[Senate Hearing 110-]
[From the U.S. Government Publishing Office]


 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                          MONDAY, MAY 21, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 2 p.m., in room SD-116, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin, Cochran, and Stevens.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENT OF DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL 
            INSTITUTE OF ALLERGY AND INFECTIOUS 
            DISEASES

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. The Subcommittee on Labor, Health and Human 
Services, and Education, and Related Agencies will come to 
order.
    I just thought that before we begin today's hearing I want 
to take a moment to offer my condolences to everyone, through 
you, at NIH over the recent passing of Dr. Steve Straus, the 
founding Director of the National Center for Complementary and 
Alternative Medicine. It's an enormous loss to science and to 
his many friends and colleagues at NIH where he worked for 27 
years. We always knew that Steve was a man of great integrity 
and skill and dedication. That was apparent from his many 
scientific accomplishments.
    But during his 2\1/2\ year battle with brain cancer we also 
witnessed his courage and his grace. He fought a valiant fight 
and was a teacher until the end. We were lucky to have him as 
NCCAM's founding director.
    He and I had many, many conversations and meetings on 
alternative medicine, complementary medicine, where we're going 
and how we fold that in with other mainstream research. I think 
he's one of those people of whom we can truly say that he did 
make the world a better place.
    So, this is the fifth of six hearings on the National 
Institutes of Health that the subcommittee will hold this year. 
We've heard from 13 Institutes so far. Today we'll hear from 
five more: the National Institute of Allergy and Infectious 
Diseases, the National Cancer Institute, the National Center 
for Research Resources, the National Institute of Nursing 
Research and the National Center on Minority Health and Health 
Disparities.
    I'll ask each Director to speak 5 to 7 minutes. In the 
spirit of how we've been doing this if I think of something 
while you're doing it I may even ask you a question at that 
time or--I excuse myself right now for interrupting. But we'll 
try to go through all of the testimonies and we'll just open up 
for general discussion after that.
    I kind of like this format a little bit more than the 
formal one of sitting at a dais and that type of thing. I'd 
rather have more of a free flow of a discussion, sometimes even 
amongst you sitting across the table from me.
    I think we learn a lot more and we get a better flavor for 
exactly what we're doing here. I know that C-SPAN and others 
pick this up. I look upon this as a way of also of teaching the 
public, getting information out to the public in a format in 
which they can get a better handle on just exactly what NIH is 
doing and what the different Institutes are doing.
    So with that I'll start us here on my left. Dr. Anthony 
Fauci has served as Director of the National Institute of 
Allergy and Infectious Diseases since 1984. He received his MD 
degree from Cornell University Medical College. He has 
testified before this subcommittee many, many times over the 
years on everything from AIDS to pandemic flu to bioterrorism. 
I took over the Chair of the subcommittee in 1989. That was the 
first time I met Dr. Fauci.
    So, welcome back, Dr. Fauci. All your statements will be 
made a part of the record in their entirety. Like I said if you 
could take 5 to 7 minutes or so, sum it up. I'd sure appreciate 
it.

               SUMMARY STATEMENT OF DR. ANTHONY S. FAUCI

    Dr. Fauci. Thank you very much, Mr. Chairman and thank you 
for the opportunity to talk to you today a little bit about the 
activities of the National Institute of Allergy and Infectious 
Diseases.
    I'm going to talk from some visuals that are right in front 
of you--right in front of you there.
    Senator Harkin. Okay.
    Dr. Fauci. I believe that's the top one. If you turn the 
page and look at the first slide.

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    I want to use that to tell you something that I know that 
you're familiar with. But for the sake of the record I will 
just mention very briefly what the mandate and the mission of 
the National Institute of Allergy and Infectious Diseases is. 
As you know it's responsible for the bulk of NIH research in 
the disciplines of immunology, microbiology and infectious 
diseases.
    We're driven by two major issues. One is the scientific 
opportunity and the other is the public health need. You know 
about what we do from the much publicized issues such as HIV/
AIDS, pandemic influenza and bio-defense. But we also have 
responsibility for emerging/re-emerging microbes, vaccinations 
and immunizations for adults and children, the development of 
antibiotics, vaccines as well as the study of diseases of the 
immune system, including the important issue of immunological 
tolerance, which has a great potential in many areas of 
medicine that go well beyond our Institute's mandate.
    If you look at the next slide--I talk also here about what 
I call the dual mandate. Because in addition to all that we do, 
as every other Institute does, maintain a robust, basic and 
clinical research portfolio. For us it's microbiology, 
infectious diseases and the immune system. For Dr. Niederhuber, 
it's cancer and down the line. They each have what they do and 
what their Institute is responsible for.

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    When I refer to our dual mandate I mean that we also need 
to be able to respond very rapidly to new infectious disease 
threats. You know we've discussed this at many hearings that 
we've had together on issues such as: HIV/AIDS, SARS, et 
cetera.
    In fact if you go to the next slide. This is a slide I must 
have shown to you, Mr. Chairman, over the years since 1989 
about 10 different times. The reason I can show you this--I 
hope without your getting bored, is that each year we add one, 
two and sometimes three, new emerging infectious diseases. In 
fact the print has gotten so small there that we're sort of 
running out of space. We started out with HIV/AIDS there, but 
you see there are many others that are emerging and re-emerging 
infectious diseases.

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    Of particular note this time is one that we've just 
recently added, which I hope we get a chance to discuss in the 
question period. That is extensively drug resistant 
tuberculosis, which is an issue that poses a significant threat 
to us. Also there are multiple drug resistant microbes like 
staphylococcus and enterococcus as well as things like the E. 
coli contamination of our spinach and our lettuce that was a 
major challenge just some months ago.
    If you go to the next slide it really describes 
schematically, how we accomplish this. The NIAID research, for 
example on emerging and re-emerging infectious diseases is, as 
with all Institutes, based on a fundamental matrix of basic 
research which we hopefully then apply to the things that we 
need to do for the American public. In our case, it's the 
development of countermeasures, for example, in the forms of 
diagnostics, therapeutics and vaccines.

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    What I'd like to do in the next couple of slides is just go 
over with you some of the selected accomplishments which are 
also selected opportunities. So I'll go through them rapidly 
with you. If you look at HIV/AIDS, there has been this year, in 
addition to the great accomplishments of drugs that have 
essentially transformed the lives of HIV infected individuals. 
We know now that there have been a total, in a conservative 
estimate of about 3 million years of life saved in the United 
States on the basis of the anti-HIV therapeutic regimens that 
have been used.

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    This year we have a couple of new drugs that are very 
exciting and will in fact, even improve that menu of drugs that 
we have available. In addition we have expanded HIV vaccine 
trials that we have embarked upon: one in collaboration with 
Merck and one with the Vaccine Research Center at the National 
Institutes of Health. In addition there are new tools for 
improvement such as the announcement that you probably heard of 
a few months ago about the protective effect of medically 
supervised adult circumcision for the prevention of HIV 
infection.
    If you move on to malaria there have been some exciting new 
issues that have come up. For example, the sequencing of the 
parasite itself, and at least two or three of the vectors, 
namely the mosquitoes that cause it, allow us to get a greater 
insight into transmissibility, as well as drug resistance to 
the standard malaria anti-parasitic drugs.
    In influenza we're pleased to mention to you something that 
was announced just a short time ago, is that at our last 
hearing I mentioned to you that we were in the process of 
developing a pre-pandemic influenza vaccine. Just last month 
the FDA has approved that as an approved vaccine. We still need 
to make better vaccines for pandemic flu but we have at least 
one that's approved by the FDA.

                      UNIVERSAL INFLUENZA VACCINE

    Senator Harkin. That's not a universal?
    Dr. Fauci. No, no. We'll get to that, hopefully, in the 
questions. This isn't a universal--this is for the H5N1 bird 
flu.
    Senator Harkin. Specifically.
    Dr. Fauci. Specifically for the bird flu.

                EMERGING/RE-EMERGING INFECTIOUS DISEASES

    Then on the next slide I mention tuberculosis. I mentioned 
in my very earlier comments the real threat that we're seeing 
with this extensively drug resistant tuberculosis. NIAID has 
developed a strategic plan, very rapidly, which just this 
morning, at our National Advisory Council was presented to them 
for their final comments before we actually make it public. 
We'd be happy to provide that to you and your staff if you'd 
like it.

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    Then finally potential bio-terror agents, we've enhanced 
the infrastructure. Again a year or two ago I showed you the 
blueprints for the physical infrastructure that we were going 
to do. Several of those buildings are either near completion or 
actually up or--and operational such as the building on the NIH 
campus, building 33.
    So if we go now to the last slide. I just want to close by 
saying that I've been talking to you about the threats of 
emerging and re-emerging infections and how the NIH research 
endeavor can meet these challenges, hopefully. I refer to it on 
this slide as a perpetual challenge because microbes will 
continue to emerge and re-emerge and nothing that we can do 
because of their evolutionary capability is going to allow us 
to completely eliminate the threat.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                           PREPARED STATEMENT

    Dr. Fauci. The best that we can do and I think it's 
something very important, is to maintain that balance by a very 
robust, research portfolio that can be wedded to our public 
health endeavors. We appreciate you and the committee for the 
support that you've given us over so many years. Thank you very 
much.
    [The statement follows:]
               Prepared Statement of Dr. Anthony S. Fauci
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Allergy 
and Infectious Diseases (NIAID) of the National Institutes of Health 
(NIH). The fiscal year 2008 budget includes $4,592,482,000.
    The mission of NIAID is to conduct and support research to 
understand, treat, and prevent infectious and immune-mediated diseases. 
Infectious diseases include well-known killers such as HIV/AIDS, 
malaria, tuberculosis, lower respiratory infections and diarrheal 
illnesses; naturally emerging or re-emerging threats such as pandemic 
influenza and SARS; and ``deliberately emerging'' threats from 
potential agents of bioterrorism. Preemptive medicine, in the form of 
vaccines and other prevention tools, is a major focus of the NIAID 
research portfolio in infectious diseases. Immune-mediated disorders 
include autoimmune diseases such as type 1 diabetes, lupus, and 
rheumatoid arthritis as well as asthma, allergies, and problems 
associated with transplanted tissues and organs. Here again, preemptive 
medicine is an important component of our research efforts, as NIAID 
extramural scientists work to predict, prevent, and treat immune-
mediated diseases more effectively.
    The NIAID mission has two distinct mandates. First, NIAID must plan 
and execute a comprehensive, long-term program of basic and clinical 
research on well-recognized endemic infectious and immune-mediated 
diseases. Second--and in this case distinctive among the NIH 
Institutes--NIAID must respond quickly with targeted research to meet 
new and unexpected infectious disease threats as they arise, often in 
the form of public health emergencies.
              emerging and re-emerging infectious diseases
    Despite advances in medicine and public health such as antibiotics, 
vaccines, and improved sanitation, the World Health Organization (WHO) 
estimates that infectious diseases still account for approximately 26 
percent of all deaths worldwide, including about two-thirds of all 
deaths among children younger than 5 years of age. Moreover, the 
pathogens we face are not static, but change dramatically over time as 
new microbes emerge and familiar ones re-emerge with new properties or 
in unusual settings.
    Influenza is a classic example of a re-emerging disease. Because 
circulating human influenza viruses continually accumulate small 
changes, a new vaccine must be made for each influenza season. When an 
influenza virus emerges that has undergone a major genetic shift such 
that the global population has limited natural immunity but the virus 
can be easily transmitted among people, a worldwide pandemic can 
result. Three influenza pandemics occurred in the 20th century, 
including the 1918 pandemic that killed more than 50 million people 
worldwide.
    It is imperative that we take a preemptive approach to the 
possibility that a new influenza virus will emerge to cause a 1918-like 
pandemic. How well we do that, however, depends to a large extent on 
improving how we cope with seasonal influenza, which kills an average 
of about 36,000 people in the United States each year. Control of both 
seasonal and pandemic influenza requires development of and access to a 
sufficient supply of effective vaccines and antiviral drugs, effective 
infection control measures, and clear public communication. In this 
regard, NIAID research has directly laid the foundation for improved 
influenza vaccine manufacturing methods, new categories of vaccines 
that may work against multiple influenza strains, and the next 
generation of anti-influenza drugs. Certain of these goals will be 
accomplished through basic research projects intended to increase our 
understanding of how animal and human influenza viruses replicate, 
interact with their hosts, stimulate immune responses, and evolve into 
new strains. Other goals will be accomplished through targeted 
projects, such as a program to screen compounds for antiviral activity 
against influenza viruses.
    Since last year, we have made substantial progress in influenza 
vaccine research. The inactivated-virus H5N1 vaccine currently 
stockpiled by the Department of Health and Human Services has been 
shown in NIAID-sponsored clinical trials to be safe and capable of 
inducing an immune response predictive of being protective against the 
H5N1 virus in healthy adults, children, and seniors. Although the 
vaccine dose required to induce this response is high, studies on 
enhancing the immune response to lower doses by employing immune 
enhancers called adjuvants are showing promising preliminary results. 
NIAID also is collaborating with industry to pursue several other 
vaccine strategies in addition to inactivated virus H5N1 vaccines. For 
example, trials of cold-adapted, live-attenuated H5N1 vaccine 
candidates are underway, as is a Phase I clinical test of a novel DNA 
H5N1 vaccine candidate developed at the NIAID Vaccine Research Center.
    We also have made progress in antiviral drug and diagnostic test 
research over the past year. An NIAID program that screens both 
licensed drugs and new drug candidates--first in cell culture systems 
and then in animal models--has identified several promising anti-
influenza candidates that are now being further developed in 
partnership with industry sponsors. These include FluDase, which binds 
host cell receptors to prevent viral entry; T-705, which inhibits 
replication of viral RNA; and Peramavir, which inhibits an influenza 
enzyme called neuraminidase. Research into influenza diagnostics is 
being vigorously pursued. For example, NIAID-funded researchers, 
working in collaboration with scientists at the Centers for Disease 
Control and Prevention, have reported encouraging results with a 
potentially revolutionary diagnostic device called the MChip, which is 
capable of quickly and accurately identifying many influenza viruses, 
including H5N1.
    Tuberculosis (TB) is another emerging threat, especially with 
regard to new and dangerous drug-resistant forms of Mycobacterium 
tuberculosis that are being seen with increasing frequency. About one-
third of the global population is latently infected with the TB 
bacterium. WHO estimates that 8.9 million TB cases occurred in 2004, as 
did 1.7 million TB deaths; active TB is especially common among people 
with HIV. Currently, about 20 percent of new TB cases are a multi-drug 
resistant form (MDR-TB), meaning that they are resistant to two common 
and inexpensive antibiotics and are thus far more difficult to treat 
than uncomplicated TB cases. However, an even more resistant form, 
called extensively-drug resistant TB (XDR-TB), has appeared. XDR-TB 
already accounts for about 10 percent of all MDR-TB cases, that is, two 
percent of all new TB cases.
    The emergence of XDR-TB was not unexpected, but was a predictable 
consequence of imperfect compliance with the long and complex regimens 
needed to treat TB. We have long supported a large portfolio of 
research to develop new drugs, vaccines, and diagnostics for TB and to 
evaluate improved treatment and prevention regimens. As a result of 
that sustained effort, the ``pipeline'' of new countermeasures for TB 
is robust. At least nine new drugs are currently in clinical trials, 
including SQ-109, a promising candidate being developed in a private-
public partnership with Sequella, Inc. After a hiatus of 60 years in 
which no new TB vaccines were clinically tested, nine candidates are 
now in human trials, and at least ten more are in preclinical 
development. In addition, to ensure that the NIAID TB research program 
continues to contribute effectively to the global response to this 
increasing threat, the Institute has developed a comprehensive 
strategic plan for MDR/XDR-TB that will help guide our research 
efforts. .
    Influenza and TB are just two of many emerging and re-emerging 
infections on which NIAID conducts research. Malaria, long a leading 
cause of death worldwide, has become even more problematic because of 
the emergence of drug-resistant malaria parasites and insecticide-
resistant mosquito vectors. NIAID supports a large portfolio of malaria 
research that has generated many promising drug and vaccine candidates, 
some of which are now in clinical trials; this research is related to 
the President's Malaria Initiative, which was discussed at the December 
2006 White House Malaria Summit. In addition, NIAID conducts research 
on many other less common, but nonetheless important tropical diseases 
such as leishmaniasis, trypanosomiasis, hookworm, and lymphatic 
filariasis, which exact an enormous toll worldwide.
                           hiv/aids research
    In the almost 26 years since it was first recognized, the acquired 
immune deficiency syndrome (AIDS) has become a global catastrophe. An 
estimated 39.5 million people worldwide are infected with HIV, the 
virus that causes AIDS. In 2006 alone, an estimated 4.3 million people 
were newly infected with HIV, and 2.9 million died of AIDS.
    Although the global HIV situation remains grim, our government's 
investment in HIV research has generated many solid successes, and the 
healthy pipeline of new drugs, vaccines, and other prevention methods 
promises more successes in the future. Antiretroviral therapies made 
possible by NIAID-supported research have transformed HIV from an 
almost uniformly fatal infection into a manageable chronic condition. 
In this regard, a recent study concluded that since 1996 these 
antiretroviral medications have saved at least 3 million years of life 
in the United States alone. These life-saving therapies are now 
reaching the developing world: 1.6 million persons are now receiving 
antiretroviral therapy, more than half of them with support from the 
President's Emergency Plan for AIDS Relief (PEPFAR). In addition to 
these accomplishments, several new generation antiviral drugs that 
target HIV in novel ways are in the final stages of development.
    Prevention efforts continue to be a major component of NIAID's HIV 
research program. We have improved our ability to prevent mother-to-
child transmission. Research to develop topical microbicides capable of 
blocking HIV transmission during sexual contact is proceeding 
vigorously. And in December 2006, two NIAID-supported trials in Kenya 
and Uganda showed that medically supervised circumcision of adult males 
can significantly lower their risk of contracting HIV through 
heterosexual intercourse. The most powerful tool to prevent HIV 
infection would be a safe and effective HIV vaccine. NIAID is currently 
supporting 20 clinical trials of HIV vaccine candidates. Seven of these 
have moved beyond initial Phase I safety and immunogenicity testing. 
For example, in January 2007, a Phase IIb ``proof of concept'' trial of 
a non-replicating adenovirus vector modified to contain three HIV genes 
opened in South Africa. A related trial of the same candidate is 
ongoing in volunteers from North America, South America, Australia, and 
the Caribbean in collaboration with Merck pharmaceutical company. The 
NIAID Vaccine Research Center has also developed an HIV vaccine 
candidate that is currently being tested in Phase II trials, with an 
international Phase IIb efficacy trial set to begin later in 2007. 
Because of the enormous need for human testing of HIV drug, vaccine, 
and other prevention strategies, we recently reorganized our HIV/AIDS 
clinical trials network to make our clinical research capacity more 
efficient so that we can continue to meet evolving global AIDS research 
challenges. Additionally, NIH will contribute $300 million to the 
Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria in fiscal year 
2008.
                          biodefense research
    The possibility that terrorists will use a biological agent to 
mount an attack is a serious threat to the citizens of our nation and 
the world. Research to preempt and mitigate this threat is a key focus 
of NIAID, and complements our role in meeting the challenges of 
naturally emerging and re-emerging infectious diseases. Our strategic 
planning for biodefense research includes three essential pillars: 
infrastructure needed to safely conduct research on dangerous 
pathogens; basic research on microbes and host immune defenses that 
serves as the foundation for applied research; and targeted, milestone-
driven development of medical countermeasures to create the vaccines, 
therapeutics and diagnostics that we would need in the event of a 
bioterror attack. These efforts enhance not only our preparedness for a 
bioterrorism attack, but for naturally occurring endemic and emerging 
infectious diseases as well.
    NIAID has undertaken a substantial expansion of biocontainment 
research facilities, which will greatly enhance our ability to safely 
and efficiently conduct research on infectious agents. For example, 
through its extramural program, NIAID is supporting the construction of 
two National Biocontainment Laboratories capable of safely containing 
the most deadly pathogens, as well as thirteen Regional Biocontainment 
Laboratories nationwide. Three intramural biocontainment labs--on the 
NIH campus, on the National Interagency Biodefense Campus at Fort 
Detrick in Fredrick, Maryland, and at the NIAID Rocky Mountain 
Laboratories in Hamilton, Montana--are either complete or well under 
construction. In addition to these facilities, NIAID has established a 
nationwide network of ten Regional Centers of Excellence (RCEs) for 
Biodefense and Emerging Infectious Diseases Research, which conduct 
research and development activities and provide training for future 
biodefense researchers.
    The Institute's efforts have already yielded substantial dividends 
as described in our periodic progress reports, the latest of which was 
issued in January 2007. For example, new or improved vaccines and 
therapies against anthrax, smallpox and Ebola virus have shown great 
promise; among these is ST-246, a promising smallpox drug candidate 
that protects both rodents and nonhuman primates from lethal challenge.
    NIAID also has been assigned the responsibility to coordinate 
research to develop countermeasures against a range of radiological and 
chemical threats. We have established eight Centers for Medical 
Countermeasures against Radiation and four Centers for Countermeasures 
against Chemical Threats; in addition, basic and applied research is 
moving rapidly. We continue to coordinate and collaborate on these 
important components of our national security with our sister 
Institutes at NIH as well as interagency partners, including the 
Department of Defense, Department of Energy, and Department of Homeland 
Security.
                  research on immune-mediated diseases
    Autoimmune diseases, allergic diseases, asthma and other immune-
mediated diseases are significant causes of chronic disease and 
disability in the United States and throughout the world. NIAID-
supported research in immune-mediated diseases has led to significant 
advances in our understanding of how to manage these diseases.
    One promising strategy to treat and prevent immune-mediated 
diseases is the induction of immune tolerance. Immune tolerance 
therapies are designed to ``reprogram'' immune cells to eliminate 
injurious immune responses, such as those seen in autoimmune diseases, 
while preserving protective responses needed to fight infection. NIAID 
has established a comprehensive program in immune tolerance research, 
including basic research, preclinical testing of promising strategies 
in nonhuman primates, and clinical evaluation through the Immune 
Tolerance Network (ITN). In an important study of people with severe 
diabetes, the ITN has shown that the transplantation of pancreatic 
cells can improve blood sugar control, protect patients from severely 
low blood sugar, and, in a few cases, relieve patients of the need for 
insulin injections; unfortunately, insulin independence was not 
sustained in most subjects. Further research is underway to improve 
this promising procedure.
    Last year, NIAID-supported scientists reported the identification 
of new ways to non-invasively assess the risk of kidney graft rejection 
by using gene-expression based biomarkers of immunologic activity 
present in urine. These investigators are now conducting a multi-center 
study to validate these approaches that potentially could allow 
physicians to predict, prevent, and treat kidney rejection more 
effectively.
    NIAID remains committed to improving the health of children with 
asthma, particularly those who live in our Nation's inner cities. The 
NIAID-supported Inner City Asthma Consortium (ICAC) has undertaken two 
important efforts in this area. The ICAC is conducting the Urban 
Environment and Childhood Asthma (URECA) Study. Five hundred and fifty 
inner-city children have been enrolled at birth and will be followed 
prospectively during childhood. The goals of the study are to identify 
the immunologic causes of the development of recurrent wheezing, a 
surrogate marker for asthma in children under three, and to monitor the 
development of food allergies in this patient population.
                               conclusion
    The research conducted at NIAID and at NIAID-sponsored laboratories 
encompasses a broad array of basic, applied and clinical studies. This 
research has resulted in tangible benefits to the American public and 
to individuals throughout the world. By supporting talented researchers 
and emphasizing a balance of basic studies and targeted research, we 
will continue to develop innovative interventions to prevent, diagnose, 
and treat the wide range of infectious and immune-mediated diseases 
that afflict humanity.

                         COORDINATION WITH CDC

    Senator Harkin. Would it be safe to say, Dr. Fauci that 
your Institute probably intersects with CDC more than any other 
Institute?
    Dr. Fauci. I would think that would be safe to say. Several 
of the other Institutes do interact with CDC. But since CDC is 
responsible for the disease surveillance of those precise 
diseases, those emerging infections, that we are responsible 
for the research that develop the counter measures. There's a 
natural marriage between our Institutions in working together.

                COORDINATION WITH DEPARTMENT OF DEFENSE

    Senator Stevens. Dr. Fauci, we've put up a lot of money 
through the defense bill for similar endeavors. Do you 
coordinate with them?
    Dr. Fauci. Indeed we do, Senator Stevens. In fact, we have 
very robust collaborations with them. A couple of examples have 
been influenza, the bio-defense, the HIV and malaria as just 
four examples of things that we work very, very closely with 
the Department of Defense.
    In fact, we have cooperative agreements with them. In our 
bio-defense area we actually have a facility that's with them 
up at Fort Detrick. So the Department of Defense, NIH, NIAID 
interaction is very, very healthy.
    Senator Stevens. So there's not a redundancy there. You are 
keeping that coordinated, so it's not going to be.
    Dr. Fauci. It's complementary as opposed to redundant.
    Senator Stevens. Thank you.
    Senator Harkin. Now we turn to Dr. John Niederhuber, who 
became Director of the National Cancer Institute in September 
2006. Also served as NCI's acting Director and Deputy Director. 
He received his MD from the Ohio State University School of 
Medicine and his research at the NCI has focused on the study 
of tissue stem cells as the cell of origin for cancer. 
Interesting.
    Dr. Niederhuber, thank you very much for being here. You 
may proceed.
STATEMENT OF DR. JOHN E. NIEDERHUBER, DIRECTOR, 
            NATIONAL CANCER INSTITUTE, NATIONAL 
            INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH 
            AND HUMAN SERVICES
    Dr. Niederhuber. Chairman Harkin, Senator Stevens and 
members of the staff, thank you for the opportunity to testify 
today on behalf of the National Cancer Institute and the 
National Institutes of Health.
    Over the next few minutes, I would like to describe some of 
the progress NCI has made in cancer research along with some of 
the exciting opportunities we are pursuing.
    For 2 years now we have seen unprecedented decreases in the 
actual number of cancer deaths nationally. That is remarkable 
news considering cancer is largely a disease of aging and as 
you know our country is not only growing older, its population 
is also growing.
    Today's progress is occurring in no small part because 
researchers are coming to understand cancer's basic biologic 
processes. The sequencing of a human genome, a singular 
landmark in biomedical research, is providing a foundation for 
NCI's new Center of Human Cancer Genomics. Its mission is to 
systematically identify all important inherited and acquired 
genetic alterations that now contribute to a person's cancer 
risk and if cancer occurs, that cancer will behave. We are 
diligently working to understand these genetic changes and 
apply them to cancer prevention and to cancer treatment.
    Consider if you will that under the microscope, diffused, 
large B-cell lymphoma tumors from different patients look the 
same. However, when subjected to gene expression analysis, they 
have distinct genetic signatures. These differences in their 
genetic signature predict prognosis and enable us to 
individually characterize a patient's cancer and match him or 
her with the best treatment. Importantly, this is not a 
futuristic technique. We are already beginning to apply this 
technology in clinical settings such as lymphoma, lung and 
breast cancer.
    At the same time we are learning more about the mechanisms 
of a cancer cell including a small subset of cells within the 
tumor that drive the steps of invasion and growth. This subset 
of cells may enable the tumor to spread. Interestingly, these 
cells have stem cell like characteristics.
    Evidence is building that these so called cancer 
initiators, or transformed tissue stem cells are the driving 
force behind many tumors, and are the basis for long term risk 
of cancer recurrence. Clearly these cells will be a necessary 
target for treatment of the future.
    As we move toward an era of personalized medicine, advanced 
technologies will play a significant role in cancer prevention 
and preemption telling us in real time if a new drug treatment 
is reaching its target within the cell, if the novel drug is 
saturating that target, or if it is changing the function of 
the target. These early phase tests in patients will make go or 
no go decisions possible within hours, not within months for 
early cancer drug development, thus shortening development time 
and greatly decreasing cost.
    We also realize, however, that most cancer patients have 
yet to see the benefits of our science. Too many patients lack 
the means, the mobility or even the language capacity to travel 
to a premier facility. It is clear that access to care will be 
one of the greatest determinants of cancer mortality in the 
years ahead.
    Mindful of our mission to conduct research in all areas of 
science, including the behavioral sciences, such as how best to 
provide patient education and access to optimal care, NCI will 
in the next few weeks launch the pilot phase of a community 
cancer centers program that if fully implemented will bring 
state of the art cancer care to patients in community hospitals 
across the United States. This program will encourage and 
foster the collaboration of private practice medical, surgical 
and radiation oncologists with the opportunity for close links 
to NCI's research and to our NCI designated cancer centers.

                           PREPARED STATEMENT

    There is great cause for optimism in cancer science. But it 
must be tempered by an understanding of the hurdles we face. 
Cancer is a disease of staggering complexity with a singular 
name. Our progress is exciting. It is certainly encouraging, 
but we are continually challenged--challenged by our fellow 
citizens living with cancer to make faster progress.
    Thank you for the opportunity to testify before the 
Subcommittee this afternoon.
    [The statement follows:]
             Prepared Statement of Dr. John E. Niederhuber
                              introduction
    I am most pleased to be before you today to report on the Nation's 
progress in cancer research. While there has been a steady decline in 
the cancer mortality rate (the number of cancer deaths per 100,000 
people) since 1991, we now have the excellent news that--for the second 
year in a row--there has been a decline in the absolute number of 
cancer deaths. In 2003, there were 369 fewer cancer deaths reported in 
the United States than in 2002. In 2004 (the most recent year reported) 
the decrease was almost ten times greater, at 3,014 [Figure 1]. This 
decline is even more significant when you consider that cancer is 
largely a disease of aging, and our population is not only growing in 
numbers, it is aging at an even greater rate. Progress is, indeed, 
heartening, but our work is not done. Too many of our citizens--
patients and families alike--continue to feel the pain and fear that 
come with the devastating news of a cancer diagnosis. 

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  Figure 1.--The green line represents the cancer mortality rate per 
 100,000 population. The bars represent the actual recorded number of 
                  cancer deaths in the United States.

    While we measure our progress against cancer in terms of patients 
treated and lives saved, that effort also has a measurable economic 
impact. It has been projected that even a 1 percent decrease in cancer 
mortality will result in a $500 billion benefit to the U.S. economy 
(Murphy, K. and Topel, R., Journal of Political Economy, 2006; 114(5), 
871-904). In fact, such a benefit may ultimately be magnified many 
fold, because increasingly we recognize that cancer has become a model 
for developing our base of knowledge concerning many diseases. For 
example, the study of angiogenesis (blood vessel development) 
associated with tumor growth has been applied to greater understandings 
and treatment of macular degeneration, ischemic heart disease, diabetic 
wound healing, endometriosis and neurodegenerative illnesses. 
Furthermore, the unique capabilities of NCI's cancer researchers have 
been vital in other conditions. The identification of the AIDS virus 
and the development of assays to screen banked blood for the AIDS virus 
happened at the National Cancer Institute, where the current AIDS 
therapy regimen used around the world was also developed.
    Today, the NCI is leading the way in identifying the genetic, 
molecular, and cellular mechanisms associated with cancer--research 
fronts that hold great potential to enhance research and research 
collaboration against other diseases, as well. Building upon the 
sequencing of the human genome and working in our newly developed 
``Center for Human Cancer Genomics,'' NCI is systematically identifying 
all the important inherited and acquired genetic alterations that 
contribute to cancer susceptibility. We are cataloguing genetic changes 
involved in the process of a normal cell becoming malignant, and we are 
applying this knowledge, in order to identify people at increased risk 
for developing cancer, prevent and detect cancer at its earliest, most 
treatable stages, and identify new targets for highly selective and 
specific therapeutic agents.
                        a record of real success
    The past year for cancer research and development has been one of 
substantial and heartening achievement. We are expanding both our 
knowledge and the technology tools to understand the mechanisms of 
cancer. Importantly, we are seeing scientific advances being rapidly 
applied to predict and preempt cancer.
  --We reached an important public health milestone in June 2006, when 
        the FDA approved a vaccine that prevents infection by the two 
        types of the human papillomavirus (HPV) responsible for up to 
        70 percent of cervical cancer cases worldwide. We can all take 
        great pride in the fact that our Nation's strong commitment to 
        and investment in cancer research at NCI led to this approval.
  --Researchers have begun to survey the human genome for DNA variants, 
        to identify genes that predict risk for common cancers. 
        Capitalizing on new knowledge of human genetic variation and 
        technical advances in whole-genome scanning, The Cancer Genetic 
        Markers of Susceptibility (CGEMS) project is currently 
        targeting genes that increase the risk of prostate and breast 
        cancer [Figure 2]. Work is beginning on a similar study for 
        pancreatic cancer. These studies of large numbers of patients 
        will be useful both for understanding causal pathways and for 
        developing preventive interventions. DNA variants found to be 
        associated with cancer risk will rapidly be made available 
        publicly to the scientific community through the NCI cancer 
        Biomedical Informatics Grid (caBIG?) database.

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 Figure 2.--Previously developed technologies are used to analyze DNA 
                 specimens from large patient cohorts.

  --Genomic technology is already being applied to explain why some 
        patients with diffuse large B-cell lymphomas (DLBCL) live 
        longer and respond better to therapy than others [Figure 3]. 
        Under the microscope, the DLBCL cancer cells from every patient 
        look the same, but genetic differences have been shown to 
        predict good versus poor prognosis. As a result of this 
        research, it may be possible to determine which patients are 
        most likely to respond to a specific treatment, thus sparing 
        those patients unlikely to see a significant benefit the side 
        effects of a failed treatment.

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 Figure 3.--Previously developed technologies are used to analyze DNA 
                 specimens from large patient cohorts.

            delving deeply into the cancer cell environment
    Building on the success of the CGEMS project in identifying 
inherited genetic risks, the NCI and the National Human Genome Research 
Institute have launched a pilot phase of The Cancer Genome Atlas 
(TCGA), a collaboration designed to determine the feasibility of using 
large-scale genome analysis technology to identify important genetic 
changes involved in cancer. TCGA is currently studying lung, brain 
(glioblastoma), and ovarian cancers--which collectively account for 
more than 210,000 cancer cases each year in the United States.
    Other initiatives are expanding our study of the cancer cell--and 
the networks and the cellular microenvironment that also appear to be 
significantly involved in tumor development and metastasis. These 
studies of molecular carcinogenesis are being conducted at the single-
cell or the subcellular level, using high-resolution, three-dimensional 
electron microscopy. These technologies allow us to look within the 
nucleus to study differences in chromosome movement and location during 
stages of abnormal cell growth.
    On another front, there is increasing evidence that cancer ``stem 
cells'' or ``cancer initiator'' cells are both the driving force behind 
many cancers and the basis for long-term risk. The presence of such 
cells, first demonstrated in acute myeloid leukemia patients, provides 
a different and exciting model with which to further explore cancer 
biology. NCI is establishing a group of scientists across the National 
Institutes of Health interested in embryogenesis and cancer stem cell 
biology, in order to advance the study of the underlying mechanisms in 
these processes.
               advanced technologies accelerate progress
    It is clear that the area of advanced technologies development is 
absolutely essential and critical in creating tools for speeding up and 
enabling the discovery process. In addition to the genomic technology 
projects (CGEMS and TCGA), NCI is investing in the development of 
critical technology platforms in a number of other strategic areas, 
such as nanobiology, proteomics and computational biology.
    Recognizing the key role of biospecimens in all of biomedical 
research, not just cancer research, NCI has led a pioneering effort to 
provide the first guidelines that standardize and enhance specimen 
collection and biorepositories. These guidelines have made it possible 
for NCI to develop a common biorepository infrastructure that promotes 
resource-sharing and enables data comparison among research 
laboratories, while also ensuring patient protection and ethical 
integrity.
    We also believe that advanced imaging technologies will play a 
significant role in the prevention and preemption of cancer, as well as 
in making ``go or no-go'' decisions for early oncologic drug 
development. The NCI is working now in the aforementioned subcellular 
space, to be able to view--in real time--the interactions between drugs 
and cells and the resulting secondary functional changes. The NCI is 
developing new targeted and non-targeted molecular imaging agents for 
use as lymphatic markers, angiogenic markers, and surrogate markers for 
drugs that enhance quantitative methods to measure early, real-time 
tumor response. These technologies are further examples of NCI 
initiatives that produce benefits that will be realized across multiple 
areas of biomedical research.
                       interagency collaborations
    Addressing cancer requires work across institutional and sector 
boundaries, so members of the Department of Health and Human Services 
(DHHS) family of agencies, other federal offices, and the private 
sector can share knowledge and partner in the development of systems-
based solutions. NCI has long been at the forefront of research and 
development of biomarkers for use in diagnosis and treatment for 
cancer. Now, a Biomarkers Consortium launched last year includes 
participants from the Foundation for the NIH, NIH, FDA, CMS, and 
private industry--with the goal of validating biological markers for a 
variety of diseases, including cancer. The first project approved by 
the Consortium is the evaluation of an imaging agent that detects an 
increase in cell metabolism characteristic of tumor growth. NCI is 
conducting trials in lung cancer and non-Hodgkin's lymphoma that use 
this ability to view cellular metabolism to monitor tumor masses for 
increased activity (cell growth) or decreased activity (cell death) 
during the early stages of anticancer treatment.
    The joint NCI-FDA Interagency Oncology Task Force (IOTF), 
established in 2003 to enhance and accelerate the overall process of 
developing new cancer interventions, released two new guidance 
documents and a final rule intended to streamline the early clinical 
development of new drugs and biologics for cancer and other diseases. 
This has enabled the first-in-human ``Phase 0'' trial (a step before 
the classic Phase 1 level of drug study) that measures the activity of 
a new drug in a limited number of patients using a single, small dose 
of the study agent, prior to the traditional dose-escalation, safety 
and tolerance studies. Phase 0 will substantially compress drug 
development time.
           training the next generation of cancer researchers
    Cancer is one of the most exciting and innovative areas of medical 
research. It takes a superbly trained, highly effective workforce to 
make discoveries, to translate them into new interventions, and to put 
the improved knowledge base and cutting-edge tools to work for 
patients. NCI will continue to play an important role in developing the 
cancer research workforce in the United States and in other countries. 
We stand firmly by the Institute's commitment to provide unparalleled 
training opportunities for talented researchers from a wide variety of 
disciplines to advance their careers. In fact, many of the current 
programs at NIH had their origins in the NCI.
    Of special significance are minority training programs, such as the 
Continuing Umbrella of Research Experiences (CURE), which begins with 
talented minority high-school students and continues progressively and 
selectively through long-term funding to qualified minority students 
interested in scientific, cancer research-related careers.
                   reaching the patient and community
    NCI must continue to make progress for each cancer patient. Yet, 
the recent report on cancer deaths that showed a decrease in deaths 
nationally also confirms a troubling fact: Minority and low-income 
populations shoulder a disproportionate cancer burden and are not 
benefiting equally from important advances. We must bring the best 
science to patients, 85 percent of whom are treated in the communities 
where they live. With that obligation in mind, NCI is launching a pilot 
of the Community Cancer Centers Program (NCCCP). This pilot project 
will study how best to provide easily accessible, state-of-the-art, 
multi-specialty cancer care and earliest phase clinical trials research 
to patients in their communities. Through this program we will also 
learn best how to educate patients concerning risk, healthier living, 
screening practices, clinical trial participation, survivorship, and 
end-of-life issues.
    This program is about bringing the newest science to patients where 
they live--a challenge that is more critical now than at any time in 
our history. Our nation's healthcare system faces many looming 
stresses, particularly in light of the fact that the first wave of baby 
boomers turns 65 in 2011. With the graying of a generation comes the 
need for a new way to confront the diseases of aging--and especially to 
anticipate what will be a marked increase in cancer incidence. That 
makes even more important our efforts to develop advanced technologies 
that will eventually lead to the genomic and proteomic breakthroughs 
essential to enable us to preempt disease at earlier stages.
    There is great cause for optimism, but an optimism that should be 
tempered by an understanding of the very real hurdles to progress we 
still face. These are challenges that we must address as a community. 
In doing so, the encouraging trends of decreasing death rates from 
cancer will become the rule, not the exception. We will learn how to 
deliver the best of our science to everyone--not just a few.

    Senator Harkin. Thank you, Dr. Niederhuber. Let's go on 
here unless you have a specific question right now.
    Senator Stevens. No.
    Senator Harkin. Dr. Barbara Alving was named as the 
Director of the National Center for Research Resources in 
April, although she served as acting Director before that. Her 
medical degree is from Georgetown University School of 
Medicine. Dr. Alving has published more than 100 papers in the 
areas of thrombosis and hemostasis.
    Dr. Alving, welcome to the committee.
STATEMENT OF DR. BARBARA M. ALVING, DIRECTOR, NATIONAL 
            CENTER FOR RESEARCH RESOURCES
    Dr. Alving. Thank you. Mr. Chairman, Senator Stevens, It's 
a great honor to discuss the mission and activities of the 
National Center for Research Resources today.
    The research center is very different from the two ICs that 
you've heard about earlier. They are categorical. They're 
focused on specific disease areas, specific missions. The 
National Center for Research Resources, which is greater than a 
$1 billion center. Is really focused on providing the 
infrastructure and support to investigators and institutions 
throughout the country. That can really provide the support for 
studies in the categorical diseases.

                  CLINICAL AND TRANSLATIONAL RESEARCH

    What we are focusing on at NCRR is clinical and 
translational research. By that, we're focusing on the ability 
to go from very basic studies, into preclinical studies, into 
clinical trials, and dissemination out into the public. The 
NCRR is very well situated for this.
    For example, we have a division of comparative medicine 
that provides animal resources for the preclinical studies that 
are needed to test drugs before they go into clinical trials. 
We fund the eight national primate centers. I might add we also 
support Chimp Haven for the long-term retirement of those 
chimpanzees that have been involved in research.
    We fund biomedical technology resources that provide 
cutting edge research in new imaging techniques that can then 
be used in clinical trials.
    We fund the General Clinical Research Centers that have 
been situated at academic institutions throughout the country 
to provide better ways to conduct clinical trials and the 
resources needed for biostatistics. What's very exciting is 
that this program of General Clinical Research Centers is now 
transitioning into a very large program known as the Clinical 
and Translational Science Awards.
    In addition we fund outreach programs through our Science 
Education Partnership Awards that allow investigators to 
actually partner with museums to have public displays on, for 
example, research opportunities, discussions of stem cell 
research, so that children throughout school systems can learn 
much more about the type of science, as well as the chronic 
diseases that are being studied in this country.
    On the second slide here you see a little swirly area which 
represents a clinical and translational science award for an 
academic health center. As we have said, the General Clinical 
Research Centers that are funded throughout the United States 
are now going to be the academic health centers transitioning 
into receiving these clinical and translational science awards.

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    This means that each academic health center that receives 
such an award agrees to form a home for clinical and 
translational science. This will make all of our studies much 
more efficient, so that we can bring new research and new drugs 
out into the public much more rapidly and train a new 
generation of clinical and translational researchers. So 
they'll know how to interact with the FDA and they'll 
understand the rules. They will know how to develop better ways 
of doing clinical trials so that we can have more rapid accrual 
and less time delay and less expense.
    Each of these academic health centers has agreed to form 
partnerships with the others, so this is really a consortium, 
and they will interact with industry as well as with other 
organizations such as Kaiser Permanente and the VA. These 
organizations are very rich in informatics and we want to bring 
interoperable informatics information systems throughout the 
country.
    The third slide shows the United States in yellow. The 
little red stars show the first 12 CTSAs that have been awarded 
throughout the country. This was done in October 2006, along 
with 52 planning grants. By 2012, we hope to have 60 CTSA 
awards at a total annual cost of $500 million per year. But we 
fund other large programs at NCRR, and we want to create a 
matrix of interactions with programs.

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                    INSTITUTIONAL DEVELOPMENT AWARD

    In the fourth slide you see the IDeA program. I think 
Senator Stevens is probably very well aware of this program. It 
is providing funding to 23 States and Puerto Rico that receive 
less--historically a lower amount of NIH funding. This is 
usually due because they have rural populations or small 
populations. These awards are allowing students from 
undergraduate colleges to have access to research training in 
some of the larger universities in these States.

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    We also realize they need to be connected because of their 
vast challenges of distance. So you see in the slide that shows 
the green States, those are the IDeA States red line which is 
Lariat. That's really a lasso to bring high speed information 
systems and fiber optic networks to six States that are very, 
very far apart that need to be connected. So through this 
Lariat project we've connected Hawaii, Alaska, Idaho, Nevada, 
Montana, and Wyoming. This provides the latest opportunities to 
conduct science through this high speed fiber optic system. It 
also has improved the economies of these States and allows the 
delivery of health care. We want to continue this in other 
areas.

               RESEARCH CENTERS IN MINORITY INSTITUTIONS

    If you go to the fifth slide to the map of the United 
States, you see another picture. You see the Research Centers 
in Minority Institutions. These are centers that include 
historically black academic health centers and Hispanic 
centers. These too, need to be linked up and have the latest 
opportunities.

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    We provide funding to these centers to conduct clinical 
research and training as well as basic research. What we're 
doing now is encouraging them and they are very eager to link 
up into this new clinical and translational science program. So 
we have Meharry talking with Vanderbilt. Morehouse is talking 
with Emory. Charles Drew is talking with UCLA. How can they 
form partnerships? How can they provide outreach to the 
communities?

                        MATRIX OF OPPORTUNITIES

    Basically, at NCRR, we are now focusing throughout the 
center on translational and clinical sciences. We want to 
create a matrix of opportunities for this nationally, 
geographically and racially diverse matrix of academic health 
centers and other institutions. We want to include links to 
PHARMA, biotech, state and Federal agencies, as well as to CMS 
and the FDA, so that we can have a seamless interaction.

                           PREPARED STATEMENT

    The whole result of this will be to provide better access 
to health care to our diverse populations. We're very aware of 
the increased amount of money going to health care. We want to 
make this much more efficient. We want to train the new 
generations of investigators who have to carry out this work.
    Thank you for the opportunity to discuss this.
    [The statement follows:]
              Prepared Statement of Hon. Barbara M. Alving
    Mr. Chairman and Members of the Committee: It is a privilege to 
present to you the President's budget request for the National Center 
for Research Resources (NCRR) for fiscal year 2008. The fiscal year 
2008 budget includes $1,112,498,000. I appreciate this opportunity to 
discuss with you our vision of the future of health and medicine and to 
share ways NCRR programs are transforming clinical and translational 
research.
    The NCRR, which is one of the 27 Institutes and Centers at the 
National Institutes of Health (NIH), provides NIH-supported laboratory 
and clinical researchers with the infrastructure, tools, and training 
they need to understand, detect, treat, and prevent a wide range of 
diseases. With this support, scientists engage in basic laboratory 
research, translate these findings to animal-based studies, and then 
apply them to patient-oriented research. Through innovative programs 
and resources that transcend geographical boundaries, NCRR connects 
researchers with one another, and with patients and communities across 
the Nation. These connections bring together innovative research teams 
and the power of shared resources, multiplying the opportunities to 
improve human health.
                     transforming clinical research
    Given its mission and support to more than 30,000 basic and 
clinical researchers, NCRR has become the leader of the NIH Roadmap for 
Medical Research effort to energize the discipline of clinical and 
translational research. To remove the barriers identified by the 
research community, NCRR launched the Clinical and Translational 
Science Award (CTSA) program, which is a national consortium designed 
to more rapidly and efficiently facilitate the transfer of discoveries 
made in the laboratory into new treatments for patients. Through the 
CTSAs, academic health centers are developing centers, departments, or 
institutions for interdisciplinary teams that cover the complete 
spectrum of research from basic biology to clinical medicine. These 
academic homes also will train the next generation of researchers in 
translational and clinical research.
    On September 30, 2006, we made the first CTSA awards to 12 academic 
health centers throughout the country. We will award the second group 
of CTSAs this fall. By 2012, the CTSA Consortium is expected to include 
approximately 60 CTSAs.
    The impact of the CTSA Consortium will be far greater than the 
number of awards made. The Consortium will develop better designs for 
clinical trials, forge new partnerships with health care organizations, 
and expand outreach to minority and medically underserved communities. 
The CTSAs will focus on both types of translational research--ensuring 
first that basic discoveries are applied to the clinic and second that 
they are further translated into community practice. Improving clinical 
research informatics will be a prominent focus of the Consortium. 
Institutions are taking steps to prioritize their efforts to ensure 
that standards are developed, interoperability is enhanced, and 
communication resources are accessible to researchers and their 
patients.
    To improve communication with the public and our stakeholders about 
our progress, as well as to foster collaborations within and beyond the 
Consortium, we recently launched the CTSAWeb.org site. I encourage you 
to visit the site and learn more about the CTSA Consortium. We also 
have started plans to evaluate the Consortium to ensure that the 
program spurs innovation, integration, inclusion, and dissemination.
    Already, we are starting to see significant changes within and 
across the CTSA institutions. As a result of this effort, academic 
health centers are developing new curriculums, revamping their 
organizational structures, creating unprecedented partnerships with 
other medical and research disciplines, and generating medical 
advances. For example, the Institute for Translational Medicine and 
Therapeutics (ITMAT) at the University of Pennsylvania--a trans-
institutional endeavor with the Children's Hospital of Philadelphia, 
the Wistar Institute, and the University of Sciences in Philadelphia--
is leading clinical and translational research and fostering 
interdisciplinary science. Now with the CTSA award, ITMAT will also 
become the home to new centers in bioinformatics, personalized 
medicine, imaging, and chemical biology. At the same time, the 
University of Texas Health Science Center at Houston CTSA is 
encouraging participatory research by connecting with Hispanic 
communities on the border. By linking with NCRR's Science Education 
Partnership Award program in Houston, this CTSA is improving the 
public's understanding of the importance of clinical trial 
participation. As the CTSAs begin to work together, the benefits of the 
program will extend to the greater research community and ultimately be 
incorporated into clinical care.
    I am pleased to report that this transformation is creating new 
energy and opportunities within NCRR and across the NIH. The CTSA 
initiative is further enhancing NCRR's long-standing investments in 
advancing translational research and providing new opportunities for 
community engagement. The addition of the CTSA Consortium to the matrix 
of NCRR programs is providing opportunities for increased cohesion and 
interaction throughout our entire research portfolio. Similarly, the 
truly trans-NIH nature of the CTSA program is facilitating interactions 
among the NIH Institutes and Centers and helping to ensure that the 
benefits of the Consortium are realized across the full spectrum of 
medical research.
                    advancing translational research
    Helping to propel the CTSA discovery engines are NCRR's 
translational research programs. Our readily available animal models 
and biomedical technology resources are fueling advancements in 
clinical care. We are exploring opportunities to enhance interactions 
among our translational programs and the CTSA Consortium to further 
capitalize on our research investments.
    Animal models are the bridge between basic science and human 
medicine. The NCRR provides such models through specialized laboratory 
animals, research facilities, and training. Linking NCRR's animal 
resources with CTSAs will allow for more seamless translation from pre-
clinical findings to clinical trials. This is already underway at two 
CTSAs, the University of California-Davis and the Oregon Health and 
Science University, which are connecting with the NCRR-supported 
National Primate Research Centers at their institutions. To provide 
researchers with easier access to animal models, and thus further 
accelerate translational research, we sponsored a workshop in 2006 to 
explore approaches to develop a resource that would enable researchers 
to find and use animal and other biological resources more efficiently. 
Based on stakeholder recommendations, we are planning to fund a 
comprehensive electronic catalog of animal model resources in fiscal 
year 2008.
    Technologies are critical throughout all stages of biomedical 
research--from basic discovery to clinical application. The NCRR 
support for biomedical technology (BT) resource centers provides 
researchers with a broad spectrum of technologies, techniques, and 
methods. Across the nation, researchers depend on these centers for a 
wide variety of clinical and translational studies. For example, 
researchers at the University of Illinois are developing software to 
help analyze the motions of viruses, so that they can better predict 
the virulence of these organisms. At the University of Wisconsin-
Madison, another BT resource center, researchers are using advanced 
nuclear magnetic resonance technologies to develop faster and more 
cost-effective methods for studying how biological systems work and 
respond to drugs. In the future, technologies developed at the BT 
resource centers may lead to discoveries that the CTSAs can translate 
into improved patient care.
                     enhancing community engagement
    The launch of the CTSA initiative has further enhanced our 
appreciation of the need to actively engage not only the researchers 
but also the American public. Our programs are providing opportunities 
for people in underserved communities to participate and shape medical 
research. Our innovative science education programs are inspiring 
children to pursue careers in biomedical research and are increasing 
the public's understanding of medicine. By reaching out to new 
collaborators and strengthening our partnerships, NCRR is facilitating 
connections that are sparking new discoveries and maximizing the 
effectiveness of the matrix of NCRR programs.
    NCRR has two successful programs that are creating new research 
opportunities for underserved communities. First, the Research Centers 
in Minority Institutions (RCMI) program increases the number of 
minority scientists engaged in biomedical research and enhances the 
research capacity and infrastructure at minority colleges and 
universities that offer doctorate degrees in health sciences. This 
program increases the number of minority scientists engaged in 
biomedical research and facilitates studies on minority health. Second, 
the Institutional Development Award (IDeA) program fosters health-
related research and increases the competitiveness of investigators at 
institutions in 23 states and Puerto Rico, which have historically low 
aggregate success rates for grant awards from the NIH. The IDeA program 
provides workforce development, research opportunities, science 
education, and extends high-speed connectivity to IDeA institutions to 
facilitate research collaborations. For example, NCRR funded the Lariat 
Project to provide six states (Alaska, Hawaii, Idaho, Montana, Nevada, 
and Wyoming) with high-speed, fiber-optic network connections. This 
project has improved not only research capacity in these states, but 
also enhanced their economic development, higher education, and 
healthcare opportunities. To ensure these underserved communities have 
access to innovative research opportunities, we are exploring ways to 
facilitate partnerships with these communities and the CTSAs.
    One of the many ways that community engagement is improving 
research is through a component of the IDeA program called IDeA 
Networks of Biomedical Research Excellence (INBRE) program. This 
program enables critical connections among different research 
institutions and facilities, as well as between mentors and students. 
For example, the Montana INBRE brought together the seven tribal 
colleges within the state to conduct collaborative research projects. 
Today, these tribal colleges, which prior to the INBRE program had not 
interacted on research projects, are working together to identify 
research areas and collaborate with other undergraduate institutions 
within Montana.
    Community engagement is synonymous with the NCRR Science Education 
Partnership Award (SEPA) program. By bringing together active 
biomedical and clinical researchers with educators, community leaders, 
and other interested organizational leaders, SEPA is stimulating public 
interest in health issues and encouraging young people to pursue 
careers in medical research. SEPA grantees currently collaborate with 
several RCMI and IDeA institutions and are beginning to make similar 
connections through CTSA community engagement activities. At Jackson 
State University, RCMI- and IDeA-funded researchers have partnered with 
the Jackson Public Schools through a SEPA grant to provide mentoring 
and research internships for students and professional development for 
teachers. Another SEPA project at the University of Utah, offers over 
100 online activities, podcasts, and virtual labs on topics ranging 
from cloning to stem cells.
    Innovative partnerships are providing the cohesion needed to ensure 
that the matrix of NCRR programs results in a maximum return on 
investment for all Americans. We are expanding our outreach efforts 
with the pharmaceutical industry, healthcare organizations and 
providers, and other Federal agencies, such as the Food and Drug 
Administration and the National Science Foundation. These collaborative 
partnerships will not only enable us to make research discoveries 
faster, but will ensure that these discoveries are quickly translated 
into improved patient care.
                               conclusion
    Through our matrix of programs and partnerships, NCRR expects to 
fulfill its charge to transform the practice of clinical and 
translational research and in turn, improve the future of health and 
medicine. The launch of the CTSA Consortium marks an exciting time in 
the history of NIH and for our Nation. It further enhances NCRR's long-
standing investment in basic, translational, and clinical research. Our 
innovative programs and partnerships are maximizing our research 
investment to ensure that medical advances are reaching the people who 
need them.

    Senator Harkin. Dr. Alving, thank you very much.
    Now we turn to Dr. Patricia Grady, who has served as the 
Director of the National Institute of Nursing Research since 
1995. She pursued her graduate education at the University of 
Maryland, receiving a Master's Degree from the School of 
Nursing and a Doctorate in Physiology from the School of 
Medicine. Dr. Grady's scientific focus is primarily in stroke 
research.
    Dr. Grady, welcome back to the committee.
STATEMENT OF DR. PATRICIA A. GRADY, DIRECTOR, NATIONAL 
            INSTITUTE OF NURSING RESEARCH
    Dr. Grady. Thank you, Mr. Chairman. I appreciate the 
opportunity to present to you, Senator Stevens and the staff, a 
brief description of some of the activities that are going on 
at the National Institute of Nursing Research.
    The NINR supports clinical and basic research to establish 
a scientific basis for the care of individuals across the life 
span. NINR's research has contributed to improving the health 
of the American people for more than two decades. Our 20th 
anniversary provided an opportunity to look toward the future 
and update our strategic plan which formulates innovative ways 
to address the major health challenges facing our Nation, 
including the concurrent trends of an aging population, a 
growing racial and cultural diversity, an increasing reliance 
on technology and a rising demand for nurses.
    In response to these and other challenges, you heard the 
Director of NIH call for a new kind of health care system. In 
the spirit of today's hearing I would like to briefly describe 
for you important research that is preemptive and predictive 
and how that research is shaping our vision for the future.
    The first preemptive example could have major implications 
for improving the lives of premature infants and their parents. 
Current practice during the birth of a pre-term infant is to 
clamp the umbilical cord immediately after delivery. However, 
delayed cord clamping has been shown to have certain advantages 
for the infant.
    In a recent study, NINR supported investigators compared 
the effect of immediate verses delayed umbilical cord clamping. 
The results of this simple modification were very encouraging. 
Infants in the delayed cord clamping group had nearly a ten-
fold lower rate of late onset infection and nearly a three-fold 
lower rate of brain hemorrhage. Each of these complications 
carries a high risk of disease, disability and death.
    Another study tested the effect of a coping intervention 
for parents of pre-term infants, in which parents participated 
in a program about prematurity, infant behaviors and infant 
development. The effect of this program was dramatic. Parents 
demonstrated improved parenting behaviors and reported 
decreased stress levels. Moreover, the infants averaged 3.8 
fewer days in the Neonatal Intensive Care Unit, which 
translated to a savings of roughly $5,000 per infant.
    Developing preemptive strategies to reduce the risk factors 
for cardiovascular disease is another important research focus 
for us. A group of investigators tested a community based 
behavioral educational intervention to improve blood pressure 
management among young African American men. The intervention 
reduced blood pressure and subsequently reduced by half the 
incidence of left ventricular hypertrophy, a form of heart 
damage caused by high blood pressure.
    We've also made strides in studying and preventing medical 
errors that continue to trouble our hospitals and clinics. For 
example, surgical sponges accidentally left inside patients can 
lead to complications ranging from infection to death. NINR 
investigators demonstrated that a radio frequency 
identification tag system for surgical sponges could quickly 
and accurately detect the presence of sponges retained at 
surgery. This is just one example of the type of innovative 
research needed to reduce the adverse health effects and 
significant cost implications associated with medical errors.
    Investigators have also demonstrated a clear link between 
low nurse staffing levels and an increase risk to patients.
    Senator Harkin. What?
    Dr. Grady. Low nurse staffing levels and an increased risk 
to patients. Decreased nurse staffing levels are associated 
with increased mortality and morbidity, specifically, 
infections and other complications. These studies highlight the 
importance of the growing national nursing shortage upon the 
health of our population.
    Finally, nowhere is the need for better preventive and 
preemptive efforts greater than in the minority communities and 
in other underserved populations. Recently scientists reported 
the first randomized controlled trial of a culturally tailored 
HIV risk-reduction program for Hispanic adolescents, a program 
that was successful in reducing risky behaviors for up to 1 
year.
    Another group of scientists developed an intervention that 
reduced stress and depression in low income single mothers, 
improving their ability to care for their children. Programs 
such as these are critical for reducing health problems in 
vulnerable communities and demonstrate the progress we have 
made already.
    Let me now provide you with a few examples of new methods 
for predicting the needs of patients and for anticipating ways 
to proactively maintain quality of life for patients and their 
caregivers. One example of predictive illness management comes 
from NINR's research on the care of patients at the end of 
life. As you probably know, NINR is the lead institute at NIH 
for this important area of research.
    One of our research teams characterized the functional 
decline in patients with specific illnesses in the last year of 
life. Trajectories range from--sudden, unexpected death to 
variations in illness and recovery, to steady and irreversible 
decline. This knowledge helps caregivers to better anticipate 
the course of illness, allowing the health team to tailor 
treatment strategies and improve quality of care.
    Yet another study showed that minority patients who used 
spiritual coping are more likely to want aggressive care at the 
end of life such as life support, tube feeding or mechanical 
ventilation. Such findings can allow caregivers to better 
incorporate the culturally based needs and desires of patients 
and their families.

                           PREPARED STATEMENT

    In conclusion, NINR is strongly committed to the NIH vision 
of a healthier Nation. We are proud of the important progress 
we have made toward this goal and we look forward to continued 
successes. We stand ready to address tomorrow's challenges 
based upon our 20 years of scientific accomplishments. Thank 
you, Mr. Chairman, Senator Stevens. I'd be happy to answer any 
questions that you or the Committee might have.
    [The statement follows:]
              Prepared Statement of Dr. Patricia A. Grady
    Mr. Chairman and Members of the Committee: I appreciate the 
opportunity to present the fiscal year 2008 President's budget request 
for the National Institute of Nursing Research (NINR). The fiscal year 
2008 budget included $137,800,000.
                              introduction
    The mission of the NINR is to support clinical and basic research 
that establishes a scientific basis for the care of individuals across 
the lifespan--from management of patients during illness and recovery 
to the reduction of risks for disease and disability, the promotion of 
healthy lifestyles, promoting quality of life in those with chronic 
illness, and care for individuals at the end of life. NINR's research 
programs also place special emphasis on eliminating health disparities 
and on the health issues faced by the underserved.
    NINR's research has contributed to improving the health of the 
American people for more than two decades. In 2006, NINR concluded the 
year-long observance of our 20th anniversary at NIH. During that 
period, we took stock of our scientific accomplishments, recognized our 
contributions to clinical practice, and launched a newly revamped web-
site in support of our stakeholders. We also assessed the future role 
of nursing science in addressing the major health challenges of our 
Nation: an aging population; a growing racial and cultural diversity 
and the attendant health disparities; an increasing reliance on 
technology in health care settings; and a rising demand for nurses. 
Within this context, NINR developed a new, forward-looking Strategic 
Plan.
    NINR's new 5-year Strategic Plan elucidates a unified framework for 
addressing the dynamic health care landscape. The Plan leverages key 
strengths of the NINR research community and focuses on areas of 
critical research opportunity including: Self-Management, Symptom 
Management, and Caregiving; Health Promotion and Disease Prevention; 
Research Capacity Development; Technology Integration; and End-of-Life. 
Pursuing this strategy, we seek to apply NINR's resources to the areas 
of public health which have the greatest needs, and in which NINR can 
have the greatest impact.
    Allow me to briefly describe our programs within this framework, 
highlight recent accomplishments, and share our vision for the future.
                         ninr research programs
    Self-management, Symptom Management, and Caregiving.--NINR's focus 
on the quality-of-life science continuum comprises three key research 
concepts: self-management, symptom management, and caregiving. Self-
management science explores strategies that empower individuals to be 
more involved in their own health practices. Symptom management science 
focuses on biological and behavioral components of health and illness 
that improve the management of symptoms. Caregiving science addresses 
the quality-of-life dimensions experienced by care recipients as well 
as formal and informal caregivers across diverse health care settings.
    Improving Care of Premature Infants.--According to the Centers for 
Disease Control and Prevention (CDC), half a million preterm infants 
are born in the United States each year, carrying a significant risk of 
death and disability, and often requiring care in a neonatal intensive 
care unit (NICU). In addition, their parents endure high levels of 
stress, anxiety, and depression (Miles, 1999; Singer, 1999, Wereszczak, 
1997).
    In one study, NINR-supported investigators assessed the effect of 
``immediate'' (7 seconds) versus ``delayed'' (32 seconds) umbilical 
cord clamping on health parameters of preterm infants. Compared to the 
immediate clamping group, infants in the delayed group had nearly a 10-
fold lower rate of late-onset septic infection, which carries a high 
risk of morbidity and mortality (IOM, 2006), and nearly a 3-fold lower 
rate of intraventricular hemorrhage, which carries a risk of 
developmental deficits (IOM, 2006).
    Another study by NINR-supported investigators assessed the effect 
of an educational program on the psychological care needs of parents of 
preterm infants. Utilizing the Creating Opportunities for Parental 
Empowerment (COPE) educational program, parents were taught about 
prematurity, infant behaviors, and infant development. As a result, 
parents demonstrated improved parenting behaviors and reported 
decreased stress levels. Meanwhile, the infants averaged 3.8 fewer days 
in the NICU than controls, which translated to a savings of roughly 
$5,000 per infant (Melnyk, 2006).
    Taken together, these studies demonstrate the significant potential 
benefits of combining a minor modification to a medical procedure at 
virtually no cost and an educational program during the care of preterm 
infants to improve health outcomes while reducing health expenditures. 
Their adoption into standard practice, and the exploration of 
additional approaches, could result in a more robust reduction in 
prematurity-related complications in early childhood, disability, 
death, and health care costs in excess of the $2.5 billion in estimated 
potential savings through the COPE intervention alone ($5,000 savings 
per infant multiplied by the estimated 500,000 preterm infants born in 
the United States each year).
    Quality-of-life research directly impacts populations across the 
lifespan from the very early stages of life. In 2007, NINR plans to 
support research on symptom clusters in cancer and immune diseases, as 
well as biobehavioral research methods.
    Health Promotion and Disease Prevention.--Within Health Promotion 
and Disease Prevention, NINR scientists explore dimensions of behavior, 
health in community settings, patient safety, and the biological 
factors useful in ensuring long-term positive health outcomes.
    Culturally-tailored HIV/AIDS Intervention for Hispanic Youths.--
According to the CDC, the incidence of acquired immune deficiency 
syndrome (AIDS) is up to three times higher among Latino adolescents 
than among their white counterparts (CDC, 2004). NINR-supported 
scientists tested a culturally-tailored HIV education program called 
``Cuidate! (Take Care of Yourself)'' among Hispanic adolescents. 
Compared to controls, youths in the program were 34 percent less likely 
to report having had sexual intercourse in the past 3 months, 47 
percent less likely to report having multiple partners across the 
follow-up period, and reported more consistent use of condoms. This 
study demonstrates the benefits of a customized, population-specific 
intervention and highlights its potential to reduce health disparities 
if applied across a range of settings (Villaruel, 2006; Jemmott 1998).
    In 2007 NINR plans to support research that incorporates an in-
depth knowledge of cultural factors into HIV prevention studies among 
young people.
    Research Capacity Development.--NINR is engaged in enhancing the 
research capacity of nursing science. NINR supports pre- and post-
doctoral training through both individual and institutional training 
grants. NINR also supports Research Centers to establish and maintain 
hubs of research, such as the NINR Nursing Partnership Centers on 
Health Disparities, which bring together colleagues from research 
intensive institutions and minority-serving schools of nursing, with 
the goals of exploring health disparities research questions and 
training investigators from underrepresented populations.
    In 2008, NINR will support academic research enhancement 
opportunities in minority-serving institutions.
    Technology Integration.--NINR's focus on improving health care and 
quality of life encompasses the development, use, and adaptation of 
technologies. Functional technologies that assist patients and those 
that facilitate reporting of biological indicators of health and 
disease status form the framework of the technology integration 
program, including uses of technology for telemedicine, patient 
education, communication, and patient safety.
    Radiofrequency Identification (RFID) and Patient Safety.--The 
Institute of Medicine (IOM) estimates the cost of medical errors to be 
over $37 billion annually; nearly half is associated with preventable 
errors; and, up to 98,000 deaths each year are attributable to medical 
errors (IOM, 1999). Currently, certain medical errors such as the 
retention of surgical sponges within patients after surgery persist. 
NINR-supported scientists have demonstrated that a radiofrequency 
identification (RFID)-tag system for surgical sponges accurately 
detected the presence of sponges retained at the surgery site after 
wound closure was simulated. If implemented into practice, this 
approach may not only contribute to the reduction of medical errors, 
but also decrease both the time spent in the hospital as well as heath 
care expenditures.
    In 2008, NINR plans to support studies focused on stimulating 
technological strategies that improve health outcomes through the Small 
Business Innovation Research (SBIR) and Small Business Technology 
Transfer (STTR) Programs.
    End-of-Life.--The science of end-of-life explores research 
questions of this complex period for dying persons, family members, and 
both professional and informal health care providers. End-of-life 
scientists seek to understand not only biological aspects of dying, but 
also the needs of dying persons, including symptom relief, decision-
making, advance directives, and palliative care. In addition, issues of 
culture, age, spiritual beliefs, and disease-specific considerations 
are included in research strategies.
    Chronically Critically Ill and End-of-Life Care Preferences.--
Patients who are or may become chronically critically ill may benefit 
from having advance directives in place should they lose the ability to 
communicate their preferences. NINR-supported investigators examined 
the frequency of documentation of advance directive choices of 1,128 
patients hospitalized with a chronic critical illness. Results indicate 
that about two-thirds did not have an advance directive to document 
their care preferences, and may benefit from an educational program in 
end-of-life care and documenting their preferences.
                               conclusion
    NINR's dedicated investigators act on their clinical experience and 
insight to develop and test innovative solutions to the major health 
challenges facing our society. Equipped with a new Strategic Plan, we 
aim to sustain the pace of nursing science discoveries in the years 
ahead by bringing together innovation and determination within a 
strategic framework to improve clinical practice and patient care. With 
20 years of research, NINR has garnered expertise for new opportunities 
to address tomorrow's challenges.Thank you, Mr. Chairman. I will be 
happy to answer any questions that the Committee might have.

    Senator Harkin. Thank you very much, Dr. Grady.
    Now we turn to Dr. John Ruffin, who is the Director of the 
National Center on Minority Health and Health Disparities. He's 
led the effort at NIH to promote minority health and reduce 
health disparities for over 15 years and oversaw the 
development of the first Comprehensive Health Disparities 
Strategic Plan at NIH.
    Dr. Ruffin, welcome to the committee. Please proceed.
STATEMENT OF DR. JOHN RUFFIN, DIRECTOR, NATIONAL CENTER 
            ON MINORITY HEALTH AND HEALTH DISPARITIES
    Dr. Ruffin. Thank you, Mr. Chairman, Senator Stevens. Today 
I'm here to give you a brief report on the progress the 
National Center on Minority Health and Health Disparities and 
the National Institutes of Health is making to promote the 
improvement of health among our Nation's racial and ethnic 
minority population. To advance research toward eliminating 
health disparities among all affected populations including the 
medically underserved, poor and rural populations.
    Senator Specter, I'm sure you will recall the hearings that 
you and others convened in the late 1990s on minority health 
and health disparities. I participated in many of those 
hearings which ultimately led to the creation of the NCMHD. The 
release of the Institute of Medicine report entitled, ``Unequal 
Treatment'', came right on the heel of the Center's creation. 
That report, you will recall, was a vivid depiction of the 
state of affairs of the health care system and health among 
this Nation's diverse population.
    Six years ago Congress established the NCMHD and gave us 
the authority to be the focal point at the National Institutes 
of Health for Minority Health and Health Disparities research. 
We took that authority seriously and have established the basis 
to fulfill our mission. There are a number of things that we 
know related to minority health and health disparities and then 
there are some unknowns that we continue to work toward 
understanding.
    For example, what we have not yet uncovered is the cause of 
health disparities. We still do not know why racial and ethnic 
minorities and poor populations across this Nation continue to 
be burdened by diseases and conditions like HIV/AIDS, cancer, 
infant mortality, mental health and stroke, for example. What 
we do know is that there are multiple factors that contribute 
to disparities in health.
    These are the types of issues that we are seeking to 
understand through our own research at the NCMHD as well as 
through the research efforts of the Institutes and Centers that 
my colleagues around the table spearhead, and other Institutes 
and Centers at NIH that are not represented here today.
    Our approach to health disparities is multi-proned. Through 
research we study the diseases, the conditions, and the issues 
to gain insight into the core of the problem. To conduct 
research we have to have the capacity, the facilities and the 
workforce to carry out the studies. We also need to have the 
community involved, not only as research subjects, but actively 
engaged in planning and conducting research, translating the 
research results and--disseminating the information back into 
the communities.
    To get at this, you, the Congress, statutorily mandated 
four initiatives that would set the framework for us to 
accomplish our goals in these areas. Those are our Centers of 
Excellence program, Research Endowment Program, Loan Repayment 
Program and the Community Based Participatory Research Program.
    If you look at figure 1 the map, which I gave to you in the 
book there, you will note that geographically our programs are 
in every State except Vermont and Delaware. So we have set the 
foundation by implementing the programs that you mandated.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    So what difference are we making to eliminate health 
disparities using this multifaceted strategy? If you look at 
the Centers of Excellence, much of the multidisciplinary 
research that we are conducting in communities across the 
country is being carried out through the Centers of Excellence 
Program that you authorized. We have funded 76 Centers 
nationwide since 2002.
    Our research endowments have led to the establishment of 
educational and training facilities such as pharmacy and public 
health schools. We've helped approximately 17 institutions to 
build their competitive edge for health disparities research. 
In order to attract the best and the brightest to the health 
profession, we have made loan repayment awards to about 1,100 
highly qualified doctorate level health professionals. An 
estimated two-thirds of the graduates have secured academic or 
research positions.
    Imagine cutting edge biomedical research being led within 
our communities by members of the community. That's what our 
Community-Based Participatory Research Program is about. We 
launched this three-phase program in 2005. We received an 
overwhelming number of applications, approximately 180. Today 
we are supporting 25 grants under this program.
    Mr. Chairman, our portfolio at the NCMHD is small in terms 
of dollars and numbers of programs, but that does not prevent 
us from fulfilling our mission. Collaboration is a large part 
of what we do within the NIH and with other agencies including 
my colleagues represented at this table.
    Some of the initiatives within their health disparities 
portfolio that we have helped to support include: the Health 
Disparities Nursing Research Center for the National Institute 
of Nursing Research, the Bioethics Center at Tuskegee 
University with the National Center for Research Resources, 
research on autoimmune disease with the National Institute of 
Allergy and Infectious Diseases and the Vanderbilt-Meharry 
Comprehensive Cancer Center with the National Cancer Institute.
    In conclusion, the NCMHD is making progress to predict and 
preempt disease through its Centers of Excellence and Community 
Based Participatory Research Program. We're building a 
culturally, competent workforce to deliver personalized 
medicine using the loan repayment program. Our Community-Based 
Participatory Research Program also embraces a critical element 
of medicine and that is the participatory aspect.
    Overall, our contribution has heightened awareness about 
health disparities, has increased the Nation's capacity to 
conduct health disparities research, recruited, trained and 
attracted an increasing cadre of individuals to research 
careers on minority health and health disparities and 
germinated innovative and productive partnerships involving the 
community. But we have barely touched the surface. There is far 
more to be done.

                           PREPARED STATEMENT

    The success of our health disparity effort, Mr. Chairman, 
depends upon our ability to further develop and sustain good 
models that we have all established. I thank you for the 
opportunity to brief you today.
    [The statement follows:]
                 Prepared Statement of Dr. John Ruffin
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Center on Minority 
Health and Health Disparities (NCMHD) for fiscal year 2008, a sum of 
$194,495,000, which represents a decrease of $895,000 over the 
comparable fiscal year 2007 appropriation.
    At the turn of the 21st century, the issue of health disparities 
was still a pervasive public health challenge. Racial and ethnic 
minority and medically underserved populations were suffering 
disproportionately from disease and death; individuals living in 
medically underserved communities in rural or urban cities were also 
experiencing similar disparities in health status and health outcomes; 
there was a national need for minority scientists in biomedical, 
clinical, behavioral, and health services research. There were very few 
racial and ethnic minorities in science, technology or engineering. 
This raised concern about the future of these fields and their 
potential to eliminate health disparities given the nation's changing 
demographics, and the projected significant increase of racial and 
ethnic minority populations.
    This depiction of health in America was a part of the impetus for 
the creation of a national Center to address minority health and health 
disparities. Recognizing the gaps and the challenges, and understanding 
the promise of biomedical research, the Congress wisely established the 
National Center on Minority Health and Health Disparities (NCMHD) on 
the premise that through research, training, dissemination of 
information, and other programs, minority health would be improved, and 
health disparities would be reduced in the short-term and eliminated in 
the long-term. The NCMHD has embraced multiple partnerships as the 
guiding principle for understanding and addressing this national health 
crisis.
    While the overall health of the American population has improved, 
sadly, health disparities have not declined. Nevertheless, within the 
past six years the investments of the NCMHD have positively impacted 
communities throughout this nation and globally. Our contributions have 
heightened awareness about the seriousness of health disparities; 
increased the nation's capacity to conduct health disparities research; 
recruited, trained and attracted an increasing cadre of individuals 
from health disparity populations to research careers on minority 
health and health disparities; and germinated novel and productive 
partnerships involving the community.
                    understanding health disparities
    The Centers of Excellence program has become a leading force for 
research into various diseases and health conditions in health 
disparity populations such as HIV/AIDS, mental illness, obesity, 
diabetes, cardiovascular disease, stroke, infant mortality, and cancer. 
Collectively, these Centers have published more than 200 articles on 
the priority diseases/conditions and issues related to minority health 
and health disparities among all racial and ethnic minority, medically 
underserved, and low-income populations. Leveraging of resources and 
expertise with other NIH Institutes and Centers and federal agencies, 
and among our grantees has fortified our capacity to conduct research 
into the most critical diseases and issues concerning disparities in 
health. Basic, clinical, social science and behavioral studies are 
examining the many factors that are believed to contribute to poor 
health in our communities. Understanding the cause of disparities in 
health is pivotal in determining and applying appropriate preventive, 
diagnostic, and treatment modalities.
    Access to health care is a major health problem that potentially 
perpetuates health disparities. Those who have more resources are 
better positioned to benefit from costly new discoveries in science and 
medicine. An estimated 45 million Americans have no health insurance, 
most of them being racial and ethnic minority, rural, and low-income 
populations. A lack of access can delay timely medical care and 
increase the effects of disease without proper treatment. A study 
examining adherence to cervical cancer screening guidelines among 
publicly housed Hispanic and African-American women, found that only 62 
percent of those sampled had received a screening for cervical cancer 
within the past year. 29 percent of the participants noted that no 
health care provider had ever notified them that they needed a 
screening test for cervical cancer. In this study, Hispanic and older 
women were far less likely to adhere to screening guidelines. The 
results prove the need for continued and increased efforts to ensure 
that medically underserved racial and ethnic minority women have access 
to cancer screening services. Understanding the complex nature of 
health disparities and the influence of socio-economic, biological, 
environmental, behavioral, and other factors, remains a research 
challenge that we must continue to examine through pioneering research.
             training the workforce: removing the barriers
    Access to health care is a multi-pronged problem that is 
complicated by the shortage of health professionals from underserved 
communities. Racial and ethnic minorities make up only 14 percent of 
the physicians in America. The NCMHD and its partners have been working 
to diversify and strengthen the science workforce through training. 
Two-year loan repayment awards have alleviated the financial burden of 
pursuing higher education for approximately 1,100 health professionals. 
These trainees with MD, PhD, DDS, and other doctorate level science 
degrees, engage in research, health promotion, and outreach activities 
in numerous disciplines to heighten awareness and deepen our 
understanding of specific diseases and conditions, and issues in health 
disparities.
    Racial and ethnic minorities represent 64 percent of the current 
pool of NCMHD loan repayment awardees. An estimated two-thirds of the 
graduates have secured academic or research positions. The funding 
provided by loan repayments have helped to advance the careers of 
awardees and expose them to additional funding sources for their 
research activities. The program is slowly, but evidently achieving its 
mission to recruit and retain highly qualified health professionals in 
the workforce. In 2006, endowment funding supported the training of two 
Native American students completing the four-year Doctor of Pharmacy 
program at the University of Montana. This is a significant 
accomplishment because of the critical need to create permanent tenure 
track positions for Native Americans. At the University of Wisconsin at 
Madison, School of Public Health, the infrastructure established with 
NCMHD funding has helped to secure funds for a Health Disparities 
Research Scholars Training Program. This five-year training program 
will commence in Spring 2007 and it is anticipated that it will 
increase the number of researchers committed to health disparities. We 
will continue to enhance our focus on the recruitment and retention of 
individuals of health disparity populations to develop a culturally 
competent and well-trained workforce to address the burden of health 
disparities in our diverse communities.
                     creating the competitive-edge
    The quality of health among health disparity populations, and the 
delivery of health care can be improved by training a diverse workforce 
that is representative of the community being served. However, in order 
to conduct innovative research, it is essential to have the right 
capacity such as the facility, faculty, students, and training 
programs. Notable progress has been made in developing research 
capacity at more than 40 academic institutions.
    Having an endowed chair signals an institution's strength in a 
specific discipline. It is an incentive for a medical school to recruit 
and retain the most preeminent faculty in a given field, and adds 
credibility to its medical education program. Endowed chairs 
traditionally have been located at the most prestigious medical 
schools. NCMHD funding has established endowed chairs at three 
minority-serving institutions, Meharry Medical College, Morehouse 
School of Medicine, and the University of Hawaii. These endowed chairs 
are vital to building a critical mass of distinguished scientists in 
cancer, cardiovascular disease, diabetes, neuroscience, women's health, 
and Native Hawaiian health. This will place these institutions on the 
competitive edge to advance their study of minority health and health 
disparities in these fields. At Meharry, the endowed chair funds have 
helped to recruit a nationally renowned scientist to lead its Center 
for Excellence in Health Disparities Research in HIV/AIDS.
    Research capacity in terms of physical infrastructure has increased 
considerably at several institutions after obtaining NCMHD funding. In 
some instances, facilities for health disparities research did not 
exist prior to NCMHD Centers of Excellence funding. Today, Charles R. 
Drew University has space totaling 8000 square feet, New York 
University 3,900 and Claflin University 3,403 square feet dedicated to 
conducting health disparities research. As a result, these institutions 
have been able to expand their research and training activities. The 
University of South Carolina-Claflin EXPORT Center recently erected a 
Molecular Virology Laboratory at Claflin University which houses state-
of-the-art equipment for microscopic gene cell isolation and 
examination, where HIV viral load assays for example, can now be 
studied. The University of New Mexico houses the only School of 
Medicine in the state, and endowment funds have helped to establish the 
Institute of Public Health to address chronic health issues among low 
income and racial and ethnic minority populations.
                         value of partnerships
    Our success in eliminating health disparities will ultimately 
depend on our ability to translate the lessons learned from our 
research endeavors, into usable tools and programs for the community. 
We have expanded our partnership base, and moved beyond the tradition 
of limiting partnerships to academic institutions, into domains where 
we can have the capacity to respond to health disparities in any form. 
We have continued collaborations NIH-wide, across the Department of 
Health and Human Services, and with other agencies such as the 
Department of Justice. Our efforts also have engendered unique 
partnerships between academia and the community; the community and 
local, state or federal agencies; research-intensive institutions and 
minority-serving institutions; and among NCMHD Centers of Excellence 
within a given state and state health agencies.
    In partnership with the National Institute of Environmental Health 
Services, the private sector, universities and schools, molds and other 
allergens that may trigger asthma in children are being studied post-
Katrina. In conjunction with the DHHS Office of Minority Health we 
mobilized our Centers of Excellence to respond to emergency health 
needs in the community and offer research opportunities at NIH for 
scientists after Hurricane Katrina. Today, the community is benefiting 
from electronic medical records, and telemedicine programs that are 
being incorporated into the health care infrastructure. In Oklahoma we 
have been able to reach more than 65,000 American Indians through a 
partnership of the Oklahoma Project EXPORT Center with nine tribes. The 
power and impact of our partnerships has touched the global community 
from state to state to places like Asia, Africa, Europe and the 
Caribbean where our students and faculty engage in research training.
                           imagine the future
    We have begun to set the foundation through our research, training, 
capacity development, and outreach efforts to transform the health of 
this nation, but we have barely touched the surface. There is far more 
to be done. In three years, according to the Healthy People 2010 
report, health disparities should be eliminated. However, the recent 
Midcourse Review of the report underscores the fact that not enough has 
been done overall to demonstrate any significant decline in health 
disparities.
    Imagine a Nation where differences in health status and health 
outcomes no longer exist among populations. Imagine a nation where all 
Americans can lead a long and healthy life. Imagine a country where all 
Americans can access quality health care. Imagine physicians and health 
care professionals of all racial and ethnic backgrounds, in any 
specialty, practicing in every community across this country. Imagine 
cutting-edge biomedical research being led within our communities by 
members of the community. Imagine the discovery of solutions for 
critical diseases like diabetes, mental illness, cardiovascular 
disease, HIV/AIDS or obesity emerging from a community lab.
    At the NCMHD we are cognizant that no single entity alone can solve 
the complex problem of health disparities. The sustainability and 
success of our health disparities efforts depends on strategic 
partnerships. We will continue to expand our network to address the 
diseases and issues that are already familiar to us, and examine new 
and emerging health disparities challenges in prisons, housing 
communities, or among our men. We must also be able to respond to 
health crises as they arise. Novel and multi-faceted strategies must be 
exercised and increased at the community, national and global level if 
we are to succeed in using the power of biomedical research to 
transform the health of racial and ethnic minority and medically 
underserved populations and eliminate the scourge of health 
disparities.

                             NCMHD PROGRAMS

    Senator Harkin. Thank you very much, Dr. Ruffin. I assume 
on this map you gave us, that CBPR, the green dot, is Community 
Based Participatory Research?
    Dr. Ruffin. That's correct, sir.
    Senator Harkin. We don't know how many are in each State. 
We just know there's something going on there, right?
    Dr. Ruffin. I think I can also tell you we've established 
25 of those programs thus far. I think I have a map that I 
might be able to share with you that shows the distribution of 
those 25 programs.
    Senator Harkin. Tell me again what's that loan repayment 
program? How does that work?
    Dr. Ruffin. The loan repayment program is where we pay back 
the loans of individuals who go into health disparities 
research. These individuals get about $35,000 a year, principal 
and interest is paid as a repayment for those individuals to go 
into health disparities research. It is modeled a lot like the 
AIDS-Loan repayment program which many of you are familiar 
with, except in this case, our loans are given to not just MDs 
but to all health professionals.
    Senator Harkin. Would that be nurses too?
    Dr. Ruffin. Nurses, dentists, individuals in clinical 
psychology, sociology, all of the medical professions are 
eligible to apply for these loan repayment programs.
    Senator Harkin. Interesting. I have to find out more about 
that.

                                VACCINES

    Dr. Fauci, I would like to talk a little bit about 
vaccines. As you know we have provided over $6 billion to HHS 
to prepare for a flu pandemic. A lot of that money is to 
develop both egg-based and cell-based vaccine capacity in this 
country. We've been through that many times.
    But in the case of a pandemic even after spending this 
money, it will take us months to develop a vaccine that will be 
effective against the strain of flu that proves to be able to 
be transmitted from human to human. It will still take time.

                           UNIVERSAL VACCINE

    Now, I've heard a lot about this idea of a universal 
vaccine. One that would be effective against all strains of 
flu, a vaccine that could be stockpiled now, made immediately 
available at the time of a pandemic or one that could be 
routinely administered to people giving them immunity in 
advance of a pandemic in certain areas.
    I recently met with some people who were developing a DNA 
based vaccine that identifies proteins. It was very interesting 
to me--that are common to all strains of flu. And I understand 
your Institute has supported some of this work. I just need to 
know more about this. Is there this possibility that we could 
get this universal vaccine that--since we identify proteins 
that are the same in all the different flus? Is this possible?
    Dr. Fauci. It is conceptually possible. I think over time 
it will be likely.
    When you look at a flu virus the major components that we 
traditionally over the years have made vaccines against, have 
been the H and the N proteins that are on the surface. They 
stand for hemagluttinin and neuraminidase. That's the reason 
when you hear about flu--you name flus by the differences, 
H5N1, H3N2.
    Now the good news is that the body makes a really good 
immune response against the H and the N. The bad news is that 
the H and the N change from influenza to influenza. Which is 
the reason why each season, to get a perfect match, most of the 
time you have to fine tune and tweak the vaccine a bit so that 
it's a little bit different than the one you did the year 
before to get optimum and maximum protection.
    The concept that you're referring to, Mr. Chairman, is the 
idea of getting the components of the virus that don't change 
from strain to strain and season to season. Two of those 
proteins are the M2 or the matrix protein, and the NP or the 
nuclear protein. They don't seem to change from strain to 
strain. So then you--you ask the obvious question. If I was 
infected with seasonal flu 3 years ago, why am I not protected 
against the seasonal flu the next year or the year after?
    The reason is the body does not make a very robust immune 
response against the M protein and the NP. So the strategy that 
we're working on with the people that you mentioned is to get 
those proteins and put them in a very immunogenic form. So that 
the body makes a very robust immune response that would cross 
over and help protect not only against this season's flu, but 
next season's flu and the year after.
    Also, theoretically if you do it right, you could get a 
universal vaccine that would even be protective against a wide 
variation. The way we're seeing with the H5N1. Because the H5N1 
that's circulating in birds in south east Asia right now, is 
very much different from the H3N2 that we all get exposed to 
every season. So that's the concept and the strategy of a 
universal vaccine.
    The results that we're getting, preliminarily, in animal 
studies are really rather encouraging. Now you know in vaccine 
work it takes years to go from the concept to something that's 
in a bottle for people to use. But, I, myself am quite 
encouraged about that possibility.
    Senator Harkin. So you're funding research on this?
    Dr. Fauci. Oh, absolutely. We're funding research by our 
extramural grantees and contractors. We're collaborating with 
some of the pharmaceutical companies. For example Merck itself 
is working on a M2 vaccine. We're doing intramural research.
    You mentioned the DNA approach. Where you can take the gene 
of any particular protein and code it for the protein that you 
want and essentially say I'm going to inject somebody with the 
DNA. That DNA will then cause the body to express the protein 
on a cell that makes a good immune response. At the Vaccine 
Research Center under Dr. Gary Nabel, at the NIH, that's what 
we're doing with HIV. It's easily done also in influenza.

                   FUNDING INFLUENZA VACCINE RESEARCH

    Senator Harkin. Do you think we're putting enough resources 
into that on the balance of things? This is very promising.
    Dr. Fauci. It is very promising. It's very promising.
    Senator Harkin. It would be a big deal.
    Dr. Fauci. It would. It would. As you know I've always told 
you over the years you never ask a scientist if you put enough 
in. Enough is when you get the answer. We are putting a 
substantial amount. We are concerned as we all are with--when 
we have a flat budget will we be able to take advantage of some 
of the opportunities that would arise. So we have to be very 
careful in our prioritization. But we're putting substantial 
resources into it.

                    VACCINES AND AUTOIMMUNE DISEASE

    Senator Harkin. Two other things. I just want to ask one 
about vaccines and I want to ask about allergies.
    Children get a lot of vaccines by the time they're three 
years old. I've heard estimates ranging from 18 to almost 30. 
Having a new grandchild myself last year, their parents are 
looking at all the shots that this kid is supposed to get by 
the time they're, well, 1 and then by 2. It was pretty darn 
close to 30.
    I've heard a lot of concerns. That, you know--while each of 
these vaccines are very good in terms of saving lives, building 
immunity that maybe collectively, putting them all together 
could lead to autoimmune diseases later in life. I've heard a 
lot of this, read about it. So, again, I want to know, what 
kind of research is being--done on that aspect of all of these 
together effecting autoimmune diseases later in life?
    Dr. Fauci. It's obviously a good question because it is a 
matter of concern to some people. There have been studies done 
looking at retrospective data of children who get vaccinated as 
to whether or not there's this propensity to autoimmunity.
    The basis of that concern, I think is the basis of why you 
really do want to vaccinate people because in people who have a 
genetic predisposition to autoimmunity, it is often triggered 
by an infection. We know that, for example with certain of the 
autoimmune diseases like lupus and rheumatoid arthritis and 
things like that.
    So the question is mimicking the infection by a vaccine 
going to induce autoimmunity. The answer is in studies that 
have been pretty carefully done, no. But, importantly, the 
infection itself is a much more potent potential inducer of 
autoimmunity than is the vaccine that you give to somebody to 
prevent the infection.
    So if we didn't vaccinate people and they actually got 
these infections that would be an even worse scenario. So if 
you're asking me, I can give the example: I have three children 
and they've gotten all the vaccinations. I feel very, very 
comfortable with having my children vaccinated with the menu of 
vaccines that are all recommended.
    So, the concern is understandable. The research in the 
studies that have been done to see if there is a connection 
have all indicated that there is not.

                             FOOD ALLERGIES

    Senator Harkin. One last thing, allergies. A friend of mine 
in Iowa--we're just talking about kids and our kids, grandkids. 
It turned out that their little boy had developed severe food 
allergies.
    You and I have talked about this before in previous 
hearings. Three hundred percent increase in the number of 
pediatric food allergy cases over the past 10 years. That's 
alarming.
    Dr. Fauci. Yes.
    Senator Harkin. What's going on? You know, what is 
happening out there?
    Dr. Fauci. To be honest with you, we don't know. There are 
some theories about that, but food allergy is something that we 
have now, we have had for some time. But even most recently 
based on the data you're talking about, are taking it very, 
very seriously.
    Not only is food allergies--and certainly the recognition 
of and probably the reality of, more than just the recognition 
of are increasing. Not quite sure why that has occurred. I'm 
certain that there are factors that are not fully appreciated 
by us right now. But the thing that worries us is that some of 
these food allergies are more than just trivial. You can 
actually get anaphylaxis. One of the important ones, for 
example, is--is peanut allergies is really, really tough.

                       PEANUT ALLERGIES IN CHINA

    Senator Harkin. I've heard. Now tell me if I'm wrong on 
this. Have you ever heard this about kids in China eating a lot 
of peanuts there. But they don't get peanut allergies. But we 
get peanut allergies here. Have you ever heard such a thing?
    You haven't heard that one?
    Dr. Fauci. I haven't heard that but I thought you were 
going to say that the Chinese were putting something in it that 
is toxic.
    Senator Harkin. No, it's just that China grows a lot of 
peanuts, like ours. The kids eat a lot of peanuts. But they 
have nowhere near the peanut allergies we have in this country. 
I was operating under the assumption that was factual data. I 
don't know.
    Dr. Fauci. I've not heard this.
    Senator Harkin. Look into that.
    Dr. Fauci. I certainly will. I certainly will.

                      RESOURCES FOR FOOD ALLERGIES

    Senator Harkin. But--again, with the 300 percent increase 
do we have enough resources going into that? It's our resources 
again.
    Dr. Fauci. It's the same answer to the question. We are 
doing a substantial amount. We could do more. Definitely.
    Senator Harkin. I'm told that NIH hosted an expert panel on 
food allergies in the spring of 2006. Last year. The 
participants developed a proposed road map to guide future 
research. But it has been a year now and I understand the road 
map still hasn't been approved. Give me an update on that, 
would you?
    Dr. Fauci. We met with that group in my conference room 
about 3 months ago. We walked away from that with them. They 
are quite satisfied with the portfolio that we've put together. 
With regard to a strategic plan that's almost a logistic thing, 
about getting a plan and a plan approved through the Department 
and what have you.
    But the research that we're doing right now on food 
allergy, we've developed a very good relationship with the 
constituency groups on that. I have a lot of responses to that 
meeting that were very favorable.
    Senator Harkin. Well, alright. I just wondered what was 
happening there. I just--you can jump in anytime, just jump in 
if you have some things you want to cover. Go ahead.

                COORDINATION WITH DEPARTMENT OF DEFENSE

    Senator Stevens. Tony, what about coordinating what you're 
doing with the other agencies? We're putting a lot of money in 
defense for investigation dealing with substances that might be 
used by terrorists for instance. Are you working with them too?
    Dr. Fauci. Yeah. There is a rather excellent coordination, 
Senator Stevens, between ourselves, the Department of Homeland 
Security and the Department of Defense. In fact, we feel very 
good about that. We were doing that--we've developed a good 
relationship with them.
    Even antedating bio-defense because a lot of the things 
that they have done for force protection, malaria, and things 
like that, we have worked very closely with them. When the bio-
defense issue arose following 9/11, we, in fact, strengthened 
our interaction with them. With the new Department of Homeland 
Security, we're even coordinating very nicely with them.

              BIOLOGICAL, RADIOLOGICAL, OR CHEMICAL ATTACK

    Senator Stevens. That was going to be my next question 
because it just seems with the world wide impact of the 
terrorist movements that they're going to turn to substances 
one of these days. Are we prepared for that?
    Dr. Fauci. We are not totally prepared. I would be 
misleading you if I told you we're totally prepared for any 
biological, radiological, or chemical attack that we have. But 
since 2002, we have built up a rather robust research and 
development portfolio and have made some significant advances.
    Obviously, you never know where, when or if a terrorist is 
going to strike in a biological, radiological, chemical way. 
But we have countermeasures now that we didn't have before. We 
were completely vulnerable to a smallpox attack. We had 18 
million doses of smallpox vaccine in our reserve. Right now we 
have over 400 million. That's happened just over the past 
couple of years.
    Senator Stevens. That was my next follow up because it 
seems to me that we're doing a lot of research and prevention, 
but what about reaction to such events when they take place. 
That seems to be the area that we could be most effective.
    Dr. Fauci. Right.
    Senator Stevens. We can't immunize everybody against 
anything.
    Dr. Fauci. Sure.
    Senator Stevens. But we can get prepared for specific 
problems that might arise. Are we doing that?
    Dr. Fauci. We are. We are, Senator. I'll give you two 
examples that are actually very important examples.
    You talk about treatment. We've never had any treatment for 
smallpox or pox viruses. There is a drug that we've helped 
develop with a pharmaceutical company called ST-246 which is 
very effective in an animal model against smallpox. You may 
have read in the newspaper about a military person who was 
getting vaccinated for smallpox with vacinea didn't fully 
realize that his child had eczema. When you expose the wound of 
a smallpox inoculation to a child with eczema, they can get an 
eczema vaccinatum which is a very terrible disease.
    The child did get it accidentally, and doctors tried 
everything with the child and we brought this drug in. They 
treated the patient with the drug and the child has made a very 
remarkable recovery. So that's a--N equals one in medicine that 
doesn't mean anything, but this, I think, is an important 
indication that we now have an important drug.
    We also have some antitoxins that we didn't have, for 
example against anthrax. We've developed the first Ebola 
vaccine that, I think is a very important advance.
    Senator Stevens. What about post exposure to nuclear. I 
heard the other day about something that would reduce the after 
effects of nuclear exposure.
    Dr. Fauci. Right.
    Senator Stevens. Is that really an accomplished fact.
    Dr. Fauci. What we are doing and we've had to partner with 
our colleagues from the cancer community, with the National 
Cancer Institute is to develop better versions of the drugs 
that are used on patients following a radiation to rescue bone 
marrow. For example, to allow the bone marrow to regenerate in 
a much more rapid and efficient way than it would to wait for 
it to normally respond. That's the main nuke-rad counter 
measure that we have.
    Senator Stevens. Are we stockpiling that?
    Dr. Fauci. Yes, we are. We have that in the National 
Strategic Stockpile.

                              NCI FUNDING

    Senator Stevens. Dr. Niederhuber, if I may? I was really--
you know we doubled the research money for you in one period 
that Connie Mack and bipartisan effort. We did that over one 
period. I think it was a little less than 10 years. Are we 
going to look at a necessity to double it again in the next 
decade?
    Dr. Niederhuber. Well, living as we have for the past 3-4 
years with a less than inflation budget has certainly taken its 
toll on the programs. If you calculate that up it's about a 12 
percent decrease from where we might want to be at this point.
    Senator Stevens. Well, since you had 125 percent increase 
in the past years before that. Where do you think you'd stand 
if we hadn't done it?
    Dr. Niederhuber. Oh, I think we would be much worse off in 
the country as a whole. I think the increase that Congress, in 
its wisdom, legislated and appropriated did a great job in this 
country in building up research infrastructure that was 
lagging. We built about $16 billion worth of new research space 
at our Research Universities across the country. I think that 
was badly needed.
    Having come recently from the academic community we had 
some real pent up needs in the academic community. We were able 
to increase our faculties where we needed to in the biomedical 
research arena. So I think this was all, Senator Stevens, very 
needed.
    The issue I think for us, as a country, has been that when 
you build up you need to keep moving with inflation in order to 
maintain what you've built. I think that's the issue that we 
are facing.

                          GENERATIONAL CANCER

    Senator Stevens. That's reasonable, I think.
    Let me ask you a personal question. I had three generations 
of pancreas--pancreatic cancer ahead of me and I got prostate 
cancer. Now someone told me the other day that in all 
likelihood I had the same cancer. Is that possible that it 
migrated to my predecessors but didn't migrate for me?
    Dr. Niederhuber. Well, I don't think I would look at it 
quite that way, having been involved with managing and 
operating on patients with pancreatic cancer for most of my 
career, I think these are two separate diseases. They each have 
specific risk factors. I could share that with you.
    Senator Stevens. I just want to know what to tell my sons.
    Dr. Niederhuber. Well, I think the thing to tell your sons 
is that we're working hard to better understand the risk. What 
I was going to say that actually in July of this year our 
Center of Excellence in the National Cancer Institute focused 
on trying to understand risk in populations and risk for 
developing different cancers. We've just finished a whole 
genome scanning project in prostate and in breast and this July 
we'll launch one specifically in pancreatic cancer. So it's 
relevant to your question, Senator.
    Senator Stevens. Well, let me know will you?
    Dr. Niederhuber. I certainly will.
    Senator Stevens. What do I tell them--follow their 
grandfather, their great grandfather?
    Dr. Niederhuber. Live healthy, exercise, eat well.

         ATTRACTING STUDENTS TO SCIENCE AND TECHNOLOGY CAREERS

    Senator Stevens. Which one should they be careful of? 
Anyway, let me ask you, Ms. Alving.
    Are you familiar with Norm Augustine's report titled: 
``Rising Above the Gathering Storm'', which discuses the 
problem of having enough students turning to the study of 
science and technology?
    Dr. Alving. Yes, Senator. We're very aware of this at NIH.
    Senator Stevens. But what are all of you doing about that? 
All of you have basic money, research money. I understand what 
you're doing Dr. Ruffin. That's very good.
    We do the same thing by the way. We pay some of our staff 
who have high loans, before they migrate out to where they get 
paid more. So we have a little bit of a fund here. We can sort 
of entice them to stay a year or two longer. But are you doing 
anything about the concepts of trying to attract students into 
the areas so that you're not the last of the breed in terms of 
scientists who are studying these things for us?
    Dr. Alving. Yes we are, Senator. I would say that NCRR is 
working very diligently on this. The other Institutes and 
Centers are working on this, as well, because across NIH we 
recognize this as a very large challenge. We also recognize----
    Senator Stevens. Let me interrupt you. Do you have 
internships for people in college to attract them so they'd be 
interested to go to graduate school? Do you reach out to 
people?
    Dr. Alving. Absolutely. For example, let's look at the IDeA 
program that I mentioned earlier. I personally visited Montana 
this last year and I saw how the investigators at the more 
research intensive universities are reaching out to the tribal 
colleges. So there are now research projects underway at the 
tribal colleges. The tribal students can go to the University 
of Montana and really envision research careers.
    I remember one young man told his father he was going into 
biomedical research. He was Native American. His father said 
well, that's not what we do. But he said yes, this is what I do 
want to do.
    So we are reaching out to students, I would say, of all 
ages, because to really attract students into research and into 
biomedical careers, you really have to get them at a very young 
age. In one of our SEPA programs, our Science Education 
Partnership Awards, one of our very fine investigators has 
developed a bus in Boston that actually is well equipped as a 
laboratory. It's even visited the NIH campus.
    The bus goes throughout Boston. So it goes into the 
underserved areas. Students can get onto this bus, which is a 
traveling mobile lab, and learn about DNA and learn some of the 
simple experiments. In fact, I think this has been really 
replicated throughout many of the States.
    So we're really attacking this, I think, at multiple 
levels. We're reaching out to the Hispanic community as well. 
And many of our very well funded researchers have very active 
programs where they serve as mentors and bring high school 
students into their labs. It's probably still not enough, but 
we're all very aware.
    Senator Stevens. If this Nation has a problem--the problem 
is the downward trend of our students who seek graduate 
education in science, technology, and engineering, which are 
very difficult areas of study. We've got to find some way to 
move out and give them incentives to continue.

                           CONGENITAL DEFECTS

    I know I'm using my time. Dr. Grady, I just recently came 
about in connection with a relative. The problem of a defective 
heart valve which came from, they tell me, from what you 
mentioned, a problem at birth. Now what my question to you is 
have we any way to check this as people grow older? Whether 
they do have those defects that develop because of improper 
handling at birth?
    Dr. Grady. There are a number of tests that are now 
available where we can through imaging and other diagnostic 
tests tell very early on in children if there is a 
developmental defect.
    Senator Stevens. I'm talking about this person's almost 60. 
He was just determined--to have blood clots going to the brain. 
Suddenly they find out that was--escaped through some valves 
that have been defective since child--since birth. Now I--and 
he's had exams. He's been in the service. Why doesn't--why 
won't that show up on exams?
    Dr. Grady. Well, it turns out that many of us have 
problems, birth defects, congenital defects that we are really 
unaware of. Sometimes we die without being aware of them. But 
now that the life expectancy of the average American is longer, 
many of these things which would not have surfaced before are 
now surfacing.
    Senator Stevens. But how can we--can we discover them?
    Dr. Grady. Up until recently the imaging technology and the 
other technologies that we had were not able to. But we now 
have imaging technologies which have a very high resolution. 
You can tell things are happening in tissue that are structural 
and even metabolic disorders much earlier in life.
    Senator Stevens. Those valves could be discovered with the 
proper test?
    Dr. Grady. Yes. Very likely they could have been.
    Senator Stevens. Are we developing any indications that 
would lead people to take those tests?
    Dr. Grady. Actually there is a move on for people to do 
screening, whole body scans, et cetera and much higher 
technological screening early on in life. Some of these things, 
as we're all aware of, are not covered by insurance so people 
opt not to do them. But I think the technology is now becoming 
available and people's awareness that they should screen for 
things and that they should have check ups early is much 
higher. So hopefully, we'll be catching these earlier.
    Senator Stevens. We saw something that both the government 
and the insurers are not going to pay the cost of scans, 
particularly full body scans.
    Dr. Grady. That is currently the situation. There is a 
great deal of discussion, whether or not they should be 
available and for what particular conditions they would be most 
helpful.

                           MEDICAL SCREENING

    Senator Stevens. This is very disturbing. This person is 
now blind, partially. He's got tunnel vision because of those 
clots and had no idea that that existed. I was told it could 
have been diagnosed at any time prior to that if he had had the 
proper exposure to the scans. But I don't know how.
    We've got all these systems. I don't know how we can get so 
that subjective to the people who need help, know that need 
help. Is that part of any of the studies we're making? How do 
we find out who needs this help?
    Dr. Grady. It is a problem in that we are trying to inform 
people. But we also have difficulty getting people to come in 
for screening exams which we know are helpful: mammography, 
breast cancer screening, and there are a number of other 
screenings that people do not necessarily take advantage of.
    We are studying--we're funding a number of studies however, 
that look at what it takes to get people incentivized to come 
in for screening. We have some very interesting information 
related to, you mentioned relatives, related to mothers and 
daughters. Daughters being more tuned into health prevention, 
getting mothers to come in, senior citizens and younger people, 
et cetera. So we're working on a number of techniques to 
incentivize people to come in for screening.
    Senator Stevens. I was told last week that there is now a 
system where you can go and have your--what your gene chain set 
out. They can compare that to the types of illnesses that come 
from these genes that you are determined to have and they can 
then give you a prediction on what you're going to suffer. I 
said why don't we all get that? They said, well, it's cost. 
That it's not available to the average income person today. Are 
we going to get to where we can get that for the average 
person?
    Dr. Grady. Well, it is true that it is not covered by 
insurance but also--we're not quite there yet where these tests 
are 100 percent accurate.
    For some things such as stroke, we have developed and 
identified risk factors. We can weigh each one and there's a 
whole scale where you plug in your blood pressure, your age, et 
cetera. Then you can alter--what if your blood pressure came 
down a certain amount and you get a score which you can then 
program. If I alter my diet, if I lower my blood pressure, if I 
exercise more, that will reduce my chance of getting a stroke 
by x percent or so many points. So I think we are moving in 
that direction in some areas, but we're really not there yet.
    Senator Stevens. Maybe some of us don't want to know that's 
the problem.
    Senator Harkin. Do you have thoughts on what Senator 
Stevens just asked?
    Dr. Niederhuber. I was just going to comment that we--all 
of the Institute Directors were at a conference all day on 
Friday at the NIH and during that day we were talking about 
some of the latest technology coming online to do rapid 
sequencing. I believe, you can correct me, colleagues, if I'm 
wrong, but I believe the quote was that, ``with this new 
technology today we can sequence half of our genome in 3 days 
at about $3,000.''
    So you can see how quickly within the next few years we 
will be approaching our goal of being able to sequence the 
entire genome of you as a patient within 3 or 4 hours for 
$1,000.
    Senator Stevens. Would it be cost effective for us to do 
that publicly?
    Dr. Niederhuber. Well, that's a very good question, 
Senator. I think that we all recognize in the science community 
that this information, this alphabet if you will, is the base 
of the information. We know that we have a lot more work to do 
in taking that code, if you will and understanding what that 
code means in terms of the proteins that our cells produce.
    The changes in those proteins as they're produced and how 
they relate to what makes you function and you as an individual 
and your diseases and me, as an individual and my diseases. So 
we have a lot to build on. But that is like the periodic table 
of chemistry, if you will. It is the information based upon 
which we will gain this kind of knowledge and this kind of 
understanding of the disease. It's a step, but a very important 
step.

                                GENOMICS

    Dr. Fauci. Can I add we should be careful though not to 
think that if you--if we, even if we get it inexpensively that 
if you get your genome and you look at your sequence, you're 
going to know exactly what's going to happen to you. That's--
most diseases are multigenic. They rely a lot on interaction 
between the genetic factors and the environment.
    So although you could get some probabilities there's still 
going to be the need for the broad, healthy things you need to 
do no matter what your genome is. So we spoke about that also.
    Senator Stevens. I said it was the last question. But I 
forgot this one.

                              END OF LIFE

    Dr. Grady, you gave us this chart, tracking patient 
disability in the last year of life identifies opportunities to 
tailor interventions. We were told last year that in the last 2 
years of the person's life they would probably spend as much 
money for health care as they've spent in all previous years. 
Are you suggesting here that there's some way to alter that?
    Dr. Grady. Your statement is true. What we are suggesting 
is that these are trends. So it's a very large population study 
but it gives parameters within which you can better be able to 
predict what a course of illness may be like. That doesn't mean 
it will necessarily be that way for each individual person, but 
it gives you parameters.
    So it gives you a sense of what one could expect and 
hopefully to be able to better plan. It's an imperfect system 
when translated to single individuals but it does give the 
patient, the family, and the health care team some idea.
    Senator Stevens. Are you suggesting you think science can 
tell us when a disease is really terminal no matter what 
happens?
    Dr. Grady. We're still not there yet. It's very difficult. 
You can, as we all know, predict within some time frames. But 
still individuals are very different from person to person. So 
you have guidelines, but I would not be offering a finite 
timeline.
    Senator Harkin. Well, I want to pick up a little bit of 
what Senator Stevens just said this end of life care. I just 
wrote it down here. It's got to be more rational, caring and 
cost effective.
    A lot of it is just irrational. The way it's administered. 
I don't know if it's more caring for a person to--to do 
expensive operations or anything like that knowing full well 
that the end of life is coming anyway than it is to just give 
him palliative care. Address yourself to that too.
    Most--our health care system is not very good when it comes 
to palliative care--and then so a lot of people stay in acute 
care until they die. It just costs a fortune.
    Dr. Grady. It's very complicated, Senator, both Senators. 
What we found out so far--we've just scratched the surface.
    What we've found out so far however that is disturbing is 
that some of the things that we could do we are not doing 
consistently. For example, pain management. We know a great 
deal about pain management and our ability to handle pain in 
these stages of life. Yet, we find great disagreement between 
what the health team advises, what the patient says they want 
and what the family says that they think the patient wants.
    So whether it's an intensive care unit setting or a hospice 
setting or chronic care setting, we find great disagreement. 
This is all within the therapeutic window of pain medication 
that could be administered that would be safe to administer. So 
that's one thing we know.
    The other thing we have found is that--that many patients 
do not have advanced directives. They haven't really thought 
ahead. They haven't talked with their family, but even if they 
have many of the systems that we have are required. They 
basically are not allowed to withhold treatment, even if that 
is the patient's request.
    So if in an emergency the ambulances are called or 
anything, it doesn't usually matter in practice if the person 
says no advanced measures.
    Senator Harkin. What would you think about that? I've never 
talked to Senator Stevens about this but this idea of having 
advance directives? People don't. They just don't think about 
it. Maybe when people get on Medicare that ought to be a part 
of when you qualify for Medicare that you ought to have a 
requirement that you have some kind of advance directive.
    Dr. Grady. Well if the person would have an opportunity to 
do that it would at least allow them to think about it. It 
would give the family some sense of where they should go and 
some guidance. It turns out the other studies we've done that 
look at the caregivers of terminal patients that the largest 
stress for them is reported to be that they didn't know what 
their family member wanted. They had to make a decision really 
acting in the dark by their report. That they felt was, by 
their report, almost as stressful as seeing the disability.
    Senator Stevens. But is that partly related to the 
liability factor of the caregiver in case another person--
family member says you could have saved them and you didn't.
    Dr. Grady. There seems to be a great deal of anxiety about 
that.
    Senator Stevens. Well, I think, Senator Harkin is right. I 
think we ought to try to do something. I witnessed my first 
father-in-law after he had brought back to life. He was a 
minister and a grand man. He was in his mid 90s. I never heard 
him swear in his life, but he swore at the doctor that brought 
him back to life. He died about 2 months later and I think that 
is a very unfortunate thing. He did not have a directive. But 
there ought to be something to deal. Maybe we could tie to 
Medicare.
    Senator Harkin. I've thought about that. I hear this all 
the time. There is a liability problem there. People don't 
think about it. Families don't know what to do.
    Senator Stevens. I see my friend is here. I'm late for 
another appointment. So thank you very much, Senator.
    Senator Harkin. Thank you, Senator Stevens.
    I want to follow up on one thing and that's on the nursing 
shortage.
    Dr. Grady. Yes.

                            NURSING SHORTAGE

    Senator Harkin. We had a hearing on global health a few 
weeks ago. We talked about the brain drain and other countries.
    What's happening in other countries is a lot of their 
nurses especially in health care professionals are getting 
their degrees and that kind of thing. Then they come here, 
better paying jobs. We have a shortage of nurses here now so we 
started looking into this.
    Well then, what did we find out? There's a shortage of 
nurses in this country. There's a demand for nurses. American 
Schools of Nursing last year turned away 42,866 qualified 
applications for baccalaureate and graduate programs due to a 
shortage of nurse faculty.
    Dr. Grady. That is correct.
    Senator Harkin. Now, we're in a real problem here.
    Dr. Grady. We are.

                         TRAINING NURSE FACULTY

    Senator Harkin. We need more nurse faculty. But if we don't 
have the slots for them, it seems to me pretty soon, they're 
going to start retiring and we're going to have fewer and 
fewer. I don't know.
    Your Institute supports a lot of nurse faculty through 
research grants. So what role does your Institute play in 
increasing the number of nurses trained here in America, 
especially teaching nurses, faculty--teaching nurses? I don't 
mean just nurses that are out in the community, but I mean 
teaching.
    Dr. Grady. Senator Harkin, those are the nurses that we 
support in our training line. We have 7 percent of our budget 
devoted to training.
    Senator Harkin. 7?
    Dr. Grady. Yes, 7 percent, which is twice the NIH average. 
So we're dedicating a reasonable chunk of our budget to 
training. The people that we train are those individuals who 
become the teaching faculty. We train them to do research, but 
that's what faculty do on campuses of Schools of Nursing across 
our country.
    So we have designed a number of programs to try to get 
these students in early. We work with the K through 12 
programs. We work with the other graduates to encourage them to 
get doctorates. We also have what we call fast track programs 
so that they come into the baccalaureate program, come out with 
their Ph.D. without stopping.
    Senator Harkin. Thank you. What if you were advising us? If 
you could say here's what we're going to do. What would we do 
say; give us 3, 5 years. What would a 5-year plan look like to 
get more teaching faculty in this country?
    Dr. Grady. I think the 5-year plan would have some loan 
repayment, but I think that looking at loan repayment or 
service repayment. For example and this dates back to the older 
days, but we used to, if people had supported education that 
they would not have to pay back the loans, but they would pay 
back in service, teaching at schools as faculty, et cetera. I 
think maybe something of that sort.
    Incentives to get people into the field earlier, I think 
there is a real sense and this is partly what we're working on 
internally is people are expected to get their advanced 
education but they're expected to work along the way because it 
is clinical profession. So we are trying to help design 
programs so that that is not necessary.
    Believe it or not, many States require, in order to teach 
in a School of Nursing, that you have to have a Masters in 
Nursing and not just get your Bachelor's and then go on to a 
Ph.D. So there are a number of issues that we're working on. 
But it is safe to say that that the demand over the next 10 
years is going up in excess of 20 percent. We're only supplying 
another 6 percent.
    So we need programs that are attractive. We need programs 
to help retention. We have programs to help get people in but 
we need to figure out how to retain them. I think we need also 
to work on the quality of life issues such as loan repayment.
    Senator Harkin. Well, we need some advice. I mean if you 
turn away 42,000 last year. I assume the same will happen this 
year, maybe more.
    Dr. Grady. Yes. We are, as you had identified very 
astutely, expecting an increased retirement. It turns out that 
faculty in Schools of Nursing tend to retire earlier than 
later, 62 versus 65 or so on. So we really are getting a crunch 
from several directions. So we're hard pressed to try to design 
as many programs as possible to get people in and to make the 
field as attractive so that they will stay in.

                            NURSING RE-ENTRY

    Senator Harkin. Let me ask you this. I was amazed to 
discover in my State of Iowa a few years ago that there are a 
lot of nurses in my State, and I'm sure it must be true in 
other States. They went to nursing school. They became an RN. 
They were an RN for a while. They got married, started having 
families. They got out of nursing, raised their families. Kids 
are grown. They may not have been in nursing for 15, 18, 20 
years. I was amazed to find out how many there were in my 
State.
    So I began asking a few of them once I found out. In 
meeting people you never knew they were nurses. You meet them 
in other walks of life and find out they were a nurse. Would 
they ever think about going back into it. And they said, Oh, 
yes. But you know I don't, you know, have the wherewithal. It 
costs money to get retrained, go back to school. You know we're 
now in our late 30s, 40s. You know, yeah, if I had the ability 
or had the financial resources and stuff.
    I just wonder if there's an untapped pool out there of 
nurses who may be in their late 30s, early 40s that would get 
back in if they had the wherewithal to do so.
    Dr. Grady. I believe there is, Senator. We've been talking 
with some of the schools about a re-entry program and with the 
AACN about re-entry programs. That is precisely what you're 
describing. To get people to come back in, if they have 
incentives.
    You know it probably would not take a great deal of 
incentive. But to get people to think about it and to try to 
figure out some creative ways to get people back into the 
field. It is a wasted resource. Basically if people would like 
to come back to work, they have the background. I think it's an 
untapped resource.
    Senator Harkin. We ought to look--we ought to just see if 
there's some suggestions out there.
    Dr. Grady. I'd love to--we'd love to work on this, with 
you.

            SUPPORT FOR WOMEN PURSUING PROFESSIONAL CAREERS

    Dr. Alving. The reason I'm nodding my head is that if you 
look at medical schools now, about 50 percent of the students 
in medical schools are women. We have a very big problem in 
this country in that there's very little support, child care 
support for example, for women who are trying to pursue 
professional careers. So this pertains to veterinarians, of 
whom 80 percent of the students are women, nurses and now 
physicians.
    So I think we're going to have to think about some sort of 
ability to provide resources, child care, for those 
professional women. These nurses might not even drop out. They 
might stay in if they felt that their families and their 
children could have the appropriate type of child care.
    Other countries have organized centers where they can, you 
know, provide day care. So that's another component of it. But 
I do support re-entry. I would also support it if they could 
only drop back to half time and not drop out, because once you 
drop out it's harder to re-enter. You lose confidence and 
that's a little bit more difficult.
    Senator Harkin. Interesting concept. I'm justified that the 
programs--programs for specified for certain groups like 
nurses. That's interesting.
    Dr. Ruffin. Senator Harkin, I think one of the areas too 
where we need to pay more attention is to our 2 year 
institutions around the country. This is an untapped resource 
to a great extent. I think that the attitude as it relates to 2 
year colleges around the country has changed.
    It used to be that the thinking was that individuals would 
go to the 2 year institutions to sort of bone up for the 4 year 
experience. That attitude is totally gone. We have great 
instructors now at these 2 year schools and good students at 
these 2 year institutions.
    The problem is we're not bridging them. They're not 
transitioning to the 4 year institutions. We need more bridging 
programs that we can tap that vast resource of individuals who 
are at these 2 year institutions and begin to bridge them into 
our 4 year institutions in those challenging programs like 
nursing.
    That's one of the areas that I think we need to concentrate 
on. It is a place where we need to visit that we haven't put 
much attention on.
    Senator Harkin. Very good. Dr. Niederhuber, let me ask you 
before I just turn to Senator Cochran.
    I just wanted to ask you about clinical trials. Flat 
budgets for NCI over the past few years have taken a toll on 
clinical trials. When we finalized the fiscal year 2007 budget 
earlier this year, NCI was asking the cooperative groups that 
run cancer trials to trim their cost by 10 percent and reduce 
the number of open slots for patients by 3,000. Are those 
figures still accurate? I mean we did put some more money, as 
you know, in.
    Dr. Niederhuber. When we were trying to guess what that 
2007 appropriation might be we were forced to ask everyone to 
do a worst case scenario. So they did work on a 10 percent cut. 
We actually, just the past few days, have been meeting together 
at NCI to put in place our funding program for the cooperative 
groups that are the bulk of the grants that support clinical 
trials research across the country, as you know.
    It looks like it's going to be closer to a 5 percent 
decrease from last year. But that still translates into a 
decreased number of trials that will be open and a decreased 
number of patients that will go on trials as you understand.
    One of the difficulties with this uncertainty in the budget 
for the clinical trials aspect of research, it's complicated to 
explain, but part of the support goes for infrastructure, bio-
statistics and just the infrastructure people that have to be 
there. Another part of the budget is a bit of a guess in that 
we set aside resources that pay on a per patient basis. So as a 
patient goes on trial, that capitation gets allocated to cover 
part of those costs. It doesn't in any way cover the cost of a 
patient going on clinical trial. We're lucky in most trials if 
we come even close to 50 percent of the cost.
    So, the problem the community at large is facing across the 
academic universities is not knowing exactly how that budget is 
going to grow or stay flat over the next few years. They have 
to be very careful on deciding to start a trial, get it up, and 
get it in place. That takes time and commitment. Not knowing 
for sure if the dollars are going to be there to support that 
trial in the second, third, and fourth years.
    One of the things we do not want to do is to have to stop a 
trial in the middle. That would be a disaster. We just wouldn't 
want to do that. So I think that what I am seeing is that my 
community is being a little cautious in the number of trials 
they're willing to open up and willing to start because they 
can't predict down the road 2008, 2009, and 2010, what the 
resource flow is going to be.
    Do you follow that? It's a complex issue. It's hard to 
explain a little bit until you get your hands into it.
    Senator Harkin. But you can assure that this 10 percent cut 
is no longer valid because of the----
    Dr. Niederhuber. It's not going to be that much in 2007. 
It's going to be closer to 5 percent.
    Senator Harkin. We need some kind of--I'll have to think 
about that a second. I have a question about pancreatic cancer, 
but I wanted to turn first to Senator Cochran.
    Senator Cochran. Mr. Chairman, thank you very much for 
convening this hearing.
    It is good to meet with the heads of the different 
Departments at NIH where you're undertaking very important 
research. We appreciate the hard work that all of you are 
doing.
    We want to be sure that the budget request is as generous 
as it can be as well as the appropriations that follow. That 
when we approve a budget for this next fiscal year it reflects 
our genuine concern about doing the best we can do in 
developing research programs that will give us answers to 
problems relating to health and disease, infectious diseases, 
all the gamut of subjects that the Institute is working to help 
us understand.

               PANDEMIC FLU AND OTHER INFECTIOUS DISEASES

    I noticed that in Dr. Fauci's National Institute of Allergy 
and Infectious Diseases, you're doing a good bit of work in 
Avian flu and some other areas of that kind. I wonder what 
progress, if you can tell us is being made in coming up with 
new ways of dealing with some of those challenges of infectious 
diseases.
    Dr. Fauci. Well we have a very extensive portfolio in 
emerging and re-emerging infectious diseases, as you know. That 
is a major component of what we do. You mentioned pandemic flu 
and the concern that we have now because of the activity that 
is going on with bird flu particularly in south east Asia.
    What's happened over the last year since I testified before 
the committee is some significant advances in that regard. We 
tend to link, Senator Cochran, our preparedness for seasonal 
influenza with that of pandemic. We feel as a group that we 
don't prepare well enough for seasonal flu. We have not 
advanced the vaccine technology for seasonal flu. The shots 
that you and I get every year that everyone else gets every 
year or should get every year, we haven't advanced that 
technology to the 21st century. We really need and we are not 
only re-looking at it but really transforming it.
    For example, we make influenza vaccines now by growing them 
in eggs and then harvesting the virus in a very antiquated 
process which has great restrictions on scalability and the 
amount you can make. We've invested a lot of money to get the 
more up to date, 21st century methodologies for vaccine, either 
growing it in cells or doing recombinant DNA technology. We've 
made some significant advances in that regard.
    I mentioned before you came in that the pre-pandemic 
influenza vaccine for H5N1 that we tested over the past couple 
of years has now been approved by the FDA as a licensed 
vaccine. What we need to do and are doing rather successfully 
is applying, for example, the technology of adjuvants, which is 
a substance which enhances the body's response to a vaccine so 
you can get away with a much lower dose and can scale up 
rapidly.
    So I would report to you today that the work on emerging 
infections in general but in particular with regard to your 
question about pandemic flu is coming along very well.

                           HEALTH DISPARITIES

    Senator Cochran. That's very encouraging. We appreciate the 
good work that you're doing. I noticed in one of my staff memos 
here that a recent report indicated that one of our counties in 
Mississippi has the highest mortality rate from breast cancer 
in the Nation. That stopped me. It's twice the national average 
in Madison County, Mississippi.
    I wonder, we've talked about disparities. I think this 
might be something that the Research Centers in Minority 
Institutions program may be involved in. Dr. Alving, I think 
you'd know about that and can contribute something to our 
knowledge about what progress we're making at the National 
Center on Minority Health and Health Disparities.
    Dr. Alving. At the National Center for Research Resources 
we fund the RCMIs, or the Research Centers in Minority 
Institutions. We also work with Dr. Ruffin of the National 
Center on Minority Health and Health Disparities. I think also 
at the NCI there is a very big program in minority centers in 
cancer outreach.
    I would wonder if there isn't a multi-factorial reason for 
this high mortality. The first question would be is it due to 
lack of screening. Second we would want to know that if there 
are women who have increased breast density which can also 
affect the screening results or the mammography. But I would 
really wonder about access to care and preventive measures.
    As you know, the NHLBI funds the Jackson Heart Study in 
Mississippi, which is not only an observational study, but is 
dealing with ways of getting the participants used to the idea 
of preventive care and screening. We and the Research Centers 
in Minority Institutions are setting up a translational 
research network, with Jackson State as the data coordinating 
center, where we can do improved outreach and clinical trials 
in minority populations and also work collaboratively with my 
colleagues here at the table.
    Senator Cochran. Let me ask Dr. Ruffin to comment on that 
too.
    Dr. Ruffin. Senator Cochran, I think that first of all what 
I would like to do is really congratulate the people in the 
State of Mississippi, if you're looking for an example of 
partnerships.
    I just believe that whatever the disease area happens to be 
whether it's heart disease in the case of what we're doing with 
NHLBI or whether it's breast cancer or any of the other 
studies, whether we're talking about just getting the 
communities to participate in a clinical trial, I think there's 
a model in Mississippi that ought to be emulated. That is the 
ability of the institutions in the State of Mississippi to come 
together and work together.
    We've got programs at the Center that are working. The one 
that you're referring to, the Center for Health Disparities in 
the State of Mississippi has brought all of the institutions 
there together. The University of Mississippi Medical Center, 
Tougaloo College, Jackson State and many other institutions 
come together to work on these issues. So I believe that 
irrespective of which disease we're talking about, because 
health disparities is a very complex issue, it deals with a 
whole plethora of different disease areas and you have so many 
experts there who are working on various aspects of this issue.
    I think that by bringing these individuals together and 
everybody working together and understanding where their 
various strengths and weaknesses are, we're going to get an 
answer to a number of very important questions here.
    Senator Cochran. Well, that's very encouraging and we 
appreciate your hard work and efforts in that regard. Now, you 
mentioned, was it Dr. Niederhuber or Dr. Fauci, did you have a 
role--do you have a role in this specifically?

                       INFORMATION DISSEMINATION

    Dr. Niederhuber. Dr. Niederhuber. Dr. N. is easier.
    Senator, we as you might imagine at the Cancer Institute 
track very carefully the hot spots, if you will. We color them 
red. I don't know if that's significant politically or not but 
we know where those hot spots are for various cancers. Some of 
those areas are industrial; others are what you would call 
rural.
    Appalachia, if you go down through Appalachia we have very 
high incidence of certain kinds of especially female associated 
cancers. It's a multiple factorial problem. There's not one 
simple fix to this. Part of it has to do with education. Some 
of it has to do with socioeconomic status of those communities.
    We look also very carefully at the environment and whether 
there are environmental relationships that we can pin to risk. 
We look at the genetic changes in the population to see whether 
there's a relationship with the genetic background or inherited 
genetic patterns in those communities that relate to this risk 
as well.
    We're looking at all aspects of it. It's a very complicated 
issue. Certainly an awful lot of it though has to do with 
education and an opportunity or access to science, to care.
    As I mentioned in my opening statement before you arrived, 
Senator, we're launching in the next few days actually, 10 
pilot centers across the country that are specifically targeted 
at rural communities. Not universities, but in community 
environments around community hospitals and probably about 100 
to 250 bed facilities. The purpose of those pilots is to try to 
learn as much as we can about what we're going to need to do to 
bring the latest of our science, the latest of our discoveries 
directly to those people.
    We know that 85 percent of patients with cancer get the 
care for their cancer in the community where they live. They 
don't leave the community. They don't travel to M.D. Anderson 
in Houston or to Memorial Sloane Kettering or to Duke 
University or wherever. They stay right at home for a variety 
of reasons. Part of it has to do with age and the dependency on 
the family for support and care. That's just what's happening 
in this country.
    We have to understand that better. We have to understand 
how we're going to get our science, our discovery to people 
where they live.
    Senator Cochran. It's very interesting. Well, we thank you 
for the good work that you're doing. We appreciate your being 
here at the hearing. We look forward to continuing a close 
relationship with you as we go through the mark-up process. 
Thank you.

                         CANCER SPORE'S PROGRAM

    Senator Harkin. Thank you, Senator Cochran. As I said, Dr. 
Niederhuber, pancreatic cancer, number four killer among 
cancers. Once it strikes, very little hope. Senator Stevens had 
talked a little bit about that. It's one of the few cancers for 
which mortality rates are virtually the same today as they were 
30 years ago. So that makes the work of the three pancreatic 
cancer SPOREs so important, the Specialized Programs of 
Excellence.
    Dr. Niederhuber. Absolutely.
    Senator Harkin. I understand that NCI is considering 
changes to the SPORE program that could have a significant 
impact on pancreatic SPOREs. Could you tell me about your plans 
in that area?
    Dr. Niederhuber. Actually, I think that the changes that we 
have been making, Senator, have actually strengthened the 
program. We have been working very hard to keep as much 
resources, financial resources into this program as we have had 
in the past. So we've been scraping to do that.
    When I came onboard I looked at some of the struggles and 
some of the problems. Having come from the academic community 
and having been Cancer Center Director and knowing a little bit 
from the outside about the issues that this SPORE program has 
and how difficult it is to bring the basic scientist together 
with the clinical scientist. It's not an easy accomplishment 
for any university to build one of these programs, one of these 
collaborative efforts.
    So I began working directly with the currently funded 
leadership of the SPORE program across all of the diseases. 
Some of the things that we decided to do together, 
collectively, was one to have them come in separately.
    Senator Harkin. Individualized.
    Dr. Niederhuber. We would have the lung cancer programs all 
coming in at the same time but then not being able to come back 
in for 2 or 3 years for funding. That didn't make a lot of 
sense to any of us. So we've changed that structure around. 
We've put in place three separate times a year when anybody who 
comes together and creates a SPORE program in breast or 
prostate or pancreatic cancer. They have the resources to put 
into this and to compete for one of these grants. They can come 
in September/October or January/February or in the springtime.
    They also now have the opportunity, if the study section 
who reviews that application doesn't give it quite the score to 
get funding, a score level, they then have the opportunity to 
immediately respond to that, revise their application and come 
right back in. That was not something that existed before.
    I met with the SPORE PIs about 3 weeks ago at the American 
Association of Cancer Research meeting in Los Angeles, since 
they were mostly all there. We had a special opportunity for 
them to come and sit with me. I reviewed with them the funding 
plan we have put in place so that they could understand the 
resources and how the resources were being distributed. They 
could see the same detail that I have.
    I think they really appreciated that. It was the first time 
that anybody had been that open and shared with them the 
details of funding. We talked about the future. We talked about 
some innovative things that we might do with the program that 
might further enhance the SPORE program.
    So I think we have a very collegial working relationship 
with the research community that's committed to putting these 
grants together and to keeping them going. The goal is the best 
science.
    Senator Harkin. I understand but again I think there's some 
concern that the pancreatic cancer SPOREs will get squeezed 
out.
    Dr. Niederhuber. No. You're talking to a person who's spent 
his whole life doing pancreatic cancer surgery. So, I'm very 
committed to being sure we continue that.

                           PANCREATIC CANCER

    Senator Harkin. One last thing.
    Dr. Niederhuber. I'm hopeful that there will be other 
Institutions that will feel they have the resources, academic, 
and intellectual resources, to come in. If we get another good 
application that number is not frozen at three, we'll fund the 
best we can get.
    Senator Harkin. Ok. One last thing. Pancreatic cancer is so 
bad because there's no early detection.
    Dr. Niederhuber. Correct.
    Senator Harkin. Once you've found out and we all assume 
we've all had friends die of it. I just had one recently within 
the last couple of years who was my back seat guy when I flew 
in the Navy. Literally within, probably, 9 months he was dead.
    Dr. Niederhuber. Six months to a year.
    Senator Harkin. I've had others say the same thing. By the 
time you detect it, it's too late. What kind of hope can you 
give us? What kind of research is going on for some kind of 
early detection, methodology for pancreatic cancer?
    Dr. Niederhuber. If you remember in my opening presentation 
I highlighted that. Our genome-wide scanning that we are doing 
to look at large cohorts of patients to determine what genetic 
changes may be present in their genome, in their code of DNA, 
what changes they may carry with them that predict. For example 
we studied breast first, then prostate. We've learned quite a 
bit from that.
    We've had, I think, over the past 3 months, six papers I 
believe it is. Don't quote me for sure on that number. But I 
think it's six papers in Nature which is one of the leading 
journals as a result of that work in both prostate and breast. 
So in July of this year we will begin the same kind of study in 
pancreatic cancer.
    I am a person very interested in pancreatic cancer. I'm 
very excited about that because I think that's the first step 
in getting the kind of background information we need in terms 
of what changes may exist in your genome that says you've got a 
greater risk over your lifetime of developing this kind of 
cancer. It's a huge step for me, I think, in what we need to 
know. It will be a great foundation to build on. I hope that 
out of that we will get some clues of what kind of, we call 
them biomarkers, to look for in this particular cancer.

                              TUBERCULOSIS

    Senator Harkin. Thank you very much. Dr. Fauci, I'm hearing 
more and more about drug resistant tuberculosis. I just had a 
question on it this weekend from someone. How big is the threat 
and how prepared are we to deal with it?
    Dr. Fauci. It's a growing threat, Mr. Chairman that we're 
concerned about. As you know, TB is a very, very important 
global problem. One third of the world's population is infected 
with tuberculosis, not sick with it, but infected with it.
    Senator Harkin. One-third of the world's population is 
infected with tuberculosis.
    Dr. Fauci. One-third of the world's population is infected 
with tuberculosis, right. We get about 8 million new cases a 
year with 1.3 to 1.6 million deaths. Twenty percent of all of 
the tuberculosis active cases are multiple drug resistant. It 
means that it's resistant to the standard drugs that we use. 
But we do have alternative drugs. Ten percent of that 20 
percent have what we call extensively drug resistant 
tuberculosis or XDR as it's referred to. It's a growing 
problem.
    We are ratcheting up very aggressively our tuberculosis 
portfolio to address the issue of drug resistance. We just, as 
I mentioned earlier, put together a strategic plan that I 
presented to my National Advisory Council this morning. Then we 
will be formalizing that plan. It is a real serious problem.
    It was first brought to the attention of the scientific 
community from about 54 cases that were identified in South 
Africa, of which an astounding 52 died. That's a very, very 
high rate. The reason it is likely because they were also co-
infected with HIV. It isn't just confined to people with HIV.
    But when you say extensively drug resistant you mean that 
the standard INH and rifampicin, the drugs that you usually 
give. It's resistant to them. It's resistant to the 
fluoroquinilones and it's resistant to at least one injectable 
third-tier tuberculosis drug like amikasin and drugs like that. 
So it's a very serious problem.
    In some cases it is completely non-curable. So we have to 
work really fast to get other drugs into the pipeline. But 
importantly to make the right diagnosis because you get drug 
resistant TB by not properly treating regular TB, and you don't 
properly treat it because you don't diagnose it early enough. 
Then when you do, people don't come back for follow-up because 
they start to feel better right away. So we need to have a good 
screening process and a very sensitive diagnostic. All of that 
is part of our strategic plan that I was talking about a moment 
ago.

       MULTIPLE DRUG RESISTANT AND EXTENSIVELY DRUG RESISTANT TB

    Senator Harkin. I think most people would be alarmed to 
find out tuberculosis which we thought was in the Dark Ages has 
come back so strongly. I had not known that 1 out of 3, 30 
percent. That's alarming.
    From the figures that you gave me it's about--you say about 
20 percent are multiple drug resistant.
    Dr. Fauci. Ten percent of that 20 percent are extensive.
    Senator Harkin. So 2 percent are resistant to anything.
    Dr. Fauci. Right. Exactly.
    Senator Harkin. Is that in just a certain area of the 
world? Is that confined to a certain area?
    Dr. Fauci. Thirty-seven countries now have extensively drug 
resistant tuberculosis. There are a few cases we have in the 
United States that have been taken care of and contained. The 
problem is very serious in southern Africa. Interestingly we 
have a considerable number of cases in the Eastern European 
bloc countries and even in Korea. But there are 37 countries 
worldwide that have extensively drug resistant tuberculosis. 
That's reported.
    But given the fact that most of that one-third of the 
world's population is in the developing world in areas in Asia 
and India and China and in Africa. That's where you don't 
likely get the medical care to get the diagnosis to get it 
treated. So it's a problem that's probably underestimated. So 
I'm telling you it's 20 percent and then there's 10 percent of 
20. It's probably an underestimate as to what's really going 
on. It's a serious problem.
    Senator Harkin. Is it highly transmissible?
    Dr. Fauci. Well, it's transmissible like any tuberculosis. 
You need close continued contact and it's aerosolized droplets 
that contain the tuberculosis bacillus.
    Senator Harkin. Anthrax.
    Dr. Fauci. Yes.
    Senator Harkin. Recent estimates have said we need to be 
prepared for an anthrax attack. HHS has stockpiled anthrax 
vaccine and antibiotics. The problem with antibiotics is that 
they have to be administered shortly after any kind of attack 
or event. I've heard that there are other therapeutics that 
could target the toxins released by the anthrax bacteria and 
therefore could be effective even after the onset of symptoms.
    Dr. Fauci. Correct.

                   ANTHRAX ANTIBIOTICS AND ANTI-TOXIN

    Senator Harkin. Tell me more about that.
    Dr. Fauci. Sure. We started a program right at the point of 
a few months after the anthrax attacks here in our capital. One 
of the concerns we had is that we have very, very good 
antibiotics for anthrax. In fact, the clinical trial was done 
among Senate and House staff when they were given Ciprofloxacin 
following known exposure.
    In fact it's very interesting. Some of you may not know 
that when they did blood test screening of antibodies that many 
of the people who just did perfectly well because they took 
Ciprofloxacin or doxycycline. Actually you have proof that they 
were exposed, which means that if they did not take the 
antibiotic they very likely would have gotten sick. So the 
people who took the antibiotics did the really, the right thing 
about taking the antibiotics. I say that because we have good 
antibiotics.
    But what we are concerned about is, remember, several of 
the postal workers here in the city who were misdiagnosed 
initially. Then when they finally had the right diagnosis and 
were put on Ciprofloxacin, they were so advanced in the disease 
that the circulating anthrax toxin was the thing that killed 
them as opposed to the replicating anthrax bacillus.
    So, what we've done and we've been rather successful at it 
is to develop antibodies against the toxin itself. So if you 
have the antibiotic, prevents the replication of the bacteria, 
but the anti-toxin neutralizes the circulating toxin which is 
the thing that actually caused the death of several of those 
people. So we do have it. Some of it is already in the 
stockpile and we're working on even better ones.
    Senator Harkin. I was not aware of that.
    Dr. Fauci. Yeah, yeah, it's true.
    Senator Harkin. You actually have it in the stockpile now.
    Dr. Fauci. We have an order for it through Bioshield.
    Senator Harkin. Again this would be effective even after I 
become symptomatic--after the symptoms arise. You could target 
that? You say you're working on others, you mean there's----
    Dr. Fauci. There are multiple--there are three major toxins 
and we have antibodies to all of them. One of the ones, the 
lethal toxins that are the ones that we're most concerned 
about. We have now molecular biological techniques where we're 
trying to make monoclonal antibodies against. Monoclonal 
antibodies in anybody you actually code and manufacture to make 
only the response against a particular toxin you're worried 
about.
    Senator Harkin. How certain are you? I mean, what's the 
success rate if you had 100 people who became symptomatic with 
anthrax and you gave them this vaccine? What's the survival 
rate?
    Dr. Fauci. It depends when you get it. I have to tell you 
being an infectious disease person and having taken care of a 
lot of people who have advanced septicemia and shock. Once a 
person goes into the toxic septicemia of endotoxic or other 
types of shock the salvage rate of those individuals is very 
low.
    So I think even with an anti-toxin, if given early enough, 
before you have a lot amount of accumulated toxin, it would 
probably increase the salvage rate and decrease the morbidity 
and mortality significantly. I can't put a number on it for you 
because the clinical trial has not been done. So it would be 
folly for me to say, oh it's a 90 percent, 80 percent. We just 
don't know. We just don't know.
    Senator Harkin. How soon?
    Dr. Fauci. I hope we never have to test it.
    Senator Harkin. How will you know? How will you ever know?
    Dr. Fauci. We'll know when we have another attack.
    Senator Harkin. That's about the only way.
    Dr. Fauci. We have animal models which have worked very, 
very well in the animal models. But again we always be 
careful--if you tell me based on the animal model would I 
project that it would be a success I would say yes. But I have 
to be very cautious because there's a big leap between a 
successful animal model and what works in the human.

                           CANCER STEM CELLS

    Senator Harkin. I've got to go but a couple of things I 
wanted to cover. Cancer stem cells. There's an idea that within 
a tumor there are cancer stem cells are really the driving 
force. That if we could just figure out how to get to those 
stem cells and target those that we would have a better success 
rate in curing cancer. What can you tell me about that?
    Dr. Niederhuber. Well, it's a very exciting area of 
research. It is not a totally new concept. It's really an old 
concept. But it has come back in just the past few years.
    An example, Senator Harkin, a year ago at the AACR, the big 
national research meeting, there were maybe 20, 25 papers. This 
year there were over 225 papers at the meeting. So it just 
shows you how the community has become excited and interested 
in this concept.
    So we know that within our tissues, the normal tissues of 
our body there are cells that are responsible for regenerating 
those tissues. Let's take the lining of the intestine, the 
colon, for example. We know that there are what we call tissue 
stem cells that have a certain division property that allows 
them to regenerate that lining of the colon.
    So the concept is that the genetic changes that occur that 
lead to a cancer may have to occur in those cells, in those 
tissue stem cells, in order for the cancer to become a 
significant lesion--to have the property or potential for 
invasion and the potential for spread. In the tumor the bulk of 
the tumor cells don't carry that kind of genetic imprint.
    It's like thinking of the cell as an orchestra. Some of the 
instruments that give that orchestra in that cell the 
properties of being stem like in character are in a 
subpopulation of the tumor, maybe 1 percent, maybe as much as 2 
percent of the tumor. The bulk of the cells in the tumor don't 
have that set of instruments playing at that particular moment.
    We think we're doing a good job of getting rid of the bulk 
of the tumor but what gets left behind is that one percent of 
cells that can lie quiescent in the tissues of the body for a 
number of years. Those of us who practice oncology over the 
years have been always puzzled by seeing a patient with breast 
cancer seemingly cured 15 years or so later coming back with 
the disease seemingly everywhere. It may be part of the 
explanation of this.
    So without question we need to learn more about these 
cells. We need to learn what gives them resistance to the 
therapies that we use. We know that they have certain 
properties that can pump drugs that get into the cell 
immediately back out of the cell. So there are a lot of things 
that are--that make them more difficult to target. Maybe we 
haven't been specifically targeting them in the ways that we 
need to.
    Some of the new research is showing pathways that are 
unique to those cells. That is, signal pathways within the cell 
and potential ways to target them that are unique. So I think 
you'll see over the next few years a lot more research going on 
that is trying to get at that population of cells, better 
characterizing it and better targeting it for therapy.

                   NATIONAL PRIMATE RESEARCH CENTERS

    Senator Harkin. Thank you very much. I have a couple of 
last questions for Dr. Alving. This subcommittee has been very 
supportive of the primate centers. We included report language 
in a lot of our past bills, so I was disappointed to see in 
your budget request that your plans cut the funding for the 
centers by $1.7 million for a total of $72.3 million. What's 
the reason for that cut in the primate centers?
    Dr. Alving. This was in the congressional justification 
estimate and now the fiscal year 2007 joint resolution, which 
was a higher change from the CJ. But what we have had to do and 
what we are doing throughout the NCRR is to look at where we 
can best put our resources.
    We are actively working with the primate centers to better 
manage the consortium. We're saying that they need to work 
together as a consortium in managing their animal facilities 
and in managing the breeding of the animals. We're very 
supportive of the work and they also are working with the 
CTSAs. So if we have improved funding we will be able to put 
more money into that program.
    Senator Harkin. Your budget request cut that funding.
    Dr. Alving. This was according to the amount of money that 
we had allocated as we went across the budget. We will put this 
money back in. We also are committed----
    Senator Harkin. So, if we--I mean, excuse me for 
interrupting. So if we do better than the President's budget 
will you put that money back in?
    Dr. Alving. Yes. Yes, we will.
    Senator Harkin. Ok.
    Dr. Alving. But also realize, Mr. Chairman, that we are 
working on building up our CTSAs and that's another challenge 
in NCRR. As we are building the primate centers, we'll be 
working with the CTSAs. For example, two of our CTSA awardee 
institutions, Oregon and UC Davis have primate centers. Those 
primate centers are working in that consortium as well.
    But we are very supportive of the primate centers. They're 
doing excellent work. I visited four out of eight of them. We 
want to work with them as a consortium to support them.

                       GCRC TRANSITION INTO CTSA

    Senator Harkin. Ok. Well we'll try to put some more money 
in there for it. It's not that big. One last question on the 
CTSAs. As you say you're building them up, but what happens to 
the General Clinical Research Centers? I guess they're going to 
be folded into them or something like that?
    Dr. Alving. There will be a transition into the Clinical 
and Translational Science Awards. For example, of the first 12 
CTSA awards that were provided, 16 General Clinical Research 
Centers were included. Those have become part of the CTSAs.
    We're also emphasizing pediatrics in the CTSAs. For 
example, at the University at Pennsylvania, two General 
Clinical Research Centers were folded into that CTSA award, one 
from the Children's Hospital of Pennsylvania, one from the 
University of Pennsylvania. Now they are absolutely working 
together.
    Senator Harkin. So you can assure me there will be no 
diminution of training researchers the next generation in 
translation and clinical research because of this new 
structure.
    Dr. Alving. What we're really building is the training of 
the clinical researchers because the GCRC program never 
included training. So this is a big component of the new CTSAs.
    Senator Harkin. Thank you. Any last things from anyone else 
that I didn't touch on or that you wanted to express yourself 
on before I gavel this closed here? I thought it was a very 
good hearing. I think we got a lot out and a lot of good 
information.
    Again, I thank you all very much for your leadership in all 
these various areas. I just hope that we can get a little bit 
better budget than what the President requested. We will. We'll 
get better than what the President requested. And now we're 
looking ahead to see how we can repair some of the damage of 
the last few years. The 12 percent or 13 percent that we've 
come down in NIH over the last 4 or 5 years and we've got to 
get it back up again. But that's our problem. We'll see if we 
can do better on that.
    So with that, thank you very much. We have one more group 
from NIH and we haven't scheduled a hearing but I assume it 
won't be this week and it won't be next week because we're not 
here. So it will be sometime in June we'll have the last set of 
hearings.

                     ADDITIONAL COMMITTEE QUESTIONS

    So I thank you very much and we will keep the record open 
for any questions that other Senators who weren't here today 
have for you that they might submit in writing.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
               Questions Submitted by Senator Tom Harkin
                     food allergies and anaphylaxis
    Question. Dr. Fauci, children who have had atopic dermatitis, also 
known as eczema, are more likely to have severe food allergies and 
asthma. Has the NIAID considered the possibility of funding a 
complementary initiative, perhaps in coordination with the NHLBI, on 
atopic dermatitis as it relates to asthma and food allergy?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID) is committed to supporting research to better understand the 
relationship of atopic dermatitis (AD) to asthma and other allergic 
diseases, particularly food allergy. At this time, the NIAID is 
supporting several studies in this area. The Consortium of Food Allergy 
Research is conducting an observational study of the development and 
loss of tolerance to foods in a cohort of 400 children, ages three to 
twelve months, at a high risk of developing food allergies, including 
children with AD. The study will correlate biological markers and 
immunologic changes associated with the development of peanut allergy 
and the resolution of allergies to egg and cow's milk, and evaluate 
genetic and environmental influences on these food allergies.
    Another NIAID-sponsored program, the Immune Tolerance Network, is 
conducting two clinical trials related to food allergy and AD. The 
first will determine whether feeding a peanut-containing snack to young 
children at risk of developing peanut allergy will prevent development 
of this allergy. The subjects are children between 4 and 10 months of 
age with AD and/or allergy and they will be followed until they reach 5 
years of age. The second clinical trial is enrolling children with AD 
who are between the ages of 18 and 30 months and at high risk for 
developing allergies. This trial will determine whether oral 
administration of cat, grass, and house dust mite allergens will 
prevent the development of allergy to these and other allergens and 
asthma in these children.
    The NIAID Inner-City Asthma Consortium is conducting the Urban 
Environment and Childhood Asthma (URECA) observational study, which 
will assess antibodies to milk, egg white, and peanut in infants at 
risk for developing allergic diseases, including asthma, allergic 
rhinitis, and AD. The study will look for a correlation between food 
allergies and the onset of asthma later in life.
    Lastly, the NIAID currently collaborates with NHLBI on two 
initiatives related to asthma. One of these, Immune System Development 
and the Genesis of Asthma, includes a grant which studies the 
relationship of AD to asthma.
    Question. What plans does NIAID have to encourage research 
applications on anaphylaxis? Has the NIAID considered the need for 
clinical studies of emergency room treatment for anaphylaxis?
    Answer. To address the problem of anaphylaxis, the NIAID is 
pursuing two major approaches: expanding support for research on the 
causes, treatment, and prevention of allergic diseases, including food 
allergies and food-allergy-induced anaphylaxis; and supporting national 
and international conferences that will disseminate new knowledge and 
promote a more cohesive approach to the diagnosis, prevention, and 
clinical management of anaphylaxis.
Expanding research
  --The Report of the NIH Expert Panel on Food Allergy Research 
        discussed food-induced anaphylaxis in detail and emphasized the 
        need to study the pathogenesis of severe food allergy.
  --The NIAID-funded Consortium of Food Allergy Research is conducting 
        an observational study of the natural history of food allergy, 
        which is expected to provide new information about severe 
        allergic reactions and anaphylaxis. In addition, the Consortium 
        is conducting a clinical trial focused on severe food allergy, 
        which will use increasing oral doses of egg to treat patients 
        with severe egg allergies.
  --The NIAID has just announced a new initiative, Exploratory 
        Investigations in Food Allergy, which encourages studies on 
        severe life-threatening food allergy.
Supporting national and international conferences
  --The NIAID, in partnership with the Food Allergy and Anaphylaxis 
        Network (FAAN), a patient advocacy group, convened meetings in 
        2004 and 2005 to establish clinical criteria to identify cases 
        of anaphylaxis with high precision, review evidence on the most 
        appropriate clinical management of anaphylaxis, and outline 
        research needs in this area. Participants included experts and 
        representatives from professional, governmental, and lay 
        organizations. The proceedings of these symposia were published 
        in the March 2005 and February 2006 issues of the Journal of 
        Allergy and Clinical Immunology.
    The NIH Expert Panel on Food Allergy Research considered the need 
for clinical studies of emergency room treatment for anaphylaxis and 
presented its recommendations as part of its report.
    Question. Does NIAID make information available to health 
professionals about the best approaches to treating food allergy?
    Answer. The Consortium of Food Allergy Research was initiated in 
2005 to develop new approaches to treat and prevent food allergies. As 
such, one of the goals of the Consortium is the development, 
implementation, and dissemination of educational programs for children, 
their parents, and pediatric health care workers. In addition, the 
Consortium supports preclinical research, observational studies, and 
immune-based clinical trials for treatment or prevention of food 
allergies.
    To ensure that the information on diagnosis, prevention and 
management of anaphylaxis is developed and widely disseminated to the 
medical community, NIAID, in collaboration with FAAN and the American 
Academy of Allergy, Asthma and Immunology, is organizing a series of 
meetings. These are scheduled to begin in July 2007 and will develop 
evidence-based guidelines for the diagnosis and management of food 
allergy, including anaphylaxis.
                        tobacco-related research
    Question. Dr. Niederhuber, in March, you told NCI's Board of 
Scientific Advisors that the Tobacco Control Research Branch has been 
cut by $6.5 million between fiscal year 2004 and fiscal year 2007. Are 
those numbers still correct? If so, can you tell us how cutting back on 
this type of research will affect our ability to prevent tobacco-
related cancers?
    Answer. The Tobacco Control Research Branch (TCRB) budget was $19.2 
million in fiscal year 2004. We are still in the process of making 
final funding decisions, but the current estimate for fiscal year 2007 
is $12.7 million, which is a reduction of $6.5 million from fiscal year 
2004. Part of the reduction during the period between fiscal year 2004 
and fiscal year 2007 was due to the expiration of some tobacco control 
research initiatives. However, additionally, the period following the 
doubling of the NIH budget has resulted in very difficult choices in 
terms of setting priorities and implementing funding decisions. The NCI 
Executive Committee and advisory boards have worked diligently to 
conduct strategic priority setting and decision making related to the 
scientifically appropriate distribution of resources. In order to 
pursue new and emerging opportunities in cancer research, we must make 
choices about which programs and research initiatives come to an end.
    In terms of planning for the future, scientists in TCRB are 
currently working on several new research concepts in response to the 
2006 NIH State of the Science Conference, ``Tobacco Use: Prevention, 
Cessation and Control,'' and other priority setting reports. NCI will 
use these concepts to develop and redirect initiatives in tobacco 
control research in the future.
    NCI's research efforts in the prevention and control of tobacco use 
are premised on three fundamental facts: all tobacco products are 
hazardous; there is no safe level of tobacco use or ETS exposure; and 
the only proven way to reduce the burden of disease and death due to 
tobacco products is to prevent their use and to assist those who use 
tobacco products to quit. Further progress in reducing tobacco use is 
an important challenge facing the public health, medical, and policy 
communities.
    The Tobacco Control Research Branch (TCRB) maintains a diverse 
portfolio of research and dissemination activities. Most noteworthy are 
the following:
  --Transdisciplinary Tobacco Use Research Centers (TTURC). The TTURCs 
        are a collaboration between NCI, NIDA, and NIAAA to study 
        tobacco use control and addiction research spanning diverse 
        areas ranging from molecular biology, genetics, neuroscience, 
        and epidemiology to imaging, primary care, behavioral science, 
        communication, health policy, biostatistics, economics, and 
        marketing. Collaborative research across disciplinary 
        boundaries permits scientific exploration of the complex and 
        interactive determinants of tobacco use.
  --Testing Tobacco Products Promoted to Reduce Harm is a program which 
        funds multidisciplinary research on the interplay of behavior, 
        chemistry, toxicology, and biology to determine the cancer risk 
        potential of reduced-exposure tobacco products.
  --Smokefree.gov is a state-of-the-art Web site developed by NCI in 
        collaboration with the Centers for Disease Control and 
        Prevention (CDC) and the American Cancer Society (ACS). It 
        offers science-based tools and support to help smokers quit. 
        Smokefree.gov complements the National Quitline Network that 
        has established a new state-supported national telephone number 
        so smokers in every state have access to information and 
        proactive smoking cessation counseling.
  --The Health Disparities Network is a unique endeavor to understand 
        and address tobacco-related health disparities by advancing 
        science, translating scientific knowledge into practice, and 
        informing public health policy. In partnership with the 
        Pennsylvania State University, core scientific activities are 
        focused on methodology, treatment/cessation, prevention, 
        translation/community, and policy. The formation of the network 
        fills a void by establishing a mechanism to bring together an 
        ethnically diverse group of researchers representing different 
        disciplines and interests to answer multiple questions related 
        to the research agenda in health disparities and explore 
        optimal mechanisms for translating research into practical and 
        effective community strategies.
                            minority health
    Question. Dr. Ruffin, if the Subcommittee were able to provide 
additional funding for the Center over the President's budget request, 
what would be your top priority for how to spend it (e.g., health 
disparities research vs. research capacity-building and 
infrastructure), and why? Please be as specific as possible.
    Answer. The fiscal year 2008 President's Budget request of $194.5 
million will support NCMHD's highest priority research activities. 
However, if the NCMHD were to receive any additional funding over the 
President's budget request, those funds would go towards research 
capacity-building specifically in the area of training. Having a strong 
and culturally diverse workforce is vital to the ability of NCMHD to 
fulfill its mission to improve minority health and eliminate health 
disparities. NCMHD would place additional emphasis on recruitment and 
retention at every level of the pipeline.
    First, NCMHD would strengthen the retention component of the NCMHD 
Loan Repayment Program in order to keep more individuals from health 
disparity populations interested and involved in health disparities 
research, as well as attract young investigators from these populations 
to the biomedical research field in general.
    Second, NCMHD would be to further develop the capacity of our 
Centers of Excellence to enhance their capability in conducting 
research into the multi-factorial issues associated with health 
disparities. The research efforts of these Centers contribute 
significantly in enhancing the nation's understanding of health 
disparities, and offer the training and professional research 
environment required for the workforce to study minority health and 
health disparities issues.
                             food allergies
    Question. Dr. Fauci, during the hearing, you indicated that the 
``roadmap'' which was developed by the leading food allergy researchers 
and experts in immunology after they met in March 2006 is still in the 
process of being approved. When will it likely be released?
    Answer. In March 2006, the National Institute of Allergy and 
Infectious Diseases (NIAID), on behalf of the Secretary of the 
Department of Health and Human Services, convened the NIH Expert Panel 
on Food Allergy. The Expert Panel met to review current basic and 
clinical research on food allergies and develop recommendations for 
enhancing and coordinating research activities concerning food 
allergies. The recommendations have now been posted on the NIAID 
website at http://www3.niaid.nih.gov/healthscience/healthtopics/
foodAllergy/ReportFoodAllergy.htm.
                                 ______
                                 
            Questions Submitted by Senator Daniel K. Inouye
                      native hawaiians and cancer
    Question. Dr. Niederhuber, Native Hawaiians have a much higher 
mortality rate from cancer than other residents of the State. What 
efforts has the National Cancer Institute taken to understand cancer in 
Native Hawaiians?
    Answer. The National Cancer Institute (NCI) continues to support 
research to find the causes of cancer health disparities and to develop 
effective ways to improve cancer outcomes for Native Hawaiians. Among 
these continued efforts are: enhancing surveillance of Native Hawaiian 
populations to document the extent of cancer health disparities and 
monitor progress in improving cancer outcomes in these communities; 
empowering Native Hawaiian communities to participate in setting cancer 
research goals and priorities; assuring access to community-based 
health care that is culturally and linguistically appropriate; 
supporting infrastructure for Native Hawaiian communities that promotes 
cancer awareness, supporting research education and training in cancer 
prevention and control research by Native Hawaiian researchers, and 
supporting the development of evidence-based information and 
interventions to improve cancer outcomes in Native Hawaiian 
communities.
Community Networks Program
    Two of NCI's Community Networks Programs continue to address Native 
Hawaiian populations: 'Imi Hale--Native Hawaiian Cancer Network, and 
WINCART: Weaving an Islander Network for Cancer Awareness, Research and 
Training. These five-year grants, engage in cancer education, 
community-based participatory research and training targeted 
specifically to the Native Hawaiian population.
    The Native Hawaiian Cancer Network, 'Imi Hale, is located in 
Honolulu, Hawaii and collaborates with key partners at the community, 
state, and national levels to provide support systems and expertise to: 
(1) provide a core organizational infrastructure; (2) increase 
utilization of proven interventions to reduce disparities; (3) increase 
the number of Native Hawaiians participating in community-based 
research to reduce cancer health disparities through recruitment, 
training, and mentorship; (4) promote research that focuses on the 
spectrum of issues relevant to cancer health disparities, with an 
emphasis on developing interventions that can be used in and by Native 
Hawaiian communities; and (5) provide evidence-based information on 
reducing cancer health disparities to decision and policy makers at the 
community, local, state, and Federal levels.
                                wincart
    WINCART aims to: (1) identify multilevel barriers to cancer control 
among Pacific Islanders; (2) improve access to and utilization of 
existing cancer prevention and control services for these communities; 
(3) conduct community-based participatory research; (4) increase the 
number of Pacific Islander researchers through training, mentorship, 
and research projects; (5) sustain community-based education, training, 
and research activity through government and organizational 
collaborations; and (6) disseminate research to aid in the reduction of 
health disparities among Pacific Islander communities. Research 
activities focus on obesity, tobacco, cancer screening, survivorship, 
and recruitment of Pacific Islanders into clinical trials. The Network 
works with the NCI-supported Cancer Information Service to develop 
culturally and linguistically appropriate educational materials.
    nci surveillance of cancer health in native hawaiian populations
    NCI continues to strengthen the Surveillance Epidemiology and End 
Results (SEER) Program which has expanded its surveillance coverage and 
activities to capture 70 percent of Native Hawaiians and Pacific 
Islanders in the surveillance network. These include cancer 
surveillance, behavioral risk factor surveillance, health information 
and health services data, and epidemiologic data. This expansion is 
critical to uncovering the extent of the cancer problem and monitoring 
progress in eliminating cancer disparities in Native Hawaiian and 
Pacific Islander communities.
                cancer in pacific island subpopulations
    The NCI also recognizes the dramatic disparities found in many 
Pacific Island subpopulations, including rural Native Hawaiian 
populations. Through the Minority Institution/Cancer Center Partnership 
Program, NCI supports a research partnership between the University of 
Guam, and the Hawaii Cancer Research Center to address the cancer 
research needs of Guam and adjoining Islands.
    Through the Cancer Information Service, NCI supports efforts to 
provide NCI products, resources and services, including promotion of 
the Clinical Trials Education Series and clinical trials to individual 
hospitals in Hawaii approved through the American College of Surgeons 
Commission on Cancer (ACoS). In addition, CIS provides professional 
training in cancer and cancer clinical trials throughout Hawaii, raises 
awareness among Kauai Community College (KC) nursing students about 
cancer clinical trials, and promotes access and dissemination of NCI 
cancer clinical trials resources. These efforts have improved screening 
rates among Hawaii's medically underserved populations.
                                nursing
    Question. Dr. Grady, could you discuss the funding rates of the 
NINR compared to other institutes at the NIH? What percentage of 
nursing studies are co-funded with other institutes? What are your 
impressions of co-funded studies?
    Answer. NINR, like the rest of NIH, calculates success rates by 
dividing the number of research project grant (RPG) applications 
selected for funding in a given fiscal year by the total number of RPG 
applications reviewed during that year. In fiscal year 2006, NINR had a 
success rate of 18 percent, slightly lower than the overall rate of 20 
percent for NIH as a whole. NINR has historically had success rates 
lower than the NIH average; however, success rates can and do fluctuate 
from one year to another based on both the number of applications 
received and the overall NINR budget. In fiscal year 2006, NINR chose 
to devote about 72 percent of its budget to the support of RPGs.
    In fiscal year 2006, approximately 7 percent of NINR-supported 
research grants were co-funded by one or more of the other NIH 
Institutes and Centers (ICs). However, co-funding is only one aspect of 
NINR's overall collaborative effort across NIH. In today's increasingly 
complex, interdisciplinary research environment, NINR views trans-NIH 
collaborations as an important part of its research mission. In 
addition to co-funding research, other such efforts include: co-
sponsoring new research initiatives with other ICs, leading the NIH 
effort in end-of-life research, and maintaining leadership roles in 
trans-NIH activities such as the NIH Pain Consortium, Public Trust 
Initiative, and Roadmap. Greater collaboration with other ICs increases 
both the visibility of nurse scientists in the greater research 
community and trans-NIH awareness of research areas traditionally 
associated with nursing science, such as symptom management and disease 
prevention. Interdisciplinary collaborations also provide our own 
investigators with opportunities to expand the breadth of their work 
into areas of research not previously associated with nursing science.
                       niaid and native hawaiians
    Question. Dr. Fauci, in your testimony, you indicate that 
autoimmune diseases, allergic diseases, asthma and other immune-
mediated diseases are significant causes of chronic disease and 
disability in the United States and throughout the world. With respect 
to asthma and lower respiratory disease, Native Hawaiian adults have a 
much higher prevalence of asthma compared to other adults in Hawaii--71 
percent higher than the total State prevalence. How can the NIAID 
contribute to a greater understanding of the asthma among Native 
Hawaiians?
    Answer. Native Hawaiians, along with other minority U.S. 
populations, have higher asthma prevalence. A recent Centers for 
Disease Control and Prevention report indicates that the prevalence of 
asthma in children in Hawaii, is among the highest in the Nation. The 
National Institute of Allergy and Infectious Diseases (NIAID) welcomes 
research grant applications focusing on the causes of increased asthma 
prevalence and morbidity. While the NIAID is not currently supporting 
research that investigates asthma in Native Hawaiians, the Institute is 
actively supporting research in other groups who have high asthma 
prevalence and morbidity.
    One of the Institute's initiatives is the Inner City Asthma 
Consortium (ICAC), which aims to identify the causes for increased 
asthma prevalence and morbidity and develop effective management 
approaches in urban, minority children populations.
    Additionally, the NIAID and the National Heart, Lung, and Blood 
Institute (NHLBI) co-sponsor the ``Immune System Development and the 
Genesis of Asthma'' program, which supports research on changes in 
immune function that occur early in life and lead to the development of 
asthma.
    Information gained from these studies will enhance our 
understanding of the mechanisms of increased asthma in specific 
populations. We hope that this understanding can be extended to Native 
Hawaiians and can lead to measures of prevention and therapy that will 
ameliorate this significant health problem.
                              dengue fever
    Question. Dr. Fauci, in 2001, Hawaii experienced an outbreak of 
dengue fever that lasted 8 months, in which over 1,500 people 
experienced severe sickness. Worldwide, dengue fever kills 
approximately 25,000 each year, and it is estimated that there are 
between 50 million and 100 million cases of dengue fever illness each 
year. Given the impact of this disease on my constituents, what efforts 
has the NIAID taken towards vaccine development?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID) is currently supporting several research projects to develop a 
safe and effective vaccine against dengue fever. Development of a 
dengue vaccine is challenging because of several factors, chiefly, the 
requirement that a dengue vaccine be tetravalent, that is, 
simultaneously protective against all four dengue serotypes. 
Researchers at the NIAID have developed components of a tetravalent 
dengue vaccine that are undergoing clinical testing. Other efforts to 
develop a vaccine against dengue fever include support of the following 
research projects:
  --Preclinical and clinical development of a recombinant subunit 
        vaccine against the 4 dengue serotypes (Hawaii Biotech, Inc., 
        Aiea, HI): Additional formulation studies and toxicology 
        testing are currently ongoing in preparation for a Phase I 
        clinical trial planned for 2008.
  --Preclinical development of live attenuated vaccine against the 4 
        dengue serotypes (InViragen, LLC., Mount Horeb, WI): Extensive 
        safety and efficacy testing is currently being conducted in 
        different animal models in preparation for a Phase I clinical 
        trial.
  --Development of a microneedle array system for delivery of a DNA 
        tetravalent dengue vaccine in the skin (Cyto Pulse Sciences, 
        Glen Burnie, MD): This vaccine is currently being tested for 
        immunogenicity in different animal models, and the microneedle 
        array will be tested in human volunteers for safety.
  --Development of dengue virus replicon system to measure dengue virus 
        neutralizing antibodies in the serum (Integral Molecular, 
        Philadelphia, PA): This assay will be evaluated using serum 
        samples of patients who are hospitalized with dengue fever in 
        Nicaragua.
  --Recombinant envelope protein domain III as a candidate subunit 
        dengue vaccine (University of Texas Medical Branch, Galveston, 
        TX): The long-term goal of this project is the development of a 
        candidate subunit vaccine that induces neutralizing antibodies 
        for all four flaviviruses that cause dengue fever.
    Question. When may we expect to have an effective product?
    Answer. The candidate vaccines listed previously are moving through 
the product development pipeline. However, the challenges facing the 
development of a safe and effective vaccine are still significant. The 
timeline for a vaccine product to be manufactured for use in the United 
States depends upon a manufacturer successfully completing late-stage 
clinical trials, including a Phase IV population effectiveness trial 
and submitting the results to the Food and Drug Administration for 
licensure. This can be a lengthy process and can extend several years 
after clinical trials have been completed.
    Question. Which other States may be affected in the near future?
    Answer. According to the Centers for Disease Control and Prevention 
(CDC), there is a small risk for dengue outbreaks in the continental 
United States. However, the epidemic in Hawaii in 2001 serves as a 
reminder that many states in the United States are susceptible to 
dengue epidemics. In particular, states in southern and southeastern 
United States, where the Aedes aegypti mosquito is found, are at risk 
for dengue transmission and sporadic outbreaks (http://www.cdc.gov/
ncidod/dvbid/dengue/index.htm).
    Question. What impact, if any, could global warming have on the 
spread of dengue-carrying mosquitoes?
    Answer. Environmental events, such as climate shifts, weather 
changes, and deforestation, can affect infectious diseases, 
particularly vector-borne diseases such as dengue virus. High 
temperatures, in combination with favorable rainfall patterns, could 
prolong the disease transmission season in places where the virus 
already exists or expand the ranges of the mosquito vectors to places 
where the disease is not usually found, such as Hawaii and the southern 
region of the continental United States.
                         terrorism preparedness
    Question. Dr. Fauci, the NIAID has been assigned the responsibility 
to coordinate research to develop countermeasures against a range of 
radiological and chemical threats. You describe how the Centers for 
Medical Countermeasures against Radiation coordinate activities with 
interagency partners, including the Department of Defense, Department 
of Energy, and Department of Homeland Security. Could you describe 
ongoing research of medications that would provide protection against 
radiation in the event of a small nuclear weapon or a dirty bomb?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID) is currently evaluating multiple compounds, including many 
drugs that are licensed for other indications, for use as 
countermeasures to combat the effects of an incident involving release 
of radioactive material. This research is part of the NIAID radiation 
and nuclear countermeasures program, which is guided by the NIH 
Strategic Plan and Research Agenda for Medical Countermeasures Against 
Radiological and Nuclear Threats.
    Examples of specific NIAID-supported research initiatives include:
  --Research on all elements of radiation injury and the development of 
        products that can be licensed and included in the Strategic 
        National Stockpile.
  --Programs to screen candidate compounds for use as radiation 
        countermeasures. These programs have tested 40,000 compounds 
        and identified 52 for further evaluation.
  --Development of improved forms of the chelating agent 
        diethylenetriaminepentaacetic acid (DTPA). A chelating agent is 
        a compound that binds to a radionuclide and facilitates and 
        accelerates its elimination from the body.
  --Research on 29 candidate drugs that exhibit activity against a 
        broad range of radionuclides that might be used in radiological 
        dispersion devices or ``dirty bombs'', including several that 
        currently lack effective treatment approaches, such as 
        Strontium 90 and Cobalt 60.
    Research to develop medical countermeasures to treat radiation 
injury remains in the early stages of development; significant research 
and pre-clinical testing is needed before we will have candidate 
products developed to treat radiation injury that can move forward for 
licensure.
                                 ______
                                 
              Question Submitted by Senator Arlen Specter
                             ovarian cancer
    Question. Dr. Niederhuber, as you are aware, there is currently no 
early detection method for ovarian cancer. Because of this, more than 
75 percent of women diagnosed with ovarian cancer die within five years 
of being diagnosed. If we were to find these cancers early, the 
mortality rate falls dramatically to about 15 percent. And, ovarian 
cancer is not alone; similar statements could be made for pancreatic 
cancer. Please share NCI's strategy for fiscal year 2008 regarding 
early detection research, such as biomarkers, for cancers like ovarian 
and pancreatic, where the incidence numbers are smaller than, say, 
breast or prostate cancer, but the mortality rates are much higher.
    Answer. NCI launched the Pancreatic Cancer Cohort Consortium 
(PanScan), which is conducting whole genome scans of common genetic 
variants in 1,200 pancreatic cancer cases and 1,200 controls from 12 
cohorts to identify markers of susceptibility to pancreatic cancer. The 
promising genetic variants (single nucleotide polymorphisms (SNPs) 
identified will be validated by testing data from participants in a 
pancreatic cancer case-control consortium. It is anticipated that SNPs 
that are highly likely to be markers for genetic variants related to 
pancreatic cancer risk will emerge from this analysis as they have in 
similar studies on prostate and breast cancers, and lead to further 
studies of gene-gene and gene-environment interactions with pancreatic 
cancer risk factors. It is hoped that the PanScan will lead to 
identification of not only susceptibility genes but early markers for 
disease. This would be particularly useful for pancreatic cancer which 
is usually diagnosed at an advanced stage.
    There are also several projects being conducted on ovarian and 
pancreatic cancer in NCI's Early Detection Research Network (EDRN). 
Scientists are conducting research to enhance early detection of 
ovarian cancer. EDRN plans to screen serum DNA from larger cohorts of 
early ovarian cancer patients and controls collected by the EDRN- and 
SPORE-funded clinical centers for validating the optimized panel of 
genes for early detection and risk assessment. There are also a number 
of similar studies to discover biomarkers for the early detection of 
pancreatic cancer.
    NCI launched a unique program in September 2006, the NCI's Clinical 
Proteomic Technologies Initiative (CPTI). CPTI represents a highly-
organized approach to apply proteomic technologies and data resources 
to support the discovery of biomarkers for the early detection of 
cancer and to monitor therapeutic outcomes. CPTI will advance the field 
of clinical cancer proteomics through the development of an integrative 
team framework that networks multiple research laboratories to permit 
large-scale, real-time exchange and application of existing and newly 
developed protein measurement technologies, biological resources, and 
data dissemination. Efforts will include refining and standardizing 
technologies, reagents, methods, and analytic platforms in order to 
ensure reliable and reproducible identification, quantification, and 
validation of proteins from complex biological mixtures; and evaluating 
new technological approaches to identify proteins that occur during 
cancer development.
    In December 2005, leaders from NCI and the National Human Genome 
Research Institute (NHGRI) launched The Cancer Genome Atlas (TCGA) 
Pilot Project, a comprehensive effort to accelerate understanding the 
molecular basis of cancer, and was the result of a ``blue-ribbon'' 
committee of the nation's leading scientists. Cancer includes more than 
200 different diseases, each with a set of genetic changes that results 
in uncontrolled cell growth. The purpose of the Cancer Genome Atlas 
pilot is to test the feasibility of completely sequencing and 
cataloging the full range of genetic defects in 3 tumor types--brain 
(glioblastoma), lung and ovarian cancers, leading the way to a better 
understanding of all cancers.

                          SUBCOMMITTEE RECESS

    Senator Harkin. Thank you all very much. The subcommittee 
will stand in recess.
    [Whereupon, at 4:10 p.m., Monday, May 21, the subcommittee 
was recessed, to reconvene at 10 a.m., Friday, June 22.]
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