[Senate Hearing 110-722]
[From the U.S. Government Printing Office]



                                                        S. Hrg. 110-722
 
                        FEDERAL RESPONSE TO THE 
                          ALZHEIMER'S EPIDEMIC

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

                                HEARING

                               BEFORE THE

                  SUBCOMMITTEE ON RETIREMENT AND AGING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                                   ON

EXAMINING THE FEDERAL RESPONSE AND ADVANCES BEING MADE TOWARD DEFEATING 
                  THE EPIDEMIC OF ALZHEIMER'S DISEASE

                               __________

                             JULY 17, 2007

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut     MICHAEL B. ENZI, Wyoming,
TOM HARKIN, Iowa                     JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland        LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico            RICHARD BURR, North Carolina
PATTY MURRAY, Washington             JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island              LISA MURKOWSKI, Alaska
HILLARY RODHAM CLINTON, New York     ORRIN G. HATCH, Utah
BARACK OBAMA, Illinois               PAT ROBERTS, Kansas
BERNARD SANDERS (I), Vermont         WAYNE ALLARD, Colorado
SHERROD BROWN, Ohio                  TOM COBURN, M.D., Oklahoma

           J. Michael Myers, Staff Director and Chief Counsel

           Katherine Brunett McGuire, Minority Staff Director

                                 ______

                  Subcommittee on Retirement and Aging

                BARBARA A. MIKULSKI, Maryland, Chairman

TOM HARKIN, Iowa                     RICHARD BURR, North Carolina
JEFF BINGAMAN, New Mexico            JUDD GREGG, New Hampshire
JACK REED, Rhode Island              LAMAR ALEXANDER, Tennessee
BERNARD SANDERS (I), Vermont         JOHNNY ISAKSON, Georgia
SHERROD BROWN, Ohio                  ORRIN G. HATCH, Utah
EDWARD M. KENNEDY, Massachusetts     MICHAEL B. ENZI, Wyoming

                   Ellen-Marie Whelan, Staff Director

                                  (ii)

  




                            C O N T E N T S

                               __________

                               STATEMENTS

                         TUESDAY, JULY 17, 2007

                                                                   Page
Mikulski, Hon. Barbara A., Chairman, Subcommittee on Retirement 
  and Aging, opening statement...................................     1
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina, opening statement....................................     2
Zerhouni, Elias, M.D., Director, National Institutes of Health, 
  U.S. Department of Health and Human Services, Bethesda, MD.....     4
    Prepared statement...........................................     5
Hodes, Richard, M.D., Director, National Institute of Aging, 
  National Institute of Health, U.S. Department of Health and 
  Human Services, Bethesda, MD...................................     8
    Prepared statement...........................................    10
Gerberding, Julie, M.D., Director, Centers for Disease Control 
  and Prevention, U.S. Department of Health and Human Services, 
  Atlanta, GA....................................................    14
    Prepared statement...........................................    15
Eschenbach, Andrew von, M.D., Commissioner of Food and Drugs, 
  Food and Drug Administration, U.S. Department of Health and 
  Human Services, Rockville, MD..................................    19
    Prepared statement...........................................    21
Isakson, Hon. Johnny, a U. S. Senator from the State of Georgia, 
  statement......................................................    26

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Clinton, Hon. Hillary Rodham, a U.S. Senator from the State 
      of New York, prepared statement............................    40

                                 (iii)

  


                        FEDERAL RESPONSE TO THE 
                          ALZHEIMER'S EPIDEMIC

                              ----------                              


                         TUESDAY, JULY 17, 2007

                                       U.S. Senate,
                      Subcommittee on Retirement and Aging,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 3:17 p.m., in 
Room 628, Dirksen Senate Office Building, Hon. Barbara 
Mikulski, chairman of the subcommittee, presiding.
    Present: Senators Mikulski, Burr, and Isakson.

                 Opening Statement of Senator Mikulski

    Senator Mikulski. Good afternoon, everyone. This afternoon, 
the Subcommittee on Retirement and Aging is hosting a 
roundtable on the subject of the Federal agency response to the 
epidemic of Alzheimer's. This is set up a lot more starchy than 
what I had originally intended it to be because to me, it looks 
like a hearing. If it looks like a hearing, it is a hearing but 
we're not going to act like it's a hearing. We wanted a far 
more casual, more interactive approach and I hope that we can 
do this.
    Today, the reason we're here and I really want to welcome 
four very distinguished Americans who have devoted their life 
to public health, to saving lives and to caring about the 
people in the United States of America. Dr. Zerhouni, the Head 
of the National Institutes of Health, Dr. Gerberding, our 
Director for the Center for Disease Control and Prevention, Dr. 
von Eschenbach, our Commissioner for Food and Drug 
Administration and Dr. Hodes, who is the Director of the 
National Institute of Aging and Dr. Hodes, we had a very robust 
hearing on research a couple of weeks ago.
    But today, where are we heading? Well, everyone knows the 
data about Alzheimer's. Five million Americans are currently 
living with it. As the baby boomers age, we expect to have more 
of Alzheimer's in our community, a disease right now for which 
there is no cure, yet the possibility of very realistic 
cognitive stretch-out. One hundred years ago, it was the first 
year that Alzheimer's was diagnosed but we don't want to wait 
another 100 years to see what we can do.
    In talking about this, what we realized is that was 10 
years after the first diagnosis of HIV/AIDS that a cocktail was 
produced that enabled people to live longer and to live better. 
It was a stunning time of cooperation. The wonderful work at 
NIH. Certainly our good friend, Dr. Fouche played a lead role 
working with obscure viruses that led the way and paved the 
way. It was the best of research. The Center for Disease 
Control mounted this incredible medical detective work when 
young men in San Francisco and throughout the country were 
developing the disease that we began to recognize--and FDA 
worked in this intense and concentrated way to see how we could 
take the best of what we knew in research, what we were noting 
in epidemiology to come with up where we were.
    Well, we wonder if we're not at this point now, where we 
need to think along the lines of where are we going with the 
issue of Alzheimer's. What we wanted to discuss with you today 
is the Federal response. To talk about what is happening in the 
area of research but knowing where we are with research, how 
this is being transmitted into essentially work that the CDC 
can troubadour out for either prevention or what clinicians can 
use. We've heard stories of one, misunderstanding and 
misdiagnosis by well-meaning, primary care doctors. Patients 
worry about what's happening to them and their family wonders, 
what should they do and where could they turn?
    At the same time, we know that there are drugs that are 
being developed, drugs that are being explored but we wonder, 
is there a kind of a focal point where, in the issue of speed, 
we still maintain the very rigorous standards of safety and 
efficacy and don't let our fear and our hope move things too 
quickly but then, a sense of urgency.
    So what we're looking for today is to hear where we are in 
kind of much-needed research but at the same time, what we're 
looking at as we mark up the Alzheimer's Breakthrough Research 
Program, what we could be doing to help you be you? We need 
you. We already count on you but what can we do to help you 
deal with the fact that this is an epidemic and we look forward 
to your thoughts and then we hope that we can progress in a 
conversational way.
    We expect to be able to really have a conversation. We 
expect more of our people to come but we scheduled this meeting 
in coordination with your very complicated schedules as well 
and we appreciate your cooperation but there is an intense 
debate going on, on the Iraq War and about the deployment of 
our troops.
    But we have here Senator Burr, our very wonderful colleague 
from North Carolina whose passion for public health is well 
known and his dedication to research and advancing medical 
science is well known. So why don't you--and I see you're 
wearing the purple colors of the Alzheimer's Association.

                   Opening Statement of Senator Burr

    Senator Burr. Well, Madam Chairman, thank you. More 
importantly, I'd like to also welcome this prestigious group of 
panelists today. As I look down, doctor, doctor, doctor, 
doctor, I'm not sure whether Dr. Gerberding's sign is 
indicative of anything other than the fact that she brought her 
own. But it is larger.
    [Laughter.]
    Senator Mikulski. It's kind of the new world order, isn't 
it?
    [Laughter.]
    Maybe I ought to get a bigger one.
    Senator Burr. A rose among thorns--Madam Chairman, I 
commend you for your leadership and your support for 
Alzheimer's patients, your passion on the issue and more 
importantly, what I've had the opportunity to learn from you in 
a short period of time. Again, I want to thank each of you for 
taking time out from what I know is an incredibly busy schedule 
and I've had the opportunity already once today to meet with 
Dr. Zerhouni on some other issues.
    I believe promising research exists for Alzheimer's. Each 
of your agencies play an important part of how we treat, how we 
educate, how we care for the 5 million individuals in the 
United States living with Alzheimer's disease and the many more 
who will be added as they age or become diagnosed.
    As we know all too well, Alzheimer's is truly costly to 
treat and quickly becoming a financial burden on the Nation's 
health care system. Loved ones and family members are feeling 
the financial and emotional burdens of Alzheimer's disease as 
well. Ten million caregivers are providing 8.5 billion hours of 
care each year, valued at $83 billion.
    Simply put, we must find a disease modifying treatment. 
There are many reasons for optimism. Both the public and the 
private sectors have identified Alzheimer's as a priority for 
research and development dollars and we've learned during our 
last couple hearings that we're on the cusp of a number of 
potential scientific breakthroughs, which is exciting. It's 
critical that we translate the information learned through 
research and through clinical practice and personal experiences 
into effective public health practices and more importantly, 
medical treatment.
    I look forward to hearing how each of your agencies are 
advancing in this very, very important research and stand with 
the Chairman to say we are committed to try to explore any and 
all avenues that provide a better level and quality of care for 
patients and also provide us a way to fill that gap of a 
disease that is extremely costly, not just to us but to 
individuals and to their families and I thank the Chair.
    Senator Mikulski. Thank you. Dr. Zerhouni, we're going to 
ask you to kick it off. Dr. Zerhouni is the Director of NIH. 
He's a respected leader in the field of radiology medicine. He 
is a well known scholar, worked at Johns Hopkins as the Vice 
Dean in the School of Medicine and has a distinguished history. 
Then we'll go right down the line.
    Dr. Zerhouni, we look forward to what you have to say but 
it's not only where we are in research but one of our questions 
is, can the Congress either through authorizing more 
appropriations, do something that would really accelerate where 
we are on breakthroughs, never underestimating the solid, basic 
research that needs to go on. But how do you see this? What are 
we doing and could we do more and what would be the best way to 
do it? And of course, we want to hear from our very wonderful 
head of the National Institute of Aging.

     STATEMENT OF ELIAS ZERHOUNI, M.D., DIRECTOR, NATIONAL 
   INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN 
                     SERVICES, BETHESDA, MD

    Dr. Zerhouni. Well, Senator Mikulski and Senator Burr, it's 
a pleasure to be here and to address your question, I think it 
would be important for us to A, review a little bit of the 
recent past and then tell you where we are and where we intend 
to be, if we have the ability to follow the pathways that I 
think are becoming very clear today.
    Over the past 30 years, Americans have--the average life 
expectancy of Americans has gone up by 6 years or about 1 year 
every 5 years. What that means is that you have a 65-year-old 
American today, their average survival beyond 65 is 18 years. 
If you're 85, your average length of life is going to be 6 
years longer or more.
    And that has changed the demographics of our country, as 
you well know and this is what makes Alzheimer's a disease that 
has been with us a long time, a current priority and a future 
urgency, if you will, that we need to address. We need to 
address forthrightly with programs that I think will, at the 
end, change the paradigm with which we treat chronic diseases 
and the thing that is very obvious to us is that the landscape 
of disease has changed and is continuously changing in the 
country. As you mentioned, there is no doubt that our 
population continues to age but a striking change is the fact 
that chronic diseases now make up 75 percent of health care 
expenditures and are continuing to grow at a rapid pace.
    Alzheimer's disease is a major component of that, as you 
said, where up to 4.5, 5 million individuals affected with this 
disease but if you really think forward, you're going to have 
up to 16 million Americans affected by this disease and as 
Senator Burr mentioned, it is a costly disease.
    So how do you change the paradigm? How do you really affect 
the outcome of this disease? What does NIH need to do? What I 
think is obvious is that with the completion of the human 
genome and the discovery of fundamental causes of diseases, 
especially diseases like Alzheimer's disease that are long-term 
diseases where it's obvious that the disease started many, many 
years before it struck the patient. What we need to do is 
strike the disease before it strikes the patient.
    This is what we call the ERO, the Four P's of the future of 
medicine. Where we have to go from a paradigm where we wait for 
the patient to get very sick, to intervene to an era where we 
are much more predictive about who, how, when is a patient 
going to suffer from Alzheimer's disease and that implies, 
Senator, a different kind of research. We need to do research 
not just on the late effects of a disease but on the early 
effects and the early signs of the disease by developing 
biomarkers.
    The second is that these conditions require us to 
understand not only the fundamental causes of the disease but 
also to manage the symptoms of the disease and lessen the 
burden of the disease on our patients. For example, we know 
that patients with Alzheimer's disease suffer from depression. 
They suffer from cognitive deficits and we need to intervene at 
that level.
    At the end of the process, what will be the ultimate 
solution for us to usher in an era where we will be much more 
predictive of the disease process being there 20 years before 
it strikes; B, very targeted approaches to treating the disease 
at the stage we find it, and; C, if we can pre-empt the disease 
all together, that would be the ideal and we've shown that in 
certain cases, we can. For example, last year we introduced the 
vaccine to prevent cervical cancer and there are areas of 
research that the National Institute of Aging is funding where 
a vaccine is being entertained for Alzheimer's disease as well.
    So we have to really cover the entire spectrum of the 
disease and this is what I think needs to be understood. We 
will not make progress unless there is total coordination 
between all aspects of the disease process, remembering that we 
are seeing correlation and associations between--in these 
patients--between the presence of diabetes and the likelihood 
of developing Alzheimer's disease, heart disease and 
Alzheimer's disease.
    We also know that the disease has great impacts on 
caregivers and therefore the delivery of the care has to be 
thought through and it has to be improved. So for researchers 
today, earlier and more accurate diagnosis is going to be 
critical. That will require a better molecular understanding of 
the disease process in its earliest stages.
    It will require us to develop biomarkers, the ability to 
either through imaging or blood tests, to detect who is at risk 
for Alzheimer's disease. The completion of the human genome has 
given us hope that we will be able to find genetic signatures 
of susceptibility for the disease. We are launching a genome 
environment initiative that will allow us to find out if there 
are environmental factors that accelerate or provoke the 
development of Alzheimer's disease.
    All in all, I think that the key here is the transformation 
of our research from a curative paradigm of the past to the 
pre-emptive paradigm of the future is truly within our grasp 
and it is the priority that we should sustain and support 
aggressively.
    I think 10, 15 years ago, we didn't know what the causes of 
Alzheimer's disease at the fundamental level were, we have 
multiple theories of the disease. You will hear from my 
colleague, Dr. Hodes, about the progress we're making but there 
are still remaining challenges and the challenges, I think, in 
this case, are that the opportunities for science to make a 
difference are many but we will not succeed unless we have an 
all-front attack on Alzheimer's disease, from the very moment 
it starts, before anybody knows that the disease is there and 
the patient feels no symptoms, to the moment it strikes. We 
have to be able to do research across that entire spectrum. 
Thank you very much.
    [The prepared statement of Dr. Zerhouni follows:]

             Prepared Statement of Elias A. Zerhouni, M.D.

    Senator Mikulski and members of the committee, good afternoon. I am 
Dr. Elias Zerhouni, Director of the National Institutes of Health 
(NIH), an agency of the Department of Health and Human Services, and I 
am pleased to be here today to talk about the advances we are making 
toward defeating Alzheimer's disease (AD), a devastating condition with 
a profound impact on individuals, families, the health care system, and 
society as a whole.
    Peer-reviewed reports estimate that up to 4.5 million Americans 
ages 65 and older are currently battling AD. Moreover, the rapid aging 
of the American population threatens to increase this burden 
significantly in the coming decades: Demographic studies suggest that 
if current trends hold, the incidence of AD will begin to sharply 
increase around the year 2030, when all the baby boomers (born between 
1946 and 1964) will be over age 65. By the year 2050, the number of 
Americans with AD could rise to as many as 16 million.\1\ In addition 
to the tremendous emotional and physical toll AD exacts upon patients 
and their caregivers, financial costs of AD are high: Some experts 
estimate direct and indirect costs of Alzheimer's and other dementias 
to be more than $148 billion annually.\2\
---------------------------------------------------------------------------
    \1\ Hebert, L.E., et al. Alzheimer Disease in the US Population: 
Prevalence Estimates Using the 2000 Census. Archives of Neurology 60: 
1119-1122, 2003.
    \2\ Alzheimer's Association, Alzheimer's Disease Facts and Figures: 
2007. http://alz.org/national/documents/Report 2007_FactAndFigures.pdf. 
Figure includes Medicare and Medicaid costs and the indirect cost to 
businesses when employees are burdened with the care of persons with 
Alzheimer's.
---------------------------------------------------------------------------
    AD's complex pathology and relentless clinical course have 
presented daunting challenges for the medical and research communities. 
However, the National Institutes of Health is poised to meet these 
challenges through a comprehensive program of research into the 
underlying causes, diagnosis, prevention, and treatment of AD.
    At the most basic level, our understanding of the brain and 
cognition in both normal aging and disease states is increasing rapidly 
and exponentially. Advanced imaging technologies have opened a window 
into the inner workings of the brain and made it possible to visualize 
the brain's activity, including changes in the brain that could herald 
the onset of disease, with a specificity that was impossible even a few 
years ago. For example, the development of new tracer compounds such as 
Pittsburgh Compound B, the first molecule that can be used to map 
amyloid plaques (one of the pathological hallmarks of AD) in the brains 
of Alzheimer's patients, could allow earlier diagnosis of AD and 
facilitate the evaluation of new treatments.
    Because research suggests that the earliest AD pathology begins to 
develop in the brain long before clinical symptoms are apparent, 
scientists are now searching for reliable, valid, and easily attainable 
biological markers that can identify cases very early in the course of 
disease. Early diagnosis of AD benefits affected individuals and their 
families, clinicians, and researchers. For patients and their families, 
a definitive early diagnosis provides the opportunity to plan for the 
future while the patient can still take an active role in 
decisionmaking. For clinicians, accurate early diagnosis facilitates 
the selection of appropriate treatments, particularly as new 
interventions are developed to stop or slow progression of symptoms. 
And for researchers, earlier and more accurate diagnosis will 
facilitate clinical studies of new therapies and preventive measures by 
allowing clinical trials on early intervention, before cognitive loss 
becomes significant. We expect programs such as the ongoing Alzheimer's 
Disease Neuroimaging Initiative (ADNI), a public-private partnership 
which Dr. Hodes discusses in his statement, to provide a wealth of 
information about both brain pathology and biomarkers that can aid us 
in early diagnosis.
    Successful early diagnosis also depends upon the identification of 
people who are at particular risk for developing the disease. Although 
we do not yet fully understand what causes AD, it is apparent that 
genes play an important role, and NIH is supporting the development of 
new techniques to speed the identification of genes that are associated 
with AD. For example, genome-wide association studies (GWAS) rely on 
newly available research tools and technologies to rapidly and cost-
effectively analyze genetic differences between people with specific 
illnesses such as Alzheimer's disease or diabetes and to healthy 
individuals. Identifying the differences may facilitate our 
understanding of genetic risk factors that influence the development or 
progression of disease.
    Several NIH Institutes recently launched, or are planning, GWAS 
initiatives with the expectation that the results will eventually 
accelerate the development of better diagnostic tools and the design of 
new, safe, and highly effective treatments. NIH is also developing a 
data-sharing policy for GWAS to harmonize the practices NIH-wide 
through which data will be made available for research use.
    As with other chronic diseases and conditions, however, genes are 
only part of the story. In addition to the genetic component, cognitive 
health can be influenced by concurrent medical conditions, 
environmental factors, and even an individual's social environment. An 
ongoing NIH initiative aimed at elucidating the underpinnings of 
cognitive health and preventing disease is the Cognitive and Emotional 
Health Project. The goal of this trans-NIH initiative is to assess the 
state of epidemiologic research on demographic, social, and biologic 
determinants of cognitive and emotional health in aging populations and 
the pathways by which cognitive and emotional health may reciprocally 
influence each other so that the most likely interventions for 
maintenance of cognitive and emotional health may be targeted. As a 
first step, a comprehensive review of measures that are associated with 
maintenance of cognitive health has been published and was a starting 
point for the development of the recently published Centers for Disease 
Control and Prevention/Alzheimer's Association's Healthy Brain 
Initiative: A National Public Health Roadmap to Maintaining Cognitive 
Health.
    By learning more about the diverse factors that may increase risk 
of cognitive decline or AD, we hope to identify interventions that 
could delay or prevent its onset. For example, we have learned from 
epidemiologic studies that diabetes, a condition affecting nearly 21 
million Americans,\3\ is associated with cognitive decline in older 
people. ACCORD-MIND, an ongoing substudy of the NIH-supported Action to 
Control Cardiovascular Risk in Diabetes (ACCORD) study, is currently 
testing whether the rate of cognitive decline and structural brain 
change in people with diabetes treated with standard care guidelines is 
different than in people with diabetes who adhere to more rigorous 
treatment.
---------------------------------------------------------------------------
    \3\ National Diabetes Statistics.'' National Institute of Diabetes 
and Digestive and Kidney Diseases, 2005. http://diabetes.niddk.nih.gov/
dm/pubs/statistics/index.htm.
---------------------------------------------------------------------------
    The translation of findings from basic research into new 
interventions to prevent or treat disease is another major focus of the 
NIH. In recent years, new insights into amyloid, tau, and inflammatory 
and oxidative stressors have enabled us, for the first time, to create 
highly specific treatments for AD that are targeted at particular 
molecules and processes in the brain; Dr. Hodes describes in his 
statement some of the newer targets that have been identified through 
this research. Some of those compounds have significant proprietary 
potential and are currently undergoing preclinical and clinical study 
by pharmaceutical and biotech companies. Others are being tested in 
NIH-supported clinical trials.
    Finally, NIH supports the national infrastructure that makes basic 
and clinical research possible. For example, researchers at NIH-funded 
Alzheimer's Disease Centers (ADCs) are working to translate research 
advances into improved diagnosis and care for Alzheimer's disease 
patients while at the same time focusing on the program's long-term 
goal--finding a way to cure and possibly prevent AD. Areas of 
investigation range from the basic mechanisms of AD to managing the 
symptoms and helping families cope with the effects of the disease. ADC 
staff conduct basic, clinical, and behavioral research and train 
scientists and health care providers who are new to AD research.
    The Alzheimer's Disease Cooperative Study (ADCS) is a major 
Alzheimer's disease clinical trials effort. Now in its 16th year, the 
goal of the ADCS is to plan and conduct clinical trials on promising 
compounds designed to improve cognitive functioning, ameliorate 
behavioral disturbances, slow the rate of decline, or delay the onset 
of Alzheimer's disease. In general, the ADCS tests drugs that are not 
typically studied by large pharmaceutical companies, such as drugs that 
are off patent or were patented and marketed for another use but might 
be useful for treatment of AD, or novel compounds from individual 
investigators or from small companies without adequate resources for 
clinical trials. ADCS studies thus fill an important resource gap 
between the identification of a potentially useful compound and its 
eventual adoption in clinical practice. October 2006, NIH announced a 
$52 million award to the ADCS over the next 6 years to conduct several 
new clinical trials. Dr. Hodes describes some of these upcoming 
clinical trials in his statement.
    An exciting trans-NIH initiative that will facilitate research into 
AD and other neurological disorders is the NIH Blueprint for 
Neuroscience Research. The Neuroscience Blueprint brings the 16 NIH 
Institutes, Centers, and Offices that support neuroscience research 
into a collaborative framework to coordinate their ongoing efforts and 
to plan new cross-cutting initiatives. By pooling resources and 
expertise, the Blueprint aims to accelerate neuroscience research and 
to reduce the burden of nervous system disorders. Working together, 
representatives from the partner Institutes, Centers, and Offices 
identify pervasive challenges in neuroscience and any technological 
barriers to solving them. This enables the Blueprint to support the 
development of new tools, training opportunities, and other resources 
to assist neuroscientists in both basic and clinical research. Each 
year from fiscal year 2007 to fiscal year 2009, the Blueprint will 
focus on one of three themes: Neurodegeneration, neurodevelopment, and 
neuroplasticity. Four funding announcements related to the 
neurodegeneration theme were released in fiscal year 2007. These 
initiatives support the identification of biomarkers for 
neurodegeneration, the development of new ways to deliver therapeutics 
to the nervous system, and two interdisciplinary training programs in 
neurodegeneration research.
    Finally, NIH conducts a number of research studies that support 
caregivers of AD patients. AD caregiving is highly stressful, 
emotionally and physically, and Dr. Hodes will tell you about some of 
the ways NIH works to develop and disseminate interventions to help the 
millions of Americans who care for a loved one with AD. To further 
explore the economic, social, and psychological costs of AD, the NIH 
supports studies such as the Health and Retirement Survey, the leading 
source of combined data on health and financial circumstances of 
Americans over age 50. Now in its 14th year, the HRS follows more than 
20,000 people at 2-year intervals, and gathers important data that 
informs health care policy regarding AD and a number of other health 
conditions.
    It is important to note that the NIH cannot and does not conduct 
its important work in a vacuum. We work closely with partners in 
academia, in the private sector, and elsewhere in the government to 
develop new diagnostic tools and methodologies, to conduct clinical 
trials, to disseminate the results of our research, and to implement 
new interventions and policies resulting from our research at the 
community level. For example, the AD Neuroimaging Initiative is a joint 
venture between NIH and a number of academic and industry partners. 
Another is the AD Cooperative Study, which I described earlier, is 
conducted in close collaboration with our partners at the University of 
California-San Diego and scores of clinical sites across the Nation. 
Compared to even a decade ago, the field of neuroscience is moving at 
an extraordinary pace. We know, however, breakthroughs cannot come 
quickly enough for the millions of Americans touched by Alzheimer's 
disease. I can report to you today that real progress is being made, 
and that we at NIH are committed to seeing that progress continues 
toward treatment, and ultimately prevention, of Alzheimer's disease.
    This concludes my statement, and I will be happy to discuss these 
matters further with the subcommittee.

    Senator Mikulski. Thank you, Dr. Zerhouni. We would now 
like to hear from Dr. Hodes, who heads up the National 
Institute of Aging and has been a long time advocate of what we 
need to do on the concept of both basic research and 
breakthrough and I think what we're looking for is, of course, 
stay the course but what are your ideas and recommendations 
here?

STATEMENT OF RICHARD HODES, M.D., DIRECTOR, NATIONAL INSTITUTE 
  OF AGING, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES, 
                          BETHESDA, MD

    Dr. Hodes. Well, thank you, Senator Mikulski.
    Senator Mikulski. We kind of have this sense of urgency and 
to move the kind of breakthrough thinking along.
    Dr. Hodes. Yes, you in your opening comments and Dr. 
Zerhouni as well, have stressed the burden at present of 
Alzheimer's disease--emotional, and financial to the public 
health system as well as the urgency imposed by the demography 
and the increased number of individuals who will age, hopefully 
successfully, and be at risk.
    As Dr. Zerhouni has stressed, the new paradigm of trying to 
understand diseases from their earliest beginnings so one can 
intervene at an early stage rather than treat at a later stage, 
perhaps have their most impressive prototype where it's been 
showed that years and indeed, decades before the disease can be 
identified clinically, there are changes in the brain that can 
be detected.
    For this reason, the research supported by NIH and I should 
in collaboration with the other agencies here, have focused 
broadly to find risk factors for disease, which can be 
translated into opportunities for intervention. These clues 
have come from a number of directions. They come from basic 
science, where genetics has been most informative, identifying 
the genes which can pre-dispose or cause Alzheimer's and 
providing, therefore, targets that have been translated, in 
fact, in clinical trials, to a point to which we could 
intervene in that process.
    As recently as a few months ago, yet a new Alzheimer's risk 
factor gene, SORL1, was described and this impetus has 
continued in now a formalized genetics initiative, which is 
typical of the directions researchers are taking now in that. 
This initiative, for example, is collecting 1,000 families with 
multiple members with Alzheimer's disease.
    This goes far beyond the work that any single investigator 
or academic institution can do. It's a coalition of 
investigators that are generating these data, who can be made 
available to the whole international and national community of 
investigators and this, I think, in terms of breakthroughs and 
trends, is one of the advances we're making to move from 
privatized research to research that becomes maximally 
leveraged in populations of scientists. In addition, we're 
learning about risk factors that accompany epidemiologic 
studies. As Dr. Zerhouni alluded to, the risk factors for 
cardiovascular disease such as hypertension earlier in life, 
diabetes, increased homocysteine levels are all associated as 
risk factors and these, too have led to translation to clinical 
trials, intervening in each of these variables in an attempt to 
determine whether the causal link can be made and indeed, 
intervention to these variables will have an impact on 
preventing or slowing progression of Alzheimer's disease.
    It's stressed, appropriately, the importance in all of 
these studies for identifying the disease early so that one can 
make early diagnosis and can track progression. Most 
importantly perhaps, is that one can identify more accurately 
and more rapidly the effect, positive or negative of any of the 
interventions and trial and among the markers being used to do 
this, as Dr. Zerhouni alluded to, are markers that come from 
nerve imaging techniques. Quite striking in the last years, 
we've seen the development, previously unimaginable, of dyes 
that can actually identify both plaques and tangles, the 
lesions in the brain of Alzheimer's patients in the living 
patient and the hope is that by tracking the progress of this 
and the ability of drugs, vaccines, other interventions to 
arrest this progression, we can have far more cost efficient 
and more rapid answers to clinical trials that are underway.
    An initiative called the Alzheimer's Disease Neuro Imaging 
Initiative is really a landmark of its kind. I think it 
stresses the kind of innovation in terms of collaboration that 
is required. This is an initiative that is looking at a number 
of older American men and women who either have no disease, 
have mild cognitive impairment or have Alzheimer's disease and 
it's over time, following them for their clinical state, their 
psychological testing results, their new imaging results as 
well as the results of tests of cerebral spinal fluid and serum 
and other evidence of biological markers, including genetics.
    What's noteworthy about this initiative is that it will 
create a panel of materials that will be used, once again, by 
all qualified scientists and equally remarkable, is the nature 
of the partnership involved. This initiative was carried out by 
NIA in collaboration with other institutes at NIH with very 
close association with the FDA, recognizing that the progress 
in this initiative has to feed into the ability of the FDA to 
access the efficacy of drugs. It involves as well, partnership 
with more than 20 pharmaceutical companies and the bio-
technology companies who are contributing not only their 
expertise but funding, recognizing that the outcomes of studies 
such as this will serve all of the public and private sectors 
with a common goal of identifying ways to intervene 
successfully in Alzheimer's disease.
    So long as we are progressing in this direction, so long as 
we are faced with Alzheimer's disease to be cared for, we also 
need to be cognizant of the burden on caregivers. As Dr. 
Zerhouni noted and was noted in the introductory comments as 
well, the burden on those taking care of loved ones, family 
members, people with Alzheimer's disease is itself, huge. It 
has an impact not only financially but on the health and mental 
State of those taking care of individuals with Alzheimer's 
disease. We're happy to identify the results of the clinical 
trial, which was targeted, in this case, at Caregivers, an 
intervention that can improve the State of caregivers. The 
study was successful, in fact, identifying the kind of 
intervention that can reduce stress and improve quality of 
life, both for those afflicted with the disease and those who 
care for them.
    So long as we are progressing in the direction of 
preventing disease and treating those already afflicted, as 
well as easing the burden of those providing important care for 
them. We will continue in our collaboration across agencies, 
across sectors to this end.
    Finally, in all of this, we maintain the sense of 
responsibility that was enacted in the congressional 
establishment of a facility through NIA in leadership to 
provide information to the public, not only a clearing house 
for publications but a multimedia effort to keep the public 
informed of progress of the state of medical knowledge, of 
needs to recruit people and their interests into clinical 
studies in support of our overall enterprise.
    I thank you again for this opportunity to speak with you 
and to continue our long and I hope, soon to be, successful 
partnership in attacking Alzheimer's disease.
    [The prepared statement of Dr. Hodes follows:]

              Prepared Statement of Richard J. Hodes, M.D.

    Senator Mikulski and members of the committee, thank you for 
inviting me to appear before you today to discuss Alzheimer's disease 
(AD), an issue of interest and concern to us all. I am Dr. Richard 
Hodes, Director of the National Institute on Aging (NIA), the lead 
Federal agency for Alzheimer's disease research. NIA is one of the 27 
Institutes and Centers that comprise the National Institutes of Health 
(NIH), an agency of the U.S. Department of Health and Human Services 
(HHS). I am delighted to be here today to tell you about the progress 
we are making toward understanding, treating, and preventing AD.
    Dr. Zerhouni's statement cites the number of Americans whose lives 
are deeply affected by AD. The numbers are indeed stark and are growing 
with the aging population. But there is another part of the Alzheimer's 
story that we can tell; although AD remains a major public health issue 
for the United States, we have made, and are continuing to make, 
dramatic gains in our ability to understand, diagnose, and treat the 
disease. This progress offers us hope of reversing the current trends 
so that the risk of AD can be reduced for millions of older adults and 
their families.
    As the lead Federal agency supporting AD-related research, the 
National Institute on Aging conducts and supports a portfolio of 
research that encompasses topics across the spectrum of AD-related 
inquiry. Active areas of research include basic brain biology, pre-
clinical and clinical research on potential interventions, and 
population-based assessment of the epidemiology, economic, social and 
psychological costs of dementia to the family and society. Our research 
agenda is broad, and we pursue that agenda in partnership with 
scientists across the Nation. In October 2006, NIA convened a major 
scientific planning meeting to discuss future directions for 
Alzheimer's disease research at NIH, with particular attention to 
research issues that need to be addressed in order to improve diagnosis 
and treatment of AD. This meeting brought together internationally-
recognized experts in the field, and the results will influence the 
direction of the research we support over the next few years.

                    RISK FACTORS AND EARLY DIAGNOSIS

    Identification of risk factors for AD may enable us to develop 
interventions to delay or even prevent its onset, and NIA-supported 
researchers are making important advances in several key areas.
    Genetics. Discovery of risk factor genes will help illuminate the 
underlying disease processes of AD, open up novel areas of research, 
and identify new targets for drug therapy. Researchers recently 
determined that variations in a gene known as SORL1 may be a risk 
factor for the development of late-onset AD. While this discovery 
provides a new genetic clue about the late-onset forms of AD, further 
research is needed to determine the role of SORL1 in AD pathogenesis.
    Research is continuing in this important area through the AD 
Genetics Initiative, which to date has recruited nearly 1,000 families 
to establish a resource for studies of the genetics of late-onset AD. 
In addition, NIA has established a national genetics data repository to 
facilitate access by qualified investigators to genotypic data for the 
study of the genetics of late-onset AD. Investigators have already 
begun submitting data to this repository and requesting additional data 
for genetic studies. We also expect genome-wide association studies, 
mentioned by Dr. Zerhouni, to provide important information about AD's 
genetic underpinnings.
    Health Conditions Affecting Risk. Population studies suggest that 
conditions affecting cardiovascular and cerebrovascular systems may be 
associated with higher risk for dementia or that the presence of 
vascular disease may influence the progression of AD. One recent report 
indicated that AD dementia may be exacerbated by other cerebrovascular 
problems such as small strokes, while another linked untreated high 
blood pressure in mid-life with increased risk of dementia in later 
life. The possible association of diabetes, insulin resistance, and AD 
is garnering increased attention as well. Recent findings from at least 
four long-term studies link diabetes with decline in cognitive 
function. The NIA is currently supporting three clinical trials to 
examine directly whether diabetes-related interventions might be 
effective in preventing or delaying cognitive decline or development of 
AD or AD progression.
    Early Diagnosis: Advances in Neuroimaging. Research suggests that 
the earliest AD pathology begins to develop in the brain long before 
clinical symptoms yield a diagnosis. Therefore, it is critical that we 
find a way to detect signs of the disease at the earliest point 
possible so that we can test interventions and, ultimately, treat the 
disease as early as we can. Toward that end, the NIA has embarked on 
ambitious efforts to find new ways to measure AD changes in the brain 
or in other systems including blood and cerebrospinal fluid. These 
programs are already yielding results. Improvements in brain imaging, 
coupled with the development of more sensitive cognitive tests, are 
enabling us to diagnose AD in the research setting with greater 
precision than ever before. The discovery of compounds such as 
Pittsburgh Compound B and, more recently, FDDNP that enable the 
visualization of AD's characteristic amyloid plaques and 
neurofibrillary tangles in the living brain--an impossibility only a 
few years ago--will not only enable scientists to diagnose AD earlier, 
but may also help researchers and clinicians develop new treatments and 
monitor their effectiveness, as well as reduce the time and cost of 
clinical trials.
    Research in this area has been intense and productive. The 
Alzheimer's Disease Neuroimaging Initiative (ADNI) is currently the 
major venue for facilitating neuroimaging research relevant to AD. 
Early results from ADNI show that, in addition to aiding early 
diagnosis, researchers may be able to reduce the time and expense 
associated with clinical trials by improving methods and developing 
uniform standards for imaging and biomarker analysis. For example, one 
ADNI study found that a standard physical model can be used 
successfully to monitor performance of MRI scanners at many different 
clinical sites; this will help ensure accuracy of the MRI images 
produced from ADNI volunteers. Investigators on another ADNI study 
compared changes over time in PET scans of brain glucose metabolism in 
people with normal cognition, mild cognitive impairment, and AD, and 
they found that scans correlated with symptoms of each condition and 
that images from different clinical sites were consistent across sites, 
suggesting the validity of PET scans for monitoring the effectiveness 
of therapies in future clinical trials. This study will continue to 
provide a foundation for future efforts to identify biomarkers.
    An important achievement of ADNI is the creation of a publicly 
accessible database available to qualified researchers worldwide. The 
database contains thousands of MRI and PET scan brain images and 
clinical data and will include biomarker data obtained through blood 
and cerebrospinal fluid analyses. ADNI includes samples and brain scans 
from 200 people with Alzheimer's, 400 people with mild cognitive 
impairment and 200 cognitively healthy people. All volunteers are 
between ages 55 and 90. Confidentiality of the participants is 
rigorously protected. To date, over 200 researchers have signed up for 
database access.

  TRANSLATIONAL RESEARCH: MOVING BASIC FINDINGS INTO CLINICAL PRACTICE

    New findings about AD's characteristic pathology are leading to 
insights that may eventually inform treatment strategies. Amyloid and 
amyloid-producing enzymes, tau, oxidative damage to the brain, and 
mediators of inflammation are all under consideration as treatment 
targets, and investigators are also looking at new ways to protect 
brain cells as they age and to validate ways to enhance memory and 
improve cognition with age. For example, recent discoveries have 
provided support for the validity of beta-secretase (BACE1) as a 
therapeutic target. BACE1 comes from a family of enzymes known as 
secretases that cut, or cleave, the amyloid precursor protein (APP) in 
the brain; working in concert with a partner enzyme, gamma secretase, 
BACE1 is responsible for the formation of amyloid in AD. In a recent 
study, NIA-supported investigators were able to silence the production 
of BACE1 in mice that were genetically engineered to develop AD-like 
pathology. They found that reducing BACE1 levels slowed the production 
of amyloid plaques and diminished the damage to neurons and synapses in 
the brains of the mice receiving the treatment. Notably, the mice in 
which BACE1 production was halted had less difficulty learning a new 
task than control mice. NIA's Translational Research Initiative aims to 
speed research across the continuum of intervention development, from 
drug discovery to full-scale clinical trials. Components of the effort 
include grant solicitations to stimulate the discovery, development, 
and preclinical testing in cellular, tissue, and animal models of novel 
compounds for the prevention and treatment of the cognitive impairment 
and behavioral symptoms associated with AD. The ultimate goal of this 
initiative is to facilitate submission of investigational new drug 
applications to the Food and Drug Administration so that more clinical 
trials testing promising therapies can be started. NIA also supports 
toxicology services for investigators or small companies that have a 
potentially viable candidate drug for AD treatment but lack the 
resources to begin the formal drug testing process.
    In addition, NIA is currently supporting approximately 25 AD-
related clinical trials. These include studies of:

     Physical exercise, which epidemiological studies suggest 
may have a specific influence on aspects of cognitive decline. Small 
clinical trials are currently testing the effects of exercise on 
cognitive decline and brain function, both in older adults with normal 
cognition and in persons with mild cognitive impairment with memory 
decline.
     Statins, which lower cholesterol levels, to determine 
whether these drugs can modify disease progression in people with mild 
AD.
     Valproate, which is used to treat epilepsy and some 
psychiatric disorders, to determine whether this drug can slow decline 
or help delay the agitation and psychosis that often accompany AD.

    Dr. Zerhouni mentioned in his statement that the Alzheimer's 
Disease Cooperative Study will implement several new clinical trials 
over the next 6 years. One, a study to determine whether 
docosahexaenoic acid (DHA), an omega-3 fatty acid, will slow cognitive 
decline in AD, has begun recruitment. Other trials planned by the ADCS 
include:

     Intravenous Immunoglobulin (IVIg). IVIg, a form of passive 
immunization, contains naturally-occurring antibodies against beta-
amyloid, and preliminary studies have shown that IVIg promoted 
clearance of beta-amyloid from cerebrospinal fluid, as well as improved 
cognition in AD. The new ADCS trial will demonstrate whether IVIg is 
useful clinically for treating AD.
     Lithium. Lithium, commonly used to treat bipolar disorder, 
has been shown in animal studies to block abnormal changes in tau and 
to regulate beta-amyloid. ADCS investigators will undertake a pilot 
biomarker study to see whether the drug can lower tau and beta-amyloid 
levels in cerebrospinal fluid and be safely tolerated in older AD 
patients.

    We have also been encouraged by several recent studies related to 
AD prevention and the maintenance of cognitive health in old age. In 
2006, results from the Active Cognitive Training for Independent and 
Vital Elderly (ACTIVE) study demonstrated for the first time in a 
randomized, controlled trial that certain mental exercises can offset 
some of the expected decline in older adults' thinking skills and show 
promise for maintaining cognitive abilities needed to do everyday tasks 
such as shopping, making meals, and handling finances. Some of the 
benefits of the short-term training tested in this study lasted for as 
long as 5 years. Investigators also recently announced the discovery of 
the first agent shown to delay the clinical diagnosis of Alzheimer's in 
people with amnestic mild cognitive impairment (MCI), an MCI subtype 
strongly correlated with the later development of AD. The investigators 
found that individuals who took the drug donepezil (Aricept) were at 
reduced risk of progressing to a diagnosis of Alzheimer's disease 
during the first year of the trial. In addition, there was benefit over 
a longer 2-year period that was limited to those individuals positive 
for the APOE-4 gene allele, which confers a strong predisposition to 
the development of late-onset AD. Although donepezil's effects were 
limited, the results are nonetheless encouraging. And although too 
little is known about donepezil's long-term effects to support a 
recommendation for its routine use to forestall the diagnosis of AD in 
people with mild cognitive impairment, these findings do suggest that 
chemoprevention of AD is possible and support our hope that future 
clinical studies will lead to more significant progress.

                           CAREGIVER SUPPORT

    Most Americans with AD today are cared for outside institutional 
settings by an adult child or in-law, a spouse, another relative, or a 
friend. Research has shown that the stress of caring for a loved one 
with AD can have a profoundly negative impact on health and well-being. 
NIA-supported investigators have found that a personalized intervention 
consisting of home visits, structured telephone support sessions, and 
telephone ``check-ins'' can significantly improve the quality of life 
for AD caregivers. The study, Resources for Enhancing Alzheimer's 
Caregiver Health II (REACH II), was funded by NIA and NIH's National 
Institute of Nursing Research and is the first randomized, controlled 
trial to look at the effectiveness of an AD caregiver support 
intervention for ethnically diverse populations. Follow up studies are 
needed to examine how the intervention might be used through existing 
community networks of health and aging services.

                         OUTREACH TO THE PUBLIC

    Since its inception, NIA has provided the public and health 
professionals with information about Alzheimer's disease and age-
related cognitive change. Twenty-one years ago, Congress established 
NIA's Alzheimer's Disease Education and Referral (ADEAR) Center to 
``compile, archive, and disseminate information concerning research, 
demonstration, evaluation, and training programs and projects 
concerning AD and related dementias.'' Today, that mission is being 
accomplished through a wide variety of materials, resources, and 
activities for the general public, health professionals, and people 
with Alzheimer's disease and their families.
    ADEAR's programs are active and comprehensive. For example, the 
number of print materials distributed went from about 377,000 in 2005 
to more than 645,000 in 2006. As more and more Americans turn to the 
Internet for health information, the Center has experienced a striking 
increase in the number of web visits, up from 1.9 million in 2005 to 
2.9 million in 2006. Further, the NIA and ADEAR Center staff, based in 
Silver Spring, MD, proactively invite the public to use its resources. 
In 2006, the ADEAR Center distributed 43 e-mail alerts to various 
subscriber lists, letting subscribers know about research news, new 
publications, and other updates.
    The effectiveness in developing information products and strategies 
is based in part on the NIA's collaborations with agencies, academic 
institutions, and other organizations. The success of new easy-to-read 
publications involved collaboration between the ADEAR Center and the 
NIA's network of Alzheimer's Disease Centers. A new project aims to 
respond to a lack of materials for the newly emerging audience of 
people with early-stage AD and their families. In this effort, ADEAR is 
working with the Northwestern University School of Medicine's 
Alzheimer's Research Center to produce a publication What Happens Next: 
A Booklet About Being Diagnosed with AD and Related Disorders. The 
booklet is actually written by early-stage patients to provide those 
newly diagnosed with resources and with comfort and support from others 
who have walked the same path.

                               CONCLUSION

    It is difficult to predict the pace of science or to know with 
certainty what the future will bring. However, the progress we have 
already made will help us speed the pace of discovery, unravel the 
mysteries of AD's pathology, and develop safe, effective preventions 
and treatments, to the benefit of older people and their families.
    Thank you for giving me this opportunity to share with you our 
progress on Alzheimer's disease. I would be happy to answer any 
questions you may have.

    Senator Mikulski. Well, we'll come back to you but now we 
want to hear from Dr. Joy Gerberding, our Director of the 
Centers for Disease Control and Prevention. I want to 
acknowledge the fact that our colleague from Georgia, Senator 
Isakson, has joined us. He has a long time, both personal and 
professional interest in this issue and his advocacy is really 
most welcome, his prudent advocacy on this committee.
    Dr. Gerberding, we're anxious to hear from you. You've been 
at CDC now for 10 years and you were there as the Deputy 
Director for Infectious Disease, dealing with things like 
Anthrax, but now tell us how you're going to deal with another 
A word. But we really count on CDC for this kind of news that 
you can use.

  STATEMENT OF JULIE GERBERDING, M.D., DIRECTOR, CENTERS FOR 
 DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND 
                  HUMAN SERVICES, ATLANTA, GA

    Dr. Gerberding. Thank you very much and CDC is very 
privileged to be here and to have a chance to speak to our 
Senators and we thank Senator Isakson for coming. We really 
appreciate the support the Georgia delegation brings us as 
well.
    You know, when you think about Americans, all of us are 
aging and when you think about what people really want when 
they age, they want to be able to work productively and then 
retire and enjoy some leisure time, do the things that they 
missed doing when they were working. They want to enjoy their 
loved ones and their friends. They want to be able to 
contribute to their communities and I think most of all, they 
want to be independent.
    But what do Americans fear? Well, about 30 percent of them 
fear loss of physical functioning but about two-thirds of them 
are afraid that they are going to lose their mental capacity 
and sadly, for about 4.5 million people today, the worst has 
happened. They have developed Alzheimer's disease and they 
really truly are suffering the most severe form of cognitive 
impairment.
    What we need to focus on is not just the 4.5 million people 
who are robbed of their independence. I like to think of this 
as the great brain robbery because it truly does take away 
people's ability to do the things that they value most in life. 
But we also need to think about their caregivers who are 
profoundly impacted, about 7 out of every 10 people with 
Alzheimer's disease live at home and we need to remember that 
there are things that we can do today to help ameliorate this 
burden on individuals, their caregivers and our society.
    I want to thank Congress for supporting CDC to bring 
together the collaboration that helped create this roadmap, the 
Healthy Brain Initiative. This represents the input of many 
people at this table but I would also like to acknowledge a 
quartet of people who are not here today and that would be 
Josefina Carbonell from the Aging Group at HHS, Betty Duke from 
HRSA, Carolyn Clancy from AARC and Leslie Norwalk from CMS, in 
four other agencies and those women would have big signs, too, 
if they were here at the table because they've made some 
tremendous contributions to this issue and I think across HHS, 
we recognize that Federal leadership really is important but we 
also need to work with the Alzheimer's Association and others 
to create and enact this kind of roadmap.
    There are two tragedies. One is the tragedy of not knowing 
what to do and you've heard, I think, some of the exciting 
research that our collaborators at NIH are working on. You'll 
hear from Dr. von Eschenbach about what the FDA can do. So 
there is the tragedy of not knowing and I think we are 
investing in learning more and being able to do more.
    But there is also the current and ongoing tragedy of not 
doing what we know and I think that's what this roadmap is all 
about, that there are things that we can and should be doing 
now. We need to make a commitment. We need to inspire people to 
share that commitment. We need to build the partnerships and I 
think most importantly, we need to get the word out that 
prevention is possible.
    We already know that vascular disease is a major risk 
factor for the development of cognitive dysfunction. There are 
some hints that physical activity may be important, some early 
hints that maybe diabetes, exposure to passive tobacco and in 
fact, if you look at the health promotion agenda for health 
aging, many of the things that we should already be 
recommending to our seniors are the same constellation of 
things that may end up having a very important role in 
protecting cognitive health as well.
    So we need to reach out and help seniors achieve the best 
possible health span and I think importantly, that includes a 
much greater emphasis on cognitive health.
    I'd just like to end with one little vignette of hope. 
There is a wonderful program that was supported in Seattle, in 
part through one of CDC's Prevention Research Centers, whom 
were using some volunteer physical trainers in the community 
facility for seniors. They initiated an exercise program and 
what they were able to show with a very small investment that 
the participating seniors had better balance. They were overall 
better fit. They were happier. They reported better mental 
health and most importantly, their program was associated with 
a 23 percent reduction in group health expenses. So a very 
small investment, a very significant improvement in health, 
even for some very senior people and I think it means that we 
have to never give up. There is always room for health 
promotion and always room for prevention at every age. Thank 
you.
    [The prepared statement of Dr. Gerberding follows:]

         Prepare Statement of Julie L. Gerberding, M.D., M.P.H.

    Good afternoon, Madam Chair, Senator Burr, and distinguished 
members of the subcommittee. I am Dr. Julie Louise Gerberding, Director 
of the Centers for Disease Control and Prevention (CDC) within the 
Department of Health and Human Services (HHS). Thank you for the 
opportunity to be here today to talk with you about the importance of 
safeguarding the cognitive health of our Nation's aging population. We, 
at CDC, share your commitment to doing all we can to address the impact 
of cognitive impairment, which includes Alzheimer's disease and other 
forms of dementia. We recognize the impact it has on individuals, 
families and society. As you know, the numbers of people with 
Alzheimer's disease and other dementias are expected to increase 
substantially over the coming decades unless these conditions can be 
prevented.
    Thanks to funding provided by Congress, CDC has established an 
Alzheimer's disease segment within the Healthy Aging Program, which we 
refer to as the Healthy Brain Initiative. We have reached out to 
collaborate with the National Institutes of Health and the 
Administration on Aging, and we have formed a strong partnership with 
the Alzheimer's Association. A critical outcome from this partnership 
is the release last month of The Healthy Brain Initiative: A National 
Public Health Road Map to Maintaining Cognitive Health. I will tell you 
more about this Road Map shortly.
    With the increase in life expectancy over the past century, most 
older adults look forward to having a long life. However, one of the 
greatest worries about living to age 75 and beyond revolves around 
memory loss.\1\ The public's concerns about losing their mental 
capacities as they age are also reflected in a recent national poll 
conducted by Research!America.\2\ When asked to think about aging and 
losing either physical or mental capacity, 62 percent of respondents 
indicated they feared losing their mental capacity as compared to 29 
percent who feared losing their physical ability. These fears of 
declining mental capacity and Alzheimer's disease have led to increased 
attention by the public, the media and public health professionals. 
Despite all the attention, the public and even many health care 
providers still know very little about the specific factors that 
increase a person's risk of experiencing cognitive decline.
---------------------------------------------------------------------------
    \1\ American perceptions of aging in the 21st century. Washington, 
DC.: The National Council on Aging, Inc., 2002.
    \2\ Research!America. America speaks. Poll data summary, volume 7. 
Alexandria, VA: Research!America; 2006. http://www.researchamerica.org/
polldata/2006/mentalhealth9-06.pdf (slide 6).
---------------------------------------------------------------------------
    CDC recognizes the importance of considering the entire person and 
not focusing on physical health alone. One of our four key Health 
Protection Goals is to ensure that all people, and especially those at 
greater risk of health disparities, will achieve their optimal lifespan 
with the best possible quality of health in every stage of life. This 
holistic approach takes into account mental and cognitive health as 
well as physical health.
    I would like to briefly define cognitive decline and talk about how 
the aging of our population is expected to affect the national burden 
posed by cognitive impairment. I will then talk about the role of 
public health, including a brief highlight of our achievements to date 
and where we expect to take these activities in the future.

                    DEFINITION OF COGNITIVE DECLINE

    Much like physical health, cognition can be viewed along a 
continuum--from optimal functioning to mild cognitive impairment to 
severe dementia. While there are certain cognitive changes that occur 
with age--what we call normal age-related changes--such as a slower 
pace of learning and the need for new information to be repeated, 
cognitive decline is not a normal part of aging. It is more serious. 
Cognitive decline can range from mild cognitive impairment to severe 
dementia, but these two conditions are not necessarily manifestations 
of the same condition. Many people never develop any serious decline in 
their cognitive performance and those who develop mild cognitive 
problems do not necessarily develop dementia or Alzheimer's disease.

               IMPLICATIONS OF A RAPIDLY AGING POPULATION

    The aging of the U.S. population is expected to place demands on 
our public health system, medical services and social services. The 
growth in the number and proportion of older adults is unprecedented in 
the history of the United States. A hundred years ago, only 3 million 
people in this country were aged 65 or older. Today, more than 36 
million Americans are in this group, and that number is expected to 
grow during the next 25 years to more than 70 million as the baby 
boomers age. Public health's prevention efforts and improved medical 
care have contributed to a significant increase in life expectancy in 
the United States during the past century. However, this success has 
been accompanied by a major shift in the leading causes of death for 
all age groups, including older adults, from infectious diseases to 
chronic and degenerative illnesses. Alzheimer's disease is one of the 
top 10 leading causes of death. We know Alzheimer's disease and 
cognitive impairment have economic costs and impacts on individuals and 
their families. Recent scientific advances have highlighted potential 
risks associated with cognitive decline and may ultimately pave the way 
for preventing cognitive decline.
    Alzheimer's disease and cognitive impairment can cause years of 
disability, and loss of function and independence. We must focus on 
preventing or delaying disability and the loss of function. Although 
the risk for disease and disability clearly increases with advancing 
age, poor health is not an inevitable consequence of aging. It is a 
priority for all of us that we work to find ways to prevent or postpone 
functional loss including losses to physical, mental and cognitive 
health.

                      BURDEN OF COGNITIVE DECLINE

    In the United States, the burden of cognitive impairment has been 
expressed mainly in terms of prevalence, incidence, and mortality for 
dementia generally or for Alzheimer's disease in particular. An 
estimated 4.5 million people currently have Alzheimer's disease, and 
census population projections indicate that by 2050, as many as 16 
million individuals will have the disease. More recently, prevalence 
statistics for mild cognitive impairment have become available. Mild 
cognitive impairment refers to a level of impairment that is more 
serious than normal age-related changes, but it is not as severe as 
Alzheimer's disease or other forms of dementia. Studies from the United 
States and Canada have suggested that mild cognitive impairment may be 
a problem for 16-25 percent of older adults aged 65 years and older.

                      SOCIETAL AND ECONOMIC IMPACT

    Alzheimer's disease and other dementias place a costly burden on 
the Nation's health care system. Individuals with Alzheimer's disease 
make up less than 13 percent of the Medicare population, yet they 
account for 34 percent of Medicare spending (approximately $91 billion 
in 2005). In 2000, Medicare spending for persons with Alzheimer's 
disease and other dementias was nearly three times as much, on average, 
as spending for individuals without these conditions (Urban Institute, 
unpublished tabulations from the 2000 Medicare Current Beneficiary 
Survey and Medicare Claims, 2005; published by the Alzheimer's 
Association, Alzheimer's Disease Facts and Figures, 2007).
    Cognitive decline can have profound implications for a person's 
health and quality of life. It affects a person's ability to use words, 
identify objects, make decisions, and communicate with loved ones. 
Gradually, people experiencing severe cognitive decline may be unable 
to care for themselves or to engage in necessary activities of daily 
living or instrumental activities of daily living, such as preparing 
meals or managing their finances. Cognitive decline may also limit 
one's ability to effectively manage medications and existing medical 
conditions. Adverse changes in cognitive abilities can make an 
individual more vulnerable to malnutrition, improper use of 
medications, injuries, and even abuse and other crimes.
    The adverse effects of cognitive decline go well beyond those 
suffering from it. Seven out of every ten people with Alzheimer's 
disease live at home. Caregivers often find the task of caring for a 
person with Alzheimer's disease to be physically exhausting and 
emotionally challenging. The demands on caregivers adversely affect 
their lives and eventually impact our economy when caregivers must take 
time off from work, work part-time instead of full-time, take less 
demanding jobs, opt for early retirement, or stop working altogether. 
Because of these adjustments, Alzheimer's disease costs American 
businesses billions of dollars each year--more than $36 billion in lost 
productivity (absenteeism, productivity losses, and worker replacement 
costs) plus nearly $25 billion for the businesses' share of coverage 
for health and long-term care expenses (Koppel R. Alzheimer's disease: 
the costs to U.S. businesses in 2002. Chicago, IL: Alzheimer's 
Association; 2002.).

                       THE ROLE OF PUBLIC HEALTH

    Public health's role in physical health is well defined. Thanks to 
decades of multidisciplinary research, prevention efforts are now 
applied to a variety of chronic conditions and their associated risk 
factors. In the area of cognitive health, however, we have only 
recently begun to delineate public health's roles and responsibilities.
    Alzheimer's disease and other dementias are costly and 
debilitating, and we anticipate the incidence of Alzheimer's disease 
and other dementias will increase markedly as our population ages. 
Recent scientific findings by the National Institutes of Health focus 
on factors such as high blood pressure, diabetes and physical 
inactivity associated with cognitive decline. According to the 
Cognitive and Emotional Health Project report, a large number of 
lifestyle and health behaviors may alter the risk for maintenance of 
cognitive and emotional health.\3\ However, the report cautions that it 
is not yet possible to develop individual prescriptions.
---------------------------------------------------------------------------
    \3\ Hendrie HC, Albert MS, Butters MS, Gao S, Knopman DS, Launer 
LJ, et al. The NIH cognitive and emotional health project: report of 
the critical evaluation study committee. Alzheimer's & Dementia 
2006;2:12-32.
---------------------------------------------------------------------------
    Public health has an opportunity to build upon existing knowledge, 
anticipated future breakthroughs, and the public's desire for 
information. By embracing cognitive health as a priority issue, the 
public health community with CDC's leadership can be mobilized to 
study, identify, implement, and monitor effective interventions that 
preserve this key component of health and well-being, and help to 
maintain independence and quality of life.

             COGNITIVE HEALTH: AN EMERGING PRIORITY AT CDC

    CDC recognizes the vital role that physical, mental and cognitive 
health play in shaping our overall well-being. We are committed to 
ensuring that all people, especially those at risk for health 
disparities, enjoy good health and the best possible quality of life at 
every stage of life. For older adults, a primary goal is to ensure that 
the years gained through increased life expectancy are healthy years 
and to prevent or delay illness and functional decline. It might be 
said that our goal is to help ensure Americans live a vibrant and 
productive life throughout their aging years.
    CDC takes a multi-faceted approach to improving cognitive health. 
Some of the outcomes CDC has either achieved or is working to advance 
include the following:

     Last month we released The Healthy Brain Initiative: A 
National Public Health Road Map to Maintaining Cognitive Health 
(www.cdc.gov/aging/roadmap). This call to action proposes priority 
actions to move cognitive health into the national public health arena. 
The Road Map is a major accomplishment. Under shared leadership of the 
CDC and the Alzheimer's Association, and in close collaboration with 
the National Institutes of Health, the Administration on Aging and 
others, we embarked on an intensive process to develop the Road Map. 
Several cross-cutting areas of focus are recommended drawing on the 
proven expertise and capacities of the public health community. These 
include communicating the current state of science about cognitive 
health to Americans; developing tracking measures to better understand 
the public health burden of cognitive impairment; and delineating the 
potential value of public health strategies known to be effective for 
other health issues, such as physical activity, in maintaining 
cognitive health and preventing cognitive decline.
     CDC is bringing public health practice and research 
communities together to move them forward on getting out current 
scientific information about cognitive health. CDC is funding the 
Healthy Aging Research Network, within its larger Prevention Research 
Centers Program (PRC-HAN), to increase our understanding of the 
public's, including caregivers and health care providers, needs and 
perceptions about cognitive health. Assessing the public's needs and 
how they think and talk about this issue is an important part in 
addressing cognitive health.

    CDC is excited to be at the forefront of national efforts, working 
in collaboration with Federal and private sector partners, to advance 
cognitive health. Cognitive health is a cross-cutting issue that 
touches upon areas such as vascular risk factors, physical activity, 
social engagement, and caregiving. It fits within CDC's healthy aging 
agenda and older adult health goal to promote health at every stage of 
life. It is aligned with CDC's commitment to increase the number of 
older adults who live longer, high-quality, productive, and independent 
lives. Our involvement with the Healthy Brain Initiative also is 
aligned with CDC's strategy to create and disseminate the knowledge and 
innovations people need to protect their health now and in the future.
    CDC is known for monitoring changes in health status, translating 
research into practice and providing high-quality health information. 
Maintaining cognitive health and preventing cognitive decline is a 
cross-cutting issue. CDC's activities to prevent cognitive decline 
already touch on several promising areas, such as physical activity, 
and managing diabetes and cardiovascular risk factors. However, our 
work also extends to new areas, such as the benefits of social 
engagement and caregiving concerns. Working within the framework set 
out by the Road Map, CDC has identified several national public health 
efforts we can best advance and support to safeguard Americans' 
cognitive health. We hope to build upon our existing activities with 
the Alzheimer's Association and other partners to put critical public 
health elements in place to promote cognitive health and prevent 
cognitive decline. As the science evolves, we hope to develop 
community-based public health interventions designed to help Americans 
maintain their cognitive health. And, as we proceed on this journey 
together, we look forward to collaborating with our colleagues across 
the Department of Health and Human Services to inform the Nation's 
public health infrastructure about the science undergirding our 
knowledge about cognitive health and promising interventions.

                            CLOSING SUMMARY

    Thank you for the opportunity to speak on the issue of cognitive 
health and the benefits of addressing cognitive health within the 
public health arena. No less than cardiovascular disease, cancer or 
diabetes, addressing cognitive impairment should be a critical public 
health priority and deserves committed national public health action. 
Promising research findings coupled with public health action in the 
areas of epidemiology, surveillance and evidence-based interventions 
can translate to a difference in our understanding of cognitive 
decline, and our ability to address this issue in a positive way for 
the benefit of all Americans. We at CDC appreciate your continued 
commitment to efforts related to Alzheimer's disease and other 
dementias, and we look forward to working with you and our national 
partners in ensuring that cognitive health is addressed in an 
aggressive manner commensurate with the fundamental role that it plays 
in our overall health and quality of life. I would be happy to answer 
any questions you might have.

    Senator Mikulski. Dr. von Eschenbach, you've come to us 
from FDA that has the job of standing sentry over our food 
supply and our drugs to go into clinical practice and our 
medical and biomedical products and devices. You come with an 
incredible background and you were at NIH yourself, heading the 
National Cancer Institute. And now, of course, you come with a 
background in oncology. We'd like to hear, then, from you, how 
you see FDA's role in dealing with the epidemic, at the same 
time having the mandate. We ask you to do two things. We ask 
you to move things as quickly as possible into clinical 
practice but at the same time, including this committee, has 
been very demanding in terms of the safety issues as well as 
efficacy.
    So tell us how you see we can deal with the epidemic, the 
new thinking, how you work with the private sector.

 STATEMENT OF ANDREW C. VON ESCHENBACH, M.D., COMMISSIONER OF 
 FOOD AND DRUGS, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT 
          OF HEALTH AND HUMAN SERVICES, ROCKVILLE, MD

    Dr. von Eschenbach. Thank you very much, Senator and thank 
you for framing it so well, but let me first thank you and 
Senator Burr and Senator Isakson and other members of the 
committee for convening this really extremely important 
discussion. I'm joined today from the FDA by Dr. Bob Temple and 
Susan Winkler, Rph, Esq., but it's a particular honor for me to 
appear on the same panel with my colleagues from CDC and from 
NIH.
    Dr. Zerhouni, Dr. Gerberding and I have been working hard 
to make our relationships productive and integrated so this is 
not simply a ceremonial gathering. This is evidence of a 
commitment on our part for close collaboration to be able to 
accomplish progress in the diseases like Alzheimer's.
    Every promising new drug, every diagnostic test, every 
imaging technology that's designed to help Alzheimer's patients 
must come through the FDA before it reaches those people. So 
our responsibility is to help make sure that those products are 
available and to determine that they are safe and effective. We 
are doing this immersed in the 21st century revolution in 
science and technology that I personally describe as the 
molecular metamorphoses.
    It's particularly important because it now provides us, as 
you heard from Dr. Hodes, unique opportunities to understand 
diseases like Alzheimer's at the genetic, molecular and 
cellular level and therefore be able to make possible 
extraordinary new opportunities, new interventions, new 
solutions to prevent, treat and slow the progression of this 
disease.
    In that context, FDA--the FDA of the 21st century must be a 
bridge and not a barrier to that new future. From the very 
discovery of promising new therapies through their development 
and ultimately to its delivery to Alzheimer's patients, FDA is 
committed to be immersed in promoting and fulfilling our 
promise to the American people.
    We must be actively engaged at every step along that 
continuum and we want to do that in a way to be an efficient 
and effective pathway so that we're free of speed bumps and 
potholes in our regulatory process. But as you pointed out, 
also be sure that we have strong guard rails on that pathway 
with guidances, regulations and standards that will also 
protect the American people.
    Central to our efforts in this regard to modernize the FDA 
is the Critical Path Initiative, which is bringing the tools of 
modern science and technology to the regulatory journey that 
these medical products, these solutions must make from the 
earliest stages of development to their use in patients. We, 
among the Critical Path Initiatives, have many activities that 
are being carried out in partnership with NIH and others, 
particularly, for example, around the area of developing 
biomarkers that can be used to determine the impact of a drug 
on the amyloid plaque that is associated with Alzheimer's 
disease or to use new clinical trial designs that will not 
require 20 years for us to determine whether a new product can 
help prevent this dreaded disease.
    We are, in a sense, attempting to try to open the 
floodgates of the development of products for Alzheimer's 
disease and we will continue to move this process forward in 
concert with and in collaboration not only with our partners 
but with the community. Over the past year, I've personally met 
with two prominent Alzheimer's disease patient advocacy 
organizations, the Alzheimer's Association and the 
organization, Accelerate New Treatments for Alzheimer's 
disease. I share their concerns around the urgency of FDA's 
ability to bring these new products to patients.
    We are continuously, throughout FDA, remaining in contact 
with these organizations and particularly to be able to 
understand the opportunities that we must be addressing. We 
also are engaged with the academic industry and particularly 
seeing this as a problem in which we are all in this together: 
industry, government, caregivers and the scientific community.
    I just want to highlight a few of the important initiatives 
that I think are tangible contributions to this overarching 
strategic perspective. During fiscal year 2006, our Division of 
Neurological Products and our Center for Drug Evaluation and 
Research held 18 formal meetings with industry and this doesn't 
include internal FDA meetings to discuss sponsors' 
investigational new drug applications. To this date, the 
Division has met with industry six times in an effort to help 
facilitate their ability to develop and bring to the regulatory 
process, successful drugs for Alzheimer's disease.
    We need to also be able to leverage progress that's being 
made in other neurologic diseases. For example, we are 
conducting a planning meeting to help determine the best 
designs for clinical trials for Parkinson's disease but we are 
doing that in a way in which we expect to extrapolate those 
results for our formal guidance that would be directed and 
applicable to trials, clinical trials, in Alzheimer's.
    We're working to improve our internal processes, our 
standards, our processes for expediting review and we've 
established within the FDA, an inter-agency neurological 
working group so that we're focused across the agency on the 
critically emerging problems that we're discussing today. This 
group meets monthly, includes members from our Center for 
Biologics Evaluation and Research, our Center for Drug 
Evaluation and Research, our Center for Devices and Radiologic 
Health, along with the Office of the Commissioner, Office of 
Critical Path Programs, Office of Special Health Issues and 
Office of Science and Health Coordination. This is an effort to 
bring the full force of the FDA to bear on this critically 
important problem.
    We're also attempting to contribute to the underlying 
understanding of this disease and the tools that we must apply 
so that within the FDA's National Center for Toxicological 
Research in Arkansas, we have two very specific Alzheimer's-
related projects underway. One is to develop a non-invasive 
automated technology for assessing patients with Alzheimer's 
disease so that we may be able to provide reliable and 
objective measures to monitor the progression of the severity 
of the disease and the impact of these innovations on that 
progression. We see this as an invaluable tool that will spur 
academic research in the pharmaceutical and biotechnology 
industry in the development of these medical products.
    We're also looking at a new histochemical test battery that 
will enable us, as regulators, to assess the efficacy and 
toxicity of potential drugs for Alzheimer's and this could help 
us be able to streamline and improve the development of these 
drugs to be able to bring them more reliably, more safely and 
sooner to patients that are threatened by this degenerative 
disease.
    These are just a few examples of how we at the FDA want to 
be a bridge and not a barrier to providing hope and expectation 
for those with and those threatened by Alzheimer's disease for 
a new future, a future in which they will not fear the 
consequences of this terrible degenerative process.
    [The prepared statement of Dr. von Eschenbach follows:]

          Prepared Statement of Andrew C. von Eschenbach, M.D.

                              INTRODUCTION

    Madam Chairman and members of the subcommittee, I am Dr. Andrew C. 
von Eschenbach, Commissioner of Food and Drugs at the Food and Drug 
Administration (FDA or the Agency). I would like to applaud the 
subcommittee for holding this roundtable discussion to discuss Federal 
initiatives to address the cruelly debilitating condition known as 
Alzheimer's disease. FDA shares your commitment to vigorously 
addressing Alzheimer's disease, and shares your hope that safe and 
effective treatments for this condition will be approved in coming 
years. It is a pleasure to be here today with my colleagues from the 
Department of Health and Human Services, Dr. Julie Gerberding, Dr. 
Elias Zerhouni, and Dr. Richard Hodes.
    I very much appreciate the opportunity to join this discussion to 
explain FDA's role as it applies to new products being developed for 
treatment of Alzheimer's disease. Further, I will describe several 
initiatives FDA is undertaking to transform the Agency in an effort to 
meet the regulatory challenges arising from rapid advancements 
occurring in all areas of medical research including Alzheimer's 
disease, and several special initiatives underway at FDA that are 
directed toward Alzheimer's disease.
    In the two recent hearings on Alzheimer's disease before this 
subcommittee you heard current statistics recently released by the 
Alzheimer's Association including that this disease now afflicts one in 
eight Americans over the age of 65 and some 47 percent of Americans 
over the age of 85. At the present rate, the estimated 4.5 million 
cases of Alzheimer's disease today can be expected to rise to around 16 
million by 2050. With the aging of the baby boom generation over the 
next several decades, without safe and effective treatments and 
preventatives, a huge population of seniors stands to be robbed by this 
disease of the enjoyment of their later years. In addition to the 
burdens placed on patients and their families, insurance programs 
surely will face overwhelming demands on their services and resources.
    There is cause for some cautious optimism. You also heard of 
exciting advancements in research on Alzheimer's disease such as 
identification of amyloid peptide as a possible molecular cause of 
Alzheimer's disease. Some researchers believe it is realistic to expect 
that the progress of Alzheimer's disease can be slowed or halted by 
products developed to affect the amyloid peptide. However, researchers 
also have emphasized that this is a very complex disease that will need 
to be approached from several different directions. A number of 
promising new treatments in many areas are in the works; a few were 
mentioned in your previous hearings as approaching the stage of 
clinical trials.
    As you may know, FDA is legally restricted from discussing any 
individual products that already may be under review by the Agency. 
This precludes me from being able to discuss specific unapproved 
products in today's public forum. I can tell you, however, that 
Alzheimer's and other neurological diseases are very active areas of 
research and of work within the Agency. FDA reviewers interact 
constantly with manufacturers and sponsors of prospective new products 
(drugs, biologics, medical devices or combination products) to help 
develop, and then to review, suitable clinical trials to test whether 
their products are safe and effective. This is a very intricate and 
time-consuming process. Our reviewers work with industry in all phases 
of the development of a new product, both before and during clinical 
trials, as requested by the sponsors. As always, FDA stands ready to 
expeditiously review applications for any breakthrough products that 
are presented to us.
    FDA recognizes its dual role as evaluator of the safety and 
effectiveness of new therapies and as the encourager and facilitator of 
efforts to apply new scientific discoveries to patients who are in 
need. FDA serves as a bridge to the future of successful new medical 
product development. The Agency has a proud record over the past 
hundred years of being the world's gold standard in medical product 
regulation, but FDA cannot rest on its past and must come to grips with 
the new realities of our regulatory responsibilities. Therefore, we 
have embarked on a process of looking internally at transformations 
that must occur within the Agency, and to identify opportunities to 
collaborate with drug developers and other scientists on the discovery, 
development, assessment and delivery of new treatments. I would like to 
share some of these efforts with you.

                      THE CRITICAL PATH INITIATIVE

    In today's world of health care and medicine, we are on the brink 
of unprecedented advances in our ability to predict, diagnose, and 
treat disease. Approximately 100 years ago, our ability to understand 
disease moved from the macro level, where we were limited to what was 
visible to the naked eye, to the micro level--when we gained a 
microscopic view of disease at the cellular level. In the last decade 
or two, we have been able to approach disease at the molecular level, 
where we now can observe and understand disease as a process. As our 
knowledge of genetic molecular mechanisms evolves and our understanding 
improves, we will be uniquely positioned to develop interventions 
against disease processes at the molecular level.
    Yet a problem emerges. Despite an unprecedented increase in funding 
for biomedical research, both in the private sector and through Federal 
funding, this increased research has not translated into many new 
medical products being available in the medical marketplace. There are 
exceptions, of course, notably in the development of new treatments for 
cancer and AIDS, and some inflammatory diseases. Close to 9 in 10 
pharmaceutical products in phase 1 clinical testing are never approved 
for marketing, and half of all drugs that enter phase 3 clinical trials 
are never approved. In an effort to help expedite and simplify the 
medical product development process, in 2004, FDA advanced the notion 
of focusing on the critical path which medical products must travel 
from the earliest stages of development to their use in patients. The 
Critical Path Initiative is FDA's effort to stimulate and facilitate a 
national effort to modernize the sciences through which FDA-regulated 
products are developed, evaluated, and manufactured.
    FDA is working with the academic community, the public, the 
pharmaceutical industry, and other Federal health agencies (e.g., the 
National Institutes of Health (NIH), the Centers for Medicare & 
Medicaid Services, and the Department of Veterans Affairs) to modernize 
and transform the development and use of medicines. After intensive 
consultation with many stakeholders, last year the Agency published our 
Critical Path Opportunities Report, which details 76 specific 
scientific projects with great promise for smoothing the path from lab 
to bedside. Last December, we followed up by announcing more than 40 
very promising scientific projects that we have helped launch. These 
projects support the development and approval of new treatments for 
conditions such as Alzheimer's, diabetes, cancer, and chronic pain. For 
example, improved predictive and evaluative tools that help identify 
candidate products that are likely to fail early in the development 
process will enable the investment of resources in those products most 
likely to succeed. Streamlining clinical trials--making them more 
efficient and safer--will help move new therapies to patients sooner 
while protecting clinical trial participants. Among many other 
activities, the Initiative also supports the implementation of 
information technologies that will enable us to tap into existing data 
repositories to expand research into disease areas and improve 
efficiencies. The Critical Path Initiative is a long-term, national 
effort that is helping to ensure that promising new therapies in the 
development pipeline today will reach the patients who need them sooner 
and at less cost. The projects under way today as part of the Critical 
Path Initiative will improve treatment, improve safety, and improve 
patient access.
    Another example of the Critical Path Initiative is The Biomarkers 
Consortium launched in October 2006. This is a public-private 
biomedical partnership established by FDA and many colleagues in the 
scientific community that is supported by the Foundation for the 
National Institutes of Health. The Biomarkers Consortium strives to 
accelerate the delivery of successful new diagnostic approaches and 
therapies to prevent, detect early, diagnose, and treat a wide variety 
of diseases. Among other efforts, the Consortium seeks to identify 
biomarkers and develop tests to determine whether a drug is appropriate 
for an individual patient. It also is working to find ``markers'' that 
will show whether a drug is having the right effect in the patient. For 
example, researchers have found that patients whose tumors have 
specific genetic mutations or surface properties respond to particular 
treatments. This mutation then serves as a ``marker'' to identify the 
patients who are best treated with these medications.
    Over time, similar discoveries related to other tumors, other 
diseases and conditions, and other drugs will yield a major public 
health impact--and that is the point of the Critical Path Initiative. 
Working with all stakeholders, the Critical Path goal is to get the 
right medicine to the right patient, in the right dose, and at the 
right time. It will make innovative medical products available sooner, 
increase our ability to monitor their safe use once they have reached 
the medical market, provide for personalized diagnosis and treatment, 
and introduce great efficiencies while reducing risk.

         TWO EXAMPLES OF ALZHEIMER'S RESEARCH WITHIN THE AGENCY

    Now, I would like to talk about two Alzheimer's-specific projects 
that FDA has undertaken. First, FDA scientists from our National Center 
for Toxicological Research (NCTR) collaborated recently with scientists 
at the University of Arkansas for Medical Sciences, the University of 
Arkansas at Little Rock, and the Central Arkansas Veteran's Health Care 
System to conduct an automated cognitive assessment of persons with and 
without Alzheimer's disease. The study investigated performance on 
metrics for a variety of behavioral test tasks that measure timing 
perception ability, short-term memory, and learning ability using an 
automated system called the NCTR Operant Test Battery (OTB). The study 
outcome indicated that the persons with Alzheimer's disease were 
significantly less accurate in the time perception and short-term 
memory tasks and were rarely responsive in the learning task. The OTB 
is a non-invasive, automated, non-threatening assessment technology 
that can differentiate between normal controls and persons with 
Alzheimer's disease. This automated assessment instrument has the 
potential to provide reliable, objective measures that can be used to 
monitor the progression and severity of the disease process and assess 
effectiveness of interventions over time. A report on this study is in 
preparation.
    Currently, FDA/NCTR scientists are initiating a study to develop a 
histochemical test battery for assessing the efficacy and toxicity of 
putative anti-Alzheimer's disease drugs, the safety of which will need 
to be evaluated in the FDA regulatory review process. There are two 
broad categories of anti-Alzheimer's drugs: those that provide 
symptomatic relief and those designed to prevent or slow the 
degenerative process. So far, those in the first category have been 
developed and shown effective, and are approved for use by FDA. Those 
designed to cure or reverse the disease process are in early 
development or, in some cases, in clinical trials. The development of a 
therapeutic histochemical test battery has the potential to help 
identify earlier and more reliably drugs that might slow the 
degenerative process. This study is scheduled to begin later this 
fiscal year.

           THE PATIENT REPRESENTATIVE AND CONSULTANT PROGRAMS

    FDA also has engaged with the Alzheimer's disease patient advocacy 
community regarding that community's involvement in FDA decisionmaking 
during development of new medical products. Through FDA's Patient 
Representative Program, they will be able to participate in FDA 
advisory committee meetings, advising the Agency on marketing approval 
decisions and in response to issues arising with marketed products, as 
well as help advise the Agency about the development of investigational 
drugs. Their involvement is important to FDA's capacity to make 
informed regulatory decisions that are sensitive to the needs and 
preferences of those affected by this disease.
    This expansion of FDA's programs has involved considerable 
challenge, as FDA has negotiated with Alzheimer's disease advocacy 
organizations regarding the role of Alzheimer's disease patients 
themselves. FDA considers patient involvement important, since patients 
with a given disease are generally best able to speak for others with 
that disease. Involvement of patients with Alzheimer's disease is also 
an important priority to the Alzheimer's disease advocacy community. 
However, participation of patients with Alzheimer's disease is 
problematic because of diminished intellectual function that is a 
primary manifestation of this disease. This challenge is exacerbated by 
Alzheimer's disease patients' deterioration in intellectual function 
over time.
    After extensive negotiation, we have agreed to recruit advocates 
from the Alzheimer's community, including couples consisting of a 
patient with early-stage disease and his or her caregiver, both of whom 
have a background appropriate for involvement as FDA patient advocates. 
The caregiver will serve as the primary spokesperson for the couple, 
but both parties will have access to materials for review, will be able 
to review and discuss those materials prior to their engagement with 
FDA, and will have the opportunity to participate. When the patient is 
no longer able to participate, the caregiver will continue to serve 
with FDA. FDA and the Alzheimer's community agree that this approach 
involves challenges, but both parties are willing to work to maximize 
involvement of patients.

              THE FDA INTRA-AGENCY NEUROLOGY WORKING GROUP

    Next, I would like to mention FDA's Intra-Agency Neurology Working 
Group. Neurology products regulated by FDA, comprised of drugs, 
devices, biologics, and combination products, are a diverse group of 
products aimed at advancing patient care in a number of disease areas 
for which the unmet therapeutic need is great. Some diseases affect a 
large number of patients, such as Alzheimer's disease and Parkinson's 
disease, while others affect smaller numbers of patients. In either 
case, the consequences can be devastating for patients and their 
families.
    FDA's goal is to improve communication about neurological disease 
across the Agency among the various groups charged with regulating 
these products. To accomplish this end, FDA has established a Working 
Group to serve as a forum for information exchange on leading-edge 
developments, enable sharing of technical and regulatory expertise, and 
provide for greater consistency of review standards and processes 
across the Agency. Further, we are expanding patient advocate 
involvement in FDA neurological disease-related review and 
decisionmaking to include Parkinson's disease, Alzheimer's disease, and 
other neurological diseases as Agency resources allow.
    Meetings occur monthly and are chaired by Dr. Celia Witten, 
Director, Office of Cellular, Tissue, and Gene Therapy in our Center 
for Biologics Research and Evaluation (CBER), and Dr. Robert Temple, 
Director, Office of Drug Evaluation I and Director of the Office of 
Medical Policy in our Center for Drug Evaluation and Research (CDER). 
Other members include Dr. Russell Katz, Director of the Division of 
Neurology Products (CDER), and supervisors, reviewers, and project 
managers from CDER, CBER, and our Center for Devices and Radiological 
Health. Also included are staff from the Office of the Commissioner, 
including the Office of Critical Path Programs, the Office of Special 
Health Issues (OSHI) and the Office of Science Health Coordination. 
Standing agenda items include policy development (guidance, workshops, 
and advisory committee meetings), opportunities for Critical Path 
projects, significant review projects (major investigational/marketing 
applications under review, marketing approvals, studies of interest, 
etc.) upcoming neurology-
related meetings and patient advocate involvement, and OSHI updates.

             ADDITIONAL FDA ALZHEIMER'S-RELATED ACTIVITIES

    The Agency is engaged in a number of additional Alzheimer's-related 
activities. For instance, FDA is helping with a study called the 
Alzheimer's Disease Neuroimaging Initiative. This is a 5-year public-
private initiative involving industry, academia and the NIH. The goal 
of this study is to obtain standardized MRI, biochemical, and clinical 
data over several years in prospectively followed groups of normal 
elderly patients with mild cognitive impairment, considered the very 
early stages of Alzheimer's disease, and patients with diagnosed 
Alzheimer's disease. We anticipate that this study will help in the use 
of some of these measures in future clinical studies to expedite the 
development and approval of drugs to treat patients with Alzheimer's 
disease, especially in its very earliest stages. A particularly 
exciting and important aspect of this study is that the data are 
available to scientists all over the world in real time as the data are 
acquired and entered into the database.
    Additionally, FDA has a productive and close working relationship 
with the Alzheimer's disease advocacy community. For example, FDA has 
worked closely for many years with the Alzheimer's Association on 
scientific, technical, and advocacy issues. Their counsel and direct 
assistance to FDA have been invaluable as we have worked to improve our 
regulation of Alzheimer's disease treatments and to expand patient 
involvement in FDA decisionmaking.
    FDA recently met with, and remains in contact with, the Accelerate 
Cure/Treatments for Alzheimer's Disease (ACT-AD) Coalition. They are 
concerned that the Agency retains a strong focus on drug development 
for Alzheimer's disease. The Agency works and keeps in contact with 
these organizations through OSHI. I certainly encourage this important 
exchange of ideas with advocacy groups.
    Development of drugs with an effect on disease progression is the 
most critical need in Alzheimer's disease, as it is with other 
progressive neurological diseases. FDA is planning a future public 
meeting to discuss design of clinical trials and how to design studies 
to determine whether or not a drug for Parkinson's disease has an 
impact on the underlying cause of the disease and not just the symptoms 
of the disease. It is expected that the designs useful in Parkinson's 
disease should be equally applicable to drugs for Alzheimer's disease.
    In addition, FDA is organizing an upcoming meeting with 
neurological disease organizations involved in advocacy and medical 
research. This meeting will involve discussion of scientific, 
technical, and advocacy issues related to their and FDA's roles in 
development of important new treatments for serious neurological 
diseases, including Alzheimer's disease.

           CURRENTLY APPROVED DRUGS FOR ALZHEIMER'S TREATMENT

    Finally, I want to make sure that I mention to the committee that 
there currently are five drugs approved for the treatment of 
Alzheimer's disease: Cognex (tacrine); Exelon (rivastigmine); Razadyne 
(galantamine); Aricept (donepezil); and Namenda (memantine). All except 
Namenda are approved for the treatment of mild to moderate Alzheimer's 
disease. In addition, Aricept also was approved recently for severe 
Alzheimer's disease. Exelon was approved on July 6, 2007, in the form 
of a transdermal patch, which reduces gastrointestinal side effects 
compared to the oral form of the medication. All of these drugs except 
Namenda act by increasing brain levels of acetylcholine, a 
neurotransmitter that is abnormally low in patients with Alzheimer's 
disease. Nerve pathways in the brain that are thought to be involved in 
memory and cognition, that ``use'' acetylcholine as a neurotransmitter, 
degenerate in patients with Alzheimer's disease.
    Namenda is approved for the treatment of moderate to severe 
Alzheimer's disease only. It works differently than the other approved 
drugs. It interacts with a receptor that is thought to be involved in 
preventing the death of certain cells in the brains of patients with 
Alzheimer's disease. However, the drug has never been shown to prevent 
or slow the underlying nerve degeneration in these patients, nor have 
any of the other approved drugs been shown to do anything other than 
treat the symptoms of Alzheimer's disease.

                               CONCLUSION

    We await, together with the rest of the world, for new drugs that 
may some day be able to treat the underlying cause of this insidious 
disease as well as other neurological diseases, not just the symptoms. 
We are very encouraged by the progress being made in the scientific 
community and pharmaceutical industry on products you heard about in 
testimony in the previous two hearings. As indicated earlier, FDA 
stands ready to facilitate any breakthrough product applications that 
are submitted to the Agency for review.
    This concludes my formal statement. I will be pleased to respond to 
any questions from the subcommittee.

    Senator Mikulski. Well, thank you very much, Dr. von 
Eschenbach. I think already--did you want to ask a couple of 
questions and I'd be happy--but I just wanted to say first of 
all, it's a very impressive group but it's impressive already 
at the level of coordination and communication that's going on. 
So I said, this is not to be a roundtable. Our friend, Senator 
Isakson, has to leave and I didn't know if you had a couple of 
questions you'd like to pose and the way we see it, is we're 
just going to kind of jump in and even though you might pose it 
to someone, if somebody else has got something to add, we don't 
have to be starchy and choreographed here.

                  Opening Statement of Senator Isakson

    Senator Isakson. Well, thank you, Madam Chairman. I am 
going to have to leave because I have another Georgia company 
waiting in the office but anytime Dr. Gerberding shows up, I 
show up because I am her biggest cheerleader. She's done a 
marvelous job for CDC and I'm very grateful for the many 
contributions that she makes.
    I won't ask a question. I'll just make a comment. The 
reason I have a passionate interest in this, I lost my mother 
to Alzheimer's. But over the years, I've had some experiences 
that illustrate to me how important it is for us to get into 
the surveillance business that you talk about in your pathway 
and look for some answers because I've had one of my doctor's 
wife, at the age of 46, who was diagnosed with Alzheimer's, 
Governor Carol Campbell, a great governor of South Carolina in 
his fifties was diagnosed and died in 3 years and in my church. 
I have two members whose wives--both of their wives have had 
Alzheimer's for a significant period of time and it's apparent 
in the last decade that some pharmaceutical therapies and other 
treatments are beginning to work to prolong and improve the 
quality of life of those individuals with it but it's a must--
and I agree with what Dr. Gerberding said that everybody fears 
physical impairments but everybody is more fearful of cognitive 
impairment.
    So I appreciate the Chairperson's diligence on this effort 
and her real passion in seeing to it that we raise the 
eligibility and as I told her a few months ago, I'm here to be 
a soldier in that army and I'm grateful to you all for what you 
do.
    Senator Mikulski. Thank you very much, Senator. At the end 
of this conversation, we will begin to meet on getting ready 
for our markup on our Alzheimer's Breakthrough bill, 
particularly the research component. It would be the goal of 
Senator Burr and myself to have this marked up either by the 
end of July or certainly in September and move it on through to 
get it done. So we've heard from the Alzheimer's Association, 
research community and we're going to have more conversation 
with you.
    Let me jump in with my question. Of course, we agree with 
Dr. Zerhouni that intervention, even before physical or mental 
manifestations of anything from heart disease--you don't want 
to wait for that out-of-breath shooting pain or for women, 
fatigue and other symptoms. And we'll be talking about that. 
But one of the things that I'm interested in is how we can now 
take basic research findings that we already know that might 
not need a pharmaceutical intervention and move it into 
clinical practice, better diagnosis because we've heard that in 
many instances, it's misdiagnosed as depression early on or 
when people start that 36-hour day, the agitated behavior where 
other medications are prescribed.
    That's one--use information we already have, say at NIH or 
the private nonprofit community and then how does that get 
translated into clinical practice or what we fund. Let me go to 
something else, which is what seems to be emerging from the 
research is the low-tech solution that what is needed of good 
diet, exercise of both the body and the mind, is very good. If 
you have heart disease, diabetes--any propensity that you might 
have that is starting back here, though you might not be able 
to beat change, you can delay the consequences of genes and so 
on and my question then is, if that's so and that's thoroughly 
been validated and I think it has, then how does it get out to 
both clinical practice and then even to entities like the 
Office on Aging? What does all that mean while we're working on 
even more sophisticated and more precise breakthroughs? Do any 
of you want to comment on translating research into clinical 
practice? I just throw out diagnosis and I just put that out 
for discussion, the techniques we now know for the management 
of any chronic illness seems to have a major role also or 
significant role in preventing cognitive decline, whether it's 
Alzheimer's or something else. Do any of you want to comment on 
that?
    Dr. Hodes. I think you posed a very critical question about 
our translation from scientific findings from what we know into 
practice and let me try to give two examples because I think 
it's important that we recognize our obligation to do the most 
we can with what we know.
    Now let me first take one of the more precise examples of 
an attempt to translate genetic and biological information at 
the interventions and this comes from the original observations 
100 years ago, when the initial patient with Alzheimer's 
disease, by the professor of the same name, identified plaques 
and tangles in the brain and we've seen over the past years, 
his remarkable identification of the biochemical nature of 
these plaques and tangles, the genes that encode the products. 
This has led, in turn, to the ability to generate animal models 
that reproduce much of the lesion, the memory defect of 
Alzheimer's disease caused by introducing a particular gene 
product. So there is very strong evidence that it is quite 
possible that a particular molecular lesion is responsible for 
Alzheimer's disease.
    This is now leading to clinical trials. The only way to 
completely verify the ability to intervene in this pathway and 
have an effect--the trials are not simple as with any drug 
trials but they are attempts to modify the effect of the 
enzymes that cause the amyloid plaque or as we've heard, 
immunization treatments to try to prevent or reverse the 
accumulation of amyloid plague.
    So this is an example of translating the most basic 
molecular level through very rigorous levels of evidence to 
establish whether or not an intervention, pharmacological, 
immunological, have the desired impact and this is one 
important pathway to pursue. It's important that our basic 
science from institutions like NIH are translated to both 
private sector enterprise and academic enterprise and 
ultimately to the FDA to deal with final demonstration of 
efficacy.
    There is another pathway and one that you've eluded to that 
deals with evidence or associations of certain lifestyle 
factors and risk factors with Alzheimer's disease. So as you've 
noted, there is strong epidemiologic data that indicate that 
individuals who have many of the risk factors for 
cardiovascular disease, diabetes, high levels of homocysteine 
are more likely to have Alzheimer's disease. Therefore, it is 
important that we carry out rigorous clinical trials to see 
whether the interventions for those treatments will or will not 
have effect on Alzheimer's disease.
    Now, do we need to wait until we have that information 
before recommending that people follow lifestyle interventions 
such as diet, control of blood sugar in individuals with 
diabetes, diets that are demonstrated to protect against 
cardiovascular disease--of course not. So this is a case in 
which we don't have the highest level of evidence to show these 
interventions will, without doubt, from randomized clinical 
trials, prevent Alzheimer's disease. We know enough to 
recommend to the public that in terms of general, successful 
aging in health, these are strong measures that should be 
translated while at the same time, I would suggest we pursue 
the rigorous science to see just how they affect variables such 
as cognitive function.
    I think the same is true for----
    Senator Mikulski. It wouldn't hurt, would it?
    Dr. Hodes. We certainly think it wouldn't help. It's been 
demonstrated that these interventions are helpful for many 
other aspects.
    Senator Mikulski. Well, let me tell you when I first heard 
about this and Dr. Zerhouni, you'll enjoy this. Senator Burr, 
you might want to come with me. The National Institutes of 
Aging is the one campus called Bayview at Johns Hopkins but 
it's not in the main Broadway campus, which is like the mother 
ship, contiguous to a neighborhood called Greek Town. Now, 
Greek Town is where a large number of Greek immigrants settled 
and oh gosh, they have food that is both the Mediterranean 
diet, which we're supposed to follow but then they've got the 
fried calamari and they have the baklava--you get it?
    Dr. Zerhouni. You tell me where to eat and I'll go.
    Senator Mikulski. And I'll get it for you. So I went to 
visit then, that old creaking building that I know we're 
replacing, but one of the first things that we heard was the 
research in animals that really, the reduction in calories, the 
improvement of exercise enables, at least it seemed to have a 
positive impact. But what we also know is diabetes is a factor, 
maybe. That this is a preventive act that does no harm, which 
as all of you have taken that oath that the first thing is, we 
could do things that do no harm. So Dr. Gerberding, what you do 
think about that? Should we now, as a major public policy, take 
what you're saying in the Healthy Brain Initiative but really, 
what we already know for heart-smart, we could really be 
troubadouring and promulgating. Do you have a reaction to this 
and what you already know, knowing that we could always 
validate more? And also then, what is CDC doing about this, say 
in conjunction with the Office on Aging that funds every senior 
center in America.
    Dr. Gerberding. My reaction is enthusiasm in a short word. 
I think we've got to set a stage to get this ball rolling and 
one of the remarkable things that I observed on the times that 
I was participating in some of the Medicare sign-up events or 
some of the Welcome to Medicare, get your prevention screening 
activities going on at the grass roots level, is how extensive 
the network of support for seniors really is in our communities 
because of the Agency on Aging and HERS and others and many, 
many not private and other organizations. We have an extensive 
network of community support in many communities and even 
reaching into those populations that are hard to reach and have 
the worst health disparities. But that network is not aware 
that this is a critical strategy for protecting brain health 
and I think the concept of social marketing, getting out to the 
grass roots level and really informing people that it's not 
only good to do these health promotion activities because they 
are heart healthy. Some aspects of them are highly likely to 
preserve mental functioning and as the database for that grows, 
it will be able to give us stronger scientific basis for that.
    So the first thing is to get the word out into the 
community to the affected people but also that incredible 
hidden network of support that already exists and mobilize it 
to start really adding this to the perspective.
    Senator Mikulski. Is that what CDC does and are you meeting 
with the Office on Aging to do that?
    Dr. Gerberding. Absolutely. And I think we did not have 
these strong ties, admittedly in our Department but we have 
come together in many different ways to support some of the 
modernization of Medicare activities and we've discovered how 
much leverage we actually have within HHS. I mean, Medicare 
pays $91 billion a year for Alzheimer's disease. That's a 
tremendous investment and we ought to be able to work with that 
kind of resource and do more to help people prevent this in the 
first place. But the other piece of this that we can't forget 
is that clinicians also play a very important role and I do 
think we need to be more aggressive about clinician education.
    You've described in your written testimony, some 
centralization of testing for Alzheimer's and cognitive 
dysfunction so that we make a more accurate and early diagnosis 
in those patients that can benefit from drug treatments, get 
access to them but also it helps us understand the relationship 
between cognition and capacity to engage in physical exercise 
and the other Heart Healthy activities.
    The tragedy here is as your cognitive function declines, 
your ability to take your medications and to maintain your 
mobility and control your blood sugar declines concomitantly so 
you get into a vicious cycle of deterioration.
    Senator Mikulski. Exactly.
    Dr. Gerberding. I think we can do a lot more at the 
clinical interface to prevent that deterioration.
    Senator Mikulski. Well, I know Dr. von Eschenbach wants to 
talk. I'll turn to Senator Burr but as we now get ready for our 
markup, would you have your team meet with us to see how, as 
part of our Alzheimer's Breakthrough, where we move to increase 
funding for research, we look at how we can also more 
effectively involve the role of CDC exactly in this 
coordination in kind of moving out what we do know.
    That if nothing else, how it's managed, the chronic illness 
that Dr. Zerhouni said, you said, 75 percent of those people 
over 55 consulting a clinician is for the consequence of a 
chronic condition, not an acute episode or a fall or an 
orthopedic injury or anything like that. So we want to come 
back to you. Dr. von Eschenbach, did you want to say something?
    Dr. von Eschenbach. With your permission, I'd just like to 
amplify on two points I made in my statement, which go along 
with the comments that have already been made. I indicated this 
fact that today, we're in the midst of this molecular 
metamorphosis. I also indicated that we're all in this together 
and I think that bodes very well for tomorrow.
    First of all, one of the implications of this tremendous 
progress in biomedical research is the fact that as Dr. 
Zerhouni alluded to, health care will be personalized, much 
more predictive, pre-emptive and more participatory. And the 
implications of those four P's for tomorrow is that first of 
all, one of the things that's going to go a long way for us 
having these public health interventions is to be able to 
define populations at risk and to do that in a way that we can 
really hone in on where these targeted interventions have to 
occur that are going to be much more preventative and we'll 
know that they'll be predictive because we know the evidence of 
their outcomes.
    At the same time, when we look at what's happening today 
with information technologies and communications, we're seeing 
health care become much more participatory. Faces no longer are 
just passive recipients but actively participating in their 
care and we now have the tools of communication and interaction 
that enable us to help continuously guide patients in terms of 
interventions that they should be carrying out day by day and 
that's where agencies and organizations like the Alzheimer's 
Associations have alluded to and others, like AARP, have a real 
role in continuing the impact of these interventions at the 
public health or community level and to do that in a way that 
mobilizes and moves us to a better level of health.
    I think it's comprehensive, it's integrated but I don't--
and I think the tools are going to enable us to do it far more 
effectively tomorrow than we could do it yesterday.
    Senator Burr. Thank you, Madam Chairman. I was struck, as I 
listened to Dr. von Eschenbach, that we have a tendency to 
focus on specific diseases and it just struck me with some of 
the things you were saying, Andy, that we have a health care 
delivery system designed in America not to fully engage us in 
prevention and wellness and not really in disease management 
unless someone is triggered from a quality of life standard to 
do it.
    And I would say to my good Chairman, maybe it's an area 
that we can explore. I'm sure the answer to this is in the 
challenge of how do you continue to see a population of a 
country increase at the rate we are, while we devote 16\1/2\ 
percent of the GDP to health care and not be influenced by 
other models around the country where they say, ``well, we do 
it so much cheaper'' and the reality is that we can look here 
today and as Dr. Zerhouni said, in X number of years that 5 
million individuals with Alzheimer's are going to be 16 million 
with Alzheimer's and there's full agreement at the research 
table that the answer here is, we have to get ahead of the 
curve. We have to be preventive. We have to be predictive.
    We have to be willing to personalize and that's a 
tremendous goal that NIH is under and it puts tremendous 
strains on you from a standpoint of the agency at the end 
that's going to be trying to approve therapeutics and vaccines 
that are trying to keep somebody from getting the disease. What 
a tremendous step we've made.
    Dr. Hodes, today, how is the typical patient with 
Alzheimer's diagnosed? What is it that triggers that person to 
go in and say, ``boy, I think I got it.'' Or that family 
member--who is it that initiates that and what process do they 
go through?
    Dr. Hodes. I think the simple answer is that it's very 
heterogeneous and very variable. With a spectrum from 
individuals who are very sophisticated, families are very 
perspective and connected to a medical care system so that at 
the early appearance of changes in behavior, including changes 
in memory, they turn to physicians who are informed and 
capable.
    All too sadly, though, a large percentage of our population 
is unfamiliar with the concept of these changes or anything 
more than a part of aging and they are accepted as such and 
diagnosis is, therefore, delayed. It isn't so many years ago 
that everyone accepted dementia as an accompaniment of aging 
and so we're at a point of transition where I think the best 
informed and we need to make all of Americans better informed, 
are tuned to seeking medical attention.
    Once having come to medical attention, to a physician or 
care provider, in the best of settings, estimates are that 
approximately 90 percent accuracy in diagnosing Alzheimer's 
disease is the theme. This is what we see in the best of hands 
and far less accurate in others. So here, our commitment is to 
try to identify the psychological test and our imaging tests 
that can continue to refine a standard strategy for diagnosis 
that will allow all of the care providers around this country 
to be more astute in making diagnoses.
    The impetus for making diagnosis is, of course, an 
important issue. What is the motivation? Right now, a great 
deal of the motivation is to rule out other causes of dementia 
that are clearly treatable and reversible and one of the 
greatest tragedies would be to be missing one of those. If 
Alzheimer's disease is diagnosed and diagnosed early, of 
course, there are real advantages to the individual and the 
family in terms of planning and understanding prognosis and 
finding those treatments, which are able to modify the course 
of the disease.
    But we have to concede that those treatments, those 
interventions are currently of limited effectiveness and 
effective for a limited period of time so that the motivation 
to identify disease early, to come to diagnosis and to treat, 
is going to become more critically important as we identify and 
communicate interventions that make a difference.
    Senator Burr. Well, we probably all agree that the first 
interventions are probably going to be therapies that 
potentially either slow or stop the progression of disease, 
therefore the earlier we can detect, the better off the quality 
of life and the outcome is.
    Dr. Hodes. I should maybe just comment that while we have 
great hopes and need for much more improved interventions, it 
was just in the past months that there was a statistical 
significance from a clinical study showing that one agent, 
Donepezil, was in fact able to reduce the risk of moving from 
mild cognitive impairment to a diagnosis of Alzheimer's 
disease. It was a limited effect. It occurred only over the 
first year of the study in most individuals but I think it 
provides the first prototype, if you will, of an intervention 
that can actually prevent the onset of disease.
    I should also reinforce what's been said by my colleagues 
about the importance in the area of public education, of 
organizations that are in the grass roots. The organizations 
prominently including the Alzheimer's Association, with whom we 
have great interactions, not only in the planning of research 
agendas but in the grass roots contact with individuals who are 
affected in their families, important to providing and 
communicating information, to recruiting individuals interested 
in participating in clinical studies, which I need to stress, 
is very important to progress so that all of the Federal 
agencies, private sector organizations need to work together to 
inform the public so they can both understand early signs, seek 
diagnosis and then participate with us in the research that is 
necessary to come to better means of intervention.
    Senator Mikulski. I just want to come back to Senator 
Burr's point about diagnosis. My father died of the 
consequences of this, but these early signs--no one was quite 
sure what it meant and this is when we had access at Johns 
Hopkins, to a geriatric evaluation program, where a 
geriatrician, someone skilled in the diseases or effects of 
aging, could evaluate, what is the medications Dad was taking 
for some other things, where the synergistic effect affected 
his cognitive ability? Was it that he needed that shot of 
Vitamin B-12, which we all hoped he needed, et cetera.
    Well, unfortunately, it wasn't that but it could have been 
that. And isn't this where, really, there needs to be some type 
of really overall assessment? But do you feel that also, there 
needs to be more of the specialized centers where a primary 
care physician to validate what they suspect would occur? Or do 
you feel that you can develop these--I don't want to say check, 
but prototypes for at least the primary care people to make 
some type of diagnosis?
    That's not a catch-22 but it all goes to what should be 
supporting here, one of which is accurate diagnosis even though 
we might not have some magic bullet now. There are tools 
available.
    Dr. Zerhouni. I'd like to, if I may, really stress the 
point you just made and that is, if you look on the forecast 
basis, on how many geriatricians are going to be available to 
really take care of an age population, what you find, in fact, 
is that the number of geriatricians is not growing. It's 
actually flat or decreasing in terms of the number of people 
who graduate to study the diseases of old age.
    So I think if you were from the 50,000-foot view before we 
go to Alzheimer's, we have a fundamental issue in orientation 
of resources toward creating the human capitol needed to take 
care of this population as we go forward. There will be a 
deficit in healthcare providers at all levels. It will be care 
providers at home, care providers at the intermediate levels of 
care.
    So it's clear that when you really look at the total 
system, we have an issue and we need to really work together on 
finding ways of preventing the loss of the talent.
    The other is that Alzheimer's disease today is a diagnosis 
of elimination. You try to eliminate every possible potential 
causes of cognitive deficit before you can make this diagnosis 
because it is only diagnosable at this point through a biopsy 
and we're not going to perform biopsies on live individuals, 
biopsies of the brain.
    So one of the things that need to be done is more 
standardization of the diagnostic tests, an educational program 
for centers to diffuse around them because we're not going to 
be able to do it just with geriatricians. So we're going to 
have to educate, at a very fast pace, not only in terms of the 
prevention activities that Dr. Gerberding was talking about but 
just pure clinical medicine for family doctors, internal 
medicine doctors, a little bit of what we did for heart 
attacks.
    I mean, it was clear they didn't have enough cardiologists 
to take care of heart attacks so you had to really diffuse the 
knowledge way beyond the specialists. I think if you really 
think about it, Senator, what you have to have--you have to 
have a systems approach to the disease, from the first point of 
contact, the loss of cognitive function, mood disorders, 
wandering, losing your keys, losing the address of your house, 
knowing how to go back, all these signs are overlapping with 
many other conditions. So you have to eliminate it but at the 
end, we as scientists, have to agree on a standard set of 
parameters and tests to develop sets that are more objective. 
There is no blood test today like there is for diabetes, for 
Alzheimer's and we need to really come up with something, some 
answers.
    We've funded very innovative research at the NIH. We funded 
nano-medicine, to pioneer, to in fact tell us whether he could 
detect the very first signs of Alzheimer's disease in the fluid 
that is within the brain, what we call the CSF, the cerebral 
spinal fluid. And for the first time, we had a positive result 
so there is hope to be able to do that on an objective basis.
    My message here is this: if you look at any one point and 
try to improve that, you're not going to get to your goal. In 
other words, fighting Alzheimer's disease is only as strong as 
the weakest link in the chain of research, intervention, 
prevention, payment systems--how do you cover that? The 
workforce planning, how many healthcare providers do you need? 
This is truly, I think, the challenge that we have.
    We have tried to educate, from our standpoint, we're just 
releasing today the progress report on the research, on the 
Discovery Pathways for Alzheimer's Disease and I want to 
commend the National Institute of Aging and all our sister 
agencies participating in this but this, in fact, is the 
message that you will not solve this problem with a one magic 
bullet approach.
    Senator Burr. I'm sure Senator Mikulski agrees with me that 
we really need each of you to pledge to work with us on this 
legislation. There's only one way to get a perfect bill and 
that's to make sure that all the stakeholders are on board at 
the beginning of the process rather than to shoot at a bill 
that we think is a pretty good product and I hope you'll do 
that.
    I remember years ago, Dr. Zerhouni, among the--almost the 
completion of the mapping of the human genome. I was at SAS 
Corporation in North Carolina, the largest privately owned 
software company in the world and they envisioned at the time 
that when they got the final genome mapping that they would be 
able to go in and write a computer program that could then take 
all of the known drugs and things that we had and could 
potentially test them on what they had learned. How far are we 
from that?
    Dr. Zerhouni. We've made tremendous progress. I have to 
tell you that over the past 3 years--when I became NIH 
Director, I can recount the story about the fact that the human 
genome had been completed. We, in diabetes, we knew one gene, 
suspected gene. This was the effect of 30 years of work and it 
was p-parg gamma as an enzyme and that's what we knew. Since 
then, just this year, we found 10 very, very strong candidates 
to understand at the genetic level, what makes a person 
diabetic and why is it that they become diabetic, very, very 
early in their natural history.
    If you look at all of the progress that has been made 
because of the biotech advances and the technologies today, we 
have a project and it's called pharmacogenetics. It started 
about 4 years ago and we have over 400 discoveries that show 
why you or I would respond differently to a drug. The next step 
is what we call the Gene Environment Initiative, which we 
launched this year, where we're going to find the common 
genetic traits of the 10 most common diseases, including 
Alzheimer's, actually, which is also being researched.
    We're very close to this. We have to accelerate our 
research there. The opportunities are enormous. This is the 
basis, actually, of this personalized medicine idea that you 
and I, even though our DNA is only different by .1 percent, we 
can react to the same treatment in completely different ways. 
To know that ahead of time is very important.
    Let me give you a very specific example. Today, we use 
cholesterol lowering drugs, statins--Lipitor and Zocor on 
millions of people but we know from the epidemiology that only 
10 maybe, 10 percent of these people would ever develop a heart 
attack or cardiovascular disease. Yet we give it to a hundred 
percent of the people.
    Wouldn't it be great if I had a signature that told me I am 
part of the 10 percent that's going to get it and I need that 
drug and you're part of the 90 percent that do not need to have 
that drug. So you can see the impact on the cost of health 
care, the precision with which we will treat people--all of 
this is related to the advances of the past 2 years.
    Senator Burr. Let me ask, I'm sure somebody has put 
together information that's more global in scope for 
Alzheimer's. The percentage of the American people that are 
affected by Alzheimer's, is the percentage consistent with the 
percentage of other countries in the world?
    Senator Mikulski. Good point. Interesting.
    Dr. Zerhouni. That's a good question. I actually will defer 
to my colleague here.
    Dr. Hodes. Well, there's incomplete information but enough 
to be responsive. That is, I don't think that we have 
comparable information on the prevalence of Alzheimer's by 
similar standards in so many countries that we can answer that 
with precision. But we do have information from very specific 
studies that have, for example, compared the risk of 
Alzheimer's disease in particular populations, one versus the 
other. For example, in the population of individuals still 
residing in Nigeria versus population in Indianapolis, in fact, 
a very direct Nigerian descent and one can find in that sort of 
comparison, a very significant increase in the proportion of 
Alzheimer's disease in those individuals who now reside in the 
United States.
    Similarly, there have been comparisons of Japanese, 
Japanese Americans in Hawaii, Asian Americans, which have 
indicated the change and prevalence of Alzheimer's, it appears, 
over a generation with a change of environment. These are 
important because it is unlikely although not yet definitely 
established that these changes result from selective genetic 
differences but more likely, do reflect the impact of 
environmental risk factors.
    So we know that populations, when studied in some of these 
discreet areas, do differ. We don't have a global national/
international comparison.
    Senator Mikulski. You could also go to diet. Dr. von 
Eschenbach, you seem eager to say something here.
    Dr. von Eschenbach. Dr. Gerberding is right. I just wanted 
to emphasize one other element of this equation. I think it has 
been pointed out, we really do need to continue our investment 
into the discovery end of the continuum, to learn more about 
this disease so we're not just recognizing it when we're 
looking at the end stages of the degenerative process and 
people have already lost function. And at the same time, we 
have to have attention to the deliver end of the continuum so 
we get the kind of prevention and intervention that Senator 
Mikulski was talking about.
    But there's that middle piece between discovery and 
delivery of development and I think we need a strategic 
approach to that from the perspective that we are going to need 
platforms, be they genetic or genomic platforms or whatever 
that helps to find risk. Who is likely to succumb to this 
disease? We need platforms for earlier diagnosis. They may be 
imaging strategies. They may be nano-technology strategies. We 
need development of interventions that are going to prevent the 
disease at its very earliest stages before someone has 
obviously lost the ability to remember where their keys are.
    So that development piece has to be thought of 
strategically, as where in this disease process, given what we 
know about its molecular basis, can we target and define and 
develop interventions that are going to help us predict, 
detect, prevent and when necessary, intervene and hopefully 
even reverse. I don't think we should lose sight of that in 
this overall approach that you are fostering, to say we, as a 
nation, have to do something about this disease from the very 
beginning through its entire course.
    Senator Mikulski. Thank you. I think that's an excellent 
point. I just want to ask one other question and then maybe we 
can go to wrap-up. I know Dr. Gerberding has got to leave and 
we already delayed the hearing and I'm sure you all have, we 
know you have ongoing responsibilities.
    Dr. Zerhouni, you talked in your testimony about the 
Alzheimer's disease cooperative study and in it, you talk about 
something called the ADCS drugs. You say they are not typically 
studied by the large pharmaceutical companies that are off 
patent or were patented and are marketed for another use. Here 
goes my question--is this an area when we look at our overall 
framework for our legislation, we should be sure that we 
specifically mention and also in Appropriations that this is an 
area where you do things that the private sector--that's not 
where the private sector is going to go. They might add value 
to what you're doing but you're spending $52 million on this 
over 6 years, which is what? Seven million dollars a year or 
five, six and a half million?
    Dr. Zerhouni. Eight, eight and a half.
    Senator Mikulski. Yes. Is this an area that we should----
    Dr. Zerhouni. Right. There is definitely a need for that 
because obviously as you know, what we do at NIH--think of it 
as a pyramid for our budget and our efforts. Sixty percent of 
what we do is really the basic discovery, understanding the 
disease. Twenty-five percent is what we call translational. 
When we have an idea and we want to have a proof of concept at 
a very early stage so that eventually, this will become an 
incentive, if you will, for the private sector to take it and 
develop it further and 15 percent, we spent on really doing, 
for example, things in orphan diseases where at one point there 
was no incentive, really, to develop these treatments for rare 
conditions.
    So in the ADCS, what the institutes--the National Institute 
of Aging, National Institute of Neurological Diseases have come 
together in a collaboration to say, when we have gaps like 
this, how do you tackle them and it's not so easy. Because 
you're talking about doing, for example, trials on things that 
may be very useful but they are not patentable and therefore, 
no one is going to do them. So you have cracks in the system 
from either the need for us to do a trial on drugs that exist 
that are not patented, that the FDA has already approved, but 
that may be useful--in fact, one of the treatments for 
Alzheimer's disease actually was out of patent and became quite 
useful in the treatment of Alzheimer's disease early, and 
delayed the onset of the disease.
    So we do need to have a framework to understand the gaps in 
the system. Like the Institute for example, will fund young 
scientists with good ideas who have no access to what a drug 
company would have access to. They can't figure out if the idea 
they have is going to be positive and then be followed. So 
that's something that NIH has to do but it's very, very 
expensive and very difficult.
    One of the things that we did through the Roadmap for 
Molecular Research is we built what we call a molecular library 
system for all academic sector investigators who can have 
access to it for all diseases so that we can at least allow our 
scientists to fill those gaps.
    Senator Mikulski. Well, first of all, I find that very 
instructive. I want to thank all of you for coming. I think 
it's been a very enlightening and instructive conversation. I'm 
going to reiterate what Senator Burr said, which is an 
invitation now to take a look at our legislation. Our 
legislation really has two parts. What we call the Alzheimer's 
Breakthrough doubles the funding for NIH research and some of 
the others and then there is a second component that will 
really go to the Finance Committee on some tax breaks for 
caregiving and we'll be looking at caregiving later on. But 
we're not going to slow that down for what we want for our 
Alzheimer's Breakthrough. So we ask you now to think about what 
we could be emphasizing in the bill or authorize that would 
really enhance prevention and be willing, as an approach, for 
prevention of all chronic challenges that our population is 
facing because there seems to be so many similarities that 
there will be consensus within the public health community.
    Second, how you think in our legislation, we can make sure 
that we help with the Healthy Brain Initiative, which everyone 
worked on and is so promising because I think the way we both 
see it, is one, we don't want to be disease d'jour. This is a 
very important issue. A national epidemic is on its way but we 
want to do this in a way that's really a groundwork to help you 
be you that would have a multiplier effect with so many other 
things you're working on.
    But to just conclude about Alzheimer's, I do see an analogy 
with diabetes again and that's a situation where my own mother 
died because of the consequences of it. She started on oral 
insulin at age 40 and died at about 82. But look at where we 
are now. When Mother was first diagnosed, it was diabetes, yes 
or no. And you had either the injected insulin or this enormous 
breakthrough called Diabinese, which was of great help. Then 
she had to go for her test but then came something called Home 
Testing, which looked like a 13-inch TV set. Now you can test 
at home with reasonably 75 percent accuracy, Senator Burr, with 
something that looks like a stopwatch. And when you look at the 
array now, one would say this is a genetic propensity.
    We start back here. You have to say goodbye to the baklava, 
you have to say goodbye to the pirogue. You have to say hello 
to broccoli and so what. It sure beats some of the other things 
and then moving along to dealing with insulin resistance to all 
these other kinds of tools. There are now 300 or more things 
that her primary care physician or endocrinologist could have 
had of avail. And this is, I think, the way we see here. Back 
here, the prevention we're talking about would be for all 
chronic illness and really get that going because we will do no 
harm in helping diet and exercise, physically and mentally and 
really getting this out in any way we can and particularly in 
the centers where seniors gather and then to look at what are 
the other continuum of things like we now see because it's no 
longer diabetes, yes or no. It starts before you see it. It's 
been insulin resistance and then it progresses.
    But at the end of the day, you don't want to have that 
disintegration in mitro-vascular disintegration of your 
neurons, your kidneys and your eyes and with what we now know, 
look what's already happening. So diabetes now, rather than a 
cure, is viewed as a chronic illness and if controlled and 
managed with so many tools, you're preventing the consequences 
of it and so on.
    So this is where we see heading to diet with Alzheimer's 
and this is the continuum here. But we want to work with you to 
get this going and I mention this because I think this is the 
way you see it, too. From genetic propensity--not genetic 
determinism--but genetic propensity, all the way through to 
what we can do for prevention, intervention and in each passing 
year, to get even more precise about it.
    So Senator Burr, do you want to say something?
    Senator Burr. I'd only end this way, Madam Chairman. I 
think the big question is, what is our role? We need you to 
share that with us, not just limited to Alzheimer's. What is 
the role Congress can play today in the agencies that you head 
that best helps you to do what we've asked you and your many 
talented employees to do? Because at the end of the day, this 
is about the impact that we can make on the quality of life of 
individuals and what the cost of healthcare looks like in the 
future.
    I thought as the Chairman talked about the advances in 
diabetes, a month ago, actually being at a Community Health 
Center, seeing a remote monitor where an individual could take 
it home or could run the software on their computer where it 
could check their blood sugar multiple times a day, not just 
for the purposes of them but for the purposes of their doctor 
electronically receiving it and knowing exactly the tolerance 
that they've been able to maintain on their blood sugar or for 
the congestive heart patient who hooks up to five times a day, 
remotely transmits that to a cardiologist.
    The cardiologist can detect whether there is fluid that's 
beginning to form, can verbally call and change that 
individual's medication, which eliminates that emergency room 
visit. The 3-day stay, as they begin to mobilize again and then 
a routine back on medication.
    We have the capabilities today to make sure that a 
physician and a patient do exactly the right thing on disease 
management and it's back to something you said, Dr. Zerhouni. 
At some point, we have to figure out how to pay for it, if in 
fact we want people to implement it and to use it. I go back 
to, I think what we started on, this hearing, when the Chair 
talked about HIV/AIDS and the reality is that when did people 
get serious about a cure for HIV/AIDS? It was really when we 
realized that it was cheaper to make sure that everybody with 
HIV got drugs because we knew exactly how many hospital visits 
they were going to have that year. We knew the cost of those 
hospital visits at the time, the original time, was about 
$25,000 a year. A case of pneumonia. A case of retinal eye 
infection. They'd visit twice but for $14,000, we could give 
them the medication and save ourselves a $25,000 inpatient 
experience twice a year.
    That's a budgetary answer to something that also has a 
quality of life component and that's that we stop disease in 
its tracks, but the reality is that sometimes it takes 
understanding what we're saving to understand what we're 
willing to invest. Unfortunately, we don't have a scoring 
mechanism within the Congress that we can dynamically score 
things to show us what we save. It will only show us what we 
spend. That's where we're going to have work in partnership 
together to make sure that we implement the right types of 
policies that not only address the quality of life but address 
the budget savings that is absolutely vital for us to be able 
to pay for it. I thank the Chairman. I thank our witnesses.
    Senator Mikulski. Well said and yes, this committee stands 
in adjournment, subject to the call of the Chair and at that 
time, we will begin to proceed to mark up our bill. We want to 
thank all of our witnesses for their outstanding contribution.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                 Prepared Statement of Senator Clinton

    I would like to thank Chairman Mikulski and Ranking Member 
Burr for convening today's hearing on what we are presently 
doing at the Federal level to combat the growing threat that 
Alzheimer's poses to the health of our citizens, our healthcare 
system, and our Nation's financial resources.
    I applaud Senator Mikulski for her tireless work on issues 
related to Alzheimer's disease, and I'm proud to work with her 
and Senator Bond on the Alzheimer's Breakthrough Act. This 
important legislation is critical in our fight against the 
disease, and I look forward to its markup in the HELP Committee 
next week.
    Last week I joined Senators Mikulski and Burr, as well as 
my fellow co-chair of the Senate Alzheimer's Task Force, 
Senator Collins, in welcoming the creation of a new Alzheimer's 
Disease Study Group. As envisioned by the Alzheimer's 
Association, this Study Group would be an independent, non-
partisan collection of health policy experts who will assess 
America's current approach to Alzheimer's and will develop new 
strategies for how the private and public sectors can better 
meet the challenges posed by this devastating disease.
    Former Speaker Newt Gingrich and former Senator Bob Kerrey 
have agreed to take the lead as co-chairs of the Alzheimer's 
Disease Study Group. The combination of balanced, independent 
viewpoints and expert opinion should make a strong contribution 
to America's current efforts to combat Alzheimer's disease, and 
I look forward to the release of the Alzheimer's Disease Study 
Group's findings and recommendations.
    While outside advice is important in the fight against this 
terrible disease, it is our responsibility as elected officials 
to do all we can to advance the cause of prevention, diagnosis, 
and treatment of Alzheimer's, including rigorous examination of 
whether we are doing all we should at the Federal level.
    Are we setting aside enough resources so that current 
researchers have the tools they need to investigate the 
etiology of this disease? Are we prioritizing the recruitment 
and training of the next generation of scientists and 
physicians who will make finding a cure for this disease their 
life's work? Are we doing all we can to support the millions of 
caregivers who make tremendous personal sacrifices--and suffer 
emotionally, mentally, physically and financially--in order to 
take care of and advocate for someone who is suffering from 
Alzheimer's? Are we making every effort to safeguard the mental 
health and physical well-being of adults with Alzheimer's and 
other dementias--who constitute one of our most vulnerable 
populations?
    Even as we pause to take assessment of our actions and ask 
ourselves these questions--the toll of the disease continues to 
grow. An estimated 5.1 million Americans now have Alzheimer's--
and their loved ones and caretakers wake up every day and not 
only provide support and comfort for a loved one, but confront 
the difficult toll of the disease. We are approaching a crisis 
as the Baby Boom generation grows older. By the year 2050, up 
to 16 million older Americans are expected to be living with 
Alzheimer's.
    This stark increase is more than a statistic. It represents 
millions of families facing an emotional struggle and 
tremendous financial pressure; a new strain on our healthcare 
system; new costs for Medicaid and Medicare.
    For the past 3 years, Senator Collins and I have co-chaired 
the Senate Task Force on Alzheimer's Disease. We have 
highlighted the importance of early detection of Alzheimer's; 
helping people with Alzheimer's and providing support services 
for their families and caregivers; highlighting promising 
research findings that suggest that healthy diet, regular 
exercise, as well as social and mental activity may help to 
decrease the risk of Alzheimer's; and the latest innovations 
for facilitating early detection and intervention.
    Senator Collins and I are also working to improve older 
Americans' access to mental health services. Diseases such as 
Alzheimer's can contribute to depression and anxiety for both 
those who suffer from the disease as well as their caretakers. 
In last year's reauthorization of the Older Americans Act, we 
successfully enacted Title I of the Positive Aging Act of 2005 
which authorized grants for the delivery of mental health 
screening and treatment services for older adults and grants to 
promote awareness and reduce stigma regarding mental disorders 
in later life.
    While this took an important step toward improving mental 
health services for older adults, significant efforts are 
necessary to ensure comprehensive geriatric mental health care. 
That is why Senator Collins and I introduced the Positive Aging 
Act of 2007, which will integrate mental health services into 
primary care and community settings.
    But improving access to mental health services is just one 
element of responsibly providing the care that Alzheimer's 
patients require. The majority of caregivers have outside 
employment in addition to their caregiving responsibilities at 
home. Research tells us that, because of the lack of support 
services, most caregivers either miss work or quit their jobs 
in order to meet the health needs of their family members.
    Respite care services provide temporary relief for 
caregivers and decrease the likelihood of formal long-term 
care, thereby resulting in significant savings for the 
healthcare system and taxpayers. Further, respite care also 
provides family caregivers with the relief necessary to 
maintain their physical and mental health, as well as bolster 
family relationships.
    Last December, my Lifespan Respite Care Act was enacted 
after 4 years of bipartisan effort. The law will help millions 
of Americans who struggle to provide care for a family member 
with a chronic illness or disability so they may remain at home 
and out of more expensive institutional care. Now we are 
working to fund the bill with $300 million over 5 years. 
Compare that to nearly $300 billion--the cost of the services 
family members provide as caretakers of a sick or disabled 
loved one.
    A great deal has been achieved in the last 15 years in the 
awareness, diagnosis, and treatment of Alzheimer's disease. But 
much more still needs to be done. We must continue to make 
Alzheimer's a national priority. The more we learn, the further 
we travel on the path toward a world without Alzheimer's--and 
we know that we cannot travel on that road quickly enough.

    [Whereupon, at 5:04 p.m., the hearing was adjourned.]