suggested that we put 
brochures and pamphlets in every Meal on Wheels tray that's 
deliver. I think that's something we will do. We have all that 
material, we spend considerable amount of effort and money to 
put those together. Each of my colleagues will be able to talk 
to you about that.
    Dr. Battey. Yes, we are quite interested in the information 
dissemination. In fact, within the last few years, we have 
launched a campaign we call Wise Ears to inform the public 
about the dangers of noise induced hearing loss. We estimate 
that roughly 10 million Americans have lost significant amounts 
of hearing because of exposure to noise that could have been 
avoided. We guess that there's many more than that that are 
currently at risk right now.
    The plain simple fact of the matter is, these folks don't 
know that, although it doesn't hurt now and they don't know 
they're losing their hearing, that they're accelerating the 
hearing loss process that accompanies aging by unnecessary 
exposure to loud noise. This is particularly true of 
individuals, for example, who come in with leaf blowers in your 
yard.
    If you run a leaf blower for 15 minutes every weekend, 
you're not going to lose significant hearing. But if a person 
does it eight hours a day, five days a week, week after week 
after week, by the time that individual is 40, he may not.
    Mr. Kennedy. If I could interject, why hasn't the 
Department of Labor done something about passing regulations on 
noise?
    Dr. Battey. There are OSHA standards, but----
    Mr. Kennedy. Yes, 30 years old.
    Dr. Battey. They are old, and they don't typically apply to 
very small businesses. So your automobile workers are well 
protected, but individuals who run a gardening service, for 
example, don't have the same kind of regulatory protection.
    Mr. Regula. How about mechanics?
    Mr. Kennedy. Ear protection.
    Dr. Battey. It's simple. It's preventable hearing loss that 
could stop millions of people from losing their hearing sooner. 
It's not rocket science, it's very simple.
    Mr. Sherwood. Mr. Chairman, when you're mowing those huge 
pastures in Ohio, we'll expect to see you with earmuffs now. 
[Laughter.]
    Mr. Regula. That's music to my ears.
    Dr. Battey. It's music until it gets over 80 decibels.

                           SCIENCE EDUCATION

    Mr. Sherwood. I realize that maybe we've been talking about 
geriatric problems and mental health problems, but we also 
have, in diabetes and in lots of things, we have lots of health 
problems with young people.
    Do we have a good program with the American public school 
system?
    Dr. Kirschstein. I think we do, but I think we could do 
better. We always can. Dr. Spiegel was here last Thursday, I 
believe, from the Diabetes Institute, and he will supply you 
with materials that we have.
    [The information follows:]

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    Dr. Vaitukaitis wanted to add to some of the things we've 
been talking about.
    Dr. Vaitukaitis. We have a science education program whose 
central purpose is to get information from NIH research to the 
lay public to help them make healthier lifestyle choices. For 
example, we have convinced the Boston Museum of Science, Howard 
University and Colorado State University to incorporate the 
recently announced findings from the diabetes prevention trial 
the exhibits that they already are working on that advise 
students about healthy choices in terms of nutrition. 
Colorado's program focuses on K through 6th grade students and 
follows them over that entire period to see if they are making 
healthy lifestyle decisions.
    The Boston Science Museum exhibit focuses on the importance 
of exercise and appropriate nutrition to prevent diabetes, and 
uses multimedia, live interactive presentations by scientists, 
and has touch screen approaches to help educate the public.
    We have about 30 science museums involved with this kind of 
approach across the country. We are going to modify the program 
so that we can work directly with NIH institutes who have 
health messages in order to take advantage of this creative 
source of talent that can get the information on health out to 
the public.
    Mr. Kennedy. If I could interject for a second, Mr. 
Sherwood----
    Dr. Kirschstein. We also have an office of science 
education within our intramural program. We know that there are 
activities all around the country. The advisory committee to 
the director will be meeting on June 6th, and we're going to 
have a group of high school kids come down from Boston to show 
us what they're doing at City Lab, for example.
    Dr. Nakamura.
    Dr. Nakamura. You had a question.
    Mr. Kennedy. My colleague is asking about how to get a 
bigger bang for the buck, as a businessman, from all the 
research that's going on. It seems as though we should step 
back and figure out what gives us a better bang for our buck in 
terms of our research dollar.
    With respect to diabetes, for example, if you properly 
educate the kids and identify the risk factors and do a lot of 
prevention, this country would save itself billions of dollars 
in treatment costs down the road. Maybe you could comment on 
that with respect to diabetes.
    Mr. Sherwood. Treatment and lost productivity.

                          PREVENTION RESEARCH

    Mr. Kennedy. If you could give us some feedback on what it 
costs for prevention versus what it costs to treat. It seems as 
though it is not even a close call. Why aren't we spending more 
of our dollars on prevention.
    Dr. Kirschstein. We are spending a great deal. Dr. Spiegel, 
who is the Director of the Diabetes Institute, talked about 
this at the session last Thursday. What everybody has realized 
is what you're talking about. What everybody has also realized 
is what Dr. Nakamura and you, Mr. Kennedy, have alluded to, the 
difficulty of doing this. We have a population of young people 
who are not in the mode of walking and engaging in exercise. 
They are in the mode of sitting in front of their television 
sets and eating.
    So what we are seeing is what used to be called adult onset 
diabetes occurring in children as young as nine and ten years 
old, and certainly a number of teenagers. We have a form of 
juvenile or young people's diabetes, which is unfortunately an 
inherited disease and for which we've made a great deal of 
progress, we know a lot about the genes, and we probably are on 
the cutting edge of doing something that will really help it. 
We know that we can prevent the onset of diabetes in young 
people, adult diabetes in young people, if we can break the way 
in which something happens.
    We spend a good deal of money on diabetes research. It is 
$6 billion [Clerk's note: later corrected to $845,000,000]. You 
gave it a 15.6 percent increase this year, and a large amount 
of that is the diabetes education program, which we work on in 
conjunction with the CDC. That's been mandated by law. We have 
a great deal of money. But it is difficult to move it, and it's 
what you've been talking about.
    Mr. Weems. Maybe I can add just a bit to this. This is a 
big concern of Secretary Thompson's, especially diabetes.
    Dr. Kirschstein. That's the prevention part.
    Mr. Weems. This year in HRSA, he's formed a department-wide 
effort called Healthy Communities for diabetes, asthma and 
obesity, to leverage the resources of the NIH, the CDC, move 
into five communities, roughly five communities, and get an 
agreement from that community on actual targets for reduction 
of diabetes, asthma and obesity. So to become a grantee, we 
would ask the community for a target, then we would work with 
that community to achieve actual reduction targets in that 
area.
    Mr. Regula. May Mr. Sherwood and I suggest the communities 
that they should participate?
    Mr. Weems. This will be a competitive process, but we 
always listen to any of your suggestions, sir.
    Mr. Regula. We'd have a little edge?
    Mr. Weems. I think so.
    Mr. Kennedy. Mr. Chairman, I propose it for all those 
members that are currently present in the room. [Laughter.]
    Mr. Regula. Go ahead, Mr. Sherwood, you still have the 
time.
    Dr. Kirschstein. That was prevention research I was talking 
about. There's been much more than that on diabetes.
    Mr. Kennedy. Right. But it seems to me, Mr. Chairman, in my 
State, our public health Department works very closely with our 
insurance companies when it comes to inoculating our children. 
Because they get the money actually from the private sector, 
from the insurance companies, to do the inoculations. Why? 
Because the insurance companies know they're going to get 
saddled with the cost if they don't pay up front. So the 
Government acts as kind of the clearinghouse for that money.
    Now, we have so much understanding and knowledge of 
behavior, how it affects health and how that health costs 
usmoney. We know about what research models work in terms of prevention 
and the like, but why don't we work with all this brain power here into 
formulating a model whereby we translate that and use our capitalist 
system of for-profit to fix our health care system. Then the money 
would go into actually saving people's lives and keeping people 
healthy, rather than taking care of people after they get sick.
    I think that this is part of the area that Dr. Sherwood is 
referring to. That's what we need: prevention. We need health 
promotion, not sickness care.
    What are you doing to get our health insurers to do that?
    Mr. Regula. You heard it, Mr. Sherwood, Mr. Kennedy is on 
record in favor of the capitalistic system. [Laughter.]
    Mr. Kennedy. I think it's a legitimate question. Because if 
we don't figure out in a way, we're just putting a ton of money 
behind very unsuccessful, costly health care or sick care, 
versus putting our money behind health care. If you can suggest 
to us ways that we can, it seems to me if the private sector 
knew this stuff and we could figure out a way for them, we 
could show them, you and the scientists could show them, here's 
how you make the money. If you do this, you're going to have a 
bigger profit.
    Why can't you do that?

                       INFORMATION DISSEMINATION

    Mr. Regula. I think this goes back to Mr. Sherwood's 
original contention, you need to get the material out, and 
you're saying to the private sector, so they can make use of 
it.
    Dr. Kirschstein. We're getting the information out. We can 
always do a better job with that. We have had discussions with 
the health insurance companies and we have had some evidence 
that several things are happening.
    One of the things that is working well, and I think it is 
again a tribute to the Department and to the Secretary, is that 
we now have coverage of clinical trials, particularly in cancer 
chemotherapy, by the Medicare system, so that people can be on 
the best trials for the situation that they find themselves in. 
We have been working for years to try to get that done in 
regard to private health insurance, and frankly have not made 
much progress.
    Mr. Kennedy. We don't do it in the public health care 
sector. For example, chemotherapy, with prostate cancer, one of 
the most successful things is this Brachytherapy type of 
therapy, which is the isotopes that they implant. It's costly, 
but when you look at the overall cost of chemotherapy plus 
surgery, it's incredible. Do you think Medicare is changing its 
reimbursements to accept it? No. Why? Because the money is 
behind the cutting and the surgery, and the money is behind the 
chemotherapy.
    We have the science, the data is in. They use their own 
data at CMHS or whatever it's called now, CMS. So it's not 
working. We're not breaking through. I think my Republican 
friends would be very disappointed to know that this Republican 
Administration is funding inefficiency when it comes to cost 
outcomes and effectiveness when it comes to treatment, in our 
public system.
    So how are we going to convince the private sector to make 
the changes? We're not even willing to do them within the 
Medicare and Medicaid system.
    Mr. Regula. Mr. Sherwood for the defense. [Laughter.]
    Mr. Sherwood. I am very interested that Mr. Kennedy just 
sort of endorsed the HMO model.
    Mr. Kennedy. I do endorse the HMO model, in the ideal sense 
of managed care, I endorse it wholeheartedly. Although in its 
practice it's never been more than managed cost. And that's not 
managed care.
    Mr. Sherwood. Well, but we need to have managed care. And 
we need to have healthy practices for good outcomes as opposed 
to expensive treatments later. We all agree with that.
    I'm not sure they want to listen to us any more, although 
you sound a great deal like my brother, the Doctor Sherwood 
when he gets going on this.
    I think we've made it very clear to you that from two ends 
of the spectrum a little bit on where we stand ideologically, 
that we agree very much that we think, as great as your work 
is, we're inefficient in getting it down to the end user.
    Dr. Kirschstein. I would agree with you.
    Dr. Battey. I think we all agree that it would be better to 
prevent disease than to treat after disease ensued. But the 
issue of prevention and changing people's behavior and habits 
is a very difficult affair. My 15 year old son can tell you 
that fatty foods are not good for him and that he ought to get 
up off his backside and go out jogging rather than watch TV. 
And he'll tell you that while he's trundling off in the car to 
McDonald's to buy a Big Mac and a bunch of fries. It's very 
difficult.
    In fact, the Cancer Institute and a number of others have 
spent, I don't know how much money, but a lot of money on an 
anti-smoking campaign.
    Mr. Kennedy. In Rhode Island, we've had great success 
showing that there are proven models to successful smoking 
cessation. Behavioral models, I might add.
    Dr. Kirschstein. Mr. Kennedy, to some extent that is true. 
We have not had great success in all our young people. The most 
difficult problem we have is with young, adolescent girls. 
Because they are not stopping smoking the way our young men 
are, and they are concerned because there is a myth that if 
they don't start to smoke, or if they're already smoking and 
they don't stop, they will gain weight. It is something that we 
have been concerned about and we have had campaigns out for at 
least 20 years, when I first started doing things about women's 
health.
    Mr. Regula. That's very true.
    Mr. Kennedy. I would say, though, the success we have had 
in this prevention is probably as meaningful as any other 
success we've had in the whole cancer area. Because when you 
look at the savings down the road----
    Dr. Kirschstein. It's hard, as Dr. Battey says, and what's 
hard takes convincing. We've worked at it and we haven't----
    Mr. Regula. Because fries taste better than carrot sticks. 
Bottom line. [Laughter.]
    Dr. Battey. Unfortunately, the human organism is adapted to 
an environment of 40,000, 50,000 years ago when we were hunters 
and gatherers and we ate anything we could get our hands on, 
because we didn't know when we were going to eat next. The body 
simply has not had time enough to evolve to a modern world. The 
instincts that served us well way back then are now serving us 
very badly.
    Mr. Regula. Do you have any further questions, Mr. 
Sherwood?
    Mr. Sherwood. We've run the gamut. [Laughter.]
    Mr. Regula. Mr. Higgins advises me that in the case of 
juvenile diabetes, I guess the insurance companies are 
recognizing that this is cost savings to them----
    Dr. Kirschstein. Yes.
    Mr. Regula [continuing]. To persuade people to change their 
dietary habits.
    Dr. Kirschstein. I hope so. That's a good start.

                            DRUG PREVENTION

    Mr. Regula. That's perhaps a model. Are we having any 
success with drugs? Does your work reach out to drug 
prevention?
    Dr. Hanson. They just gave the example of tobacco 
cessation. We have seen a decrease in tobacco use by young 
people. A lot of prevention work is going to be targeting 
adolescents and young people. When they start to pick up those 
habits, whether they be tobacco or they be other substances of 
abuse, and they do it when they're young, they become 
entrenched in that habit.
    I showed you that graphic where there is actually a change 
that occurs in the brain, in the way it processes information 
from when they start using drugs, they're driven by the reward, 
the feel good phenomena of the drugs, but then things change, 
and now a motoric system, a system that driveshabit and 
compulsive use takes over. When you ask people that are using drugs for 
long periods of time, ``do you enjoy this?; why do you use the drug?'', 
oftentimes they'll say, ``I hate the drug, I would do anything not to 
smoke.'' But the urge is so intense that they can't resist it.
    We have to figure out, what does this mean? Why is the 
brain changing in the way it processes information and why are 
young people vulnerable early on? We know that young people 
don't make good decisions sometimes. There are some interesting 
neurobiological development studies showing that there are 
things that take place in the frontal cortex, the front part of 
the cortical structure, that are developmental and probably 
underlies the issue of why they don't make good decisions.
    Now, if we can understand these mechanisms and develop 
strategies for developing and maturing that decision making 
process, we'll go a long way to dealing with drug abuse, 
diabetes, anything that has to do with decision making. This is 
an underlying theme, and we can manipulate it.

                                CRAVING

    Mr. Regula. You're suggesting that maybe research will lead 
us to ways in which we can alter this craving, if you will?
    Dr. Hanson. Exactly. Alter it or understand what's going 
on. Then maybe work with our education system in such a way 
that we help to develop the skills for better behavior and 
better decision making.
    Mr. Regula. That would be an enormous breakthrough, 
wouldn't it?
    Dr. Hanson. Exactly.

                          ADDICTIVE DISORDERS

    Mr. Kennedy. Mr. Chairman, in the genome project, I think 
they've identified some areas where it's hereditary, and they 
can actually be able to predict which people have a higher 
propensity to fall into addictive disorders.
    Dr. Hanson. Exactly. There's a lot of overlap not only in 
terms of substance abuse and addiction, but also in terms of 
not making good decisions about lifestyles and not making good 
decisions about education. So it just falls right through the 
entire spectrum of behavior.
    Mr. Regula. Seems to me you all have a lot of challenges. 
Any further comments, questions? Thank you all for coming. It's 
a provocative discussion. With this, as with previous ones, I 
wish America could sit in via C-SPAN. It would be a tremendous 
education for the public to understand what's happening.
    NIH is somewhat of a well kept secret. If I go down the 
street in Navarre, Ohio, or any city and say, what's NIH, you'd 
get very many positive answers, probably not a lot.
    Dr. Kirschstein. We would be pleased to visit any of your 
districts at any time.
    Mr. Regula. I understand that. But it does, the message 
doesn't get out. The first lady in Ohio is very immersed in 
drug efforts, but I think you make a thought provoking notion 
that we could deal with this by altering mental behavior. How 
to do that, of course, is probably still a locked up secret 
that you're seeking.
    Dr. Hanson. But we're learning a lot about it. There are 
some substantial inroads into understanding what that process 
is, and maybe even how to manage it.
    Dr. Nakamura. As well as using social behaviors in order to 
influence the behavior of people. We are learning a lot on how 
to change human behavior just through social influence.
    Mr. Regula. By peer pressure.
    Dr. Nakamura. Absolutely.
    Mr. Regula. That seems to be a very significant part of 
what's happening. We're dealing with this in education, to get 
kids to stay in high school. Because I think peer pressure is 
what oftentimes persuades them. They just announced a $31 
million project in Ohio funded by the Gates Foundation and the 
Ford Foundation and the Knowledge Works Foundation. I think one 
of the keys to that will be able to deal with peer pressure.
    I'm dropping out, I'm going to get a job. His pal says, 
well, I'm going to drop out, too.
    Dr. Kirschstein. We have been partnering with the Gates 
Foundation to do a number of activities related to the things 
NIH is involved in.
    Mr. Regula. Is that right? So much to do. Thank you for 
coming.
    Dr. Kirschstein. Thank you, sir.
    Mr. Regula. Hearing is adjourned.

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                                            Tuesday, April 9, 2002.

                     NATIONAL INSTITUTES OF HEALTH

                               WITNESSES

DR. RUTH L. KIRSCHSTEIN, DIRECTOR
DR. STEPHEN KATZ, DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS AND 
    MUSCULOSKELETAL AND SKIN DISEASES
DR. STEPHEN STRAUS, DIRECTOR, NATIONAL CENTER FOR COMPLEMENTARY AND 
    ALTERNATIVE MEDICINE
DR. DUANE ALEXANDER, DIRECTOR, NATIONAL INSTITUTE OF CHILD HEALTH AND 
    HUMAN DEVELOPMENT
DR. DONNA DEAN, ACTING DIRECTOR, NATIONAL INSTITUTE OF BIOMEDICAL 
    IMAGING AND BIOENGINEERING
DR. JOHN RUFFIN, DIRECTOR, NATIONAL CENTER ON MINORITY HEALTH AND 
    HEALTH DISPARITIES
DR. GERALD KEUSCH, DIRECTOR, FOGARTY INTERNATIONAL CENTER
KERRY WEEMS, ACTING DEPUTY ASSISTANT SECRETARY FOR BUDGET, U.S. 
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Mr. Regula. We will get the hearing started today.
    We are happy to welcome you, Dr. Kirschstein. Welcome again 
and again and again. Always happy to see you here with your 
team. So I will let you sort of manage the witnesses as you see 
the way that would be the most productive, and you can 
introduce them as we go.

                    OPENING REMARKS--DR. KIRSCHSTEIN

    Dr. Kirschstein. Thank you, Mr. Chairman--Mr. Chairman, Mr. 
Obey. We are pleased to continue the fiscal year 2003 
appropriations hearings for NIH and expand on the two previous 
presentations.
    Today's presentations will discuss the various 
collaborations that are so important to modern-day biomedical 
research, which are far more complex, covering many more 
disciplines scientifically, and require broader interactions 
than ever before. These collaborations are among the various 
Institutes and Centers of NIH, between NIH and other agencies 
within the Department of Health and Human Services, with other 
agencies of the Federal Government, with industry, with private 
foundations and with philanthropic organizations and between 
NIH staff and patients and patients' advocates and all 
combinations of the above.
    [The information follows:]

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    Dr. Kirschstein. Again, it is clear that each of the 
Institutes and Centers have developed such collaborations to 
fulfill its mission and you will hear about some of them today. 
The panel members to my immediate left, are Dr. Donna Dean, the 
Acting Director of the new National Institute of Biomedical 
Imaging and Bioengineering; Dr. Stephen Katz, Director of 
Arthritis and Musculoskeletal and Skin Diseases; Dr. Stephen 
Straus, Director of the National Center for Complementary and 
Alternative Medicine; and Dr. Duane Alexander, Director of the 
National Institute of Child Health and Human Development.
    To my immediate right, Dr. John Ruffin, the Director of the 
National Center on Minority Health and Health Disparities; Dr. 
Gerald Keusch, Director of the Fogarty International Center; 
and as always, we are delighted to have Mr. Weems with us.

                 COMPLEMENTARY AND ALTERNATIVE MEDICINE

    Mr. Regula. Alternative medicine, what is alternative 
medicine?
    Dr. Kirschstein. I am going to let Dr. Straus answer that 
for you.
    Dr. Straus. Complementary and alternative medicine involves 
diverse health care modalities that are unproven 
scientifically--chiropractic, massage, herbal medicines, 
acupuncture and the like--and I will be happy to speak more 
about those in time.
    Mr. Regula. I just wanted you to clarify it.
    Dr. Kirschstein. We will start with Dr. Katz.

                             OSTEOARTHRITIS

    Dr. Katz. It is an honor to be here to represent the 
National Institute of Arthritis and Musculoskeletal and Skin 
Diseases. We have a number of very effective collaborations in 
which the American people benefit.
    The focus today is on the newly launched osteoarthritis 
initiative. Let me put it in the context of the importance of 
osteoarthritis. It is the most common form of arthritis and 
affects more than 20 million people currently; and the 
incidence will increase as the number of older people in the 
United States increases.
    Osteoarthritis results from a wearing away of cartilage. 
Cartilage is the cushion that sits on the ends of our bones so 
that when bones come together either in the elbows or the knees 
or the hip or the fingers or the ankle in some peoples' cases, 
and that cushion doesn't work, it is due to the wearing away of 
that cushion. We know what has come to be called osteoarthritis 
is probably due to many, many different causes, and we know 
that osteoarthritis is the most common form of arthritis in the 
world.
    Currently, there are no treatments to modify the disease. 
We can offer only analgesics, pain medications, some 
alternative therapies, some physical therapy and ultimately, 
when it becomes totally disabling, we can offer total joint 
replacement, which is a commonly used procedure these days.

                       OSTEOARTHRITIS INITIATIVE

    After a number of scientific meetings, we concluded there 
was a clear need to identify and develop surrogate markers for 
disease progression in osteoarthritis. This was the basis for 
the osteoarthritis initiative, which is a public-private 
partnership.
    This initiative requires the enrollment of a large cohort 
of individuals who would be studied over a long period of time, 
a long enough period of time so that they will develop the 
disease. The analysis will be of serum, as well as DNA, as well 
as images from MRIs that are going to be done over the course 
of the study, which is approximately seven years.
    Now, I brought three posters along to illustrate the 
collaborations in this initiative. The first poster illustrates 
the structure of the consortium. On the right, you can see that 
there are six centers or institutes that are involved from NIH. 
Each of these centers or institutes has a particular interest 
in osteoarthritis. The leaders of this consortium are the NIAMS 
and the National Institute on Aging. The industrial partners 
are shown on the left.
    The NIH Foundation is utilized in order to take the dollars 
from industry and put them into this partnership. As well, the 
FDA, as an important partner in this, serves as a liaison to 
this consortium. We also have a steering committee with a 
project officer and contracting officer, and this is the 
outline of the structure of the consortium.
    The second poster illustrates how financial resources will 
be managed in this consortium. Money from industry goes into 
the NIH Foundation, and then that is commingled with the money 
from the NIH institutes and centers, and all of that money goes 
into contracts to support a data coordinating center as well as 
the clinical sites that will accrue the study patients. There 
will be four to six clinical sites in order to follow these 
5,000 individuals during the course of this study.
    If I could have the last of the posters, that shows how 
data and specimens will be managed. The data and specimens will 
all be sent to the data coordinating center, which will be the 
repository. This material and the information from the imaging 
will then go back to the NIH institutes and centers. A most 
important element of this partnership is the immediate public 
access to all of the materials. There is no special access by 
any of the partners, either industrial partners or NIH 
partners. Everyone will have access according to a review 
process, so that the partners, as well as all of pharma, as 
well as all of the bioengineering companies, as well as 
academics, academic institutions around the country, as well as 
the intramural research program will all have access to this 
material. This process will form the basis for information 
sharing so that all of this material becomes available very, 
very quickly to everyone.
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    We anticipate that the initiative can speed progress 
towards identifying risk factors, the development of better 
markers for the disease and its progression and, ultimately, 
better treatments and preventive measures.
    In summary, the initiative represents significant 
investments of time, energy and financial resources; and we are 
very excited about the promise it offers for advancing medical 
research and improving public health, which are the goals of 
the NIH.
    I would be happy to answer any questions about this or 
anything else later on.
    Dr. Kirschstein. The next speaker will be Stephen Straus, 
the National Center for Complementary and Alternative Medicine, 
who has already started to give you the definition.

                         Opening Remarks--NCCAM

    Dr. Straus. Thank you, Mr. Chairman and Mr. Obey. It is a 
privilege to join my NIH colleagues and research partners and 
talk to you about collaboration.
    NCCAM, the national center for complementary and 
alternative medicine, by funding rigorous research, determines 
which CAM--complementary and alternative medicine--practices 
are safe and effective and why. These are highly popular 
modalities that millions of Americans are using despite the 
fact they are unproven. CAM claims to benefit or prevent 
countless health conditions across the entire lifespan, 
addressing virtually all disciplines of medicine.
    For NCCAM, then, collaboration is not just a means of 
leveraging our funding; it is a necessity to enrich our 
scientific understanding and outreach to address all the 
important challenges of complementary and alternative medicine.
    If I can begin with this poster to your right, let me point 
out that our research enterprise from basic early studies and 
clinical trials to the dissemination of information to 
scientists, practitioners and the general public is a process 
that is driven, enhanced and informed by input from many 
individuals: investigators, the general public, from members of 
our national advisory council, and members of the transagency 
CAM coordinating committee, which I chair, and which includes 
representatives of over 30 NIH institutes, centers and offices 
and other health agencies in the Federal Government.
    Collaboration of this type enhances our productivity 
throughout. I am going to illustrate our collaborations in a 
way that I would with all of our colleagues.

                      NCCAM AND NCI COLLABORATION

    We collaborate with most of the institutes and centers by 
highlighting the example of the National Cancer Institute. Our 
collaboration with NCI is based on the fact that most patients 
with cancer, particularly as their disease progresses, turn to 
complementary alternative practices to sustain the quality and 
dignity of their life, to improve their last months on Earth 
and to afford them some relief from the discomfort of their 
disease and its treatment. With the NCI, we are supporting 
basic research and large clinical trials.
    An example of basic research is a study in the laboratory 
of breast cancer, where we are looking at the interaction of 
the important hormonal drug that breast cancer patients take 
known as Tamoxifen with soybean phytochemicals. Soy contains 
hormonal-like chemicals that women often take to relieve the 
side effects of menopausal change, including side effects 
caused by Tamoxifen. We are mounting such a study today with 
the NCI.
    With the NCI, as well, we are mounting two of the largest 
CAM studies ever conducted rigorous, Phase III multicenter 
trials. The first is a study of shark cartilage as adjunctive 
therapy in 570 men with inoperable non-small-cell lung cancer. 
The second trial is testing Vitamin E and selenium to prevent 
prostate cancer, a study involving 32,000 American men 
oversampling for African American men in whom prostate cancer 
has a greater burden of disease. Those are examples of basic 
and clinical projects that NCCAM supports.
    Our studies also require collaborations with industry and, 
particularly, small businesses, because the American consumer 
can't access highly standardized, high quality herbal and 
chemical products. We work with industry to manufacture them so 
they meet our standards, so that our research findings will 
hopefully be replicable and generalizable to the American 
public. The end result of our research from basic to clinical 
is information that flows to the public and the practitioners.

              NCCAM'S INFORMATION-DISSEMINATION ACTIVITIES

    In this regard, we partnered with the National Library of 
Medicine over a year ago to mount a Web-based system, known as 
CAM on PubMed, which puts at the fingertips of every American 
with a computer at home or in their public libraries, over a 
quarter of million articles related to this field from 70 
countries in 45 different languages.
    In addition, we have a toll-free clearinghouse in English 
and Spanish, fact sheets newsletters and town meetings. We 
reach out to the entire United States, rural and urban to 
communicate our findings.

                         NCCAM CLINICAL TRIALS

    If I could have the final poster, the capping result of our 
research enterprise is the large clinical trials, and I 
mentioned two with regards to the National Cancer Institute, 
but we are privileged to work with the Aging, Heart, Lung, 
Blood and Neurology Institutes in the largest study of a herbal 
medicine, ginkgo biloba, for prevention of Alzheimer's disease.
    With Dr. Katz and his colleagues in the Arthritis 
Institute, we are supporting two large studies of alternative 
practices for osteoarthritis, the very disorder that he 
discussed a moment ago, one involving acupuncture and one 
involving glucosamine and chondroitin. Similarly, we have 
studies with the National Institute of Mental Health, the 
National Heart Institute, Diabetes Institute and many others.
    Mr. Chairman, collaboration is essential for NCCAM. It is a 
large part of what we do, and I believe a large part of why we 
are beginning to succeed. I am very happy to take your 
questions on this and related issues later. Thank you.
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                         Opening Remarks--NICHD

    Dr. Kirschstein. Dr. Duane Alexander, the Director of the 
National Institute of Child Health and Human Development.
    Dr. Alexander. Mr. Chairman, Mr. Obey, the extensive 
collaborations of the NICHD and other NIH institutes and 
centers that are the focus of today's hearing are undertaken 
for a variety of reasons.

                     MATERNAL FETAL MEDICINE UNITS

    Collaborations in research often take advantage of a 
specific resource that one institute has that fills a purpose 
of another institute. For example, NICHD maintains a network of 
maternal fetal medicine units that comprises 14 sites to 
conduct cooperative clinical trials in obstetrics. Their 
purpose is to design trials with a common protocol used at each 
site to study ways to improve pregnancy outcome, and quickly 
recruit a large enough number of patients to get a clear answer 
rapidly.
    The Neurology Institute and the Heart-Lung Institute, 
rather than start up similar networks for their own perinatal 
studies, are partnering with the NICHD network to do these 
studies. Doing it this way saves time, money and staff 
resources.
    On a given topic, we may collaborate with many different 
institutes. Women's health is one example. We work 
collaboratively with the Infectious Diseases Institute in 
research on topical microbicides to prevent HIV transmission; 
with the Diabetes and Kidney Institute, on urogynecology and 
incontinence; with the Dental and Arthritis Institutes, on 
osteoporosis prevention; with the Cancer and Heart Institutes, 
on contraceptives in relation to cancer and cardiovascular 
disease; with the Fogarty Center on international reproductive 
research and training; and with Minority Health and Women's 
Health, on supporting women's reproductive health centers.

                LONGITUDINAL ENVIRONMENTAL HEALTH STUDY

    Sometimes Congress specifically asks us to work 
collaboratively. For example, in the largest collaborative 
activity of all, Congress in the year 2000 asked NICHD to lead 
a consortium of Federal agencies in developing a longitudinal 
study of environmental influences on children's health and 
development. The Environmental Health Sciences Institute at 
NIH, the Centers for Disease Control and the Environmental 
Protection Agency have joined NICHD in leading a consortium of 
22 NIH institutes, 11 DHHS agencies and nine departments in 
planning and designing this study.

                         BACK-TO-SLEEP CAMPAIGN

    Different types of collaboration are used when we try to 
translate research findings to practice. For example, this 
graph that you see documents the constancy of the rate of 
sudden infant death syndrome deaths before research revealed 
that a back-sleeping position reduced SIDS risk, and then the 
reduction by half in the SIDS rate since the NICHD-led ``Back-
to-Sleep'' campaign began in 1994.
    Our initial major collaborators in the public information 
campaign were the Maternal and Child Health Bureau, the 
American Academy of Pediatrics and the SIDS Alliance. To 
broaden the message, we enlisted the support of industry. 
Gerber put the message on six million boxes of baby cereal; and 
Pampers put the ``Back-to-Sleep'' message on all of their 
infant baby diapers. You can't miss this message. It is in 
three languages--French, Spanish, as well as English.
    To reach the African American community more effectively, 
the Minority Health Center helped us join with the National 
Black Child Development Institute in designing culturally 
appropriate materials and outreach methods.
    This collaborative campaign made it possible for the 
Department of Health and Human Services to reach its goal of 
reducing infant mortality in the country to below seven deaths 
per thousand live births by the year 2000. Substantial portions 
of our 2003 budget request will continue and enhance these 
collaborative studies.
    Thank you.
    Dr. Kirschstein. Dr. Donna Dean, the Acting Director of the 
National Institute of Biomedical Imaging and Bioengineering.

                         Opening Remarks--NIBIB

    Dr. Dean. Thank you. Good afternoon, Mr. Chairman, Mr. Obey 
and Mr. Sherwood. As the Acting Director of the National 
Institute of Biomedical Imaging and Bioengineering, I am 
delighted to speak to you about collaborations that NIH is 
fostering as one of the two newest Institutes and Centers at 
the NIH.

                      COLLABORATIVE OPPORTUNITIES

    A little over a year ago, the Congress noted that a number 
of Federal departments and agencies support imaging and 
engineering research with potential medical applications, but 
felt that a central body was needed to lead these efforts. 
NIBIB was created to fill this role to support research in 
areas that cross disciplines, science areas, diseases and organ 
systems.
    The very existence of NIBIB is rooted in collaboration, 
bringing together scientists working in multiple disciplines 
from multiple agencies and working to develop innovative 
technologies in biomedical imaging and bioengineering.
    I brought to you today two examples to show you the work we 
are supporting. These projects were initially funded by 
existing NIH Institutes and Centers and were subsequently 
transferred to NIBIB as they are exemplary of our mission.
    The first poster shows one of our bioengineering projects, 
microfabricated microneedles for drug delivery, originally 
funded by the National Institute of General Medical Sciences 
and transferred to NIBIB this year. The left side of the poster 
illustrates the size of the microneedles relative to the size 
of a finger. The right side of the poster is a magnified view 
of the needles that are used to deliver a drug, such as insulin 
for diabetes. Because the needles are long enough to penetrate 
the skin, but short enough to avoid hitting nerves the patient 
feels no pain.
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    Dr. Dean. The second poster shows images from a newly 
developed micro CT scanner, an NIBIB biomedical imaging project 
originally funded by the National Center for Research Resources 
and transferred to us in this fiscal year. Along the right side 
of the poster, high resolution images showing the 
microarchitecture of a living animal are seen. Tiny structures, 
such as the middle ear, which is the third picture down on the 
right, are shown in minute detail. These scanners will enable 
researchers to observe diseased states in small live animals 
and, it is hoped, develop technologies that can then later be 
translated into imaging technologies for use in humans.
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                        NEW RESEARCH INITIATIVES

    Dr. Dean. I am proud to announce that yesterday NIBIB 
announced that we awarded our first new competing research 
project grant. Other NIH Institutes and Centers have worked in 
a foster parent role with us over the past few months to assist 
us in shepherding applications through the Peer Review and 
Secondary Institute Council review process. Our first grant, a 
Bioengineering Research Partnership (BRP) awarded to Yale 
University, brings together six academic partners and one 
industrial partner to develop high resolution functional MRI 
and MR spectroscopy at high field strength. This grant, as well 
as others we will be awarding in the next few weeks, reflects 
research that brings together several disciplines.
    These exciting projects that I have highlighted today are a 
few examples of the types of scientific challenges that provide 
rich opportunities for NIBIB research. After only one year, we 
are making substantial progress in translating the vision that 
Congress had for NIBIB into the reality of a forward-looking 
research Institute.
    I am pleased to respond to any of the questions from the 
committee later.
    Dr. Kirschstein. Dr. John Ruffin, the Director of the 
National Center on Minority Health and Health Disparities.

                         Opening Remarks--NCMHD

    Dr. Ruffin. Mr. Chairman and members of the committee, I am 
very pleased to be here today to testify on the subject of 
collaboration. This is a topic that goes to the heart of how we 
operate.
    I am honored to be here with my distinguished colleagues 
from the National Institutes of Health. As we are far from 
eliminating health disparities, it is imperative that we 
continue to work together to address health matters that 
disproportionately affect racial and ethnic minorities and the 
medically underserved.
    As you can see from poster one, Congress mandated that the 
NCMHD serve as the focal point for planning and coordinating 
minority health and other health disparity research across the 
National Institutes of Health. The NCMHD programs are aimed at 
addressing gaps in health disparities research and training. We 
focus on inclusive or targeted research domains or training 
programs relevant to the health of minority or medically 
underserved populations.
    I am pleased to report that over the years, the NCMHD or 
its predecessor, the Office of Research on Minority Health, has 
collaborated with every NIH Institutes and Centers on minority 
health or health disparity research study or training programs. 
Last year, Mr. Chairman, we were involved in 214 collaborations 
with the other NIHICs, the HHS Office of Minority Health and 
the Agency for Health Care Research and Quality.
    I would like to use poster two to cite a few examples of 
our approach to collaborations. Just this past Friday, the 
American Academy of Ophthalmology released a very important 
study showing that glaucoma is the leading cause of blindness 
among a sample of Hispanic southern Arizona residents of 
Mexican descent, age 40 and over. The Proyecto VER program, 
which stands for vision evaluation and research project, was 
sponsored by the NCMHD and the National Eye Institute.
    This was the first comprehensive study of vision loss and 
blindness among U.S. Hispanics. The study underscores the need 
for early detection of eye disease among Hispanic Americans. It 
also demonstrates the mutual benefits of collaboration: NEI 
obtained increased knowledge about eye disease and the NCMHD 
gained insight into an important disparity affecting the 
Hispanic population.

                      DIABETES PREVENTION PROGRAM

    The NCMHD collaborated on two important studies with the 
National Institute of Diabetes and Digestive and Kidney 
Diseases. The first was the Diabetes Prevention Program which 
revealed that moderate diet and exercise could delay the onset 
of type 2 diabetes in overweight people. The second study with 
NIDDK is the minority organ and tissue donation program, which 
was designed to educate minorities on facts about organ and 
tissue transplantation. The study found that nationally 
supported, community-based programs can assist changing 
behavior impacting on a person's health, wellness norm and 
values.

                          JACKSON HEART STUDY

    In partnership with the National Heart-Lung and Blood 
Institute, we are currently funding the Jackson Heart Study, 
whose participant enrollment is significantly increasing, with 
average of 50 participants a week; as of February 2000. A total 
of 1,441 participants have gone through the program since it 
started in September of 1999. The study evaluates the 
environmental and genetic factors influencing the development 
of cardiovascular disease in African American men and women.

                          HUMAN GENOME CENTER

    With the National Human Genome Research Institute, we have 
established a human genome center at Howard University. The 
goals of the center are to improve the health status of African 
Americans through research on genome variation and to apply the 
knowledge to better understand the biomedical significance of 
gene-based differences.
    The final poster illustrates some of the other 
collaborative work we are engaged in with some of the ICs that 
are present here at the table today. Dr. Alexander or I would 
be happy to discuss any of the child health projects in more 
detail with you. Dr. Keusch, who will present next, can also 
discuss our work with Fogarty on the Minority International 
Research Training program. Time permitting, I can also discuss 
what we are doing with the National Institute on Aging.

                             STRATEGIC PLAN

    The NCMHD has worked with the NIH Director and other ICs to 
develop the NIH comprehensive strategic research plan and 
budget to reduce and ultimately eliminate health disparities. 
This plan will ensure a coordinated approach to addressing 
health disparities in the United States. We expect to continue 
collaborations with the ICs and other Federal agencies on a 
variety of minority and health disparity issues.
    Finally, I want to again thank you for inviting me here 
today to discuss NCMHD's work and plans for the future.

                          Opening Remarks--FIC

    Dr. Kirschstein. And last but not least, Dr. Gerald Keusch, 
the Director of the Fogarty International Center.
    Dr. Keusch. Mr. Chairman, Mr. Obey, Mr. Sherwood, it is an 
honor to be here.
    In fiscal year 2003, the Fogarty International Center will 
celebrate 35 years of international collaboration in biomedical 
research and research training. However, at no time in our 
history as a nation is this mission more relevant or more 
important. Disparities in health and resources result in 
tragically high infant and child mortality rates in developing 
countries, while in the past decade the life expectancy of 
adults throughout Africa has plummeted erasing the gains of the 
previous quarter century.
    In a speech to the U.N. General Assembly in November 2001, 
President Bush recognized the inevitable consequences of the 
desperation and hopelessness that accompanies poverty and ill 
health, saying that we must offer an alternative of opportunity 
and hope. Biomedical research is an alternative of opportunity 
and hope.
    As NIH conducts research to improve the health ofAmericans, 
we can also share our new knowledge and work to ensure that research 
addresses the critical global health needs that impact us all.

                      NARROWING THE KNOWLEDGE GAP

    The Fogarty International Center is the leading edge for 
the NIH internationally. The Center is widely respected for its 
work to promote science for global health. As in the poster 
(figure 1) that is up at the moment, in the April 2002 issue of 
The Scientist, a profile of the Fogarty International Center 
subtitled "The Seeding of Third World Science" will 
demonstrate, science is inherently international and discovery 
knows no borders.
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    NIH collaborated research conducted abroad is essential for 
Americans. Research on tropical infectious diseases that may 
affect travelers, businessmen or our military cannot be done in 
the U.S., and research to better prevent mother-to-infant 
transmission of HIV is most definitively done where, 
unfortunately, the burden of disease is greater than it is 
here.
    The Fogarty International Center also ensures that this 
research is of the highest ethical standing and of mutual 
benefit through its training programs and research ethics.
    Sometimes overlooked is the important role of science as 
diplomacy. Fogarty currently supports research by a U.S.-
Israeli-Palestinian team to identify genes for hereditary 
deafness in the susceptible bedouin population. As featured in 
the New York Times last week, this project is an example of 
bridging the enormous gap of politics through scientist-to-
scientist relationships developed by working together on a 
shared agenda.
    Science training also trains leaders. As one of many 
examples, Dr. Crisps Kiyonga, Chairman of the Global Fund for 
AIDS, TB and Malaria, was an earlier trainee in the Fogarty 
International AIDS training program. His experience in Uganda, 
using the knowledge gained through collaborative research to 
identify interventions that would really work, is essential to 
the future of this global initiative.

               SCIENTIFIC COLLABORATION ON GLOBAL HEALTH

    Today's theme is collaborations, and these are at the very 
center of the Fogarty. The next poster (figure 2) are 
diagrams--just three--of our Fogarty global programs on AIDS, 
tobacco use, prevention and cessation, and environment and 
health to illustrate how essential collaborations are. They 
involve other ICs across the NIH, other parts of the Department 
of Health and Human Services and a multiplicity of outside 
organizations. Each of the spokes you see represents a 
collaboration between Fogarty and a partner.
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    These three programs alone involve 65 countries around the 
world, primarily low- and middle-income nations and including 
Eastern Europe and the former Soviet Union. The programs are 
based on close collaborations and networking between U.S. and 
foreign teams of scientists. It is entirely apt to say that for 
Fogarty and for the other ICs at the NIH engaged in 
international research that collaboration is a way of life.
    I will be happy to answer any questions you have about 
these or any of the other Fogarty programs, as well as our 
plans for the coming year.
    Dr. Kirschstein. Mr. Chairman, we are prepared to proceed 
as you wish.
    Mr. Regula. Dr. Kirschstein, would you characterize these 
as clearinghouses to assemble activities that are happening in 
many different areas?
    Dr. Kirschstein. These are our ability to use 
clearinghouses. We use the word ``clearinghouse'' in a very 
particular way among the institutes. It is something in which 
information is deposited and can be sent out to the public as 
needed. And most of our clearinghouses are on Web sites or are 
used by people who answer telephones and so forth, and some of 
them are ordained by Congress. But in general all of the 
information is sent out in the form of some sort of 
clearinghouse, yes.
    Mr. Regula. Well, if you had a question on let us say 
osteoarthritis, would you go to Dr. Katz's agency?
    Dr. Kirschstein. Each one of these institutes is 
characterized as being the lead institute in these 
collaborations. Dr. Katz started off by saying the major 
collaboration is between the Arthritis Institute and the Aging 
Institute. It is the disease plus the population that is most 
affected. But there are many other collaborators, and Dr. Katz 
will serve as the clearinghouse to be able to field the 
information.
    Mr. Regula. So it is, in a sense, one-stop shopping for the 
public that wants information on a particular subject? They can 
go to any one of these agencies and elicit that, and they can 
learn from that what is happening in the private sector as well 
as the public sector?
    Dr. Kirschstein. That is correct, provided what is going on 
in the private sector is known to us.
    But in addition we have at NIH some central clearinghouses 
which will provide information if the caller, for example, does 
not know exactly what institute he or she wishes to have things 
referred to. We have all our clinical trials listed on a 
clinical trials.gov database on the Web, to which anybody can 
go on the Web, if they have access--and I understand, they 
don't all have it--to get information.
    Mr. Regula. Would that include information from outside the 
United States?
    Dr. Kirschstein. Yes. The requirement for the clinical 
trials database and information service was set up under the 
Food and Drug Administration Reauthorization Act several years 
ago, but the responsibility was not given to the Food and Drug 
Administration. It was given to the NIH, which, in turn, gave 
it to the National Library of Medicine, because it had the 
widest ability to set something up in that regard; and Dr. 
Lindberg, who is the Director of that institute, will be here 
for our final hearing, which is communications, and will be 
pleased to address that.

                       PUBLIC INQUIRIES TO NCCAM

    Mr. Regula. I know for a period of time, at least in my 
area, people thought there was a magic cure for cancer in 
Mexico; and they would actually go to Mexico, and it didn't 
necessarily pan out. But would they be able to access your 
agency and find out what was being proposed in Mexico?
    Dr. Straus. They not only would, but they do so on a daily 
basis. It is a toll-free clearinghouse by telephone and Web and 
provides information to about 7,000 Americans just through the 
clearinghouse, and 1.25 million inquiries to our Web site each 
year.
    Mr. Regula. You get the same thing on various drugs and 
magic potions, if you will, for health cures.
    Could someone who reads or hears about that check it out 
through your Web site?
    Dr. Kirschstein. That's correct.
    Mr. Regula. And they could access a Web site that would be 
sort of a master source of information and, in turn, could go 
to osteoarthritis or to cancer.
    Dr. Kirschstein. And we have an index of these, which is on 
the Web site for the Office of the Director, Office of 
Communications, specifically.

                        OSTEOARTHRITIS TREATMENT

    Mr. Regula. Let me ask you about osteoarthritis. Somebody 
was telling me that for knees, they have an injection system, 
some kind of a material that ends up replacing, if you will, 
the cartilage; is that true?
    Dr. Katz. I think what you are talking about is Hyaluron, a 
product that is being produced by a few different companies and 
in the short-term studies that have been reported, there is 
some benefit with regard to pain. With regard to its modifying 
the disease, that is not very clear. But with regard to short-
term pain improvement, two studies have shown a significant 
improvement.
    Now a significant improvement is not a tremendous 
improvement. These two medications that are injected into the 
knee are made by two different companies. Some of these 
products were developed in Europe and then were adapted by the 
United States.
    Mr. Regula. So you do collate information from around the 
world?
    Dr. Katz. We do. We all do. I think it is important to know 
that there are so many proposed treatments particularly for 
osteoarthritis and other chronic diseases, that there is no way 
we can provide information on all of the inquiries that we get. 
There are many, many drugs,devices, and interventions that we 
are asked about in terms of whether they are efficacious or not 
efficacious.
    We report on what we, with the community, come to realize 
is an effective therapy. We have informational booklets; all of 
those booklets are available on the Web. Interestingly, we are 
getting more inquiries percentage-wise from the Web than paper 
inquiries. We have booklets available in other languages as 
well, so that more of our population has access to the 
information.

                              PUBLIC INPUT

    Mr. Regula. Do you get feedback from the public as to what 
works?
    Dr. Katz. We get many suggestions from the public as to 
what we should try in terms of doing studies, and I am sure Dr. 
Straus probably is the champion of all of these suggestions.
    Dr. Straus. Obviously, our center is studying modalities 
that are popular, and that the public is interested in, but 
which are largely untested and certainly unproven. But we do go 
out and solicit feedback from the community as I indicated 
several moments ago. We have held three national town meetings. 
The last was held last month in Portland, Oregon; 700 members 
of the public came to tell us what they are interested in 
hearing about, what they want to see studied, as well as some 
of their own anecdotes.
    There are often germs of wisdom in some of those popular 
choices.

                            PUBLIC INQUIRIES

    Mr. Regula. I notice the proliferation of stores that sell 
magic potions for health, all types of things. If a member of 
the public contacted you via the Web site and said, does XYZ 
really do what the allegations say it does, what would your 
answer be? How would you respond?
    Dr. Straus. We do respond to that question every day, Mr. 
Chairman. It turns out we already have about four dozen 
summaries of statements and reviews of data on the most popular 
questions that are asked, dealing with arthritis and pain and 
cancer and the like. There are, unfortunately, areas that are 
not studied and sometimes our answer is simply that the person 
has to be somewhat skeptical about something whose claims sound 
too good to be true, because they often are.

                              ACUPUNCTURE

    Mr. Regula. Does acupuncture have merit?
    Dr. Straus. Acupuncture is a venerable practice and people 
have used it in Asia for thousands of years. But today the best 
evidence about acupuncture is that it is probably a good 
alternative form of relief for certain kinds of pain 
disorders--not for everything for which it has been touted. It 
does appear to benefit pain--and we are getting more definitive 
answers with degenerative arthritis pain in the large study I 
mentioned that we are conducting at the University of Maryland 
at Baltimore.
    And we are beginning to understand the mechanisms by which 
acupuncture works using very sophisticated brain imaging 
technology.
    It is clearly an active modality. It certainly appears to 
benefit some people. The question is whether it is superior to 
other standard treatments.
    Mr. Regula. Mr. Obey.
    Mr. Obey. Mr. Chairman, Dr. Straus indicated that sometimes 
scientific claims are without merit. I think it is safe to say 
that that is often the case in politics as well. I think you 
mentioned Mr. Chairman, the fact that some people used to go to 
Mexico for a magic bullet for cancer. I can remember when 
laetrile sales were used to finance real bullets for Posse 
Comatatis and militias back in my neighborhood--some pretty 
nasty stuff.
    Dr. Kirschstein, in your statement, you said the existence 
of the National Institute of Biomedical Imaging and 
Bioengineering is rooted in collaborations and then you listed 
the various Institutes. I agree with that. But I frankly have 
to confess some concerns about the creation of that Institute 
and the creation of a number of other Institutes, because we 
have had a tremendous proliferation of Institutes through the 
years. I am not convinced that all of that is for the good, 
because it leads to more administrative costs and it can lead 
to fragmentation.
    When I look at the House Democratic Caucus, I see Democrats 
identified as ``New Democrats,'' as ``Blue Dog Democrats,'' as 
``Progressive Democrats,'' and I don't think that any of those 
monikers especially add to our effectiveness. I think they do 
emphasize our fragmentation.

                        GRANT TRANSFERS TO NIBIB

    With that skeptical mind-set in mind, let me ask you a 
couple of questions. I understand that NIH is in the process of 
reviewing existing research projects to determine which will go 
to the new Institute and which will stay with existing 
Institutes. It seems to me that those decisions call for 
careful balancing, because on the one hand you have the fact 
that the Institute was created in order to provide a central 
home for basic, crosscutting research and imaging, and yet on 
the other hand those technologies are important not for their 
own sake but what they can help us to understand about other 
diseases. And I think it would be unfortunate if the 
establishment of a new Institute led to the artificial 
separation between scientists with expertise in particular 
diseases and scientists with expertise in the technology that 
is supposed to help us diagnose and treat those diseases.
    Could you tell us a bit about the criteria that would be 
used to determine which projects go to the new Biomedical 
Imaging Institute and which stay in the disease-focused 
Institutes? How are you approaching the problem of using new 
Institutes to help stimulate technological advances without 
creating an undue separation between work on technology and 
work on the substantive problems that the technology is 
supposed to help solve?
    Dr. Kirschstein. Mr. Obey, we share your concerns and we 
have shared them from the beginning. The purpose of several of 
the Institutes that have been in existence for quite some time 
is to support multidisciplinary, interdisciplinary research, 
particularly in technologies. There is and has been a 
proliferation of Institutes over the years and there has been 
some concern. The Congress has expressed that concern, and as 
you know, the National Academy of Sciences will be undertaking 
a study of this at the behest of Congress to start. Now that a 
Director has been nominated, just about immediately because it 
is expected to report within one year of the Director taking 
office.
    However, after careful deliberations, the Congress in its 
wisdom decided that this new Institute should exist and--
    Mr. Obey. I am not so sure how careful those deliberations 
were.
    Dr. Kirschstein. Yes, sir. I understand.
    It is our mandate to try to do that without disruption of 
many things. This was true way back when the Eye Institute was 
formed out of theNeurological Diseases and Blindness Institute, 
when the Deafness Institute was started out of the Neurological 
Diseases and Stroke Institute, the word ``blindness'' having been 
removed because the Eye Institute had been formed and so forth and so 
on.
    I believe we have to work very hard to make sure this new 
Institute succeeds and does not diminish, but enhances the 
activities of all the other Institutes; and Dr. Dean and I have 
been doing that. We have just completed the search for a 
director of the new Institute, and I have made a recommendation 
to the Secretary that I think everybody will applaud.
    That said, the decision about what is to originally be 
transferred to NIBIB was put in report language that this 
committee gave us as to how we should go about that procedure. 
Indeed we had a meeting that was requested by our oversight 
committee and their staffs to talk about this. The criteria was 
set based on a series of well-developed strategies, which have 
always been used when new institutes are established. First and 
foremost, to develop a mission statement.

                 DEVELOPMENT OF NIBIB MISSION STATEMENT

    And we had a number of Institute directors, at least one of 
whom is sitting at this table, Dr. Katz, along with Dr. Dean, 
who we had determined would be the acting director in the 
period before we searched for the new director, put together a 
mission statement. The law required that there be a transfer of 
grants upon the establishment of the new Institute. And it was 
directly stated in the law and not just in the conference 
language or report language.
    Dr. Dean then developed a list of search terms from our 
mission statement that everybody had agreed to. She fed them 
into our computer base that puts grants forward; and we had an 
agreement between ourselves and members of the Congress as to 
how we would constitute the group that was going to review 
those grants. The working group developed the criteria from the 
mission statement. We are still in the process of doing that 
review and have not completed it, but we are working very 
carefully and very hard.

            MULTIDISCIPLINARY AND INTERDISCIPLINARY RESEARCH

    We are as cognizant as you are that there is a great deal 
of importance in doing research on imaging, and on biomedical 
engineering in particular diseases, research which is closely 
associated with those diseases. There are a series of about six 
Institutes which have a major interest in those areas. In fact, 
as we have gone through the process, it clearly shows that some 
of the material that is being supported in the six Institutes 
is there because there was no home for the developing 
technologies. Not even a home in one of the two Institutes 
which usually has been given that responsibility.
    If Dr. Dean wishes to expand on that, I would be pleased to 
have her do so.
    Dr. Dean. I would like to offer one particular comment that 
I have.
    Among my Institute colleagues over the last year, I have 
been very careful--and I believe very strongly that the NIBIB, 
as we are building it, will be adequate to, will complement 
what is already happening at the NIH and will not detract or 
subtract from the other missions of the other Institutes.
    What I have found particularly gratifying, as I have been 
to probably more than 40 professional meetings of engineering, 
physics, optical societies over the last year, is to tell them 
about the new Institute, about the number of physicists, 
engineers, mathematicians, other scientists, who have never 
come to the NIH before for research grants and who are now 
looking to the NIH as an area of opportunity. I think that is 
one of the missions that we can build our new programs on.
    I am also pleased to say that we have developed two new 
programs for Requests for Applications (RFA), and the response 
to that has been overwhelming. I think we are--as any new 
organization would be, showing our way. We are developing new 
areas, and the path is not always as smooth as I think all of 
us would like it to be.
    Mr. Obey. Let me simply say that it is not that I was 
opposed to the creation of the institute, but I recognize that 
the Congress is the possible instrument by which political 
pressure is brought to bear on scientific questions; and often 
that pressure is in the wrong direction and it meets more the 
political needs of the participants than the medical or 
scientific needs of the public.
    And so I guess all I would say is, I assume you recognize 
that the conference report language is considerably softer than 
the original Senate version.
    Dr. Kirschstein. Very much aware of that.
    Mr. Obey. And that the term ``should generally reside'' 
leaves an awful lot of room for interpretation. And I guess my 
advice would be, go slow and use caution.
    Just one other question on this. There have been reports in 
the press and elsewhere that some Members of the Senate and the 
House are actively campaigning to have all or part of this new 
Imaging Institute located not on the NIH campus but in another 
location. Am I correct that no such shift is currently being 
proposed by NIH or the administration?
    Dr. Kirschstein. Correct.
    Mr. Obey. I am pleased to hear that. I think that the White 
House and the agency made the right decision to date.
    Secondly, without wanting to put any of you on the spot 
about this or any other specific proposal, could you comment 
generally about the merits of keeping the NIH intramural 
research program largely together in one piece and the 
disadvantage of dispersing various activities to various parts 
of the country. As an example, let me tell you a story.
    My predecessor on this committee, Mel Laird, was very 
interested in seeing that the new Institute of Environmental 
Health Sciences be located at the University of Wisconsin, and 
so he arranged to make certain that there was a geographical 
description of where it could not be, paving the way for the 
University of Wisconsin to run the show. It didn't quite turn 
out that way.
    Dr. Kirschstein. I was there at the birth.
    Mr. Obey. Being from Wisconsin, it would have been 
personally delightful to me to see it located there. I think 
from a scientific standpoint it is never good for the Congress 
to determine where this research ought to take place because 
those decisions would be political rather than scientific.
    Dr. Kirschstein. And I think the institute you are 
referring to, part of the reason when it ended up being in 
North Carolina rather than in Wisconsin--it did succeed, and I 
think it would have succeeded in Wisconsin, as well--is because 
it was an institute that grew out of the National Cancer 
Institute, which had had responsibilities for many, many years 
and therefore the major staff and people had had experience 
being with NIH as a whole and were able, although not as easily 
as they could have if they had stayed on thecampus, to operate 
because they knew what was going on.
    I felt particularly strongly about an institute that really 
had no roots for a long period of time; and at any one unit in 
NIH--and how difficult it would be for that institute and that 
intramural program, in particular. Because all the intramural 
programs, although they are all associated with the individual 
institutes, work together, have a dual reporting authority not 
only to their institute directors, but to the Deputy Director 
for Intramural Research at NIH, it would be very, very 
difficult to have that happen at the new institute and it would 
be to the detriment of the institute, of its intramural program 
of the State that wished to have it, and of NIH in general and 
the American citizens.
    So we had a great deal of discussion and came to a solution 
that I think will work quite well, which will be to help the 
various organizations around the country, both those who want 
to have intramural activities that will remain at NIH--and, in 
fact, we originally didn't set up an intramural program for 
this institute at all--not every institute has one--because we 
thought the major concern was to provide a home for the people 
that Dr. Dean has been talking about, namely the physicists, 
engineers, optical scientists, radiologists, academic 
institutions across the country.
    Mr. Obey. Mr. Chairman, I will put some other questions in 
the record. Let me simply say that we can have lots of 
differences on this committee, philosophical differences and 
political differences, but I think the most important 
accomplishment of this subcommittee since it has existed has 
been that it has on almost all occasions--not all, but on 
almost all occasions, it has resisted efforts on the part of 
Members of Congress to put their mitts on health research.
    It is one thing to be supportive of health research. It is 
another thing to have politicians directing what research ought 
to be conducted and where it ought to be conducted. If we get 
into that business, we will rapidly discredit ourselves.
    Mr. Regula. Mr. Sherwood.
    Mr. Sherwood. Thank you, Mr. Chairman.

                         BACK-TO-SLEEP CAMPAIGN

    Dr. Alexander--and it gives me great pleasure to say that 
because the country doctor that ministered to us all in the 
small town I grew up in and was a great effect on our community 
was a Dr. William Alexander. You have done such a great job 
with your publicity campaign on the Pampers and Gerbers for 
your ``Back-to-Sleep'' campaign. You are to be commended. I 
think that is great public relations.
    That is getting the message out, and that is one of the 
things we have talked about on this committee several times, 
that it is very difficult to get the message of the new and 
best treatments to where it ought to be delivered.

                          OBESITY IN CHILDREN

    And in that regard we have heard so much about obesity in 
children, and it is leading to early diagnosed Type 2 diabetes, 
and it is really an epidemic. What Federal, State and private 
agencies are you working with to help parents and schools and 
kids do a better job of getting and staying fit? In other 
words, what would be the magical deal like you did on ``Back-
to-Sleep'' that we can do on obesity in kids?
    Dr. Alexander. Mr. Sherwood, I wish there was something as 
easy that we could do for obesity. It was just a matter of 
which position we put an infant down to sleep in; that was one 
of the easiest behavioral modifications. The subject couldn't 
even object very easily to it, and so it was relatively easy to 
implement.
    And we really have to thank the partnership that we got 
with industry. They put that message on the cereal boxes, free; 
on the diapers, free. That was their public contribution to 
public health, and we owe them a big thank-you for helping to 
get that message out so effectively to change the sleep 
position and, consequently, change the SIDS rate so 
dramatically.
    Dr. Alexander. Obesity is harder. It is like stopping 
smoking. It is like some of the other health behaviors that are 
very difficult to change. What we are seeing as a new 
phenomenon is the enormous increase in obesity among young 
people, and this is due to a combination of factors. Partly it 
is increased caloric intake, but much more significant has been 
the reduction in physical activity, physical exercise. If you 
look at overall population data, caloric intake has not 
increased that much. It is much more a reduction in caloric 
expenditure resulting from less exercise.
    Secretary Thompson has been extremely interested in this 
topic. He is greatly concerned about the increase in diabetes, 
Type 2 diabetes in children in particular, and the increase in 
prevalence of obesity. He wants to put the whole department on 
a diet; so we are all walking around very carefully, tummies 
tucked in and things like that around the Secretary. He is 
interested in focussing this on children, on schools, and has a 
task force convened to look at things that can be done. One of 
the things that is being looked at is physical education, and 
physical activity in schools.
    We are in the midst of a phenomenon where physical 
education has virtually disappeared from the Nation's public 
schools. Whereas it used to be a routine part of every child's 
day, elementary school through high school, it is now less than 
20 percent of middle and high school students that participate 
in physical education. So there is a move afoot to try and 
restore physical education as a requirement in elementary 
school through high school.
    There is a movement also related to the school lunch 
programs in terms of their caloric content, their fat content 
and some other activities. There are also activities planned in 
conjunction with the Department of Education and the Department 
of Health and Human Services in trying to improve the education 
of children and of their parents in terms of what they send to 
school in their kid's lunch, and an increase in education with 
regard to the importance of physical exercise, physical 
activity and that side of the coin, not just the caloric intake 
part.
    Mr. Sherwood. I think you are on the right track when you 
try to do it through the public schools, and with many years of 
public school board experience, I think some of the things that 
we have done that we thought were progress have been 
counterproductive. We now bus kids to school when they only 
live a half mile away and you never used to do that, and where 
there are safety issues. But what they eat and the soft drink 
machines in the schools and things likethat are 
counterproductive, and I think we gave physical education a bad rap 
maybe as we tried to improve our academic standards. A very necessary 
move to try to improve academic standards, we shortchanged that.
    So I agree with you that the public schools is the place to 
go about this. And I think anecdotally, I think caloric intake 
is certainly different than it used to be. I think when the 
chairman and I grew up, we didn't have a lot of those things 
available, and so anything we can do in that would be great. I 
have one other thing that I would like to talk with Dr. Dean 
about. I know one of the greatest challenges that are faced by 
health care providers at home in northeastern Pennsylvania is 
finding trained medical technicians who have mastered 
biomedical imaging equipment. And in developing relevant 
standards and guidelines for this equipment is consideration 
given to ease of use and level of training required of 
operators.
    Dr. Dean. Yes, Mr. Sherwood. And in fact, one of the areas 
of the law that established NIBIB said that we were to pay 
attention to those critical issues as we develop our programs. 
One of the most tangible things that we have done is that we 
have entered into support of a study with the National Academy 
of Engineering, which is going to be looking at the 
facilitation of what we know in imaging and engineering 
research into improving the Nation's health care delivery 
system.
    We were very pleased to partner with them in that activity, 
and we are hoping, through that partnership with them, to 
identify those things as you referred to as standard-setting, 
how those can be widely deployed across the Nation and used.
    Another area of interest that we have within NIBIB is to 
explore the advances in telemedicine and teleradiology and how 
that technology can be used to employ the delivery of high 
quality medical care to rural citizens and other underserved 
populations. So while I cannot tell you explicitly that we have 
a whole portfolio of programs that NIBIB can roll out today, I 
will tell you it certainly is an interest of NIBIB. It is a 
personal interest of mine, because I grew up in a rural 
underserved area in eastern Kentucky, and I truly appreciate 
the problem, but also recognize there are wonderful 
opportunities to create solutions.
    Mr. Sherwood. Thank you. I don't think I ever understood 
what the term ``user-friendly'' meant until I tried to get into 
the 20th century on my personal ability to operate computers, 
and then you realize that our military services for years have 
tried to standardize things and make the directions crystal 
clear and make it simple, and I think anything we can do in our 
biomedical imaging stuff in that regard would be good.

                  HEALTH DISPARITIES IN RURAL AMERICA

    Dr. Ruffin, in the line that we just started on, I 
understand that your center studies health disparities, and are 
you aware of any good studies into health care access in rural 
America? I am well aware of the anecdotal reports of such 
disparities, but have there been any findings that you are 
using and could recommend policy changes to make health care 
more available in rural areas?
    Dr. Ruffin. Mr. Sherwood, the creation of the new center 
broadened our mandate to address health disparities not only in 
racial and ethnic minorities, but also in other populations, 
such as those in rural America.
    And we are now beginning to attack that issue the same as 
we did as it relates to the minority population, and that is 
that we are beginning now to go out into those communities to 
identify what it is that we ought to be doing in those 
communities that we are not doing and then coming back with 
that information and partnering with the NIH IC's to develop 
new initiatives to deal with those issues. There are also 
several congressionally mandated programs, we are putting in 
place. For example, the loan repayment program establishing 
Centers of Excellence in communities around the country to deal 
with these various programs. We are now bringing technical 
assistance workshops to the communities around the country to 
make them aware of these programs.
    Health disparities we find in one part of the country are 
vastly different than those found in other parts of the 
country. So we are trying to pay some attention by listening to 
the individuals in those communities and asking a very simple 
question, what is it that we ought to be doing in these 
particular communities that we are not doing. We are beginning 
to get some feedback on that and working with our partners to 
collaborate to develop models and programs that will address 
these needs.
    Mr. Sherwood. If you have any good information there that 
you would like to forward to my office, I would be glad to look 
at it.
    Dr. Ruffin. Thank you, sir.
    Mr. Sherwood. Thank you, Mr. Chairman.
    Mr. Regula. Mrs. Northup.
    Mrs. Northup. Thank you, Mr. Chairman. Let me start with 
Dr. Dean, and thank you for your visit to Louisville. I 
understand you were coming back to the State where you 
apparently grew up but coming to our city meant a lot. I am 
interested in the issues of mental health and bioengineering 
and I know the chairman and I had a conversation recently about 
this, but in deference to some of my fellow committee members 
who have talked about mental health parity for a long time, and 
their concerns obviously are evident to us all.
    I have the anecdotal experience of all of us that meet with 
people in our district that have concerns for their children, 
their families, other members, and inevitably it seems like the 
discussion of people with mental illness being able to stay on 
their medications are hugely important, and yet I am not aware 
of any sort of timed-release bioengineered thing that we are 
developing for, say, diabetes, for other things, slow release 
efforts, and I just wondered if there are efforts that I am 
unaware of.
    The professionals in my district talk about the difficulty 
of even researching mental health because of the difficulty of 
making sure that you know exactly what your research population 
is taking in order to see whether it is working, whether it 
needs to be changed, and it just strikes me that when I talk to 
families who, in particular, have just really terrible concerns 
that often they find they can get their child stabilized, they 
can get their family members stabilized, they then get out on 
their own, get off the medication, and get into a crisis again.
    Dr. Dean. I can provide a response but I suspect it willnot 
be an answer with the clarity that I would like to be able to give you. 
First of all, I would say that NIBIB has entered into a number of 
research partnerships with both the National Institute of Mental Health 
and the National Institute of Neurological Disorders and Stroke in 
generating new research grant applications that probe the application 
of engineering and imaging approaches to assessing central nervous 
system function and mental health. But I would speak from the 
engineering imaging side is that I think there are significant 
opportunities in the imaging arena, particularly the functional 
neuroimaging arena to identify brain function, and perhaps aberrations 
that would be outside the norm of brain function. I think there are a 
lot of opportunities there. I am very excited by what the Mental Health 
Institute folks tell me they see as opportunities for developing new 
drugs from their perspective.
    I won't comment on the drugs that are needed because I am 
not expert in that area. I will say secondarily that one area 
that NIBIB sees that we can develop and foster in a trans-NIH 
way is the general area of biomaterials because we see the 
opportunity to develop new materials that perhaps could be used 
in controlled drug delivery release of various kinds of drugs.
    Earlier, one of the projects I highlighted is actually 
microneedles that actually could be used to deliver insulin for 
diabetes, but this same technology, once it is matured and can 
be used in humans, could also be used to deliver things such as 
vaccines or small particles that could do controlled release of 
medications.
    Mrs. Northup. I guess my concern is I don't see this being 
applied. I understand the imaging is a different question, and 
maybe yours isn't the right institute to be asking this 
question of, but I do not see any effort being made to develop 
the delivery of these drugs for mental health issues, and I 
would say it is the one area where, while I don't share some of 
the parity issues that other members of this committee do, it 
strikes me that it might be that nobody is trying to because 
there is not any money in that area and so let me just say 
again can you answer for me whether any of these sort of slow 
released or other applications of drugs are being tried with 
the treatment of mental health?
    Dr. Kirschstein. Ms. Northup, we will ask Dr. Nakamura of 
the National Institute of Mental Health to provide you with the 
answer. I think it is going to be yes, but I would like to make 
sure and have him answer.
    [The information follows:]

                  Slow Release Drugs and Mental Health

    Dr. Nakamura: Adherence to treatment is a critical aspect 
of mental health care, as it is in other medical care. 
Unfortunately, lack of adherence to treatment is common in 
mental health care and is a significant contributor both to 
inadequate improvement and to recurrence of episodes of mental 
disorders such as depression, mania, and psychosis. Research 
indicates, for example, that fewer than 50 percent of patients 
who are prescribed an antidepressant continue taking it for 
longer than 6 weeks, despite evidence that antidepressant 
treatment should last for at least 6 months after full 
remission of symptoms. Long-acting, slow-release formulations 
of drugs could address this problem. Over the years, a number 
of slow release formulations for antipsychotic and 
antidepressant medications have been developed by the 
pharmaceutical industry. Antipsychotic medications are 
available for which a single dose is therapeutically effective 
for as long as four weeks; for antidepressants, formulations 
with 24-hour effectiveness are a vast improvement over the need 
to take medications two-to-three times daily. Extended release 
preparations of stimulant medications for attention deficit 
hyperactivity disorder also have been approved and now are 
being marketed.
    The actual effectiveness of slow release medications is 
currently being investigated in several large clinical trials 
treatment studies funded by the National Institute of Mental 
Health. Slow release preparations of antipsychotic medications 
are used in the Clinical Antipsychotic Trials of Intervention 
Effectiveness project (CATIE) in schizophrenia, which is run at 
multiple sites across the country and aims at recruiting up to 
1,600 patients in the next 4 years. Likewise, slow release 
antidepressants are used in Sequenced Treatment Alternatives to 
Relieve Depression (STAR*D), a multisite trial for patients 
with major depression.

    Mrs. Northup. I would appreciate that, because it is 
possible that I may want to talk about some language in the 
bill this year that----
    Dr. Kirschstein. There certainly are slow release things 
for other diseases, the pump for diabetes and so forth, but we 
will get specific answers related to the mental health 
situation.

                      BOTANICAL-DRUG INTERACTIONS

    Mrs. Northup. Thank you. I assume I have a few more 
minutes, Mr. Chairman. There are two other areas I will try to 
hit very quickly. One of them is alternative medicine, and I 
can't thank you enough for the advancement of the new therapies 
and alternative medicine. I remember the first year I was here, 
I asked about it and I think it had not been started, and 
clearly it is a much more aggressive institute for you all now.
    I will tell you a story of traveling with about eight 
friends, and we all arrived at breakfast in the morning and 
literally poured out into our hands all the vitamins that we 
take, and when I started running a year ago, my hip started 
bothering me about 6 months ago, so the first thing I did was 
get on the Internet and I found chondroitin and glucosamine and 
have been taking that. It is a miracle. I have never stopped 
running one day, and it is all gone, but if that hadn't worked, 
I was going to go to acupuncture. And I would have gone to a 
doctor sooner or later. I am sure the doctor would have said 
don't run for 6 weeks, which is what kept me from starting 
there, but I just think that very many Americans you can just 
look at the catalogues on the development of these drugs.
    My question is what are these things doing to my liver and 
my kidney? And if we don't research these, we are going to be 
running fine. It is the other parts of the body that----
    Dr. Straus. If I may, Mrs. Northup, let me say your point 
is well taken. Americans are captivated by easy solutions, 
something in a pill that would take care of their diabetes, 
their overweight----
    Mrs. Northup. Eternally young.
    Dr. Straus. Eternally young. We have come to expect to 
remain fit forever because biomedical research has given us so 
much in the past century and we want the rest.
    The problem we have is these products that are in the 
public domain have not been tested. We at the NIH are 
interested with our partners not just in whether they work but 
how they work and exactly, as you said, what else they are 
doing. For example, you may know that the FDA posted an alert 
about Kava a very popular herbal product for anxiety, several 
weeks ago because reports throughout the United States and 
Europe suggested that it may be associated with rare but very 
serious liver injury.
    We are funding studies of Kava, looking at basic mechanisms 
and what it does to liver cells. We have put our clinical 
studies on hold for a moment pending an analysis of some of the 
safety data to be sure it would be ethical to proceed. We have 
completed today, and you will see in the press tomorrow, 
results of a major study of St. John's Wort for the treatment 
of depression. Before finishing that study, our colleagues at 
NIH and grantees around the United States studied St. John's 
Wort as a natural substance. It might be effective but it does 
interfere very potently with the body's metabolism of important 
drugs, AIDS drugs, birth control pills, cancer drugs in a 
report from----
    Mrs. Northup. So if you weren't depressed before, you might 
be depressed after----
    Dr. Straus. That is right. If your birth control pill 
fails, you now have a reason to take St. John's Wort.
    Mrs. Northup. I really appreciate that. I am somebody who 
believes you should be able to buy the vitamins and so forth, 
but I think that all of us want to be warned and I guess the 
week before elections I shouldn't take Kava, no matter how 
stressed I feel?
    Dr. Straus. Probably not. But the issue of the message to 
the public, I think the American public wants not only a quick 
answer, they also want the correct answers. The packages of 
these products say ``the product has not been shown to be safe 
or effective by the Food and Drug Administration. That is not 
exactly the information the public would like to be armed with. 
We hope to arm the public with statements like ``please avoid 
using it in the following context: With this medication, with 
this health condition and expect it to be effective only under 
these circumstances * * *'' just as we do for all conventional 
medicines.

                           READING READINESS

    Mrs. Northup. Thank you. And finally, if I could just 
comment on the National Institute of Child Health and Human 
Development, Mr. Chairman, we are spending probably the biggest 
increase in dollars in defense, secondly in education. And the 
question is primarily, how do we make sure every child succeeds 
in school and it starts with how do we make sure they are ready 
for school; and secondly, when they get there, how do they 
succeed? And the more you spend money, the more I find you have 
a line outside your door with people that have the program that 
they believe will make sure that every child succeeds in 
school.
    And the best thing we could do for us to make sure that our 
dollars are spent in the best way, not only so we get a return 
on our investment, but so that every child who is 6 years old 
really does get the best education possible is to fund the 
studies that give us a true insight into whether programs work 
or not. I don't know whether Dr. Alexander can--I have asked 
before and I will ask again whether you feel like there is 
adequate testing or research done, or if you all even have the 
capacity to do this of the programs that we are enacting in 
terms of what the results are, both short-term and over some 
amount of time.
    Dr. Alexander. Ms. Northup, some years ago when we entered 
the field of trying to assess the effectiveness of different 
education programs, particularly methods for teaching kids to 
read, we found a situation in which decisions on these programs 
were based on what books had pictures that were most appealing 
to kids, or what colors were used, and the research that was 
done was public acceptance or market appeal kinds of work 
rather than evaluations of the effectiveness of the programs in 
helping kids learn to read. These were the bases on which 
decisions were made about selecting textbooks, educational 
regimens, programs, whatever.
    We have brought scientific rigor to this whole area of 
trying to assess effectiveness of educational programs. The 
success of this effort, which has not included everything that 
ought to be tested but some of the most important ones, was 
reflected, I think, in the passage of the President's 
legislation, the education bill that focused on not leaving any 
child behind. The bill requires that all reading instruction 
needed to be research-based and scientific in its approach and 
to be demonstrated to be effective if Federal dollars were 
going to be used to support it.
    Our research continues. We also intend to be a resource to 
States and communities in trying to assess whether there is 
information to buttress their selection of these materials and 
how they are applied, but the President has asked us also to 
move beyond this to school readiness and how we can help 
children enter school maximally ready to learn.
    So the research that we are starting this year and have 
requested dollars for in the 2003 budget focuses on the 
preschool area, relatively a new area for us in which we are 
looking at effectiveness of Head Start-type programs, how to 
bring cognitive efforts into the social and behavioral arenas 
that Head Start has focused on primarily in the past, how to do 
that most effectively, how to work in the community level, and 
at the home level to help parents stimulate their child in the 
most effective ways to provide the readiness kinds of 
activities that will enhance the likelihood that that child 
will succeed when they get to kindergarten or first grade.
    We are looking at different approaches that can be taken in 
these kinds of settings, again in a partnership, a 
collaboration with the Department of Education, with the 
Administration for Children and Families and HHS.
    Mrs. Northup. There would be some that would think we get 
things a little backward. First of all, we appropriate billions 
of new dollars for early childhood and getting kids ready, and 
then after the fact, we appropriate money for research, but I 
think it reflects a true concern on the part of us that we 
don't want to wait any longer for addressing young children's 
problems.
    But Mr. Chairman, if I could just endorse that we provide 
all the funding we need so we get as good an insight as we 
possibly can as to what works, how it works best, what sort of 
intervention works because we are going to keep investing in 
early childhood. We are not going to give up on children, and 
in the meantime, to not have a guiding light is a big problem. 
I would like to also encourage you, though, to go beyond that 
and to establish some parameters for every single group that 
walks in your door, in my door, and says they are research-
based.
    If I could give one example, I think someone ought to write 
the tenet that you can't do your research on your own product, 
that if you develop a reading program that you then can't also 
do the research about whether it works. Somebody else has to 
and you see and you can understand this. Everybody wants to see 
research-based, but they do the research then they take a 
control group, a school, it might be their best school and do 
the research and show the gains, and then try to sort of sell 
that as repeatable strategy for addressing certain concerns, 
but there are others that as I listen to things, but that is 
the first one is that you can't research your own product, and 
it is just too subjective, and I can certainly think of some 
other scientific things but I feel that either there needs to 
be a good seal of approval, that there needs to be some sort of 
standards about what is research-based.
    The other problem is, of course, that what you have now are 
some schools or some superintendents that actually pick up a 
program and if it were applied as it was meant to be applied, 
it might be research-based and successful, but they sort of 
pick and choose what they actually apply and then don't get the 
results that we are hoping for. But in any event, I think we 
all recognize that the promise to our children is primarily, or 
at least essentially an educational promise, and we need all 
the research we can get to give us better insights. I would be 
also very disappointed if we appropriated all this money to you 
all and you didn't give us very clear answers back, even if 
they are not always politically popular.
    Dr. Alexander. Ms. Northup, I certainly agree with your 
statements. Many programs, most programs claim that they are 
research-based. But the quality of that research is often 
lacking. For example, the National Reading Panel which the 
Congress directed us establish, indicated that less than 10 
percent of the studies in the scientific literature were done 
up to quality standards such that they could be relied upon in 
terms of the validity of their results. So we had to throw out 
over 90 percent of the studies. And some of those were based on 
testing done by the sponsor, by the developer of those 
materials, but some were actually done by academics too. So it 
is important that we focus on the quality of the research and 
that judgments be made based on the quality of that work and 
not just that somebody claims it was based on some research.
    Mrs. Northup. Thank you. Thank you, Mr. Chairman.
    Mr. Regula. I have a couple questions and then I will get 
back to you Mr. Sherwood. Let me use Vioxx as an example. You 
see all the allegations of the good things it will do and then 
you read the little literature that is inside, and as to all 
these disclaimers, if you are over five feet tall, you 
shouldn't use this and on and on and on.
    So I would like to have just one statement, this is 
approved by the NIH or it is not approved by NIH. I know you 
can't do it, but you see what I am getting at? How do you know 
where truth lies? You mentioned about what is effective all of 
this on your liver and spleen and other organs of your body. It 
makes you run but many of the trade-offs aren't worth it.
    Mrs. Northup. Yes.

                         ARTHRITIS MEDICATIONS

    Mr. Regula. Where do you go to get some degree of security.
    Dr. Katz. Mr. Chairman, let me respond, since you are 
talking about Vioxx, which is a COX-2 inhibitor, and there are 
several such drugs, but you can generalize to almost all of 
them. When you look up a drug in the Physicians Desk 
Reference,it lists the chemistry and the dosage of these drugs, you 
also list the contraindications; that is, if there are drug 
interactions. But also there is always a long list of potential side 
effects. Some of those are very, very, rare. Some of them are almost 
expected.
    So as a physician, I would tell you that there is a 
physician's judgment that has to come into play in terms of 
balancing what you are treating with what the potential adverse 
effect is, and that is where physician's judgment comes in. We 
try to help that physician's judgment enormously.
    Let us go back to what Ms. Northup talked about with regard 
to glucosamine and chondroitin sulphate. There are short-term 
studies that have shown that it is effective as you mentioned. 
As we are talking about collaborations here, I could tell you 
about a very good collaboration that has gone on for the last 
couple years between the National Center for Complementary and 
Alternative Medicine and the National Institute of Arthritis 
and Musculoskeletal and Skin Diseases. These studies on 
glucosamine and chondroitin sulphate are looking at a longer 
term effect of that combination of alternative medicine. In 
addition from our standpoint at our Institute, we are 
interested in knowing whether it actually modifies the 
disease--whether it modifies this loss of the cushion between 
these joints--the same issue raised in your initial question 
about the injection of the Hyaluron.
    So as a consequence, we are doing studies together, both 
contributing, both center and institute contributing to trying 
to get the answer in terms of disease modification. But to go 
back to the specific question, it is a physician's judgment. 
There is no way that the NIH is going to say yes, you can use 
this or no, you can't, because there are these so-called side 
effects that are expected. And then there are what are called 
idiosyncratic side effects where some individuals, probably 
because of some genetic predisposition, which we will know 
about one day, react in an adverse way.
    Mr. Regula. So you roll the dice, you hope the benefits are 
going to far exceed the downside?
    Dr. Katz. I think as physicians we like to think that we 
are not rolling the dice, but we are making educated judgments 
with the patient's participation.

                             PLACEBO EFFECT

    Mr. Regula. A rose by any other name is a rose.
    Dr. Kirschstein. And balancing the benefits and the risks. 
For cancer drugs we take certain risks that we might not take 
for drugs for other diseases which are less fatal.
    Mr. Regula. Dr. Straus, the old Indian medicine man relied 
on the fact that as he went through all these gyrations, that 
the patient said I am going to get better. Do you think that is 
a factor?
    Dr. Straus. Yes. The power of the mind to affect the body 
is a very real component in healing. We learn as children when 
our mothers comforted us that we are going to get better and we 
understand that expectation is followed by improvement. And we 
in the NCCAM are pursuing this very issue of how the mind and 
body communicate with each other in many ways. As an 
illustration, Mr. Chairman, in a partnership with 10 institutes 
this year, we have announced and will be funding next year, 
applications to understand the placebo effect.
    This is exactly what you are discussing. We used to think 
this was just a sham that is in the mind, but in fact, we 
understand from recent studies that the expectation of getting 
better turns on certain centers of the brain and mediates that 
improvement. That phenomenon has been demonstrated very clearly 
in placebo benefit for pain disorders, and we at the NIH are 
using brain imaging technologies and molecular biology, to 
understand how this communication takes place so we can harness 
it and find better ways of assisting that expectation and 
process of self-healing.
    Mr. Regula. It is a very interesting observation and yet 
alternative medicine has, to some degree, be predicated on this 
placebo effect. I read the other day that in some of these 
tests, that people on the placebo were getting the same benefit 
as those taking the drug.
    Dr. Straus. This is true of all medicine. Good research 
today, when it can include a placebo control arm does, because 
there is a certain rate at which any research subject will 
improve. There are two articles about this issue in tomorrow's 
Journal of the American Medical Association. The placebo effect 
is so great in certain kinds of conditions that it is 
occasionally difficult to prove that new drugs are superior to 
it--if we could just package the placebo.
    Mr. Regula. Interesting. Dr. Keusch, have you done any 
study on the correlation between Health and Economic 
Development in a nation, the prosperity of a nation is tied to 
health?
    Dr. Keusch. Yes, Mr. Regula. There is a lot of evidence 
that health, in using certain measures, for example, longevity 
is directly related to income, and this is true in the 
developed world as it is in the developing world. There seems 
to be a break point at about $10,000 per capita and the 
increment of improvement in longevity as a measure is very 
limited thereafter, but this is actually a very important 
concept as we look at the larger world that we live in and as 
we are trying to deal with issues of poverty and development 
and all of the antecedent of the kinds of events that we saw in 
September of last year.
    The paradigm is changing, and we are trying to generate 
evidence for this that improved health results in greater 
productivity and economic development, and that translates into 
better life, better quality of life, and we hope political 
stability markets and a whole set of secondary gains that 
occur.
    The Fogarty International Center with a number of our 
colleagues at the National Institutes of Health, and an 
offshoot of The World Bank, called the Global Development 
Network are now sponsoring a series of research projects 
between U.S. Institutions working in developing countries to 
examine this hypothesis in order to be able to convince a 
minister of finance to invest in health, because unlike in our 
country, the ministries of health don't have any money, whereas 
we are able to put a significant amount of resources into 
improving our Nation's health. This is probably one of the main 
reasons why the United States is where it is today globally as 
a power.
    Mr. Regula. Would you agree that perhaps the mantra ``leave 
no child behind'' should have a health component as well as an 
education component?
    Dr. Keusch. They go hand in hand. If you are not well, you 
can't go to school, and if you are not healthy, you can't 
learn.
    Mr. Regula. Mr. Sherwood.
    Mr. Sherwood. It has been my experience that chondroitin 
also works very good on draft horses.
    Mr. Regula. They can't read the fine print on the back.
    Mr. Sherwood. And on your comments on placebos, I am 
reminded of the story of my uncle Don, who was a dairy farmer 
and had 50 or 60 high producing dairy cows over a 50-year 
period, 45-year period. So he had a couple thousand dairy 
cattle over this period of time, that he knew every one by name 
and attended to their health and care with great precision. And 
he said over his 40 years, his favorite veterinarian was Dr. 
John Gashian, because when John came out to the farm, you felt 
better, even if the cow died.

                         GLOBAL HEALTH THREATS

    Dr. Keusch, in the Fogarty International Center, since 
September 11, we are all very concerned with terrorism and 
bioterrorism and global health, but we have long known 
infectious diseases can be, to a certain degree, contained by 
political boundaries, and is your center involved in global 
tracking of health threats to us and how do you report 
potential threats to American public health from foreign 
nationals coming here or Americans traveling abroad?
    Dr. Keusch. Well, you say that some diseases respect 
borders, but I know that mosquitos do not in transmitting 
malaria, and we have certainly seen the movement of infectious 
disease agents around the world through the rapid 
transportation systems that we have available. The Center and 
the NIH is not involved in surveillance from that perspective. 
We are involved in obviously studying the epidemiology and the 
movement of disease in order to be able to better define 
interventions. There are global systems to track disease in the 
context in which I think you have raised it.
    Our job is to better understand the mechanisms in order to 
be able to devise interventions and carrying that back into the 
mechanisms of disease in order to develop both new drugs and 
new vaccines and their implementation. We need to understand 
how these diseases track in order to effectively intervene, and 
that certainly is an important research question using a whole 
range of tools including imaging, satellite imaging, and the 
use of mathematical modeling. So there is a whole range of 
activities that the Center and our colleagues at the National 
Institute of Allergy and Infectious Disease, child health, 
general medical sciences and others are engaged in.
    Mr. Sherwood. Thank you. Dr. Kirschstein, and Mr. Chairman, 
this has been very informative, and if I was a little smarter, 
I would ask some for more questions, but I think I am okay for 
today. Thank you.
    Mr. Regula. You have been doing very well.
    I do have a couple more, and that is, I note that our 
budget has $49 million, to do research in collaboration with 
the Defense Department, and it would seem that this would be a 
productive situation because you have somewhat of a controlled 
group if you are doing a study of an impact on a group of 
military people. Are you involved? Is it working out? Does this 
provide a pretty effective way of doing certain types of 
research?
    Dr. Kirschstein. Among the groups that we collaborate with 
is the Defense Department. The particular funds that you are 
talking about occur in three areas: The major area where there 
is collaboration going on is being used for a study of AIDS 
vaccine with the army in Thailand, and that is being done very 
specifically by National Institute of Allergy and Infectious 
Diseases. Both the military and that Institute have been 
studying varying candidate vaccines for AIDS for some time 
under different circumstances. The Army is particularly 
interested in using the vaccine in countries such as Thailand 
where our soldiers are at risk, and we are interested in both 
developing countries, as Dr. Keusch has described, as well as 
in the United States, and they are going to combine efforts in 
this regard. Some of the other funds are for research 
activities that are related to some of the things we do within 
the institutes, and this will be a matter of providing 
sustenance for some of the programs that the Army can no longer 
provide funds for, and we will do so.
    Mr. Regula. So you would say this is a money well spent, 
the 49 million?
    Dr. Kirschstein. It will be in the future, I am sure.

                       SHARING KNOWLEDGE GLOBALLY

    Mr. Regula. One last question. Do you get information from 
around the world? In other words, are there other parts of the 
world where activities similar to what you are doing are 
happening and that you can share with them, or are we pretty 
much the world's resource on the kind of work you are doing 
here?
    Dr. Kirschstein. As Dr. Keusch said, research is 
international, and he can elaborate on this.
    Dr. Keusch. We certainly have--and this is across the whole 
of the NIH, great connections with the other major supporters 
of research. For example, in the United Kingdom the Medical 
Research Council and the Wellcome Trust, the Pasteur Institute, 
and there is a constant exchange of information, of planning, 
of thinking, of interaction in many of the disease areas. A 
number of institutes and institute directors have been involved 
with the World Health Organization. I am currently serving on 
the Advisory Committee on Health Research to the director 
general of----
    Mr. Regula. Could I interrupt you? What does a World Health 
Organization do? How does a World Health Organization affect 
Ralph Regula, for example, what exactly is the value of this? I 
have been thinking about whether there would be a value--and 
maybe you can answer this, take the Subcommittee, where is it, 
Switzerland?
    Dr. Keusch. In Geneva.
    Mr. Regula. To meet with these people, is there a value in 
that?
    Dr. Keusch. I think there is absolutely value. You don't 
have to go to Geneva to get a sense of what these international 
organizations are doing. Just down the road from here is the 
Pan American Health Organization and the Pan American Health 
Organization has been, for example, exceedingly effective in 
eradicating measles and polio from the Americas that has a 
direct impact on Mr. Regula, if you are traveling or your 
children are traveling to those parts of the world.
    The difference between an organization like the National 
Institutes of Health, which is looking at the health issues 
from the perspective of science, and the World Health 
Organization is that it purports to--I don't know how many 
institutes and centers we have at the National Institutes of 
Health, and I don't know how many countries there are in the 
world right now, because there are increasing numbers of 
countries, but for the 190 countries, they must respond to each 
one of those and it makes it sometimes a bit difficult to focus 
in on what is absolutely necessary to do. I think as some of 
the discussion this afternoon, a science-based agency such as 
the NIH, can really address the scientific issues, as for 
example, Dr. Straus has been talking about in complementary and 
alternative medicine.
    Mr. Regula. Does the World Health Organization just 
assemble information to disseminate to its members, or does it 
do some types of research, or does it compare research in the 
U.K. versus what is being done in the U.S.?
    Dr. Keusch. It does all of that. It addresses the needs 
throughout the whole developing world as well as the 
industrialized world. It makes recommendations. It pulls 
together expert committees. Many people from the National 
Institutes of Health serve on those committees. I would be 
delighted at some point, if you would like, to spend a little 
more time and tell you more about what WHO does and how the NIH 
interacts with that organization, because we do have a good 
interaction.
    Mr. Regula. You think it is a very useful organization? Is 
it financed by contributions from various countries?
    Dr. Kirschstein. It is basically the equivalent on the 
health level to the United Nations.
    Dr. Keusch. Yes. And I think it is a useful organization. I 
think it has limitations as well and we try to maximize the 
good parts of it and deal with the rest.
    Mr. Regula. Do other countries draw on your knowledge and 
your research to improve their health internally?
    Dr. Keusch. Absolutely. Every week there are delegations 
from ministries of health and science and technology visiting 
the National Institutes of Health, and those visits are 
productive not only for them, but also for us as well.
    Dr. Kirschstein. In addition, Mr. Chairman, I think one of 
the very important functions we serve both at our academic 
health centers as well as within our intramural program, 
because we are the premier science organization of the country, 
is to be the training ground throughout the country where there 
are pockets of expertise in various fields for scientists from 
all over the world who come here to study and learn, many of 
whom, almost all of whom hopefully will go back to their 
countries and set up programs.
    And in addition, Dr. Keusch and Dr. Ruffin can expand for 
you on programs where we send our scientists abroad. Now, that 
used to be much more prevalent back in the 1930's and 1940's, 
and right after World War II, it was quite prevalent for us to 
send scientists abroad to learn. We have become much more 
preeminent and the traffic goes much more the other way.
    Mr. Regula. Very interesting. Mr. Sherwood, no more? Well, 
thank you all. It has been a productive hearing. There is a lot 
more we can ask. We will have questions for the record, but it 
sounds to me like you are doing the Lord's work out there, and 
we take our health for granted in so many different ways. It is 
reflected, I guess, in the ever-growing longevity of people. 
The average age of individuals in the United States is going up 
in terms of death, and in some countries, particularly Russia, 
are going the other way. Just an aside, do we have much 
interaction with Russia? They seem to have some good science 
over there.
    Dr. Kirschstein. We have a great deal. We used to have a 
great deal more with the Soviet Union. We had all sorts of 
inter-institute agreements, particularly in heart disease, and 
in cancer. This became less the thing to do as our 
relationships generally with the Soviet Union got more 
difficult, and we are trying to build these up again with the 
various individual countries that made up the Soviet Union.
    Again, Dr. Keusch, if you wish, can expand on that. The 
State Department has a program that is involved in that and we 
are relying on those scientists from Russia in particular who 
have ended up in this country who have some knowledge of what 
has been done in the field of organisms for bioterrorism as to 
what they know. Dr. Fauci, who is coming down on, I believe, 
May 8, for a hearing on bioterrorism, may well be able to 
expand on that for you.
    Mr. Regula. Very interesting. Thank you all for coming.
    Dr. Keusch. Mr. Regula, we can provide you with some 
information on our activities across the NIH with the Soviet 
Union, if you would like it.
    Mr. Regula. I would be interested. Thank you very much. 
Hearing is adjourned.
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                                         Tuesday, April 16, 2002.  

 DEPARTMENT OF HEALTH AND HUMAN SERVICES, NATIONAL INSTITUTES OF HEALTH

                               WITNESSES

DR. RUTH L. KIRSCHSTEIN, ACTING DIRECTOR, NATIONAL INSTITUTES OF HEALTH
DR. CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
DR. FRANCIS COLLINS, DIRECTOR, NATIONAL HUMAN GENOME RESEARCH INSTITUTE
DR. KENNETH OLDEN, DIRECTOR, NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH 
    SCIENCES
DR. PAUL SIEVING, DIRECTOR, NATIONAL EYE INSTITUTE
DR. LAWRENCE TABAK, DIRECTOR, NATIONAL INSTITUTE FOR DENTAL AND 
    CRANIOFACIAL RESEARCH
DR. PATRICIA GRADY, DIRECTOR, NATIONAL INSTITUTE OF NURSING RESEARCH
DR. DONALD LINDBERG, DIRECTOR, NATIONAL LIBRARY OF MEDICINE
DR. RAYNARD KINGTON, ACTING DIRECTOR, NATIONAL INSTITUTE ON ALCOHOL 
    ABUSE AND ALCOHOLISM

                         CAREER OF CAROL MURPHY

    Mr. Regula. I would like to start the meeting of our 
subcommittee. We have a lot of important testimony today, but 
first of all, I want to say that this is Carol Murphy's last 
day. She is going to take over the clerkship of the D.C. 
committee, so she will have some new and interesting 
challenges, and I think perhaps her experience in dealing with 
health issues will be of constructive value to her in dealing 
with D.C. because they probably have some of the different form 
but nevertheless challenging issues and, Carol, we wish you 
well in your new role. You have been a wonderful staff person. 
You have been providing great leadership in dealing with the 
issues that confront this subcommittee. It is a very important 
subcommittee because the things we do touch the lives of all 
280,000,000 Americans either in education or in health care or, 
in some cases, in labor issues.
    Mr. Obey, would you like to make a few comments before we 
start the hearing?
    Mr. Obey. You bet. I simply would like to say, Carol, I 
think you are making a terrible mistake.
    Mr. Regula. That is encouraging.
    Mr. Obey. I really hate to see you leave. I mean I served 
my penance on the D.C. Subcommittee years ago. I think you are 
a perfect example of how this institution works because there 
are so many people at the staff level who do all of or almost 
all of the real work and who do most of the negotiating and who 
come up with the ideas that enable the politicians in this 
place to occasionally reach common ground even when sometimes 
it is very hard to find, and in the process you have managed to 
help an awful lot of people who will never know your name or 
never even know you were here, and I think on behalf of them, 
we both owe you a profound vote of thanks.
    Mr. Regula. Mr. Obey, I think you said it well. The 
American people were fortunate that you gave the years of 
service to this committee that you have, and many of the 
products of this committee in legislative initiatives have 
resulted in Carol's work ambition. So we are pleased with her 
service and we all wish you well with the new challenge.
    Dr. Kirschstein, we are glad to have you back and to have 
some members of your team here. We will wait for an opening 
statement from you. Put your full statement in the record, and 
then you can introduce the members of your team as they each 
make their presentation.

                  Dr. Kirschstein's Opening Statement

    Dr. Kirschstein. Mr. Chairman, Mr. Obey, we too at NIH want 
to thank Carol Murphy for all that she has done. She has been 
extraordinarily helpful to us and we feel that we are going to 
miss you just about as much as they are going to miss you. We 
have the opportunity to see some of these gentlemen again next 
year, and we hope you will come andvisit the committee so we 
can retain our friendship.
    Mr. Chairman, we again want to tell you how pleased we are 
to have had these opportunities to present our programs. This 
is the last of the panel sessions for NIH. This is the 
continuum of presentations and we ended with a discussion of 
disease prevention and health promotion. In this area, as in 
all others, each of the institutes has a major role not only 
doing research but in communicating the results of research. In 
fact, communication is the critical link between the scientific 
knowledge we uncover and preventing disease, maintaining 
healthy lives and managing chronic diseases and conditions. 
These research and communications activities must be carefully 
coordinated among the NIH institutes and centers, among these 
institutes and centers and other agencies, such as CDC and the 
Food and Drug Administration, the Substance Abuse and Mental 
Health Services Administration, and among all the agencies of 
the Federal Government, NIH, DHHS, USDA, the National Science 
Foundation, et cetera.
    I have submitted an opening statement which highlights a 
few of them which brings forward material that my colleagues 
will present which is representative of what all the institutes 
and centers do. The panel members with me today are, to my 
left, Dr. Claude Lenfant, Director of National Heart, Lung and 
Blood Institute; Dr. Francis Collins, Director of Human Genome 
Research Institute; Dr. Kenneth Olden, Director of National 
Institute of Environmental Health Sciences; Dr. Paul Sieving, 
Director of the National Eye Institute. To my right, Dr. 
Lawrence Tabak, Director of National Institute of Dental and 
Craniofacial Research; Dr. Patricia Grady, Director, National 
Institute of Nursing Research; Dr. Donald Lindberg, Director of 
National Library of Medicine; and, finally, Dr. Raynard 
Kington, Acting Director, National Institute on Alcohol Abuse 
and Alcoholism. And with us, as usual, is Mr. Kerry Weems from 
the department whom we are pleased to have. I will call on each 
of them in turn. Dr. Lenfant.
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                         Opening Remarks--NHLBI

    Dr. Lenfant. Thank you, Dr. Kirschstein, Mr. Chairman. I am 
very pleased to be here because this is--prevention and health 
promotion are truly the hallmarks of the institute program 
because so many of the diseases that we care for are 
preventable. Health education is a very powerful tool to 
achieve prevention and health promotion.

                   ACT IN TIME TO HEART ATTACK SIGNS

    I would like to discuss one of our programs which is called 
``Act In Time to Heart Attack Signs,'' as it may save thousands 
of lives. Mr. Chairman, in the next 12 months, 1.1 million 
Americans will have a heart attack. For 650,000 of them, it 
will be the first one. For the others, it will be a repeat, 
maybe second or third heart attack. Of the 1.1 million 
patients, 520,000 will die, half of them not having reached the 
hospital. Why do people not go to the hospital? There are all 
kinds of very bad reasons for it. Frequently they do not 
recognize the symptoms, and even if the patient thinks they may 
have a heart attack, even if the doctors tell them to go to the 
hospital as quickly as possible, they do not get there in time. 
Why not? Not because the emergency personnel do not respond 
quickly, but because the patients just do not want to be 
embarrassed by having an ambulance coming to their driveway 
with sirens and lights or they do not want to upset their 
families or they are too busy to go to the hospital or they 
believe they will feel foolish if, after all, they do not have 
a heart attack. So we have started a new campaign to counteract 
misconceptions about heart attack signs, alleviate patients' 
fears, and emphasize the importance of getting treatment 
immediately after symptoms begin. We have developed materials 
such as this one that you have in front of you, actually, to 
help doctors to teach their patients the key messages.
    First, recognize the symptoms and, second, call 911. And 
this material that you see here is being distributed to all 
parties and physicians so that they can think about those 
things they have to tell their patients.
    But, in addition, patients do not have to wait until their 
doctors bring up the subject of heart attack before they can 
educate themselves about symptoms and develop a heart attack 
survival plan. We are helping them with public education 
programs. And I should say at this point in time the program is 
already successful. It has been in existence for only 6 months 
and the Act in Time message is now an official course of the 
American Red Cross which publicized and institutionalized a 
program, and the National Council on the Aging is also offering 
classes in more than 1,000 senior centers throughout the 
country.
    We work also with the American Heart Association to 
distribute and diffuse information about this program 
throughout the whole network. Our expectation is that the Act 
in Time to Heart Attack Signs will be successful as many of 
their campaigns have been. In time I will be pleased to respond 
to your questions, Mr. Chairman.
    [The information follows:]

National Heart, Lung, and Blood Institute, Act in Time to Heart Attack 
                                 Signs

    Wallet Card: http://www.nhlbi.nih.gov/health/public/heart/
mi/wallet.htm
    Physcian Quick Reference Card: http://www.nhlbi.nih.gov/
health/prof/heart/mi/provider.htm
    Brochure: http://www.nhlbi.nih.gov/health/public/heart/mi/
core__bk.htm

    Mr. Regula. Thank you.

                         Opening Remarks--NHGRI

    Dr. Kirschstein. Dr. Francis Collins.

                     GENETICS TO DISEASE PREVENTION

    Dr. Collins. Mr. Chairman, Mr. Obey, research on the human 
genome, our own DNA instruction book, is running dramatically 
ahead of schedule and will provide opportunities for better 
disease prevention and health promotion, the theme of today's 
hearing. Consider, the family shown on the poster. A father and 
four of his five sons, here marked in red, have all been 
affected with prostate cancer. The numbers that you see on each 
figure indicate the age at which each was diagnosed. Only one 
son, the one marked in blue, has been spared. Only a few years 
ago there would have been no way to track down the cause of 
this strong familial pattern. But now with the tools provided 
by the Human Genome Project, the ability to identify hereditary 
susceptibility factors for common disease is advancing rapidly.
    [The information follows:]

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    Just two months ago, scientists in the intramural program 
of the National Human Genome Research Institute, together with 
colleagues at Hopkins and the Cleveland Clinic, were able to 
find the needle in this particular DNA haystack, a misspelling 
in a particular gene on chromosome one, the first gene for 
prostate cancer to be discovered and validated. This disease 
kills more than 30,000 men in the U.S. each year.
    If you look under the normal individual, the one in blue, 
you see the normal DNA sequence, CATAGAGAT. But in the affected 
males, instead of a G in that one vulnerable spot there is a T. 
That T essentially creates a stop sign that knocks out the 
function of this gene. Based on this discovery, it is now 
possible to warn the man marked with a question mark of his 
potential future risk for prostate cancer, based on a genetic 
test.
    Similar research of this sort is now proceeding rapidly to 
identify hereditary factors in diabetes, heart disease, breast 
cancer, colon cancer, Parkinson's disease, and Alzheimer's 
disease, to mention just a few. These advances raise the real 
possibility of individualized preventive medicine for all of us 
in the next 5 to 10 years, based on our highest 
susceptibilities. Perhaps even more importantly, these gene 
discoveries provide new treatment approaches that simply could 
not have been achieved otherwise.

                         EDUCATION IN GENOMICS

    This promising future of better prevention, treatment and 
cure will only happen if we are preparing health care 
professionals and the public for this coming revolution in 
genomic medicine. To do this successfully, those generating 
health care messages and answering public inquiries must remain 
closely aligned with the physicians and scientists conducting 
this research.
    Among our current products for the public are a free 
multimedia educational kit, which has been requested by more 
than 60,000 individuals, many of them high school teachers, and 
is now available on the web. Together with the Office of Rare 
Diseases, we have also just opened a Genetic and Rare Diseases 
Information Center. In just ten weeks this center has already 
handled hundreds of complex inquiries about rare diseases. 
Furthermore, to provide accessible, validated information about 
genetics to primary health care providers, doctors and nurses, 
we have founded the National Coalition for Health Professional 
Education in Genetics, in collaboration with the American 
Medical Association and the American Nurses Association.
    This is a unique time in the history of medical research. 
With the availability of the sequence of the human genome in 
all its dazzling complexity and elegance, we have the 
opportunity to solve mysteries of health and disease that have 
vexed humankind since the dawn of time. With the support of 
this Congress, which has been visionary from the very beginning 
in seeing the promise of the Human Genome Project, the National 
Human Genome Research Institute will pursue an ambitious and 
aggressive research agenda to make those dreams come true.
    Thank you very much and I will be glad to answer questions.

                         Opening Remarks--NIEHS

    Dr. Kirschstein. Dr. Kenneth Olden.
    Dr. Olden. Mr. Chairman and Mr. Obey, complex diseases are 
not caused by any single factor. It is now widely accepted that 
most devastating diseases that plague humankind are caused by 
the interaction or combination of three risk factors. They are 
one's genetics, one's environment, and one's behavior or 
lifestyle. While genes may program one for a disease, when or 
if one develops the disease is largely determined by one's 
physical environment and one's behavior. Therefore, to prevent 
human illnesses will require identification of the various 
genetic, environmental and behavioral risk factors involved in 
the development of specific diseases. Once the risk factors 
have been identified, one can begin the process of studying the 
interaction between the various agents.
    Now such information can be very important and can lead to 
public health or clinical prevention intervention strategies to 
prevent these chronic or incurable diseases. Although most of 
the visible environmental problems of the 1950s and 1960s have 
been ameliorated, massive quantities of toxic agents are still 
polluting our environment. Whether current levels of these 
exposures are contributing to the high incidence of cancer, 
Parkinson's, Alzheimer's, diabetes, autism, learning 
disabilities or other complex disorders is still a matter of 
considerable concern.
    Take the recent determination to lower the permissible 
level of arsenic in drinking water from 50 parts per billion to 
10 parts per billion. The policy decision is consistent with 
the concern that maybe ambient levels of exposures are still 
subjecting the American people to some risk. Also a paper was 
recently published by two of our grantees in the March issue of 
the ``Journal of the American Medical Association'' and it 
showed that tiny soot particles present in the ambient air of 
major U.S. cities was causing about a 12 percent increase in 
lung cancer.
    The investment in environmental health and prevention 
research and translation of these results into public health 
policy and the practice of medicine is one strategy to 
eliminate the epidemic of diseases. To quote Ms. Karen Miller 
of the Long Island Breast Cancer Coalition, ``Prevention is the 
cure.''
    Thank you for your attention and I, too, would be pleased 
to answer any questions you might have.

                          Opening Remarks--NEI

    Dr. Kirschstein. Dr. Paul Sieving.

                  EYE DISEASES--EXTENT OF THE PROBLEM

    Dr. Sieving. Mr. Chairman and members of the subcommittee, 
eye disease is a major health problem in the United States and 
causes significant suffering, disability, loss of productivity 
and diminished quality of life, particularly for our elderly 
citizens. A report issued by the National Eye Institute just a 
few weeks ago showed that more Americans than ever are facing 
the threat of blindness from age-related eye diseases. More 
than 1,000,000 Americans age 40 years or older are currently 
blind and another 2.4 million are visually impaired, and as 
Americans are living longer and generally healthier lives, 
vision problems associated with aging can be expected to grow 
substantially in the future.

                          PROMOTING EYE HEALTH

    In response to these problems, the National Eye Institute 
has developed programs for promoting eye health. The NEI is the 
lead Federal agency addressing the eye health education needs 
of the Nation. Our activities in this area represent a natural 
extension of our support for vision research. In the 
dissemination of research results, we translating these results 
into practical applications for health care professionals, for 
patients, and for the public, which is integral to our mission 
of improving the eye and vision health of our country.
    In 1991, in response to a congressional mandate, the 
National Eye Institute established the National Eye Health 
Education Program, or NEHEP. NEHEP currently includes education 
programs targeting three areas. The first is directed toward 
glaucoma, a disease that damages the optic nerve of the eye and 
that can lead progressively to blindness.
    A second program involves diabetic eye disease, a term for 
the visual complications that result from abnormal blood 
vessels that develop in the eye due to underlying diabetes.
    A third program is for low vision education. Low vision is 
a visual impairment that cannot be corrected by standard 
glasses, contact lenses, medicine or surgery. Impaired or low 
vision interferes with the ability to perform even seemingly 
simple every-day activities of reading and driving or even to 
see the smile of a spouse. Education and practical assistance 
from an eye care provider can help those with low vision to 
optimize their remaining sight.
    NEHEP is coordinated by the National Eye Institute in 
partnership with more than 65 national organizations 
representing professional associations, voluntary, civic and 
fraternal organizations, and other government agencies. Through 
this partnership, the NEI multiplies its efforts in 
disseminating information to the public. NEHEP also provides 
opportunities for the partners to collaborate on community-
based programs and to implement these through their own 
networks. NEHEP utilizes a variety of outreach strategies, 
including program planning guides and reports for health 
professionals, public service announcements for radio, 
television and print media, and the distribution of educational 
kits.
    NEHEP developed and coordinates traveling exhibits that 
visit shopping centers around the country, thereby reaching a 
diverse population. The NEI also disseminates research results 
that impact public health. For instance, lastOctober the Eye 
Institute released results of a major 10-year clinical trial showing 
that supplementing the diet with high levels of antioxidants and zinc 
substantially reduced the risk of developing advanced age-related 
macular degeneration, and this lowered the risk of vision loss. The NEI 
coordinated a national and locally-based dissemination process so that 
over 174,000,000 people had the opportunity to learn about these 
important results through print, radio, television and Internet 
coverage.
    Further, a public vision information network coordinated by 
the NEI assisted in disseminating these results nationwide. 
With these efforts, the National Eye Institute is playing a 
valuable role in placing vision on the public health agenda and 
bringing the importance of vision and eye health to a broader 
community.
    Thank you, and I will be pleased to answer questions.
    Mr. Regula. Thank you.
    Dr. Kirschstein. Dr. Lawrence Tabak.

                         Opening Remarks--NIDCR

    Dr. Tabak. Mr. Chairman and Mr. Obey, I am pleased to 
appear before you on behalf of the National Institute of Dental 
and Craniofacial Research. Our Institute was founded 54 years 
ago on the principle of prevention. Indeed, the prevention of 
dental decay by water fluoridation has been hailed as one of 
the top 10 public health achievements of the 20th century. 
Today our Institute's disease prevention efforts are quite 
broad, including our continuing efforts to prevent dental decay 
in at-risk patients.

                        ORAL CANCER EXAMINATIONS

    However, today I will focus on NIDCR's ongoing efforts to 
increase public and professional awareness of oral cancer and 
the need for oral cancer examinations. The poster to your left 
demonstrates how to perform an oral cancer exam, and this was 
sent to 145,000 practicing dentists and dental students as part 
of the special issue of the ``Journal of the American Dental 
Association'' that you have in front of you. Only 20 percent of 
adults in the United States reported ever having an oral cancer 
examination. The fact that so many Americans are not receiving 
this 90-second painless examination is disturbing because, 
unlike other cancer sites, the mouth, head and neck are readily 
accessible. Yet half of all oral cancers go undetected until it 
is too late. Five-year survival for these cancers is among the 
lowest of all major cancers and it is worse for blacks than for 
whites.
    [The information follows:]

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    During this decade an estimated 74,000 Americans will die 
from oral and pharyngeal cancer. Thousands more will undergo 
multiple surgeries to remove advanced tumors and to reconstruct 
their faces. Through increasing awareness about oral cancer 
prevention, we can make early detection the norm, never the 
exception.
    Recently we funded five states--New York, North Carolina, 
Florida, Michigan, and Illinois--to develop models of oral 
cancer prevention and early detection. These grants will enable 
them to tailor intervention strategies to each state's specific 
demographic and professional needs.
    In tandem with its outreach efforts, NIDCR has invested in 
research to develop powerful new tests for the rapid diagnosis 
of oral cancer. NIDCR's scientists are defining the molecular 
signature of cells undergoing the earliest cancerous changes. 
These signature molecules can be detected in oral fluids, thus 
forming the basis of a simple noninvasive diagnostic test. 
NIDCR is currently supporting a research initiative designed to 
exploit the use of oral fluids for detection of a broad range 
of infectious agents as well as harmful chemicals.
    To conclude, I invite you to give the booklet, ``Detection 
of Oral Cancer,'' which is inserted in that journal I gave you, 
to your own dentist during your next appointment; and if you 
have not yet had an oral cancer examination, ask your dentist 
to do so.
    Thank you for the opportunity to speak with you and, of 
course, I would be pleased to answer any questions.
    Mr. Regula. And we can charge him for that professional 
advice; is that correct?

                         Opening Remarks--NINR

    Dr. Kirschstein. Dr. Patricia Grady.
    Dr. Grady. Mr. Chairman, Mr. Obey, as of this year, our 
15th anniversary, NINR-supported research is providing a 
scientific basis for patient care that is used by the many 
disciplines among health care professionals, especially by this 
Nation's 2.7 million nurses. Our research studies in health 
promotion and disease prevention include the effects of diet 
and exercise programs on both healthy and ill people, ways to 
reduce risky behavior, and ways to prevent or reduce the impact 
of illness. Let me give you four examples.

                  POST-TRANSPLANT PROBLEMS OF PATIENTS

    With the number and longevity of organ transplant patients 
increasing, nurse researchers are addressing the post-
transplant problems related to survival once patients leave the 
hospital. The programs of research focus on recognizing and 
managing the symptoms of rejection and promoting quality of 
life. After one year, study findings indicated a 50 percent 
decrease in rehospitalization for infections and fewer 
immunosuppressive drug toxicities for these patients. Costs 
were also decreased by 21 percent.

          CESAREAN DELIVERY INCREASES RISK OF UTERINE RUPTURE

    Another example is that of a recent study published in the 
New England Journal of Medicine demonstrating that cesarian 
delivery can increase by three times the risk of uterine 
rupture during labor in a subsequent pregnancy. If drugs are 
used to induce labor, the risk increases 15-fold. Since 60 
percent of women with prior cesarian deliveries attempt labor 
with the next pregnancy, it is important that this information 
be incorporated into patient education.

                REDUCING LEAD POISONING IN THE COMMUNITY

    Third, a major health problem in both rural and urban 
communities is the issue of lead poisoning. Investigators 
formed a partnership with an academic nursing center and a 
community consisting primarily of African-Americans. Analysis 
of the data following an education and awareness program 
indicates a decrease in lead levels of the study group by 11 
percent. This program has received the National Environmental 
Education Achievement Award.

           NATIVE AMERICAN TALKING CIRCLES TO REDUCE DIABETES

    And, finally, you may have seen last week a Washington Post 
article on our community-based study using Talking Circles for 
rural native American tribes with diabetes in South Dakota and 
Nebraska. Native Americans are about three times more likely to 
develop diabetes, and the condition is often related to a high 
fat diet and insufficient exercise. In this study, Talking 
Circles, which capitalize on the oral tradition of story-
telling in group settings, were used to discuss prevention 
strategies and avoidance of risky behaviors. After findings 
indicated a change in attitude toward diabetes and improved 
health outcomes, the research has now been translated to 
practice. The communities are continuing the Talking Circles 
and incorporating healthy diet instruction and blood sugar 
testing.
    Another outcome is the development of a cookbook that 
combines a controlled diabetic diet with traditional foods such 
as buffalo and rice soup.
    In conclusion, NINR and the investigators we support strive 
through dissemination to make benefits of nursing research 
available, including successful interventions and novel uses of 
technology. Incorporating positive results such as these will 
make a long-term difference in improving the health of our 
Nation's people. Thank you.

                          Opening Remarks--NLM

    Dr. Kirschstein. Dr. Donald Lindberg.
    Dr. Lindberg. Mr. Chairman, Mr. Obey, NLM's major mission 
is to acquire, organize, and disseminate the biomedical 
knowledge of the world for the benefit of the public health, so 
we are intimately involved in the mission of preventing disease 
and promoting health. Increasingly the dissemination occurs via 
the worldwide web and Internet, and we have a display of this 
home page. It merely is there so we can show you that one can 
go from that one display either in the direction of helping a 
doctor to get information to treat a patient or in the 
direction of a researcher to follow up a discovery in the 
scientific literature or to the consumer, which increasingly is 
an important user of this information. So, of course, 
increasingly the dissemination occurs in this method, but 
increasingly the discoveries come from NIH institutes and the 
grantees that they fund.
    In the case of the health professional, he or she has to 
deal with the fact that 500,000 articles every year are 
published on these discoveries. So you need a computer to find 
your way to exactly the right one. This particular display also 
shows that it links to--in this case we chose the example of 
macular degeneration, but it links to Online Mendelian 
Inheritance in Man at John Hopkins, the genetic information.
    In the case of the display in the middle on the bottom, the 
patients are the beneficiaries, and starting in 1997 this 
committee and its comparable committee in the other chamber 
gave us encouragement to try to serve patients' families and 
the public directly. We had formerly tried to do this only 
through the health professional. By 1998 we had already made an 
arrangement so that the searching could be essentially free and 
we had dropped the requirement to know the identity of the 
person giving the search. Both of those are essential if you 
are going to serve the public. And we found to our amazement 
that within the first year, 10 times the number of searches 
were done, from 7,000,000 to 75,000,000, a third of them by 
members of the public. So we created a new database, Medline 
Plus, for the public and this has had very, very heavy usage. 
There is not time to go through all of these things, but I 
would like to say that the NLM serves the public by 
collaboration with colleagues at NIH. The NIH institutes are, 
of course, the first place we look for this kind of information 
although we select information that is well understood by the 
public and well presented, also nationally linked to VA and CDC 
and other HHS agencies as well as voluntary health 
organizations.
    Again the linkages are what is important so that whether it 
is the doctor, the patient or the clinician, we can link to 
clinical trials, another requirement happily given by the 
Congress and the FDA Modernization Act in 1997, so that all of 
the people really can share the same information.
    It is sort of a point-and-click world we are all living in, 
and that is literally the case that when you enter this home 
page. You can as a patient go to what you want to know or a 
dictionary to help look at it, or an encyclopedia on line to 
understand it, or a tutorial say on anthrax. In the same 
session a doctor can go to the article he wants to find to 
treat a patient. A researcher can go sort of over on the other 
side on the right where you see diagrams and maps of where is 
the gene or genes in this case associated with macular 
degeneration and which are the coding regions, and the whole 
detail of that business is available in the same site at the 
same time and through the same organization, and of course once 
again I echo my colleagues in saying we are grateful to the 
Congress for both the leadership and the support.
    [The information follows:]

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    Thank you.
    Mr. Regula. Thank you.
    Dr. Kirschstein. Dr. Raynard Kington.

                         Opening Remarks--NIAAA

    Dr. Kington. Mr. Chairman and Mr. Obey, alcohol abuse and 
alcoholism are prevalent and costly disorders in the United 
States. More than 14 million Americans abuse alcohol or are 
alcohol-dependent, and alcohol problems cost society $185 
billion annually. The consequences of these disorders are 
preventable.
    We base preventive interventions on our growing 
understanding of the biological, psychological, and 
environmental factors that contribute to the risk of developing 
alcohol use disorders. Our prevention research portfolio ranges 
from studies of individuals to studies of communities.

                      PREVENTION OF ALCOHOL ABUSE

    For example, at the individual level we are designing and 
testing interventions to prevent convicted drunk drivers from 
repeating their offenses. Another example involves community-
wide studies that are examining whether policy changes result 
in more responsible alcohol service by bars and restaurants.
    Our data indicate that some populations, however, require 
special focus. Among them are college students. The NIAAA Task 
Force on College Drinking recently issued its recommendations 
on the prevention of abusive drinking by college students, 
accomplanied by a number of additional research and outreach 
projects. I have a graphic that illustrates the range of 
educational material our Task Force on College Drinking has 
generated, including material targeted to parents and 
residential advisors. Our web site in the example, received 
over 650,000 hits in its first week, and our outreach 
information will be mailed to every college president in the 
United States. Our newly funded Multi-Campus Alcohol Problem 
Intervention Program, on 16 campuses of two California 
university systems, is just one example of the kinds of 
research projects that we are supporting in this area.
    Abusive drinking among youth extends well beyond the 
college population, however, and we now co-sponsor, with the 
Robert Wood Johnson Foundation and other Federal Agencies, the 
Leadership to Keep Children Alcohol-Free Initiative. Thirty-
three governors' spouses have joined this effort to prevent 
children between the ages of 9 and 15 from drinking. We also 
fund a major community-based intervention research project, 
which is testing among urban youth a community intervention 
that was effective in reducing underage drinking in rural 
populations. In addition, our investigators are examining the 
effects of advertising on youths' attitudes and perceptions 
about drinking.
    Our prevention research on fetal alcohol syndrome, the 
leading cause of preventable birth defects, now focuses on 
women in minority groups at risk. Overall, we support 10 fetal 
alcohol syndrome prevention research projects. We recently 
began a pilot public-information project in the District of 
Columbia, which targets African-American women.
    We also conducted the fourth annual National Alcohol 
Screening day, in the general population, just last weekend. 
This program promotes the use of proven, effective, brief 
questionnaires to identify persons at risk of alcohol abuse and 
refers those at risk for further evaluation and treatment.
    It is important to note that some of the risk of developing 
alcoholism is genetic. While we conduct behavioral preventive 
research, our basic-science investigators are seeking genetic 
and molecular markers that will tell us who is most at risk, 
and biologic factors that we can target, to form our prevention 
and treatment strategies.
    In summary, prevention, research, and health promotion are 
critical to the NIAAA mission. As we develop new knowledge, we 
are able to design more effective programs for preventing the 
consequences of alcohol abuse.
    Thank you.
    Mr. Regula. Thank you. Dr. Kirschstein, I believe this is 
your last hearing, am I correct?
    Dr. Kirschstein. Yes, sir.
    Mr. Regula. You have given wonderful service to the Nation 
and providing leadership for NIH. I think in many respects NIH 
is somewhat of a well-kept secret among the general public. 
Their lives are improved in many ways by work that is done 
there and the leadership you have provided, and most people, 
unless they really have a critical illness, they do not 
necessarily realize that what they are getting by way of 
medical services is an outgrowth of the research that has been 
done at NIH, and I know that the Congress is committed under 
your watch, in part at least, to doubling the budget. So I 
think that says very effectively the confidence that the 
Members of Congress have in the work that is now being done by 
NIH.
    We wish you well and we want to say we appreciate what you 
have done in providing leadership for the agency.
    Mr. Obey, would you want to comment?

                              NIH FUNDING

    Mr. Obey. Well, I do not think I am going to take the floor 
to disagree. I simply want to say that, Doctor, I think you 
have provided wonderful service to the country and wonderful 
leadership to NIH, not just in the two times that you have 
served as acting director, but most importantly in all of the 
time that you have served in other capacities. I think it is 
safe to say that funding for NIH has become one of those 
activities which is popular on Capitol Hill. When I came to 
this Subcommittee, we were having an argument between President 
Nixon and Senator Kennedy about who would provide the most 
money for NCI and the money that was provided to NCI was 
terrific. The problem is that it came at the expense often of 
the funding for other institutes. I think the main task through 
the years that you have had on that side of the table, all of 
you, has been to convince politicians to learn as much as we 
can about what it is you do without putting our cotton-picking 
hands on the decision-making process and trying to decide for 
ourselves where the dollars ought to actually go in fighting 
one disease versus another. Politicians like to claim expertise 
in every field. They ain't got it. And I just want to thank you 
especially forthe effort that you expended to help Congress 
play its proper role in the oversight of NIH without going to meddling. 
Thank you for everything you have done.
    Dr. Kirschstein. Thank you, sir. My colleagues and I look 
forward to visiting both your district and Mr. Regula's 
district in early May.
    Mr. Obey. I am looking forward to that, too. It is one of 
the few bipartisan activities that will occur around here this 
year, I am afraid. But, nonetheless, I am looking forward to 
going to Ralph's district and I hope he is looking forward to 
coming to mine.

                          ALCOHOL ADVERTISING

    Mr. Regula. We are. Good health does not have a label, R or 
a D. Good health is something all of us want and, Dr. 
Kirschstein, we wish you many good years of health. You know 
all the rules, I am sure, to stay that way, and you know where 
to go if you need professional advice prospectively.
    A few questions, and then I am sure Mr. Obey has some 
likewise. Dr. Kington, I read a lot of the advertising by the 
industry, the alcohol industry, and they claim that they are 
doing a lot in preventing teenage drinking and the proper use 
of alcohol. What would your evaluation be of the industry 
efforts? Are they for real?
    Dr. Kington. We are supporting a number of research 
projects that are assessing the impact of advertising on 
behavior. Already, a substantial amount of evidence suggests 
that alcohol advertisements can affect attitudes and 
expectations. We are not as sure about whether or not it 
actually affects behavior, but we have a number of studies, 
ongoing now, that will give us more information. We are 
especially concerned about advertising that targets people 
younger than 21, because it has the potential to influence 
underage drinkers, who should not drink under any circumstance.
    Mr. Regula. So you think the advertising done by the 
private sector alcohol industry has some value?
    Dr. Kington. Which advertising are you referring to?
    Mr. Regula. In other words, to try to make people 
responsible in the use of alcohol.
    Dr. Kington. We know that some forms of social marketing 
advocate responsible behaviors of all kinds, including 
responsible alcohol consumption. To the extent that social 
marketing efforts are appropriately targeted and designed, they 
hold the potential to influence behavior. Of course, the extent 
of social marketing must be viewed in the context of all the 
other advertising that favors alcohol consumption. The goal is 
to advocate responsible consumption of alcohol.

                              FLUORIDATION

    Mr. Regula. Dr. Tabak, when I was in the State legislature, 
fluoridation was a big controversy. Has that pretty much gone 
by the board and the efficacy of fluoridation and prevention of 
dental problems is a given in today's world?
    Dr. Tabak. Certainly in our world it is a given, Mr. 
Regula. Community water fluoridation benefits millions of 
Americans. For over half a century it has helped improve the 
quality of life through reduced pain and suffering related to 
tooth decay, reduced tooth loss, reduced lost time from school 
and work and less money spent on dental care. One of the 
significant advantages of water fluoridation is that anyone, 
regardless of their socioeconomic level, can enjoy its benefits 
during their daily lives, and so within the United States, 
fluoridated water is the most cost-effective method for 
eliminating tooth decay.
    Mr. Regula. I noticed many people, of course, live where 
they have wells, but now I think you could buy bottled water 
that is treated with fluoridation additives to overcome the 
fact that you are not in a city system.
    Dr. Tabak. There is no question that many persons use 
bottled water. Interestingly enough, though, many of the 
bottled waters have no fluoride at all, and particularly when 
there are young children involved, you have to assess that 
because there might be a need for fluoride supplements.
    Mr. Regula. If you do not get it in the water.
    Dr. Tabak. If you do not get it in your water or if the 
bottled water that you are using is lacking it as well.
    Mr. Regula. The staff just handed me a note here. Dr. 
Kirschstein, I see you were very much involved in the selection 
of the Sabin vaccine for public use in eradicating polio?
    Dr. Kirschstein. Yes, sir.
    Mr. Regula. It has been a real success story, has it not?
    Dr. Kirschstein. Yes, sir. But we have to watch out. If you 
saw the Wall Street Journal this morning----
    Mr. Regula. I saw that article.
    Dr. Kirschstein [continuing]. There is an article that says 
that perhaps the polio that has been seen in the Caribbean, the 
island of Hispaniola, is a result of a series of vacuumed 
mutations of the attenuated virus to a more virulent form. We 
studied that years ago because there is no question that the 
oral vaccine is excreted for what we consider to be a very long 
time. I thought a year or so was sufficient after vaccination; 
however, the article refers to the fact that there has been a 
man down there, at least one that they found, who has been 
excreting the virus since 1995. That is, to my knowledge, a 
record. And CDC and, I assume, my colleagues in the 
organization that I used to work for which regulates and 
licenses polio vaccine are studying this. I said in the car 
coming down to my colleagues that it may be we want to go back 
into the lab.
    Mr. Regula. Perhaps you will get that opportunity.
    Dr. Kirschstein. Perhaps I will.

               EYE HEALTH AS INDICATOR OF OVERALL HEALTH

    Mr. Regula. Dr. Sieving, I was interested in your comments 
on eyes. I remember reading somewhere that the eyes are the 
window to your health, that you can identify a lot of other 
health problems by examining the eyes. Is that an accurate 
statement?
    Dr. Sieving. I think that is a fair statement and an 
important statement. The eye is a complex organ. The eyeball 
has blood vessels and nerve cells and supporting cells, and 
many of the diseases that affect us systemically end up showing 
up in the eye. If one goes back in history a hundred or more 
years, at a time when it was not possible to look at blood 
vessels directly in the heart as it is today, for example, one 
could still look at the blood vessels in the eye. Observing the 
health of the eye has been one of the ways in which medicine 
has progressed and health care has progressed. And the eye 
continues to be central to us as people. It is a social organ. 
It is also a medical organ that gives us insights into some 
basic biological principles.

                   EYE TREATMENATS TO CURE BLINDNESS

    One of the very interesting things that happened this last 
year concerned treatments that appear capable of restoring 
vision in eyes that are blind. The eye is a very accessible 
biological target for trying out some of the most advanced 
therapies that we have, including work such as in gene 
transfer.

                            COUNCIL ON AGING

    Mr. Regula. Dr. Lenfant, am I saying that correctly? This 
is interesting material. Do you think it would be practical to 
get the AARP to put these in their mailers? This little 
pamphlet on heart attack, it seems to me, it would be very 
valuable to be in every household.
    Dr. Lenfant. Yes, indeed. As I mentioned earlier, we are 
working with the Council on Aging, which is an organization 
that has similar goals with AARP. What the Council on Aging has 
that the AARP does not, the AARP works with the individual; the 
Council on Aging works with organizations where you have a 
large number of elderly, assisted living and whatever. So we 
can, by going there, set up a system to have teaching to the 
subject, to the people who are there and basically say, you 
know, you feel this way or that way this morning, pay attention 
to that, and go see the nurse in that establishment, go see the 
doctor in that establishment, and they will take you to the 
hospital if it is needed. So we are expanding that network, as 
I mentioned.
    We started this program about seven months ago, and I think 
so far we have made quite a reasonable progress to reach out 
there, especially in the elderly population which is, of 
course, the population where cardiovascular events, sudden 
cardiovascular events are more frequent.
    Mr. Regula. It seems to me that that could be in 
everybody's household.
    Dr. Lenfant. That is what we would like to do.
    Mr. Regula. And something similar on stroke, because I 
always hear that the quicker you can get somebody to the 
hospital, the more likely the remedial success on strokes, 
which goes with this.

                  WORK WITH PHYSICIANS, THEN PATIENTS

    Dr. Lenfant. As I said earlier, we have a two-pronged 
attack, one of which is to work with the physicians, general 
practitioner, so that in turn they can speak to their patients, 
and then we go directly to the patients to make them realize 
that there is no reason to be ashamed to pay attention to a 
chest pain or whatever and do something about it.
    Mr. Regula. Well, in all your testimony I hear the need to 
get the information in the hands of the public. Now do each of 
you have a web site? What kind of usage do you get in the terms 
of the public accessing the web sites? Maybe you could speak 
for the group.

                ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS

    Dr. Kirschstein. Each of the institutes has a web site and, 
in addition, the NIH as a whole has a web site as well. We not 
only get tremendous usage, but we have been cited repeatedly by 
organizations that do the survey as having the most accessible 
web site, a web site that has more hits than almost anything 
except perhaps the Internal Revenue Service. In the last few 
days, the Internal Revenue Service has exceeded us, but up 
until then perhaps we exceeded it, and a web site that provides 
useful information. We are constantly bringing it up to date 
and improving it.
    In the NIH web site we highlight new discoveries so they 
can click on immediately to them and learn what is what. We 
have an excellent search engine. And my colleagues might like 
to add to that.

                      NHLBI COMMUNICATIONS NETWORK

    Dr. Lenfant. We have throughout the network, where actually 
we have 6,000 sites in all the 50 states where we communicate 
immediately the kind of information which is important that the 
public should know and hear about, and in turn the sites of 
this network distribute this information in the communities 
where they are located.
    Mr. Regula. What is the code to get onto the NIH web site?
    Dr. Kirschstein. www.NIH.gov.
    Mr. Regula. That is very simple, easy to remember.
    Mr. Obey.

                ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS

    Mr. Obey. Thank you, Mr. Chairman. Dr. Collins, as I sit 
here listening, and as I went down earlier today to see a 
display set up by the National Federation for the Blind, I was 
struck again by the disparities that we have in this country in 
the healthcare field, and it just seems to me that every dollar 
that we invest in medical research increases the immorality of 
having a healthcare system that does notguarantee affordable 
access to health care to everyone. That means that every time we learn 
something new, what we are depriving some of our citizens of becomes 
more and more important, and the gap between the health haves and the 
health have-nots becomes even more important with every single thing 
that we learn, thanks to the taxpayer dollars that are invested in NIH. 
That is why, as you know, I have been concerned for years about whether 
or not as we unravel the mysteries of the human genome our actions on 
the legal and ethical front will keep pace with what we learn on the 
scientific and medical front. As you know, 5 percent of your budget is 
devoted each year to try to deal with and study the ethical and legal 
and social implications of the knowledge that we gain from the human 
genome project. We have a high risk of discrimination, both by 
employers who may not want to hire somebody if they learn that they 
have a genetic predisposition to a specific disease, and insurance 
companies who certainly may not want to insure those same people. That, 
in my view, creates an even greater moral obligation on us.
    What I would like to ask you is how have you used that 5 
percent over the years? What have we gotten? What are we 
getting for those dollars? What do you most worry about in that 
area, and what do we need to do as policymakers in order to see 
to it that the bright side of the knowledge that we gain from 
the human genome project does not produce a dark side in terms 
of unfair treatment of persons who are found to have 
disposition to one disease or another?
    Dr. Collins. Mr. Obey, that is a wonderfully eloquent 
statement of the issues that we have been wrestling with since 
the human genome project was founded some 12 years ago in the 
ethical, legal and social implications program called ELSI 
program. This is a new experiment where we are funding research 
on the ethical, legal and social consequences of a scientific 
enterprise at the same time that we are pursuing the science, 
as opposed to the usual historical situation where you wait for 
the crisis, and then try to figure out what to do. I think this 
has been a successful experiment in that we have a wealth of 
analyses and elegant scholarship. We have recruited into this 
field legal scholars, social scientists, ethicists, 
theologians, and others who are making their careers out of 
analyzing these issues and making recommendations about what 
should be done. And through that effort we have really nailed 
down the major immediate priorities of policy decisions that 
need to be made.

                         GENETIC DISCRIMINATION

    Dr. Collins. When I came to NIH some 9 years ago, I knew I 
was coming to lead a project to try to unravel the human 
instruction book. I was unprepared for how much of my time 
would end up being devoted to these ELSI issues, but I really 
should be spending even more time, because if we don't get 
these right, then all of the scientific advances will not 
necessarily benefit the public.
    So what do we need to do? Frankly, my frustration, Mr. 
Obey, is that we do now have the scholarship. We do have the 
research. We have identified and defined the issues and 
developed possible solutions. But in areas that are most ripe 
for a solution, the solution requires Federal legislation. It 
is difficult for me and my colleagues and the ELSI researchers 
to make sure that that happens.
    Most prominent right now is the issue that you described 
very accurately, about the risk of genetic discrimination. This 
is not a hypothetical situation. There are people who have had 
their health insurance taken away or who have had their jobs 
taken away because they were found to be at risk for some 
future illness based upon genetic information. That is not 
just. It is also not workable, since we all have glitches in 
our DNA, and if that becomes a reason to lose your job, well, 
we are all going to lose our jobs. There are no perfect 
specimens, even in the United States Congress.
    And so what should be done? Well, it is pretty 
straightforward, and more than two dozen States have actually 
acted upon this. We need effective Federal legislation to 
prevent the use of predictive genetic information when it comes 
to health insurance and to employment decisions. I am very 
happy to say that in the Senate there are bills from both the 
Democratic and the Republican Party that address this issue 
quite well and have only modest differences between them. 
President Bush last summer spoke out strongly in favor of the 
need for such legislation, and the White House has continued to 
endorse that. But several months have gone by since those 
positive steps, and we have not yet seen a bill actually come 
up for a vote in the Senate--Nor, frankly, has there been much 
activity in the House for a while.
    This is such an important issue. It is already an issue for 
people who are asked about their interest in participating in 
research. Research these days often involves genetic analysis. 
People are afraid to be part of genetic research. Even though 
they want the information, they are afraid information about 
them might leak out and they might find themselves without 
medical coverage. That is the number one reason why people 
decide not to participate in a number of our research 
protocols.
    We are missing out on the chance to learn more about 
genetics because of this fear, and I am afraid the solution 
really then does need to engage the political system. I hope 
that this is the year where appropriate legislation is finally 
passed.
    There are a number of other issues, that need attention. I 
could go on, and you probably can tell that I am starting to.
    Mr. Obey. Please do. It is nice to see action coming from 
somewhere.

                            GENETIC TESTING

    Dr. Collins. We need better oversight for genetic testing 
to be sure that such tests are well-validated before they are 
offered to the public. The Secretary's Advisory Committee on 
Genetic Testing is a direct outgrowth of the ELSI program. The 
Committee, has been debating long and hard about issue this and 
have recommended that genetic testing requires additional 
governmental oversight, ideally from the FDA, and those 
recommendations are being evaluated.
    The whole question of how to carry out research in an 
ethical way when it involves genetics has been much debated 
issues include what kind of consent do you need and what kind 
of privacy protections do you need. We have made remarkable 
progress in these areas and there is a general sense of what 
theprinciples should be, though these have not yet been 
completely implemented.
    And finally, the ELSI issue that undergirds all of this is 
education, which is our topic today: If the public is 
unprepared for the complexities of genetics or if health 
professionals are unprepared to begin to practice this kind of 
medicine, then we may end up with a very confusing outcome 
where really valuable information does not find its way into 
rational health behavior decisions. We have to work very hard 
to prepare all sectors to be ready for this new area of 
healthcare.
    Mr. Obey. Well, I thank you, and I think that is a terrific 
statement, and I hope that Congress pays attention to it, 
because it seems to me that the more you learn and the longer 
it takes us to pass something, the more difficult it is going 
to be to pass something, because people will have higher and 
higher stakes in resisting the kind of legal protections that, 
in my view, are morally crucial.

                            RESEARCH GRANTS

    Dr. Collins. You are quite right.
    Mr. Obey. Dr. Olden, in looking at your budget at the 
Environmental Health Sciences Institute, it is my understanding 
that the overall number of research grants at your institute, 
both new and renewal, will go down by about 7 percent, and the 
number of new research grants declines by about 25 percent. Is 
that right?
    Dr. Olden. That is correct.
    Mr. Obey. Looking at it another way, I understand the 
success rate for applications at NIEHS is below the NIH 
average, 27 percent to 31 percent.
    Dr. Olden. That is correct.
    Mr. Obey. What is going on here? Why that drop? I mean, 
that certainly seems startling to me.
    Dr. Olden. For one thing the cost of individual RO1 grants 
is going up, and I think in our Institute, we estimate that the 
cost will go up about $50,000 per year. The other issue is that 
because of the publication of the first draft of the human 
genome, a lot of opportunities have been made available to 
environmental health scientists and toxicologists, so we have 
undertaken some new efforts through mechanisms other than 
individual RO1 grants. For example, we started an Environmental 
Genome Project, we started a Toxicogenomic Center: these are 
resource-intensive--and recently we have created a Mouse Genome 
Center. We are not using the investigator-initiated mechanism 
to generate interest in the scientific community in those 
efforts. So that is, in part, the explanation.
    We are taking on proteomics as another major effort, and so 
we are addressing, in a sense, big science issues to respond to 
the scientific opportunities and challenges made available by 
the cloning of the human genome.
    Mr. Obey. But that large drop in the number of new research 
grants, that is not duplicated across the board in NIH's 
budget. I guess I don't understand why has that particular 
impact here and not in the other institutes.
    Dr. Olden. Well, I really think the scientific 
opportunities in environmental health sciences and I don't say 
this to my colleagues here--probably exceed that in any other 
institute in the NIH, and they are made possible by the 
revolution of human genetics and the human genome database.
    One thing that I know I have talked with you about is the 
capacity to develop new, more economical, fast and informative 
carcinogenicity test systems--test systems that can identify 
carcinogens in a matter of weeks, not years, and at a cost of 
$2 to $6 million per chemical. So we are making investments in 
this area. It is a big area. It involves toxicogenomics, 
metabonomics and proteomics, and these are big science 
projects.
    Even though the grant goes to one person, it does involve a 
lot of scientists in an institution. So I think the number of 
scientists that are involved in our science is much greater 
than it ever has been, in spite of the fact that our absolute 
numbers next year will go down.
    Mr. Obey. Well, I have two other questions I would look to 
ask you for the record----
    Dr. Olden. All right.

                        ORAL HEALTH DISPARITIES

    Mr. Obey [continuing]. Because I don't have time, and I 
would like to turn to Dr. Tabak for my last question on this 
round.
    And let me simply preface my question by telling you a 
story. The data I had been the most angry in all of the 33 
years that I have spent in this Congress was the day that I 
went to a community in my district to announce a small grant to 
establish a roving dental clinic for four lower-income 
counties, and when I announced that grant--and there were a 
number of people there--there was one woman there who told me 
her story, and essentially her husband had been very sick for a 
long period of time. She had a son who had had braces on his 
teeth forever, and in that four-county area we had, I think, 67 
dentists, and only 34 of them took Medicaid patients because of 
the horrendously low reimbursement rate that is provided. And 
so she called almost all of the dentists who did take Medicaid 
patients and could not find a single one who would remove that 
boy's braces. So finally she held the kid down while the father 
took the braces off with a pair of pliers.
    Now, you can't do anything about that. On this side of the 
table we ought to be able to do something about that. I just 
want to ask you what is your understanding of the pattern of 
dental neglect that we see as it is distributed across 
America's children? What information do you have that could 
tell us what percentage of dental needs of well-off families 
are being met in comparison to what percentage of dental needs 
are being met for persons who are, for instance, at the 
Medicaid income level in this country? What do you know about 
what the national pattern of disparity is with respect to 
dental care for children?
    Mr. Regula. Would you yield?
    Mr. Obey. Sure.
    Mr. Regula. I wonder if you would include in that answer to 
Mr. Obey's question the Indian population, because it is my 
understanding that there is a severe lacking for dental care.
    Dr. Tabak. Well, certainly each of you speaks to a very 
important issue. There are health disparities and certainly 
oral health disparities. In particular dental decay has become 
increasingly polarized. That means that fewer children account 
for more and more of the burden of disease, and in part that 
relates to socioeconomic status. In part that relates to access 
to care, which Mr. Obey has mentioned. And so our response at 
NIDCR is to support the research that will help prevent the 
decay or disease from ever occurring.
    In particular, with regard to American Indians and Alaskan 
Natives, NIDCR has been working together with the National 
Institute of General Medical Sciences and the Indian Health 
Service in their so-called NARCH program; that is, the Native 
American Research Centers for Health. And we recently funded 
one of the projects in the Northwest Portland Indian Health 
Board NARCH, which specifically relates to early childhood 
dental decay among the Northwest Indian populations. We also 
have a center in the Northwest Alaskan Center to reduce oral 
health disparities with research focused on understanding 
dental fear, understanding the natural immunity that 
individuals have against oral disease, and transmission of the 
microorganisms which cause dental decay from caregivers. And so 
it is through studies of these types that we hope to be able to 
reduce and eventually eliminate these disparities.
    Mr. Obey. But isn't it true that just 25 percent of 
children now account for something like 80 percent of all tooth 
decay among children?
    Dr. Tabak. That is correct.
    Mr. Obey. Thank you, Mr. Chairman.
    Mr. Regula. Thank you.
    Ms. DeLauro.

                         GENETIC DISCRIMINATION

    Ms. DeLauro. Thank you very much, Mr. Chairman. Let me just 
make one comment about the genetic--thank you. I want to make a 
comment on the genetic nondiscrimination issue that my 
colleague Mr. Obey talked about, Dr. Collins. In the House, you 
may know this--I don't know the extent to which everyone does--
but my colleague, Congresswoman Slaughter, has had a bill for 
the last several years, the genetic nondiscrimination bill. I 
will just tell you that there are 259 cosponsors of that piece 
of legislation, which by virtue of the numbers means that is it 
is a bipartisan piece of legislation, and as I understand it, 
to date there haven't been any hearings on this piece of 
legislation, and we can't seem to get any hearings on what is a 
particularly critical piece of legislation for our times.
    It often is the case that we can be guilty or culpable of 
not acting at the right time, but this is so timely given the 
nature of the technology that we have before us today. I say 
this to make you know this. As my colleague said before, this 
is not your doing. This is our doing here. This is our problem 
here. But I guess what I do is I enlist the support of the 
medical community and the people who are dealing with this, you 
know, on a daily basis that understand more than potentially, 
you know--that we understand how quickly the technology is 
moving, and that if we do not act on this genetic 
nondiscrimination issue, that we are--you know, we are just 
guilty of not doing our job here. And unfortunately we can't be 
prosecuted on that basis, but we have the knowledge that we 
need in order that we can protect individuals today from loss 
of insurance, loss of job or anything else so that maybe you 
can, with your knowledge and the strength of your academic 
weight--and I say that collectively--is, you know, assist those 
of us here who want to move this legislation to its logical 
conclusion and provide--I am--I ask for your help in my 
colleagues' name to help us with this effort.
    Dr. Kirschstein. Dr. Collins has been doing his best.
    Ms. DeLauro. I believe you.
    Dr. Collins. Congresswoman, I really appreciate your very 
strong and effective statement. I should have given credit to 
Congresswoman Slaughter's leadership in the House in raising 
this issue and to the strong support she has had from you and 
some of your colleagues who have made this issue much more 
visible than it otherwise would have been.
    But you accurately state that despite all of those 
cosignatories, there doesn't seem to be much forward motion. I 
would certainly say I am willing to go anywhere at any time to 
make the case, backed up by fact, backed up by research, and 
backed up by case examples of people who have already suffered 
injury as a result of the lack of this kind of protection. Just 
point me in the right direction and I and a lot of my 
colleagues will be right there.

                 THALASSEMIA CLINICAL RESEARCH NETWORK

    Ms. DeLauro. Thank you. We will take you up on your offer. 
Thank you very much.
    Dr. Lenfant, let me ask a question, as I normally do. I 
have been a longtime supporter of the Cooley's Anemia 
Foundation and am grateful for all of the efforts in creating 
the Thalassemia Clinical Research Network. It is my 
understanding from the material that I reviewed that the 
network currently has two research projects that are under way, 
and that they are--and that you are reviewing additional 
projects. Can you share with the committee your assessment of 
the progress that has been made to date, and what steps will 
the institute be taking to support further research being 
conducted through the network?
    Dr. Lenfant. Well, I would say that now we are optimistic 
and confident that the program is going to be successful, but I 
have to admit that the growing pains have been difficult. But 
it is working, and it is true that now they have two research 
projects plus one data collection project. So there are 
actually three activities which are going on.
    I met with them last December at the American Society of 
Hematology, because I was very concerned that after more than 
18 months of this effort, no project had actually gotten 
started. And I said to them, we all have a problem. Within 18 
months you are going to have to consider your resubmission for 
the next 5 years of funding, but unless you get going, there 
will be nothing to show in terms of progress. And that has had 
some stimulating effect, and now they are moving faster, and we 
are confident that it will work.
    I should say that the chair of the steering committee, 
which is the group that clearly governs the program, is a good 
friend of ours, a very distinguished scientist who knew what we 
were talking about and what the problems were, and he has done 
a lot to get this project going. So, Ms. DeLauro, I have to say 
that we can expect some very good results fromthese programs.
    Ms. DeLauro. Thank you, and I would like to keep in touch 
with you on that.
    Dr. Lenfant. We would be pleased to.
    And I should say that in addition to that, we are 
supporting a number of very exciting projects of basic research 
which will feed into this clinical network for clinical 
investigations.

                   PREVENTING INFECTIONS IN HOSPITALS

    Ms. DeLauro. Thank you.
    If I might ask one more question, this is to Dr. Grady. I 
think one of the most challenging issues for health care in 
this 21st century is the issue of infections in hospitals. My 
understanding is it can cost up to about $5 billion a year in 
terms of trying to deal with it, and that currently infections 
are the fifth leading cause of deaths in hospitals. They 
continue to be the leading cause of morbidity and mortality. 
Even in the United States there are over 2 million hospital 
infections a year, and 50 percent of patients have adverse 
outcomes. Yet one-third to one-half of these infections are 
preventable.
    There are some, you know, who are suggesting that the 
hospital-acquired infections are this new century's, you know, 
most urgent health care challenge. Can you address that issue 
and talk about the veracity of the data, but also what is being 
done about it? What is the research aimed at reducing the 
infections of patients in hospitals?
    Dr. Grady. You have identified an age-old and persistent 
problem that we deal with. There are a number of infections 
that result within hospitals that are drug-resistant, which is 
a result of new technology, but the base of the problem in most 
cases appears to be simpler than that.
    We are funding a number of studies which address the issue 
of hand-washing in hospital settings, how often, how effective, 
looking to see not only do people wash their hands, but how 
effective is it? Surprisingly there is a very high incidence, 
when you have people watching health care workers, both 
physicians and nurses in hospital settings, of the number who 
do not wash their hands at each opportunity that they should. 
In tracking that, the issue of using hand wash chemicals versus 
soap, increased friction, increased time, there are a number of 
techniques that are being tested out that appear to have good 
results. The results, in fact, are close to being published, 
but it is surprising when the basic principles that we have all 
known about are adhered to, that they actually are reasonably 
effective in preventing infection.
    The drug-resistant infections are another case, and I know 
you have heard a little bit about that from my colleague Dr. 
Fauci, but we are funding several studies to address this, and 
are hopeful that we can change practice as a result.
    Ms. DeLauro. Let me just ask a question about this because 
you said it is an age-old problem, but is this something that 
manifests itself and then we, you know, kind of go back to 
basic principles? I am not talking about the drug-resistant 
difficulties, but--and then it subsides and then it occurs 
again? I mean--.
    Dr. Grady. It would appear to be so, looking at the cycles, 
and how much of that is behavioral and how much of that is 
catching up to the newer risks and dangers in a hospital 
environment is a little difficult to identify. But, yes, you 
are right.
    Ms. DeLauro. Thank you very much. Thank you.
    Thank you, Mr. Chairman.
    Mr. Regula. Mr. Sherwood.

                       GENETICS--HEALTH PROMOTION

    Mr. Sherwood. Thank you, Mr. Chairman.
    And, Dr. Collins, even the least scientific among us can 
recognize that the mapping of the human genome is a tremendous 
accomplishment. I would like to hear your thoughts, though, on 
when we will be able to use this information to cure or prevent 
disease. We presented very difficult choices to individuals who 
may be at risk for certain diseases by telling them they are at 
risk without telling them what we are doing about it.
    Dr. Collins. That is a very good question, Congressman. The 
way in which gene discoveries occur lead one to the ability to 
make diagnostic predictions almost immediately after the gene 
discovery. But the ability to intervene, to cure the disease, 
takes many years. Because of the many more, difficult, and 
challenging steps in medical research. For instance, we already 
know what the major genetic risk factor is for Alzheimer's 
disease, yet we don't offer that test to people because we have 
no intervention available to those that turn out to be in the 
high-risk group.
    There are already some valuable clinical applications 
though, in genetic research are moving rather rapidly, and for 
some diseases we already are in a circumstance where being able 
to identify someone at high risk can be life-saving. Colon 
cancer is a good example. If you are one of the roughly 1 in 
400 people in a family with several affected individuals with 
colon cancer, and you have a gene with is a particular glitch, 
your intervention would be close medical surveillance and 
colonoscopies beginning at an early age and done very 
faithfully every year. That intervention has been shown to 
reduce morbidity and mortality by finding those polyps in the 
colon and getting them removed before they turn into a nasty 
malignancy.
    One should not assume, therefore, that you have to go all 
the way through the steps from finding a gene to developing a 
drug in every case to make the information valuable. But we do 
want to develop the drugs and the gene therapies. And in that 
regard, there is a lot of excitement in the field of drug 
development based upon genetics. In fact that for a few 
diseases, we have already gone through those steps.
    Take the drug Gleevec which was approved by the FDA less 
than 12 months ago for the treatment of leukemia. In that 
circumstance, the drug was specifically designed using the 
knowledge of the genetic glitch in those leukemia cells, and 
this drug specifically work to block the effect of the glitch.
    There are over 100 drugs now in clinical trials, mostly for 
cancer, that are based on this same paradigm of understanding 
what the genetic problem is, designing a small molecule that 
will go right to the heart of the matter and block that effect. 
Not all of those drugs will succeed. Some of them undoubtedly 
will fail, but this paradigm of basing drug discovery on 
molecular understanding instead of a more empirical approach is 
already happening. Certainly every pharmaceutical company is 
putting their major bets on that pathway as the way to develop 
the drugs of the future.
    So you are right. We may have to live in this uncomfortable 
window for some diseases between pretty good diagnostics and 
not so good therapeutics, but the only way to get throughthat 
is to press on. And that is what all of my colleagues at the NIH are 
determined to do.

               NATIONAL CARDIOVASCULAR HEALTH CONFERENCE

    Mr. Sherwood. Thank you.
    I think one of the frustrations to those of us that--
without the training is the length of time it sometimes takes 
to get the wonderful discoveries and the information that you 
folks have at your fingertips out to practicing medicine.
    Dr. Lenfant, I understand that the National Heart, Lung and 
Blood Institute has just completed a very successful national 
cardiovascular health conference chaired by Dr. Lynn Smaha, a 
constituent of mine and the immediate past president of the 
American Heart Association--please tell us a little bit about 
that conference and why it was significant.
    Dr. Lenfant. Well, I am very pleased that you ask this 
question, indeed, because that was one of the most significant 
events of the last few months. This conference was held last 
Thursday, Friday and Saturday, and the goal of the conference 
was to do what this hearing is about, to communicate to the 
practicing community as well as health care systems, health 
services in communities what is going on, what can be done that 
does not necessarily cost millions and millions, but with very 
little money and much effort can get the help to the patients.
    The conference was attended by, I think, 1,300 physicians, 
nurses, health care professionals and so forth, but the 
interesting thing is that it was Web-cast in all of the States 
through the United States, and there are actually 150 contacts 
in all of the 50 States where people could go and watch the 
conference. So although we had participation here in Washington 
of maybe 1,200, 1,300 people, we do know that there were 
thousands and thousands of people out there who were in contact 
with what was going on, and who watched some of the best 
experts in the field.
    And we know that we will achieve something, because we have 
that conference, the same one, every 3 years, and after each 3 
years, we see some progress and better communication and better 
understanding.
    And one of the things that I mentioned before you came, Mr. 
Sherwood, was a campaign on acting time in to heart attack 
signs, and the purpose of it is to educate people that they 
really don't have to wait to drop on the sidewalk to do 
something about their heart, they can do it before, and that is 
the kind of thing that we need to communicate to the people 
because it works.

                            OBESITY RESEARCH

    Mr. Sherwood. Thank you very much.
    I will get to the question I always ask. We find that 
overweight and obesity are major risk factors for many, many 
different diseases. Folks have been telling us that, including 
heart attack and stroke and other cardiovascular diseases, not 
to mention early onset diabetes, but the number one killer in 
the United States, so please tell me what the National Heart, 
Lung and Blood Institute is doing to address this growing 
problem of obesity and its tremendous effect on our health.
    Dr. Lenfant. Well, we are doing a lot. In fact, we have 
multifaceted programs which include, of course, basic research 
to understand what bridges obesity and weight gain with 
cardiovascular disease. We have a program to fund treatments 
and interventions which would be successful to reduce or limit 
weight gain, and we also have educational activities to really 
help people, especially youngsters, to prevent the development 
of obesity.
    I believe that the scientific community is very firm on one 
thing. It is easier to prevent the development of weight gain 
than to treat it once you have it, and that is a message that 
we are trying to communicate through a number of programs. For 
example, in the conference that you mentioned earlier, there 
were many, many things on that very issue, what can we do to 
prevent obesity to develop. We have a program which is called 
Hearts N' Parks, which basically is working with all of the 
public parks in the country to develop programs so that the 
kids going there have physical activities, are encouraged to go 
there.

                           COMMUNITY PROGRAM

    We have programs in some communities. Let me give you an 
interesting example. In West Virginia in one community, what we 
have done is to--the community has done, not us--they have 
painted on the sidewalk steps so that the kids there know how 
many steps they take each day in order to prevent the 
development of obesity.

                                 ASTHMA

    So we do lots of things. It is a very active part of our 
programs in the prevention of cardiovascular disease, and I 
would say respiratory disease as well. We know today that, for 
example, overweight children and adults are more likely to 
develop asthma than children who do not have an excess amount 
of weight.
    Mr. Sherwood. Thank you very much.

                      INFORMATION AND HEALTH CARE

    Mr. Regula. Mr. Sherwood, if you didn't get these folders, 
be sure you--I don't know if they are in your pack there or 
not, but I would love to give one of these little cards to 
every one of my constituents. It would be so valuable to them.
    Dr. Lindberg, we live in the information age. We get 
flooded with information, and you as chairman of that area have 
a lot of responsibility. You know, the question is--and this is 
a tough one--is the availability of all of this information 
that we are inundated with improving health care?
    Dr. Lindberg. Well, I agree with others who have suggested 
that giving the information directly to the patient is 
definitely the thing to do. I mean, the patients nowadays are 
educated and are willing to participate in health care delivery 
decisions and take care of themselves. So I think we can't lose 
by giving the information to the patients.

                              NLM WEBSITE

    You had asked earlier about the activity on these NLM and 
NIH Web sites. I mean, we actually at NLM alone answer a 
million inquiries a day.
    Mr. Regula. A day?
    Dr. Lindberg. A day. It is a staggering amount. It has 
grown 400 million a year. Now, I am not sure that everybody 
leaves with what they wanted when they came to that Web site, 
and I think that is where the opportunity lies. My own 
impression is that we do a very good job of providing 
information to health care professionals and increasingly the 
researchers, but that the public, I think, is looking for 
understanding more than they are to retrieve a piece of 
information. They don't really want to know the melting point 
of some crystal. They want to understand what is under their 
skin, and to just play back four-syllable Greco-Roman words may 
be accurate retrieval, but that doesn't give them 
understanding. So I think there is a lot of research to be done 
that in that area, and we are going about doing that.
    I can give you one example of the kind of thing the public 
is after. In the 30 days after the terrorist use of anthrax, 
anthrax was searched more than everything in cancer combined, 
not surprisingly, but it happens that we have avery good 
tutorial on that and so forth. One of the things I wish I could have 
done in showing a poster is to show you how active it is. I mean, I was 
going to bring you the first speaking poster down here, but I--my 
technology--I didn't have time to work it out. But particularly in the 
older populations and low-vision populations, there is no point filling 
a screen up with thousands and thousands of little characters. Nobody 
can read them. In fact, I don't like reading them either. So 
increasingly we are having them read themselves, to say the words, and 
to show some television. So, for instance, part of it is understanding; 
part of it is attitude. Dr. Lenfant, we work with him happily on the 
collaborative Heart Attack Alert program. We know it is often an 
attitude of delaying that stops people from getting help they need.
    Now, this same thing is behind everybody's worry about 
Alzheimer's, and we are working with the Aging Institute to 
produce a senior health page, and it has a lot of good 
attributes, but the thing that appeals to me most strongly 
about it is that it can show you a television interview, a 
psychiatrist interviewing a patient, do you have Alzheimer's. 
And actually there are two, one that does, one that doesn't, 
but in most cases a member of the public would leave that 
interview relieved. I mean, they would say, well, okay, I am 
not like that. I don't have to worry about that. It is 
tremendously relieving to improve the attitude toward that 
disease to see this kind of a little thing, and we are working 
very hard to make sure that technically it will, you know, 
download fast enough on an ordinary phone line and that sort of 
thing. We don't want to put it up if it is only of use to you 
in great medical centers. We want it to be able to get out to 
where the people are.
    Mr. Regula. About a year or so ago, we had a meningitis 
scare in my area, and, of course, parents particularly were 
very alarmed. Now, could they have plugged into your Web site, 
put in the key word "meningitis" and gained information that 
would have given some degree of assurance to them or some ideas 
of how they should react to this scare that was travelling 
through the community, schools closed, et cetera?
    Dr. Lindberg. Oh, absolutely. This 570 health care topics, 
though I can't swear to you absolutely that meningitis is 
there, but----
    Mr. Regula. No. I am just using that as an analogy.
    Dr. Lindberg. I am sure that it is. The challenge there--we 
are actually actively pursuing with grants in a lot of States. 
The problem is how to localize the knowledge. In other words, I 
am certain that we tell you what meningitis is and so forth, 
but then the person immediately wants to know, well, where do I 
go? I mean, where is the local place to get tested or get 
immunized or get weighed or blood pressure, and that is really 
a very difficult proposition.

                LOCALIZE INFORMATION ON THE NUM WEBSITE

    Mr. Regula. But you could tell them that they could get 
immunized or suggest it on the Web site?
    Dr. Lindberg. I can, and no doubt we do, but I can't tell 
them that if you go down to the----
    Mr. Regula. Right.
    Dr. Lindberg [continuing]. Corner of 4th and Main, there is 
a public health place.
    Mr. Regula. No. I understand.
    Dr. Lindberg. And that is what we would like to be able to 
do. Years ago we were testing the system of how to work in 
public libraries, because not all--about half of the people 
have computers, and I think we do pretty well by them. The 
other half don't, so public libraries is one of the places we 
are doing the experiment, and one of those was New York Public.
    And I went there, and it was a very successful experiment, 
but just to test them out, I said something about flu, and it 
immediately was smart enough to understand about--I really 
meant influenza, and it was an infectious disease, and you 
could immunize--and so I said to them, okay, where do I go? 
This was at 57th Street and 5th Avenue, and it said Albany, 
because it went out and did a big Web search. I mean, it was 
right, but it didn't localize it for us. So that is the problem 
we are working on right now.
    Mr. Regula. But nevertheless, if someone went to the doctor 
and received a diagnosis that said you have a melanoma, that 
person could go to the library or go home and plug in melanoma 
and get, I would assume, a wealth of information?
    Dr. Lindberg. Yes, yes. They would get the right 
information, and I think that is a good example, because if you 
are sitting in the doctor's office, and he says that terrible 
word to you, that is not a good learning opportunity. I mean, 
you want to go back and, you know, crawl under the covers and 
emerge when you have got enough equanimity to study it. That is 
exactly what it is all about.
    Dr. Kirschstein. Dr. Lindberg might like to tell you about 
the clinicaltrials.gov.

                            CLINICAL TRIALS

    Dr. Lindberg. Clinicaltrials.gov is going very, very well. 
I mean, that, as I said, is something that was called for in 
the legislation reforming FDA, modernizing FDA. But Dr. Varmus 
asked NLM to initiate that at NIH, and so all of the trials--
the first step was to put in the trials supported by NIH, which 
is now some 5,700. There are also now are some supported in the 
AIDS area by other associations, and now we are starting to 
work with the drug companies, but that has a very brisk 
utilization. It is designed for the public. That was the 
Congress's intent.
    It actually is tremendously useful to the doctors. In fact, 
a number of the NIH institute directors have told me that that 
is the first place they go to answer a lot of different 
questions, and it gets around the problem that--I mean, it is 
nice, though, we have the institutes, and they are a lot more 
self-explanatory than CDC, but on the other hand, we don't want 
to expect that the patient has to understand how we are 
organized, how their own organs are organized and then how the 
agencies are organized. I mean, this cancer research is 
supported in clinical trials in cancer in virtually all of the 
institutes. It isn't all NCI. So it serves a very good purpose 
to have--I mean, I salute the Congress once again. You have led 
the way in bringing common sense to these biomedical problems.

               CONSOLIDATION OF PUBLIC AFFAIRS FUNCTIONS

    Mr. Regula. Dr. Kirschstein, what impact do you think the 
Secretary--Secretary Thompson's initiative to consolidate all 
agency public affairs functions--and we have been talking a lot 
here about the information--will have on NIH's routine 
dissemination of scientific information? In other words, I 
assume--well, you are aware of the efforts he is making.
    Dr. Kirschstein. Mr. Regula, NIH is not in the business of 
running offices of public affairs. We are in the business and 
providing scientific and health information to the American 
public, and we have presented to the Secretary, and he 
basically agrees, that that information is best provided by 
having the people who know how to writescientific material 
that, is understood by the public, work closely and in conjunction with 
the scientists within the particular institutes involved, the 
directors, their programs and even the researchers at the bench. And 
therefore, we have agreed that when there is to be a public 
announcement, a press release or something of the sort, we will do what 
we always have done, which is to work with the Secretary's Office of 
Public Affairs to make sure that the message that the Department wishes 
to put out there is correct. But for the vast amount of material that 
we handle, we will be allowed at the local source, meaning the 
institutes, the centers, the Office of the Director, to do this in 
conjunction with the scientists.
    Mr. Regula. Speaking of information, I think it would be 
useful, because--through the medium of television a lot of 
people will have the opportunity to hear this testimony, and 
that is great. I wonder if you might describe briefly the 
procedure. Mr. Obey mentioned that you maybe do 30 percent of 
the requests or grants. I am not sure that most people 
understand. I would suspect if you were to ask a lot of people, 
they would assume that you were doing the research out at the 
NIH campus, and I think it would be interesting for people to 
recognize or to understand the vast array of resources you 
bring to bear on this, which essentially is the entire academic 
community of America. But just procedurally how does it work?
    Dr. Kirschstein. Mr. Chairman, the appropriation that you 
provide to NIH, Congress and the President every year, is 
divided in essentially two parts. One part of that is about 80 
percent, 85 percent of the budget, which is expended for doing 
research, research training, various activities related to 
research, science communication at the great medical and 
academic institutions throughout the country of the United 
States, across the entire horizon of the country, as well as to 
small business organizations and to research institutions which 
have academic backgrounds, but not necessarily affiliated with 
academic institutions.

                          INTRAMURAL RESEARCH

    A very small percent, 10 percent, is expended in research 
that is carried out in what is called the intramural program of 
the National Institutes of Health collectively. That is divided 
up between all of my colleagues----
    Mr. Regula. And this would be led by these gentlemen and 
ladies?
    Dr. Kirschstein. Well, these gentlemen have the 
responsibility of leading both programs in terms of where the 
science should be moving--gentlemen and ladies, I might say--
programs as to where the science is moving and to how best to 
expend those funds, but basically it is to determine what is 
important. However, what we call the intramural program, the 
scientists who work for each of the institutes at NIH, the vast 
majority of them are within the Bethesda campus. But Dr. 
Olden's campus is, for example, in North Carolina where he has 
that responsibility.
    They have that responsibility, too. They have the 
responsibility for weighing the balance between those two 
efforts. It is not by accident that approximately 10 percent is 
spent within the intramural programs. It is not by accident 
that coincident with the growth of our great academic 
institutions in the United States, doing biomedical research 
starting at the end of World War II, has made the United States 
the premiere country in the world and it is because that 
balance of about 85 percent, 10 percent and a small amount to 
make sure that the lights and the heat and so forth are 
provided, that we get the most research effort and the best 
scientists working in the United States so that scientists from 
all across the world come to those institutions, as well as to 
the NIH itself, to learn and work with our prestigious 
scientists.
    Mr. Regula. Well, I am struck when I run into the--or have 
a conversation with the heads of some of our major universities 
in Ohio, and I will say to them, do you have NIH grants, and 
they say oh, yes, we have several. So obviously you are using 
the resources of the Nation to do these studies on various 
areas. And each of these people who have participated today and 
in previous hearings would have responsibility for the field 
that they lead, and procedurally my institution has--through 
the medical research, thinks they have a good idea in finding a 
cure for Alzheimer's. Procedurally what would we do?

                       GRANTS APPLICATION PROCESS

    Dr. Kirschstein. They have the good idea. They would 
prepare what is called a research grant application. The 
institution would help the individual scientist to put it in a 
form that is needed, and it is submitted to the National 
Institutes of Health.
    Two decisions then have to be made. One is as to which of 
these various institutes that research grant application would 
be assigned. If it is Alzheimer's in general, it would be 
assigned to the National Institute on Aging. However, it is 
possible if it stresses the behavioral aspects of Alzheimer's 
disease that it would be assigned to the National Institute of 
Mental Health, and if it stressed some of the neurological 
aspects, the National Institute of Neurological Diseases and 
Strokes, so that you can see that may be more than one 
institute. And indeed some grant applications are assigned to 
more than one institute to give the grantee, the applicant out 
there in academia, the opportunity to receive funding 
independent on the budgets of each of these----
    Mr. Regula. So it could be for more than just one of your 
institutes?
    Dr. Kirschstein. Yes.
    The second thing that happens, the second place it is 
assigned is to what we call the study section. You heard a 
description of that from Dr. Ehrerfeld about 2 or 3 weeks ago 
now, in which we assemble a group of, again, scientists from 
academic institutions with expertise, broad-ranging expertise, 
in the area of neurological diseases, problems of aging, mental 
health, et cetera, in heart disease, if it is a grant 
application related to heart, who do a review of that grant 
application in concert with a large number of others, sometimes 
as many as 100 at a meeting which lasts 3 days and is very 
often held 3 times a year. That is a peer review.
    So the scientist at the academic institution that 
originally submitted the grant application receives the views, 
scientifically based, of his or her colleagues. That leads to 
an assessment of the scientific merit of that grant 
application, and finally to the second level of review, which 
Congress in its wisdom set up, which is the advisory council 
mechanism, where not only do the senior scientists in the 
field, but the public, the public that knows something about 
heart disease, knows something about the ethical issues related 
to genome, about dental caries in the United States, about 
nursing, et cetera, et cetera, weighs in on what is the 
relevance of that particular grant application to the 
improvement of the health through either diagnosis, prevention, 
possibly cure and sometimes treatment ofthat disease or that 
entity, and those two reviews together lead to the decisions dependent 
on the funds that each of the institutes has as to whether that grant 
application gets funded or not.
    Anybody want to add anything?
    Mr. Regula. So what percent of the applications you 
receive--was there some kind of a benchmark? Is it 100 percent 
of them or 75 or 20?
    Dr. Kirschstein. We have had submission of grant 
applications of such remarkable scientific merit that we are 
funding, with the excellent budget that the Congress has given 
us over the last 5 years, about one-third, 30 percent, of those 
that are received. I think most of my colleagues feel that at 
this point in time the excellence of the next group, 5 percent, 
10 percent, is sufficient to be able to continue to fund if 
there were money and in addition there was relevance; that we 
would not be ashamed, but we would be proud to provide those 
funds.
    Mr. Regula. So you are saying most all of it that are 
submitted are high quality, so you are choosing between quality 
and quality plus.
    Dr. Kirschstein. That is right. And part of that is also a 
very important task that we have all done for many years, and 
that is training young people to become medical and scientific 
biomedical researchers. They are the seed corn by which we 
provide the American public the assurance that in the future 
this will continue on.

                            LIFE EXPECTANCY

    Mr. Regula. What has happened in life expectancy in the 
last 10 years, because obviously the work you do can contribute 
greatly to that?
    Dr. Kirschstein. A great jump happened somewhat more than 
10 years ago, but each year is continuing apace. Now, in his--
yes, please.
    Dr. Lenfant. That is an issue that we went over very 
carefully. Each 5 years during the last 30 years, life 
expectancy has increased by 1 year, so during the last 30 
years, 6 years. Sixty percent of that gain in life expectancy 
is due to the decline in death rate of cardiovascular disease. 
So that really is a tribute to the research establishment and 
to the Congress who have supported this.
    I can tell you that if that did not happen, instead of 
500,000 deaths from cardiovascular disease that I mentioned at 
the beginning, we would have in this country 1.8 million deaths 
each year of cardiovascular disease.
    Mr. Regula. I assume the quality of life, in addition to 
living longer, you live better as a result of all of this 
research.
    Dr. Kirschstein. In general, that is true. However, that is 
of concern, because if the quality of life is not really 
better, there is some question about it. And the more we can do 
to turn what were acute diseases, heart attack, into a chronic 
situation, the more we have to be careful about making sure 
that the quality of life remains at a level that makes people 
useful, productive citizens, even into their retirement years.
    Mr. Regula. Interesting.
    Mr. Sherwood, any----

                                 ASTHMA

    Mr. Sherwood. Thank you.
    Dr. Olden, I understand that the National Institute of 
Environmental Health Sciences has been pursuing research into 
the connection between asthma and indoor pollutants such as 
dust mites and other things, and I am wondering if any studies 
have been done on the amount of time children spend inside and 
any correlating increase in rates of asthma.
    Dr. Olden. Yes, Mr. Sherwood, that kind of research has 
been done. But let me say it has been done in collaboration 
with two other Institutes. Dr. Lenfant's Institute, the 
National Heart, Lung and Blood Institute, and the National 
Institute of Allergy and Infectious Diseases. And so maybe Dr. 
Lenfant would also like to comment.
    But yes, we, in partnership with HUD, conducted a national 
allergen survey--a population-based survey of selected regions 
throughout the United States. We identified a number of 
allergens--certainly the allergens that are responsible mostly 
for asthma are dust mite allergens, cockroach allergens, and 
indoor cigarette smoking. And yes, studies do demonstrate that 
kids today spend much more time indoors than kids a few years 
ago, and the synthetic chemicals and off-gassing of materials 
that are used in building houses is also a problem that 
certainly exacerbates the asthmatic conditions in people who 
are genetically predisposed to have the disease.
    Mr. Sherwood. It occurs to me that the advances we make in 
society to make our lives easier, with the exception of 
workplace injuries and obvious things like that, also make our 
job a little harder to protect our good health, and that a 
television set is no substitute for a baseball for a healthy 
kid.
    Dr. Olden. That is right--television, computers. 
Construction is much tighter. When we were kids and air could 
come through the cracks in the house, we thought that was a 
disadvantage, but it turns out that it is an advantage.
    There are a number of issues. Mold growing in homes is also 
a major problem that certainly exacerbates asthma and other 
pulmonary dysfunctions. But there is a lot of research going on 
in three institutes in the NIH.
    Mr. Sherwood. So in our homes in the Northeast a few years 
ago, it was all the rage to make them very tight so they would 
be more energy-efficient. And you still need your air flow or 
your air exchange, and energy efficiency and good health might 
necessarily--might work at cross purposes here.
    Dr. Olden. That is correct. Also building and construction 
materials contain a lot of synthetics, and they off-gas over 
the years, and certainly that creates a lot of respiratory 
discomforts and problems.
    Mr. Sherwood. Thank you.
    Mr. Chairman, it is wonderful the knowledge that we have at 
our disposal here around this big table. It is a rare treat. 
Thank you very much, folks.
    Mr. Regula. The big challenge is to use it effectively, 
yes.
    Last question, will the routine dissemination of scientific 
information, which all of you do with your Web sites, be 
carried out at the department level or at NIH?
    Dr. Kirschstein. At NIH.
    Mr. Regula. At NIH. So there is no change in that?
    Dr. Kirschstein. That is our understanding.
    Mr. Regula. Well, my thanks to all of you, and I think this 
has been a very valuable hearing both for us and for those that 
have an opportunity to view it out in TV-land because health is 
important to everyone and of course the quality of life is so 
much affected by having good health, and I think the American 
public is indebted to all of you for providing leadership in 
these research fields to achieve those goals and I am sure that 
plugging into your Web site is a comfort to people oftentimes 
because the medical profession doesn't always have the time to 
spend an hour with a patient saying these are all the elements 
of the diagnosis you have received and your Web site would be 
very useful in that respect. And I suppose you've get hits from 
people who got an ache or a pain of some kind and are just at 
home and it is on Sunday and they say, well, I would like to 
know what this is all about and they can use your Web site 
instead of these medical books that are sitting on our shelves.
    So, Dr. Kirschstein, we wish you well, and whatever 
challenge you have----
    Dr. Kirschstein. Thank you and the other members for giving 
us these opportunities over the last number of weeks and 
several months to present to you.
    Mr. Regula. I think the persuasiveness of your testimony 
will probably be reflected in our budget numbers. At least that 
is the goal. Thank you all for coming. The hearing is 
adjourned.

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                           W I T N E S S E S

                              ----------                              
                                                                   Page
Alexander, Dr. Duane...........................................131, 643
Allen, Claude....................................................     1
Baldin, Wendy....................................................   131
Battey, Dr. J.F., Jr...........................................131, 529
Beldon, William..................................................   131
Cassman, Dr. Marvin............................................131, 529
Collins, Dr. Francis.............................................   735
Curie, Charles...................................................     1
Dean, Dr. Donna................................................131, 643
Duke, E.J........................................................     1
Ehrenfeld, Dr. Elli..............................................   529
Fauci, Dr. A.S..............................................1, 131, 385
Ficca, S.A.......................................................   132
Fleming, D.W.....................................................     1
Gottesman, Michael...............................................   131
Grady, Dr. Patricia............................................131, 735
Hanson, Dr. G.R................................................131, 529
Hodes, Dr. R.J.................................................131, 385
Katz, Dr. S.I..................................................131, 643
Keusch, Dr. G.T................................................132, 643
Kington, Dr. Raynard...........................................131, 735
Kirschstein, Dr. R.L............................131, 385, 529, 643, 735
Leasure, Charles.................................................   131
Lenfant, Dr. Claude............................................131, 735
Lindberg, Dr. D.A.B............................................132, 735
Maddox, Y.T......................................................   132
Nakamura, Dr. Richard..........................................131, 529
Olden, Dr. Kenneth.............................................131, 735
Penn, Dr. A.S..................................................131, 385
Quntius, Susan.................................................132, 385
Ruffin, Dr. John...............................................131, 643
Sieving, Dr. Paul..............................................131, 735
Spiegel, Dr. A.M...............................................131, 385
Straus, Dr. S.E................................................131, 643
Tabak, Dr. L.A.................................................131, 735
Vaitukaitis, Dr. J.L...........................................131, 529
von Eschenback, Dr. Andrew.....................................131, 385
Weems, Kerry.........................................132, 385, 529, 643
Whitescarver Jack................................................   132


                               I N D E X

                              ----------                              

                     NATIONAL INSTITUTES OF HEALTH
                            OVERVIEW HEARING

                                                                   Page
Acknowledgment of Dr. Kirschstein................................   296
Appointments of Directors........................................   293
Bayh-Dole Act....................................................   351
Cancer in the Medically Underserved..............................   354
Caribbean Primate Center.........................................   334
Change in Medical Education......................................   313
Chemoprevention..................................................   341
Chimpanzee Sanctuary.............................................   333
Clinical Activities..............................................   294
Clinical Research Enhancement Act................................   383
Clinical Trials..................................................   312
Collaboration on Type I Diabetes Research........................   383
Comparison of the President's Budget and Appropriated Fund.......   335
Competing Research Project Grants in FY 2004.....................   342
CSR Study Section Reorganization.................................   327
Departmental Information Technology Initiative...................   337
Description of Foundation Operation..............................   319
Diabetes Research Working Group..................................   358
Director's Discretionary Fund....................................   323
DoD Collaborative Research.......................................   317
Doubling the NIH Budget..........................................   291
Earmarking Diseases..............................................   297
Earmark..........................................................   302
Encumberments to Full Funding....................................   316
Epidemics of Diabetes and Obesity................................   300
Ethical, Legal, and Social Implications of the Human Genome 
  Project........................................................   363
Foundation Appropriation.........................................   321
FTE Ceilings.....................................................   323
FTEs.............................................................   324
Fulfillment of Foundation Educational Mandate....................   320
Full Funding of Research Project Grants..........................   317
Government Performance Review Act................................   312
Grant Application Process........................................   309
Grant Application and Awards.....................................   327
Greatest Success Story...........................................   288
HIV Vaccine Research Program.....................................   372
Human Embryonic Stem Cell Lines..................................   373
Hyperbaric Oxygen Initiative.....................................   349
Implementation of Stem Cell Research Policy......................   344
Increase in Travel Funding.......................................   338
Increased Funding in Research and Development Contract.........339, 366
Informing the Public.............................................   352
Knowledge from Biomedical Research...............................   343
Loan Repayment Program...........................................   293
Mammography......................................................   377
Mentored Clinical Research Scholars..............................   361
Metals in Medicine...............................................   347
Minority Funding Tables..........................................   328
Multi-Year Funding of RPGs in FY 2003............................   362
Muscular Dystrophy...............................................   289
National Center on Minority Health Disparities...................   304
NCMHD Advisory Council...........................................   307
NCMHD Project Export Centers of Excellence.......................   333
NCMHD Construction Grant Funding.................................   335
New Investigators................................................   322
NIBIB Success Rate...............................................   339
NIH Success Rates................................................   338
NIH Research Program Goals.......................................   360
NIH Security Improvements........................................   336
NIH Funding for Diabetes Research................................   356
NIH-IDeA.........................................................   347
Noncompeting Research Project Grants in FY 2004..................   342
OAR Planning and Budget Authority................................   374
Ocular Albinism..................................................   297
Office of Loan Repayment and Scholarship.............318, 367, 375, 381
Office of Rare Diseases..........................................   328
ONDCP............................................................   337
Opening Remarks..................................................   134
Opening Statements:
    Dr. Duane Alexander, NICHD...................................   182
    Dr. James F. Battey, Jr., NIDCD..............................   207
    Dr. Marvin Cassman, NIGMS....................................   177
    Dr. Francis S. Collins, NHGRI................................   233
    Dr. Donna J. Dean, NIBIB.....................................   238
    Dr. Anthony S. Fauci, NIAID..................................   171
    Dr. Stephen A. Ficca, B&F....................................   284
    Dr. Patricia A. Grady, NINR..................................   229
    Dr. Glen R. Hanson, NIDA.....................................   218
    Dr. Richard J. Hodes, NIA....................................   197
    Dr. Stephen I. Katz, NIAMS...................................   202
    Dr. Gerald T. Keusch, FIC....................................   263
    Dr. Raynard S. Kingston, NIAAA...............................   223
    Dr. Ruth Kirschstein, NIH....................................   139
    Dr. Claude Lenfant, NHLBI....................................   150
    Dr. Donald A.B. Lindberg, NLM................................   274
    Dr. Yvonne T. Maddox, OD.....................................   269
    Dr. Richard K. Nakamura, NIMH................................   212
    Dr. Kenneth Olden, NIEHS.....................................   192
    Dr. Audrey S. Penn, NINDS....................................   166
    Dr. John Ruffin, NCMHD.......................................   258
    Dr. Paul A. Sieving, NEI.....................................   187
    Dr. Allen M. Speigel, NIDDK..................................   161
    Dr. Stephen E. Straus, NCCAM.................................   252
    Dr. Lawrence A. Tabak, NIDCR.................................   155
    Dr. Judith L. Vaitukaitis, NCRR..............................   247
    Dr. Andrew von Eschenbach, NCI...............................   144
    Dr. Jack Whitescarver, OAR...................................   279
Oral Cancer......................................................   308
Outyear Effects of FY 2003 Request Level.........................   315
Payments to GSA..................................................   337
Post-Doubling of the NIH Budget..................................   351
Post-Doubling Strategies.........................................   315
Preparing Research Community for Future NIH Budget.............315, 352
Program Evaluation...............................................   325
Recoupment of Federal Research Funds.............................   298
Research Grants..................................................   310
SAMSHA and NIH...................................................   369
Scientific Opportunities.........................................   290
Select Trial.....................................................   334
Spending by Disease..............................................   325
Stem Cell Research and Therapeutic Cloning.......................   376
Stem Cell Registry...............................................   295
Success Rate..............................................292, 339, 362
Translating Diabetes and Obesity Research Funding................   301
Type I Diabetes Research Funding.................................   358
Use of Foundation Budget.........................................   320
Witnesses........................................................   131

                        Bench to Bedside Hearing

Accessing the Newest Advanced Treatments.........................   444
African-American Hereditary Prostate Cancer Study Network........   522
ALS Research.....................................................   451
Alzheimer's Disease..............................................   404
Basic vs Clinical Research.......................................   427
Benefits Beyond Bioterrorism.....................................   462
Biomarkers for Cancer............................................   482
Bioterrorism.....................................................   461
Cancer and the Environment.......................................   422
Cancer Centers and Training......................................   424
Cancer Metastasis................................................   395
Cancer Research..................................................   412
Cancer Research Funding..........................................   452
Collaborative Research...........................................   459
Commercially Available Glucose Sensors...........................   449
Communication about Prostate Cancer..............................   523
Conception and Development of Vaccines...........................   396
Conquering Disease...............................................   413
Coordination among Women's Health Offices........................   503
Data Sharing.....................................................   526
Detection Technologies...........................................   466
Diabetes:
    Research.....................................................   410
    Research Budget..............................................   469
    Research Funding.............................................   505
    Research Working Group.......................................   423
Difference Between Type 1 and Type 2 Diabetes Research...........   450
Disability Decline...............................................   416
Distribution of Additional Resources.............................   472
Drug Discovery...................................................   514
Food Allergies...................................................   486
FY 2003 Request for NIMH.........................................   440
Genesis of the National Institutes of Health.....................   386
Global Research..................................................   433
Glucose Sensors Research.........................................   448
High Blood Pressure in African Americans.........................   506
HIV/AIDS.........................................................   421
HIV/AIDS Research................................................   476
HIV/AIDS Therapeutics............................................   429
HIV Vaccine....................................................414, 421
Human Genome Sequence............................................   414
Identifying and Developing Prevention Agents.....................   465
Immune-Based Strategies..........................................   460
Immune Tolerance.................................................   488
Impact of Anthrax Outbreaks on Research..........................   459
Impact of Funding Increase on the Office of Women's Health 
  Research.......................................................   501
Infectious Disease Research......................................   459
Inflammatory Bowel Disease.....................................486, 490
Information Dissemination......................................417, 425
International Study on African-Caucasian Differences.............   521
Interstitial Cystitis..........................................491, 492
Intramural Structural Biology....................................   430
Islet Transplants for Type 1 Diabetes............................   473
Mammography......................................................   478
Microbicide Research.............................................   476
Microbicides...................................................485, 496
Minority-Based Community Clinical Oncology Program...............   520
Minority Cancer Centers..........................................   464
NCI Center to Reduce Cancer Health Disparities...................   517
Opening Remarks................................................385, 387
Opening Statement................................................   389
Ovarian Cancer...................................................   498
Parkinson's Disease............................................408, 463
Partnering with the PKD Foundation...............................   438
Prevention Intervention Component................................   422
Prevention of Alzheimer's Disease................................   407
Prevention of Type I Diabetes in Children........................   493
Promising Treatments for Diabetes................................   445
Prostate Cancer................................................465, 511
    Prevention...................................................   512
    Research.....................................................   508
    Risk in US Blacks and Whites.................................   522
    Screening..................................................467, 512
    Treatment....................................................   513
Recoupment of Federal Research Funding...........................   495
Research Collaborations..........................................   433
Research Highlights Since DRWG Report............................   470
Research Priorities for NIMH.....................................   441
Research with Drug Companies.....................................   436
Resources for Type 1 Diabetes vs Type 2 Diabetes.................   450
Results from Stem Cell Research..................................   447
Schizophrenia Research...........................................   442
SELECT...........................................................   522
Southern Community Cohort Study..................................   520
Specialized Programs of Research Excellence......................   524
Specialized Programs of Research Excellence (SPOREs) and 
  Translational Research.........................................   468
SPORES...........................................................   521
Stem Cell Research.............................................435, 445
Stem Cell Research Projects......................................   447
Stroke Prevention................................................   451
Success Rates....................................................   442
The Prostate Cancer Prevention Trial.............................   522
Translation of Research Advances into Treatment..................   527
Translational Research...........................................   420
Translating Discoveries..........................................   415
Treatment Technologies...........................................   468
Trends Regarding Cancer..........................................   453
Vaccine Research Program.........................................   475
Witnesses........................................................   385
Zip Codes........................................................   396

                      Fundamental Research Hearing

Access to Care and Substance Abuse Treatment.....................   621
Accessing the Newest Advanced Treatments.........................   607
Addictive Disorders..............................................   574
Advances in Brain Imaging........................................   538
AIDS Center Grants...............................................   621
Aphasia..........................................................   633
Applications from New Investigators..............................   588
B&F Infrastrtucture..............................................   596
Basic and Fundamental Research...................................   608
Behavioral Research..............................................   588
Behavioral Treatment Therapies for Autism........................   616
Bioinformatics...................................................   582
Biosafety Level 4 Labs...........................................   601
Career Development and Research Training.........................   536
Center for Bioinformatics and Computational Biology..............   582
Center for Bioterrorism and Emerging Infections..................   602
Clinical Researcher Shortage.....................................   585
Clinical Loan Repayment Program..................................   555
Clinical Trials Network..........................................   592
Clinical Research Enhancement Act................................   626
Cochlear Implants..............................................590, 591
Collaboration with SAMSHA........................................   628
Coordinating Epilepsy Research Efforts...........................   630
Course and Prognosis in Schizophrenia............................   555
Craving..........................................................   573
Doubling the NIH Budget..........................................   553
Drug Prevention..................................................   573
Early Newborn Hearing Screening..................................   609
Educating the Public about Mental Disorders......................   562
Essential Safety and Regulatory Compliance Programs..............   601
GCRC Pilot Studies...............................................   622
Genomics and Genetic Medicine....................................   581
Importance of Physical Sciences to Research......................   546
Information Dissemination........................................   571
Information Technology in Biomedical Research....................   575
Innovative Mechanisms............................................   594
Instrumentation................................................535, 541
Interagency Autism Coordinating Committee........................   613
Introductions....................................................   530
Laboratory at Ft. Detrick........................................   601
Legislative Assistance...........................................   579
Level Four Facility..............................................   550
Level of Support for Research Training...........................   583
Medical Scientist Training Program...............................   608
Mental Illness...................................................   612
Mental Illness and Health Insurance..............................   556
Multi-Year Funding of RPGs in FY 2003............................   580
National Centers for Autism Research.............................   615
National Drug Abuse Treatment Clinical Trial Network and the 
  Private Sector.................................................   594
Need for Child Mental Health Researchers.........................   554
Neuronal Loss in Schizophrenia...................................   553
New Technologies.................................................   579
New Treatments for Mental Illness................................   625
NIDA's Prevention and Treatment Research Investment..............   617
NIGMS Mission....................................................   544
NIH Reauthorization..............................................   579
Opening Remarks..................................................   529
Opening Statement................................................   533
Other Areas of Infrastructure....................................   584
Outcomes of Research.............................................   548
Outreach to Secondary School Students............................   583
Oversight of NIH Peer Review and NIH-Supported Research..........   611
Parkinson's Disease..............................................   632
Peer Review Process..............................................   542
PET Scans........................................................   586
Pharmacogenetics.................................................   608
Physical Security................................................   597
Physical Security Improvements...................................   598
Prescription Drug Abuse..........................................   618
Prevention Research..............................................   569
Promoting Research on Mental Illness.............................   556
Promoting Health Messages in Educational Settings................   567
Public Awareness.................................................   564
Repairs and Improvement Projects.................................   600
Repairs and Improvements.........................................   599
Research:
    Childhood Mental Disorders...................................   554
    Infrastructure...............................................   581
    Management and Support.......................................   549
    Priorities at NIMH...........................................   604
    Projects.....................................................   544
    Technology Infrastructure....................................   540
    Training...................................................561, 580
Restructure of Peer Review Groups................................   563
Revolution in Brain Science......................................   537
Ritalin and Substance Abuse......................................   619
Safety Master Plan...............................................   596
Schizophrenia....................................................   624
Schizophrenia Research...........................................   605
Science Education................................................   566
Severe Mental Illness............................................   603
Shared Research Tools............................................   595
Shared Resources.................................................   619
Sharing Research Findings with Drug Manufacturers................   617
Speech Development in Children with Hearing Loss.................   610
Success Rates..................................................551, 605
Support of Promising Research Scientists.........................   589
Synchrotrons.....................................................   541
Trans-NIH Initiatives............................................   536
Treatment Adherence..............................................   616
Treatment Development Program....................................   584
Types of Extramural Research Administrators......................   590
Virtual Laboratories.............................................   542
Witnesses........................................................   529
Youth Suicide....................................................   628

              Collaboration in Biomedical Research Hearing

Acupuncture......................................................   671
Advisory Council.................................................   733
Arthritis........................................................   709
Arthritis Medications............................................   684
Autism...........................................................   705
Autoimmune Disease...............................................   717
Autoimmune Disease Research......................................   719
Back-to-Sleep Campaign.........................................658, 676
Bone Density in Children.........................................   707
Botanical Drug Interactions......................................   680
Collaborations...................................................   734
Collaborative Opportunities......................................   659
Complementary and Alternative Medicine...........................   648
Compliance with Public Law.......................................   733
Conflicts with Pharmaceuticals...................................   712
Department of Defense Research Activities........................   693
Development of NIBIB Mission Statement...........................   673
Diabetes Prevention Program......................................   664
Disparities......................................................   729
Early Childhood Development......................................   702
Forms of Exercise and Meditation.................................   711
Global Health Threats............................................   686
Grant Transfers to NIBIB.........................................   672
Health Disparities in Rural America..............................   678
Human Genome Center..............................................   664
Human Genome Sequencing..........................................   699
Importance of Vitamins...........................................   710
Jackson Heart Study..............................................   664
Loan Repayment Program...........................................   732
Longitudinal Environmental Health Study..........................   658
Maternal Fetal Medicine Units....................................   658
Multidisciplinary and Interdisciplinary Research.................   673
Musculoskeletal and Kin Disorders................................   708
Musculoskeletal Medicine.........................................   717
Narrowing the Knowledge Gap......................................   665
National Children's Cohort Study.................................   719
National Institute of Biomedical Imaging and Bioengineering......   659
NCCAM:
    Clinical Trials..............................................   654
    Industry Collaboration.......................................   653
    Information Dissemination Activities.........................   654
    International Health Activities..............................   701
    NCI Collaboration............................................   653
NCS..............................................................   714
NIAMS Community Health Center....................................   694
NIH IC Funding of Health Disparities Research....................   730
New Research Initiatives.........................................   663
Obesity in Children..............................................   676
Opening Remarks:
    Dr. Duane Alexander, NICHD...................................   658
    Dr. John Ruffin, NCMHD.......................................   663
    Dr. Ruth Kirschstein, NIH....................................   643
    Dr. Steven Straus, NCCAM.....................................   653
Opening Statement of Dr. Ruth Kirschstein........................   645
Origins of Research..............................................   711
Osteoarthritis...................................................   648
Osteoarthritis Initiative........................................   648
Osteoarthritis Treatment.........................................   670
Pediatric Endocrinologists.......................................   726
Pediatric Testing................................................   727
Placebo Effect...................................................   685
Post National Reading Panel......................................   704
PPRU Network...................................................699, 713
Project Export COE...............................................   732
Public Input.....................................................   671
Public Inquiries.................................................   671
Public Inquiries to NCCAM........................................   670
Reading Readiness................................................   682
Reading Skills in Older Children.................................   703
Research Endowments..............................................   732
Research Infrastructure..........................................   731
Scientific Collaboration on Global Health........................   667
Scleroderma......................................................   728
Sharing Knowledge Globally.......................................   688
Shared Scientific Knowledge......................................   696
Strategic Plan...................................................   664
Type II Diabetes in Children.....................................   715
Witnesses......................................................643, 644

            Disease Prevention and Health Promotion Hearing

Alcohol Advertising..............................................   756
Act in Time to Heart Attack Signs................................   742
Asthma.........................................................769, 775
Bioterrorism.....................................................   790
Breast Cancer and the Environment................................   810
Care for Cancer Patients.........................................   798
Career of Carol Murphy...........................................   735
Cesarean Delivery Increases Risk of Uterine Rupture..............   750
Children's Environmental Health..................................   800
Chromosome I.....................................................   744
Cleft Lip/Cleft Palate...........................................   823
Clinical Trials..................................................   771
Collaborations Between NIAAA and SAMSHA..........................   780
Community Program................................................   769
Consolidation of Public Affairs Functions........................   722
Core Blood.......................................................   792
Council on Aging.................................................   758
Dental Amalgam...................................................   794
Detecting Oral Cancer............................................   749
Development of Educational Materials...........................779, 780
Diabetes and Heart Disease.......................................   812
Diabetic Retinopathy.............................................   821
Disease Prevention and Public Education..........................   808
Educating Health Care Providers and the General Public...........   813
Education in Genomics............................................   745
Environmental Hazards............................................   789
Environmental Triggers...........................................   799
Enhanced Dissemination and Utilization Centers...................   778
Ethical, Legal, and Social Implications..........................   759
Eye Health as Indicator of Overall Health........................   757
Eye Treatments to Cure Blindness.................................   758
Fluoridation.....................................................   756
Genes and the Environment........................................   803
Genetics:
    Discrimination.............................................760, 764
    Disease Prevention...........................................   743
    Health Promotion.............................................   766
    Rare Disease Information Center..............................   784
    Testing......................................................   761
Global Initiative for Chronic Obstructive Lung Disease...........   806
Grants Application Process.......................................   773
Healthy People 2010 Electronic Gateway...........................   787
Health Promotion for Adolescents.................................   782
Heart Disease in Women...........................................   815
High Blood Pressure in African Americans.........................   818
HIV/AIDS-TB Co-infection.........................................   805
Information and Health Care......................................   769
Intramural Research..............................................   773
Intramural Research at NINR......................................   782
Life Expectancy..................................................   775
Liquor-Brand Malt Beverages......................................   821
Localize Information on the NLM Website..........................   771
Malt Liquor......................................................   820
National Cardiovascular Health Conference........................   767
National Library of Medicine Website.............................   753
Native American Talking Circles to Reduce Diabetes...............   751
NEIBank..........................................................   781
NHGRI Mentorship Network.........................................   783
NHLBI Communications Network.....................................   759
NIH Funding......................................................   755
NLM Website......................................................   769
Nursing Research on Hard-To-Reach Populations....................   820
Obesity Research.................................................   768
Opening Remarks:
    NEI..........................................................   746
    NHGRI........................................................   743
    NHLBI........................................................   742
    NIAAA........................................................   754
    NIDCR........................................................   748
    NIEHS........................................................   746
    NINR.........................................................   750
    NLM..........................................................   751
Opening Statement of Dr. Kirschstein.............................   736
Oral Cancer Examinations.........................................   748
Oral Health and Low-Birth Weight Babies..........................   824
Oral Health Disparities..........................................   763
Periodontal and Heart Disease Relationship.......................   797
Periodontal Disease and Pre-Term, Low-Birth Weight Babies........   796
Periodontal Disease and Tobacco Relationship.....................   797
Post-Transplant Problems of Patients.............................   750
Prevention Infections in Hospital................................   765
Prevention of Alcohol Abuse......................................   754
Prevention of HIV Infection......................................   816
Prevention Strategies............................................   785
Progress of Task Force on College Drinking.......................   779
Promoting Eye Health.............................................   747
Reducing Lead Poisoning in the Community.........................   751
Reducing Health Disparities......................................   819
Research Grants..................................................   762
Research on College Drinking.....................................   793
Research on Lifestyle-Related Disease Factors....................   788
Sickle Cell Disease Research.....................................   791
Studies Related to Terrorist's Attacks...........................   786
Thalassemia Clinical Research Network............................   765
Thalassemia Clinical Research network............................   815
The Nursing Shortage.............................................   804
Toxic Chemical, the Environment and Breast Cancer................   802
Witnesses........................................................   735
Work with Physicians, Then Patients..............................   758

                                

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