```

[Senate Hearing 110-96]
[From the U.S. Government Publishing Office]

                                                         S. Hrg. 110-96
 
                  THE STATE OF ALZHEIMER'S RESEARCH: 
                            100 YEARS LATER 

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

                                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 STATE OF ALZHEIMER'S DISEASE RESEARCH 
                            100 YEARS LATER

                               __________

                             MARCH 20, 2007

                               __________

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

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

                     U.S. GOVERNMENT PRINTING OFFICE

34-318 PDF                 WASHINGTON DC:  2008
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Washington, DC 20402-0001

          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 (ex officio),      MICHAEL ENZI (ex officio), Wyoming
Massachusetts

                   Ellen-Marie Whelan, Staff Director

                                  (ii)

  

                            C O N T E N T S

                               __________

                               STATEMENTS

                        TUESDAY, MARCH 20, 2007

                                                                   Page
Mikulski, Hon. Barbara A., Chairman, Subcommittee on Retirement 
  and Aging, opening statement...................................     1
    Prepared statement...........................................     2
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................     4
Collins, Hon. Susan M., a U.S. Senator from the State of Maine...     6
    Prepared statement...........................................     7
Johns, Harry, President and CEO, Alzheimer's Association, 
  Chicago, Illinois..............................................     9
    Prepared statement...........................................    11
Gandy, Sam, M.D., Ph.D., Director, Farber Institute for 
  Neurosciences, Thomas Jefferson University, Chair, Medical and 
  Scientific Advisory Council, Alzheimer's Association, 
  Philadelphia, Pennsylvania.....................................    13
    Prepared statement...........................................    15
Albert, Marilyn, Ph.D., Director, Division of Cognitive 
  Neuroscience, Department of Neurology, Johns Hopkins University 
  School of Medicine, co-Director of the Johns Hopkins 
  Alzheimer's Disease Research Center, Baltimore, Maryland.......    17
    Prepared statement...........................................    18
Egge, Robert, Project Director, Center for Health Transformation, 
  Washington, DC.................................................    21
    Prepared statement...........................................    23
Blum, Marilyn, Owings Mills, Maryland............................    33
    Prepared statement...........................................    34
Isakson, Hon. Johnny, a U.S. Senator from the State of Georgia, 
  statement......................................................    41
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio, 
  prepared statement.............................................    47

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Clinton, Hon. Hillary Rodham, a U.S. Senator from the State 
      of New York................................................    49

                                 (iii)

  

                  THE STATE OF ALZHEIMER'S RESEARCH: 
                            100 YEARS LATER

                              ----------                              

                        TUESDAY, MARCH 20, 2007

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:06 a.m. in 
Room SH-216, Hart Senate Office Building, Hon. Barbara A. 
Mikulski, chairman of the subcommittee, presiding.
    Present: Senators Mikulski [presiding], Reed, Brown, Burr, 
Isakson, and Coburn.

                 Opening Statement of Senator Mikulski

    Senator Mikulski. Good morning, everybody. The Subcommittee 
on Retirement and Aging will now come to order. This is a 
subcommittee of the Health, Education, Labor, and Pensions 
Committee. This will be a hearing on legislation to create a 
new framework for Alzheimer's. It will be a hearing devoted to 
listening to what the needs of families are, and how we can 
help families help themselves through being able to pay for 
long-term care but most of all, what we can do to help families 
with those who are affected by Alzheimer's.
    Alzheimer's affects not only the person who has it but also 
the family that must endure it and the taxpayer who must pay 
for it. I'm going to thank all of our witnesses today that are 
here and I particularly want to thank the members of the 
Alzheimer's Association, who are here and a special hello, of 
course, to the Maryland Chapter, known for their verve, their 
vigor and their advocacy on this topic.
    This is the 100th anniversary of the first diagnosis of 
Alzheimer's in Germany. Where have we come in 100 years? A 
greater awareness, a greater diagnosis but sadly, a greater 
number of people who have Alzheimer's.
    We're going to hear as our first witness, a very dear 
friend and colleague on this topic, Senator Sue Collins, who is 
the co-chair of the Alzheimer's Caucus within the Senate. The 
other co-chair is Senator Hillary Rodham Clinton.
    As we get ready to hear Senator Collins' testimony, though 
I want to say that I know that many of you, like myself, have 
been touched by Alzheimer's. More than 5 million Americans 
suffer from Alzheimer's. My father, my very dear father, was 
one of those 5 million Americans. I remember we tried to take 
care of him at home. We made sure he had the right diagnosis, 
that it wasn't that he needed a different kind of medication, 
that maybe it was the wrong kind of medications. We all hoped 
that when we got his geriatric evaluation at Johns Hopkins, 
that they were going to tell us Dad needed vitamin B-12 and a 
cruise with my mother.
    But unfortunately, that was not the case and we began, with 
our family, the long goodbye. Our mother was the primary 
caregiver and my sisters and my wonderful brother-in-laws 
helped. It was heartbreaking to my mother, heart-wrenching for 
my sisters and I because we knew what was happening to our 
father. Our father had already provided for us and our father 
had always protected us and now we wanted to do the same for 
him.
    But though I was a U.S. Senator, there was very little that 
I could do. Though I lived within the shadow of the University 
of Maryland and Johns Hopkins, there again, was very little 
that could be done at that time. Eventhough I could reach a 
Noble Prize winner on the phone and have NIH in my own State of 
Maryland. Again, we knew that we needed more research. We 
needed more ideas and we needed more help.
    Well, we've been working on that and I believe that Honor 
thy Father and thy Mother is not only a good commandment to 
live by, it's a good policy to govern by.
    When my father passed away because of the complications of 
Alzheimer's, I knew that my father was a modest kind of guy. He 
just wanted to make sure my mother was taken care of and that 
my sisters and I had the kind of family and education where we 
could take care of ourselves. But I know what legacy--what he'd 
want. He wouldn't want a fancy tombstone or big memorials and 
so on. He would like me to do what I could do to help families 
that faced what we did, to help them be able to deal with this.
    That's why we worked hard to establish the Anti-Spousal 
Impoverishment Program. That's why we worked to improve 
research and now experts have told us amazing things. We're on 
the verge of amazing breakthroughs. We have opportunities at a 
crucial point where NIH could make a tremendous difference, 
either in finding a cure or in coming up with those approaches 
that stretch out one's cognitive or memory ability.
    This week, along with other colleagues, I introduced 
bipartisan legislation, the Alzheimer's Breakthrough and Family 
Assistance Act of 2007. Congressman Markey and the Alzheimer's 
Caucus leadership, Congressman Smith, are doing the same in the 
House. Senator Bond is the lead Republican co-sponsor here in 
the Senate. For all of you in this room, it's S. 898. The 
Alzheimer's Breakthrough Act and S. 897, the Family Assistance 
Act. I will talk more about what the legislation does as we 
move through our testimony but I know Senator Collins has other 
important responsibilities and we want to hear her testimony. 
But if the Senator will withhold, I'd like to hear from our 
Ranking Member and wonderful colleague, Senator Burr.
    [The prepared statement of Senator Mikulski follows:]

               Prepared Statement of Barbara A. Mikulski

    Thank you to all of our witnesses today on our panel. I 
look forward to hearing about the state of Alzheimer's 
research, 100 years after the discovery of this disease. I am 
excited we are holding this hearing during the Alzheimer's 
Association's annual public policy conference.
    Your presence here today sends a loud message to Congress 
that Alzheimer's is an All-American disease that needs an all-
American effort. I am happy to have so many constituents from 
the State of Maryland at the hearing today--welcome to you all. 
Thank you for your tireless advocacy.
    The 2007 Alzheimer's Facts and Figures Report, released 
today by the Alzheimer's Association, is a wake-up call--we 
must respond! Many of you here today have been touched 
personally by Alzheimer's. Maybe it's someone you love. In 
fact, more than 5 million Americans suffer from Alzheimer's.
    My own dear father was one of those 5 million Americans. I 
remember when I would go to visit him. It didn't matter that I 
was a U.S. Senator who represents NIH. It didn't matter that I 
could get Nobel Prize winners on the phone. The information 
that would have made his life easier just wasn't there. My 
family and I knew about the long goodbye--we lived the 36-hour 
day. It was devastating to him, heartbreaking to my mother, and 
heart wrenching for my sisters and me. There was no safety net 
for our family. What was difficult was not just the disease. We 
felt powerless. All we could do was make my father comfortable. 
There was no cure. There was no safety net for our family.
    I vowed to do everything I could. Not just to support 
research, the search for a cure or a cognitive stretch out, but 
also to create a safety net for families. Because we know how 
hard it is. Ten million Americans have a family member with 
Alzheimer's. I believe ``Honor thy mother and father'' is not 
only a good commandment to live by, it's also a good policy to 
govern by.
    I created the National Family Caregiver Support Program. 
This successful program helps people who help themselves with 
information, resources and respite care. I established the 
Spousal Anti-
Impoverishment Program, which protects the income and assets of 
seniors who have spouses in nursing homes. This program has 
protected over a million seniors since it took effect in 1989.
    The experts have told us: ``we are on the verge of amazing 
breakthroughs;'' ``we will lose opportunities if we don't move 
quickly;'' ``we are at a crucial point where NIH funding can 
make a difference.''
    We need to do more and we need to do better. That's why 
last week, I introduced bipartisan legislation with my 
colleague Senator Bond, The Alzheimer's Breakthrough Act of 
2007 (S. 898) and The Family Assistance Act of 2007 (S. 897). 
An identical House companion bill was introduced by Congressmen 
Markey and Smith. We ask that you connect with your 
congressional representatives to support these important bills.
    Our bills do three things:

    1. Doubles funding for Alzheimer's research at NIH, from 
$640 million to $1.3 billion. We need to give researchers the 
resources they need to make breakthroughs that are on the 
horizon in diagnosis, prevention and intervention. This can 
bring us closer to a cure and find early interventions for a 
cognitive stretch-out. We are on the verge of breakthroughs, 
however we must move at a faster pace.
    2. Creates a national summit on Alzheimer's so the best 
scientists in the country can come together to look at the 
current state of research, discuss the most promising 
breakthroughs and chart the course for future research.
    3. Provides family support because we know the family is 
always the first caregiver. We will provide ``News You Can 
Use'' for families and physicians. Incredible advances are 
being made every day--we need to get the word out about tools 
and resources. The legislation also creates a $3,000 tax credit 
for families caring for a loved one with a chronic condition 
like Alzheimer's. This helps them pay for prescription drugs, 
home health care and special day care. It also includes a long-
term care tax deduction, making long-term care insurance more 
affordable for people. This helps people help themselves as 
they plan for retirement and their future.

    Today's hearing will focus on breakthroughs in Alzheimer's 
Research and care, providing news that people can use. We will 
hear facts about breakthroughs in diagnosing Alzheimer's 
disease with promising research pertaining to drugs and 
treatments; prevention techniques--what works, what doesn't 
work--and what research and programs mean for people with 
Alzheimer's and their caregivers.
    Research that is going on right now is the master key that 
will one day open doors to finding a cure for Alzheimer's. 
Ninety-five percent of what we know about Alzheimer's disease 
we've learned in the past 15 years. We must stay the course and 
continue the investment. Expanding the cognitive stretch-out 
for people with this disease by 5 years could save billions. A 
1-year delay in a nursing home placement could save $12 billion 
annually in Alzheimer's care costs. Public investment will mean 
savings to Medicare and Medicaid.
    I'm on the side of people with Alzheimer's and the families 
who love and care for them. I look forward to hearing from our 
witnesses today and getting facts about current breakthroughs 
in research, where we are today and the direction we need to 
head to make a difference in the lives of millions of people 
nationwide impacted by Alzheimer's.

                   Opening Statement of Senator Burr

    Senator Burr. Madam Chairman, let me thank you for the 
opportunity to be here and more importantly, I think everybody 
sees why she is a bulldog. She didn't even wait for me to 
start. I apologize for my tardiness and I welcome my colleague, 
Senator Collins.
    Madam Chairwoman, I commend you for your leadership and 
support for Alzheimer's disease research at the NIH. You are 
passionate about the issue and I look forward to working with 
you this Congress.
    Back in 1901, a German psychiatrist, Dr. Alzheimer, 
interviewed a new 51-year-old patient, Miss Augusta D. Her 
husband had brought her in because he could no longer care for 
her declining mental health. Dr. Alzheimer showed Augusta D. 
several objects and later asked her what she had been shown. 
She could not remember. Miss Augusta D. would be the first 
patient to be identified with what is now known as Alzheimer's 
disease.
    In 2007, there are an estimated 5 million people in the 
United States living with the disease. In North Carolina alone, 
by 2010, there is projected to be 170,000 people living with 
Alzheimer's. Currently, age is the greatest risk factor. One 
out of eight people, age 65 and older, has Alzheimer's and 
nearly half over 85 have it.
    Alzheimer's disease treatment is costly. In the United 
States, it's the third most costly disease to treat. In 2005, 
Medicare spent $91 billion on beneficiaries with Alzheimer's 
and other dementias. With the aging of our population, the 
total is projected to double by 2015, to $189 billion annually.
    Academic, scientific and pharmaceutical institutions have 
been trying to identify and develop new treatments for 
Alzheimer's. North Carolina is home to one of the 31 
Alzheimer's disease Research Centers funded by the National 
Institute of Aging, part of the National Institutes of Health. 
At Duke University, the Joseph and Kathleen Bryan Alzheimer's 
Disease Research Center focuses on early diagnosis and the 
development of treatments to delay or prevent the full onset of 
disease symptoms and disabilities. To aid in this research, the 
Bryan Center houses a Brain Bank, which includes tissue donated 
from individuals' autopsies.
    Another exciting innovation in North Carolina comes from 
the growing biotech industry in our State. For example, a 
Winston-Salem-based company, Targacept, is working with 
AstraZeneca on the development of AZD 3480, a promising 
treatment for Alzheimer's disease.
    So you see, we all have something to look forward to--
exciting research that is being done, passion of the Chairwoman 
of this subcommittee and more importantly, the statistics that 
prove that this is one of the wisest investments we can make 
from a standpoint of taxpayers to make sure that in the future, 
we have a declining cost of treatment because we've either been 
able to cure or to stop the progression of a very debilitating 
disease in its tracks.
    Once again, Madam Chairwoman, I thank you for the 
opportunity to be here.
    Senator Mikulski. Thank you very much, Senator Burr. In 
respect for Senator Collins and her other duties, that's why I 
charged ahead. I knew you'd be here. Everyone should know that 
Senator Burr is an excellent participant in this hearing. We 
also welcome Senator Isakson and ask him to withhold his 
opening statement until we move on to the witnesses.
    We have votes at 11:30 so we want to move pretty 
expeditiously so that we can hear from our witnesses and then 
can engage in a question and answer so we can hear the best 
ideas in the most affordable way to help the most people.
    With that, I'd like to turn to Senator Sue Collins, a long 
advocate of this issue, who is, as I said, the co-chair of the 
Alzheimer's Task Force and she's been a very strong advocate 
for disease and research and also on how to find ways for 
people to be able to afford long-term care and has been a long 
advocate of looking at how we can give help to those practicing 
self-help.
    Senator Collins.

                  Opening Statement of Senator Collins

    Senator Collins. Thank you very much, Madam Chairman. I 
want to point out that not only do you have the Maryland 
Chapter here today but you also have some very fine 
representatives from the Maine Chapter of the Alzheimer's 
Association and I know that a Maine/Maryland combination is a 
powerful one to get things done.
    I very much appreciate your invitation to participate in 
this morning's important hearing as well as your leadership in 
the battle against Alzheimer's. I also very much appreciate my 
colleagues being here today. This is an extraordinarily 
important issue.
    As someone whose family has experienced the pain of 
Alzheimer's, I know there is no more helpless feeling than to 
watch the progression of this dreadful disease. It is an 
agonizing experience to look into the eyes of a loved one and 
to receive only a confused look in return.
    As both you, Madam Chairman and the Ranking Member have 
mentioned, an estimated 5 million Americans have Alzheimer's, 
more than double the number in 1980. Moreover, Alzheimer's 
costs the United States just under $150 billion a year, 
primarily in nursing home and other long-term care costs. This 
figure will increase exponentially as the baby boom generation 
ages.
    As our generation moves into the years of highest risk for 
Alzheimer's, a strong and sustained research effort is our best 
tool to slow the progression and prevent the onset of this 
devastating disease.
    Our investments in Alzheimer's research have begun to pay 
dividends. Effective treatments are tantalizingly within our 
grasp. Moreover, if scientists can find a way to even delay the 
onset of this devastating disease for even 5 years, our Nation 
will save more than $60 billion every year in health and long-
term care costs and an incalculable amount in human suffering.
    If we are to keep up the momentum we have established, 
however, we simply must increase our investment in Alzheimer's 
disease research. Congress recently doubled over 5 years, the 
funding for the National Institutes of Health. As the Ranking 
Member noted, I can't think of a better investment for us to 
make. This is the largest increase in funding for biomedical 
research in our history and millions of Americans, including 
the families of Alzheimer's patients, are profoundly grateful. 
We have made considerable progress but now is no time to take 
our foot off the accelerator.
    We have two choices. We can sit back and continue to pay 
the bills and endure the suffering or we can aggressively 
pursue a national strategy aimed at preventing, delaying and 
even curing this devastating and debilitating disease. And 
that's why I'm so pleased to be an original co-sponsor of the 
Senator from Maryland's Alzheimer's Breakthrough Act of 2007, 
which would double the authorization levels for research at the 
NIH to $1.3 billion.
    In addition to increasing funding for research, we must 
also do more to support Alzheimer's patients and their 
families. Those of us who have had close relatives who have 
suffered from Alzheimer's know that it imposes an enormous 
burden, not just on the patient but even more so as the disease 
progresses, on the family members and caregivers. I'm therefore 
also very pleased to be an original co-sponsor of the 
Alzheimer's Family Assistance Act, which will provide a tax 
credit of up to $3,000 to help families meet the costs of 
caring for a loved one with a long-term, chronic disease like 
Alzheimer's. The legislation also would encourage more 
Americans to plan for their future long-term care by providing 
a tax deduction to help them purchase long-term care insurance.
    In the Homeland Security and Government Affairs Committee a 
few years ago, I was pleased to author the legislation, which 
had the Federal Government provide long-term care insurance to 
Federal employees and that is another step toward helping 
people plan for their future.
    Again, Madam Chairman, I very much appreciate your inviting 
me here to testify about an issue that I care deeply about. It 
is wonderful to see advocates from all over the country 
gathered here today so that we put a human face on the 
statistics of this horrible disease. Working together, I am 
confident, with your leadership, the leadership of the members 
of this committee--Senator Bond, Senator Clinton and others--
that we can have bipartisan support for the research that is 
necessary to find better treatments and ultimately, a cure. 
Thank you very much for the opportunity to be here today.
    [The prepared statement of Senator Collins follows:]

                 Prepared Statement of Senator Collins

    Madame Chairman, as the Senate co-chair of the bipartisan 
Congressional Task Force on Alzheimer's Disease, I appreciate 
your invitation to participate in this morning's hearing.
    Alzheimer's is a devastating disease that takes a 
tremendous personal and economic toll on both the individual 
and the family. As someone whose family has experienced the 
pain of Alzheimer's, I know that there is no more helpless 
feeling than to watch the progression of this dreadful disease. 
It is an agonizing experience to look into the eyes of a loved 
one only to receive a confused look in return.
    An estimated 5 million Americans have Alzheimer's disease, 
more than double the number in 1980. Moreover, Alzheimer's 
costs the United States just under $150 billion a year, 
primarily in nursing home and other long-term care costs. This 
figure will increase exponentially as the baby boom generation 
ages. As the baby boomers move into the years of highest risk 
for Alzheimer's disease, a strong and sustained research effort 
is our best tool to slow the progression and prevent the onset 
of this heart-breaking terrible disease.
    Our investments in Alzheimer's research have begun to pay 
dividends. Effective treatments are tantalizingly within our 
grasp. Morever, if scientists can find a way to delay the onset 
of this devastating disease for even 5 years, our Nation will 
save more than $60 billion every year in health and long-term 
care costs and an incalculable amount in human suffering.
    If we are to keep up the momentum we have established, 
however, we must increase our investment in Alzheimer's disease 
research. Congress recently doubled over 5 years the funding 
for the National Institutes of Health. This is the largest 
increase in funding for biomedical disease research in history, 
and millions of Americans, including the families of 
Alzheimer's patients, are profoundly grateful. We have made 
tremendous progress; this is no time to take our foot off the 
accelerator.
    We have two choices. We can sit back and continue to pay 
the bills and endure the suffering, or we can aggressively 
pursue a national strategy aimed at preventing, delaying and 
even curing this devastating and debilitating disease.
    That is why I am pleased to be an original cosponsor of the 
Senator from Maryland's ``Alzheimer's Breakthrough Act of 
2007'' to double the authorization levels for Alzheimer's 
research at the NIH to $1.3 billion.
    In addition to increasing funding for research, we must 
also do more to support Alzheimer's patients and their 
families. I am therefore also pleased to be an original 
cosponsor of the ``Alzheimer's Family Assistance Act of 2007'' 
which will provide a tax credit of up to $3,000 to help 
families meet the costs of caring for a loved one with a long-
term, chronic disease like Alzheimer's. The legislation will 
also encourage more Americans to plan for their future long-
term care needs by providing a tax deduction to help them 
purchase long-term care insurance.
    Again, Madame Chairman, thank you for inviting me to 
participate in this morning's hearing, which I hope will 
generate increased support for the research that is necessary 
to find better treatments and ultimately a cure for this 
terrible disease.
    Senator Mikulski. Thank you very much, Senator Collins, for 
your advocacy and we look forward to working with you.
    [Applause.]
    Senator Collins. Thank you.
    Senator Mikulski. You know, we have questions but we'll be 
able to talk with you on the Senate floor and as the bill goes 
forward. I'd now like to also acknowledge that two colleagues 
have arrived, Sherrod Brown, our wonderful new colleague from 
Ohio and Senator Jack Reed, who has also had a longstanding 
interest in this issue.
    You know, we're all so spread out. If you want to come 
closer, you can.
    Senator Reed. I can see you better from this angle.
    Senator Mikulski. Oh, come on up. Now we'd like to be able 
to move our witnesses and we'll be calling them to the table. 
Will Mr. Johns, the President of the Alzheimer's Association, 
Dr. Albert, Dr. Gandy, Marilyn Blum, a homemaker and caregiver, 
and Mr. Robert Egge from the Center for Health Transformation 
come to the table.
    First, we're just really glad to have these witnesses and 
I'd like to just kind of tell the committee about who is here 
and tell you a little bit about them and then we will just 
start with Mr. Johns. Then we'll go to Dr. Gandy, then to Dr. 
Albert and then--is it Egg or Egge?
    Mr. Egge. Egge. Thank you.
    Senator Mikulski. Egge.
    Mr. Egge. Yes.
    Senator Mikulski. And we're glad to have your testimony. I 
know you were recommended by Senator Burr and we're very 
enthusiastic. And also then, Marilyn Blum, who will tell us 
really the family perspective, after we've heard the experts.
    We're pleased that Harry Johns is here, who spent 23 years 
at various positions at the American Cancer Association. He is 
a longstanding advocate and I think he brings tremendous 
executive ability and passion to this. We're so pleased that 
the Alzheimer's Association has released a report that has kind 
of been a one-stop shop today, on everything the general public 
and policymakers need to know about it. We'd like to compliment 
you on that report but also, like the report, we don't want it 
to be like some national commissions. We want it to lead to 
action. So we thank you for that.
    Also for Dr. Gandy, who is the Director of the Farber 
Institute of Neurosciences at Thomas Jefferson University, who 
has focused his career on studying how plaques can be found on 
the brain of Alzheimer's. He is the author of over 100 articles 
and a very often quoted researcher because he can talk about 
this issue--he's really the science advisor to the Alzheimer's 
Association in addition to his own gifted and talented 
research.
    Ms. Marilyn Albert, of course, came from Harvard to Johns 
Hopkins and she is the Director of Cognitive Neuroscience and 
the Department of Neurology at Hopkins and is the co-Director 
of the Alzheimer's Disease Research Center. When I spoke about 
my dad, dad was really ill primarily during the mid-1980s and 
we had so little to turn to. There was pioneering work at 
Hopkins. Dr. Mason Ward, the social work approach and Mazi 
Rappoport, who was one of my mentors but now, there is just 
tremendous work going on at Hopkins and I might add, the 
University of Maryland and we're looking forward to hearing 
actually your ideas on cognitive stretch-out.
    And last but not at all least, Marilyn Blum from Owens 
Mills, Maryland, who is a caregiver for her husband, Steve, who 
was diagnosed 2 years ago with Alzheimer's at age 60. Often we 
think of this as a disease of the people in their eighties. She 
is also taking care of her 92-year-old father. So you talk 
about caregiver stress and living the 36-hour day. Mrs. Blum 
certainly is--but Mrs. Blum, while we listen to your story, we 
really welcome what you think would be sound, affordable public 
policies.
    Having said that, I really want to emphasize to all who are 
here, this is a bipartisan approach. I mean, Alzheimer's 
affects everybody equally. They don't know if you're a Democrat 
and they don't know if you're a Republican. They don't know if 
you're rich or you're poor, it just kind of takes your life 
away and so that's the way we're going to fight it, though, not 
only in a bipartisan basis but a nonpartisan basis. Nobody at 
this hearing has their party hats or their campaign buttons on. 
We wear the button of the Alzheimer's Association today.
    So with that, I'll turn to Harry Johns.

   STATEMENT OF HARRY JOHNS, PRESIDENT AND CEO, ALZHEIMER'S 
                 ASSOCIATION, CHICAGO, ILLINOIS

    Mr. Johns. Thank you, Chairman Mikulski, Senator Burr and 
members of the committee. I really want to thank you and I 
appreciate you holding this hearing today and I especially want 
to thank you, Senator Mikulski, for introducing with Senator 
Bond, the Alzheimer's Breakthrough and Family Assistance Acts.
    You know, today, as you said, Senator, the Alzheimer's 
Association is releasing this report, facts and figures on 
Alzheimer's disease in America and this report really provides 
evidence that Alzheimer's Disease is a growing epidemic. Today, 
our national investment is not commensurate with the effect and 
the impact of the disease already in today's world and we are 
significantly under-
invested in Alzheimer's for its future impact. So many more 
lives, our Federal budget and our overall economy have the 
potential to be so greatly affected.
    I'd like to talk about some of our key findings that are in 
the report. As it's already been said, there are now 5 million 
people who have Alzheimer's disease in America. That's up at 
least 10 percent from the last time we reported these figures. 
Half a million new cases in the upcoming year alone will occur 
in America. That's 1 every 72 seconds.
    Alzheimer's disease is not just a little memory loss. 
Alzheimer's disease kills. It's already the fifth leading cause 
of death among older Americans in America and growing. Death 
rates from this disease have risen 33 percent in the last 4 
years. This is while death rates for other diseases, diseases 
in which we have invested heavily as a Nation, we can proudly 
say, are declining every year. In fact, our success at curing 
many cancers and at fighting heart disease are exposing our 
under-investment and our failures in addressing Alzheimer's 
disease in America.
    People are surviving cancer only to face Alzheimer's 
disease. Left unchecked, Alzheimer's has the potential to wreck 
our economy. In fact, already today, Alzheimer's is costing 
almost $150 billion a year. By 2015, Medicare costs and 
Medicaid costs will be as high as $210 billion for 
beneficiaries with Alzheimer's disease alone. Within just 25 
years, unchecked, the cost for Alzheimer's beneficiaries in 
Medicare alone could be as high as the total of the Medicare 
program today. This threatens our economy and the economic 
security of not only baby boomers but generations to come.
    The human cost is even worse. There are at least 10 million 
caregivers carrying the burden of this disease for their loved 
ones and again, as you said, Senator, all of us who have been 
touched by this disease know that burden on a personal level. 
And again, Alzheimer's is not just a little memory loss. It 
kills. But before it does, it can rob people of all bodily 
functions.
    Caregivers not only lose their loved ones before they 
physically die--caregivers are perpetually fatigued. They 
suffer physical injury, depression and not infrequently, 
premature death, pre-deceasing the Alzheimer's individual. It 
doesn't say so on the death certificate, caregivers know that 
Alzheimer's disease causes deaths among caregivers as well.
    These statistics are a call for action. For the first time 
in history, there is real hope in emerging science that we can 
control this disease. There are several drugs in the final 
stages of clinical trials but no one expects these current 
drugs to cure the disease. We hope for disease modification as 
the researchers will tell you. So we have a problem. Without 
additional investments in research, we could see short-term 
progress and long-term gaps in gains.
    With sufficient resources, we can find ways ultimately to 
prevent this disease in millions of Americans and for those who 
still get it, control the disease to make it a manageable and 
chronic illness. A modest investment in total Federal budgetary 
terms has the potential for enormous returns to our country.
    To support the Alzheimer's Association's objective of 
providing access to effective treatments, we ask the Congress 
to support Senator Mikulski's legislation, the Breakthrough 
Acts, to substantially increase funding for Alzheimer's 
disease, funding and research at the NIH and we ask for an 
increase in the resources available to FDA to review new drugs 
as they become available and to support our objective for 
quality health care for people with Alzheimer's. We ask you to 
continue funding for proven programs serving Alzheimer's 
families--the Call Center, the Brain Health Initiative, Safe 
Return and the State Matching Grants program.
    Senators, again, Alzheimer's disease is a growing epidemic. 
It is not just a little memory loss. Alzheimer's disease is 
fatal. Our success in curing cancer and other disease is 
exposing our Nation's failure in Alzheimer's and we can stop 
Alzheimer's disease but we need your help to do it and I very 
much appreciate your efforts, your leadership on Alzheimer's 
disease and the opportunity to speak to you here today.
    [The prepared statement of Mr. Johns follows:]
                   Prepared Statement of Harry Johns
                                summary
    Alzheimer's is the most under-embraced, serious health crisis our 
Nation faces today. It is undermining efforts to control health care 
costs, assure access to quality care, and protect the retirement 
security of generations to come. That is the undeniable conclusion of 
the report the Alzheimer's Association report on Facts and Figures 
about Alzheimer's disease in the United States. Summarizes key 
findings:

     5 million people have the disease now (10 percent more 
than previous estimates.) By mid-century, as many as 16 million will 
have Alzheimer's.
     Half a million new cases will develop this year--one every 
72 seconds.
     Alzheimer's is now the 5th leading cause of death in older 
Americans. Death rates from the disease have risen 33 percent in 4 
years, at the same time that rates for other diseases common in the 
elderly are going down every year.
     Alzheimer's is costing the Nation $148 billion a year. 
Medicare spend $91 billion; Medicaid another $21 billion.
     By 2015, Medicare and Medicaid will be spending $210 
billion on beneficiaries with Alzheimer's.
     Alzheimer's is overwhelming the health and long-term care 
system. Twenty-five percent of elderly hospital patients, at least 47 
percent of nursing home residents and half of people in assisted living 
and adult day care have dementia.
     Yet 70 percent of people with Alzheimer's live at home 
where at least 10 million family members provide unpaid care. The 
annual value of the unpaid work Alzheimer caregivers do is valued at 
nearly $83 billion.

    These statistics are a call to action. For the first time in 
history there is real hope that we can get this disease under control. 
With sufficient resources, we will find ways to prevent this disease in 
millions of Americans and, for those who still get it, change it from a 
death sentence to a manageable chronic illness. A modest investment in 
total Federal budget terms has the potential for enormous returns. 
Within 5 years of the start of a breakthrough treatment, projected 
annual Medicare and Medicaid spending on Alzheimer's could decline by 
more than $60 billion, with even larger savings every year thereafter.
    Describes current collaborations of Alzheimer's Association with 
key Federal agencies--NIH, CDC, AOA, FDA. Presents key Alzheimer's 
Association legislative priorities for the 110th Congress:

    1. To provide access to effective treatments, increase funding for 
Alzheimer research at NIH by $125 million and provide adequate 
resources to FDA to expedite review of new drugs.
    2. To ensure quality health care for people with Alzheimer's, add a 
targeted chronic care management benefit to Medicare and continue 
support for proven programs serving Alzheimer families--the Call 
Center, the Brain Health Initiative, Safe Return, and the State 
Matching Grants Program.
    3. To protect retirement security of American families, enact long-
term care financing legislation to help insure against the economic 
risk of Alzheimer's and increase funds for caregiver support programs.

    Chairman Mikulski, Senator Burr, and Members of the Subcommittee. 
Thank you for holding this hearing, and for your persistent leadership 
in the fight against Alzheimer's disease.
    It is an honor to appear before you, on behalf of people with 
Alzheimer's and their families--hundreds of whom are behind me here 
this morning. They have come to Washington at their own expense, from 
48 States, to tell their Members of Congress about their own struggles 
with Alzheimer's, and to enlist them in an all-out war against this 
horrible affliction.
    I especially want to thank you, Senator Mikulski, for introducing 
with Senator Bond the Alzheimer's Breakthrough Act and the Alzheimer's 
Family Assistance Act. Your legislation will help millions of families 
and caregivers and will speed the day that we have a world without 
Alzheimer's. We appreciate your commitment to act quickly on these 
important measures. I assure you that all of us in the Alzheimer's 
Association will do everything we can to help you.
    Today, the Alzheimer's Association is releasing a comprehensive 
report on the latest Facts and Figures about Alzheimer's in the United 
States.  We are issuing a wake up call to Congress and the Nation. 
Alzheimer's disease is exploding into an epidemic that will undermine 
all of our best efforts to control health care costs, assure access to 
quality care, and protect the retirement security of generations to 
come. Despite its devastating consequences, which you know all too 
well, it remains the most under-embraced, serious health crisis our 
Nation faces. I do not have time here to go over all of the data. I ask 
that the report be made a part of the record and will just note a few 
of its findings.

    [Editor's Note: Due to the high cost of printing, previously 
published material will not be reprinted. The report may be found at 
www.alz.org.]

     More than 5 million people in the United States are living 
with Alzheimer's disease today. That is a 10 percent increase from 
previous estimates, but it is only the tip of the iceberg. By mid-
century, as many as 16 million will have the disease. That is more than 
every man, woman, and child currently living in Maryland and North 
Carolina combined.
     We will see half a million new cases of Alzheimer's this 
year alone. That means someone in America is developing Alzheimer's 
disease every 72 seconds!
     A diagnosis of Alzheimer's is a death sentence. It is now 
the fifth leading cause of death in older Americans. Death rates from 
many diseases common in the elderly--like heart disease, breast and 
prostate cancer, and stroke--are declining every year. But the death 
rates for Alzheimer's disease went up 33 percent in just 4 years. The 
absence of effective disease modifying drugs, coupled with the aging of 
the baby boomers, makes Alzheimer's the health care crisis of the 21st 
century.
     Alzheimer's already costs the Nation $148 billion a year. 
Medicare alone spent $91 billion on beneficiaries with the disease in 
2005 and Medicaid spent another $21 billion. By 2015 those two programs 
will be spending $210 billion just on people with Alzheimer's. And, by 
2025, the cost of today's entire Medicare program will be consumed by 
Alzheimer's alone.
     The disease is overwhelming health and long-term care 
systems: 25 percent of elderly hospital patients, 47 percent of nursing 
home residents, and at least 50 percent of people in assisted living 
and adult day care have Alzheimer's or another dementia.
     This is true, even though 70 percent of people with 
Alzheimer's live at home, where at least 10 million family members 
provide unpaid care. In Maryland, these caregivers are providing over 
145 million hours of care a year; in North Carolina, almost 270 million 
hours. Nationwide, the work Alzheimer caregivers are doing is valued at 
nearly $83 billion.

    These caregivers are the lifeblood of long-term care in the United 
States today. Our report documents the huge toll this is taking on 
families--in lost work, physical illness and injury, depression, even 
premature death. The term ``help with activities of daily living'' 
doesn't sound so bad, until you stop to think about what that means, 
day in and day out, for families struggling with Alzheimer's disease. 
It is a 70-year-old woman getting her husband in and out of bed every 
day, an 80-year-old man who never gets a decent night's sleep because 
his wife wanders the house all night and he has to keep her from harm, 
a daughter changing her father's diapers and cleaning up after him, a 
son bathing and dressing his mother who no longer knows who he is.
    This is the reality of Alzheimer's disease. It is not a pretty 
picture. But it is a picture that we can change. Today, there is real 
hope that we can get Alzheimer's under control, that we will find the 
ways to prevent millions from ever getting the disease, and that for 
those who do get it, we can change it from a death sentence to a 
manageable chronic illness. Other witnesses this morning will tell you 
about effective drug treatments on the horizon, new information on how 
to maintain our brains, and proven interventions that can reduce the 
burden of the disease.
    We cannot win this fight against Alzheimer's without an all-out 
commitment from Congress and from every relevant part of the Federal 
Government--especially NIH, FDA, CMS, CDC, and AOA. The Association is 
working closely with all of these agencies to maximize our mutual 
efforts within the limits imposed by existing law and resources. We are 
proud of our longstanding partnership with the National Institute on 
Aging. We are gratified by the response of the Food and Drug 
Administration to our Effective Treatments Initiative, to increase its 
focus on Alzheimer's and to bring patients and caregivers into the drug 
review process. Our joint projects with the Administration on Aging are 
serving hundreds of thousands of Alzheimer families. We are excited 
about our new collaboration with the Centers for Disease Control to 
expand public understanding of Alzheimer's and ways to reduce personal 
risk and improve diagnosis and treatment.
    We need your help as well. We are here on Capitol Hill to enlist 
the support of the 110th Congress on our three Key Legislative 
Priorities:

    1. Provide access to effective treatments to prevent or slow the 
onset and progression of Alzheimer's, by increasing funding for 
Alzheimer research at the National Institutes of Health by $125 million 
and by providing adequate resources to the Food and Drug Administration 
to expedite review of new drugs.
    2. Ensure quality health care for people with Alzheimer's disease, 
by adding a targeted chronic care management benefit to Medicare and by 
continuing support for proven programs that are serving Alzheimer 
families--the Call Center, the CDC Brain Health Initiative, Safe 
Return, and the State Matching Grants Program.
    3. Protect the retirement security of American families, by 
enacting long-term care financing legislation to insure against the 
economic risk of Alzheimer's disease, and by increasing funds for 
caregiver support programs.

    These proposals require a modest investment in total Federal budget 
terms but, as the other witnesses in this panel will explain to you, 
they have the potential for enormous returns--in reduced health and 
long-term care costs to Federal and State budgets and in improved 
quality of life for millions of American families.
    I would like to close on a personal note. We cannot forget the 
human faces behind all of the statistics. They are the faces of 
spouses, parents, children and grandchildren whose lives are being 
disrupted by Alzheimer's disease. I am now one of those faces. This 
past year, my mother was diagnosed with Alzheimer's. Each of us now 
lives with a new realization that, unless we deliver on the promise of 
research, our Nation's children and grandchildren may be facing a 
similar fate.
    Please, help us make sure that does not happen. Thank you.

    Senator Mikulski. Thank you very much for your call to 
action and now, let's get some ideas on the research and the 
breakthroughs. We'll turn to Dr. Gandy.

STATEMENT OF SAM GANDY, M.D., Ph.D., DIRECTOR, FARBER INSTITUTE 
FOR NEUROSCIENCES, THOMAS JEFFERSON UNIVERSITY, CHAIR, MEDICAL 
   AND SCIENTIFIC ADVISORY COUNCIL, ALZHEIMER'S ASSOCIATION, 
                   PHILADELPHIA, PENNSYLVANIA

    Dr. Gandy. Madam Chairwoman, Senator Burr and members of 
the subcommittee, I'm delighted to be here to report on the 
latest exciting developments in the field of Alzheimer's 
disease research. Senator Mikulski, you clearly understand the 
importance and promise of this research as evidenced by your 
Alzheimer's Breakthrough Act, which would commit Congress to 
the billion dollars for Alzheimer's research and I'd like to 
begin my comments by applauding your efforts.
    When my colleague, John Morris, appeared before the 
subcommittee 3 years ago, he was full of cautious optimism. 
Today, I can report genuine, tangible, quantifiable hope for 
effective prevention and treatment of Alzheimer's disease. 
Within the next 3 years, it is all but certain that we will 
have disease-modifying drugs that will fundamentally change the 
nature of the disease. For millions of Americans, a diagnosis 
will no longer be a death sentence but the beginning of a 
manageable chronic illness.
    These new drugs are very different from the ones currently 
on the market. Currently available drugs treat the symptoms but 
leave the underlying disease untouched. The new drugs are 
designed to attack the disease directly.
    Two of the most promising drugs which target the brain 
destroying amyloid plaques in the brain are well on their way 
to market. In controlled clinical trials, we've already proven 
they are safe, well-tolerated and have significant positive 
impact on slowing the progression of the disease. Higher doses 
or combination drugs might arrest the process completely. One 
of these drugs could go to the FDA for review as early as this 
fall with possible approval by next year.
    Advances in genetics and imaging have brought us near the 
point where we will be able to identify persons at risk for 
Alzheimer's, diagnose it before symptoms appear and begin 
treatment in time to prevent development of dementia all 
together.
    There is still a lot of work to be done. Alzheimer's is a 
complex puzzle and solving it will involve multiple strategies. 
Scientists are pursuing a number of other highly promising 
theories, including the chemical bases of tangles in the brain, 
the connection to heart, vascular disease and diabetes and the 
interaction of environment, genetics and lifestyle. If we can 
validate these theories through basic research, then every 
major pharmaceutical company will begin bringing new drugs into 
clinical trials. We have reached this stage because of your 
prior investments in NIH but we are now at risk of losing 
momentum. Alzheimer's research funding peaked at $658 million 
in 2003 and has declined every year since, a 14 percent decline 
in constant dollars at the National Institute on Aging alone. 
This is already having an impact. NIA is funding less than 20 
percent of the best research proposals it receives, down from 
30 percent in 2003. The grants that are approved are funded at 
20 percent below the recommended levels for the first year and 
have no inflationary adjustments for the out years.
    This means that huge scientific opportunities are being 
left on the table. Exciting projects are taking longer to find 
results and some of those promising trials are being delayed or 
are scrapped altogether and we are losing a generation of 
scientists who are either choosing more traditional careers or 
leaving research altogether. These brilliant minds are our 
greatest resource and we should be applying them to this, our 
most difficult problem. These budget cuts are not only killing 
research, they are killing the minds of millions of Americans 
and they are killing your chances of getting health research 
spending under control.
    If we let the disease continue on its current trajectory, 
in less than 25 years, Medicare will be spending almost $400 
billion on 10 percent of its beneficiaries, those with 
Alzheimer's. That's almost as much as we are spending in the 
entire Medicare program today. Medicaid will be spending 
another $50 billion on people with Alzheimer's. We can cut that 
spending in half, saving over $200 billion annually with 
treatments to delay the onset and slow progression and we could 
keep nearly 400 million Americans from getting the disease.
    Senators, we are in a race against time. With every year 
that passes, we risk losing that race. We urge Congress to add 
the funding we need to break through the finish line and 
eliminate this slow, cruel disease known as the Long Goodbye.
    [The prepared statement of Dr. Gandy follows:]
              Prepared Statement of Sam Gandy, M.D., Ph.D.
                                summary
    For the first time in history, there is genuine widespread 
enthusiasm among scientists that effective ways to prevent and treat 
Alzheimer's are within reach. Within 3 years, it is all but certain we 
will have disease-modifying drugs that fundamentally change the nature 
of the disease. Within 25 years, we could save nearly half of projected 
Medicare and Medicaid costs on Alzheimer's--savings of over $200 
billion a year. We could keep nearly 4 million Americans from getting 
the disease.
    Two of the most promising drugs, which target the brain-destroying 
amyloid plaques in the brain, are well on their way to market. In 
controlled clinical trials, we have already proven they are safe, well 
tolerated, and have significant positive impact in slowing progression 
of disease. Higher doses or combination drugs might arrest the process 
completely. One of these drugs could go to FDA for review as early as 
this fall with possible approval by next year.
    Advances in genetics and imaging have brought us near the point 
when we will be able to identify persons at risk of Alzheimer's, 
diagnose it before symptoms appear, and begin treatment in time to 
prevent development of dementia altogether.
    There is still a lot of work to be done. Alzheimer's is a complex 
puzzle and solving it involves multiple strategies. Scientists are 
pursuing a number of other highly promising theories including the 
chemical basis of tangles in the brain, the connection to heart and 
vascular diseases and to diabetes, and the interaction of environment, 
genetics, and life style. If we can validate these theories through 
basic research, then every major pharmaceutical company will begin 
bringing new drugs into chemical trials.
    We have reached this stage because of your prior investments in 
NIH, but we are now at risk of losing momentum. Alzheimer research 
funding peaked at $658 million in 2003 and has declined every year 
since--a 14 percent decline in constant dollars at the National 
Institute on Aging alone. This is already having an impact. NIA is 
funding less than 18 percent of the best research proposals it 
receives--down from 30 percent in 2003. The grants that are approved 
are funded 18 percent below recommended levels for the first year, with 
no inflationary adjustments in the out years.
    This means that huge scientific opportunities are being left on the 
table. Existing projects are taking longer to find results. Some of the 
most promising clinical trials are being delayed or scrapped 
altogether. And we are losing a generation of scientists who are either 
choosing traditional careers or leaving research altogether.
    This is killing research, it is killing the minds of millions of 
Americans, and it is killing your chances of getting health research 
spending under control.
    The scientific community is in a race against time. I urge Congress 
to provide the funds needed to break through the finish line ahead of 
the baby boomers who are nipping at our heels.

    Madam Chair, Senator Burr, and members of the subcommittee. I am 
delighted to be here to report on the latest exciting developments in 
the field of Alzheimer's disease research. Senator Mikulski, you 
clearly understand the importance and the promise of this research, as 
evidenced by your Breakthrough Act, which would commit Congress to the 
$1 billion goal for Alzheimer research. I'd like to begin my comments 
by applauding your efforts.
    When my colleague John Morris appeared before this subcommittee 3 
years ago, he was full of cautious optimism. Today, I can report 
genuine, tangible, quantifiable hope for effective prevention and 
treatment of Alzheimer's disease. Within the next 3 years, it is all 
but certain that we will have disease-modifying drugs that will 
fundamentally change the nature of Alzheimer's. For millions of 
Americans, a diagnosis will no longer be a death sentence but the 
beginning of a manageable chronic illness.
    These drugs are very different from the ones now on the market. 
Current drugs treat the symptoms of Alzheimer's but leave the 
underlying disease untouched. While they do help some patients 
temporarily, the predictable progression to death continues along the 
cruel path we know too well. The new drugs are designed to attack the 
disease directly. My own laboratory is involved in clinical trials of 
two drugs that target the brain-destroying amyloid plaques that are one 
of the two molecular hallmarks of Alzheimer's disease. Results to date 
are very encouraging. These drugs are safe. Patients tolerate them 
well. And they appear to show significant positive impact, slowing the 
progression of the disease. Higher doses or combination drugs might 
arrest the process completely. This drug could go to the Food and Drug 
Administration for review as early as this fall with possible approval 
by next year.
    The other exciting news is that we are rapidly gaining knowledge 
about genetic and other risk factors of Alzheimer's disease, and 
developing techniques to detect early changes in the brain well before 
symptoms appear. These discoveries will let us identify persons at risk 
of Alzheimer's, diagnose presymptomatic disease, and begin treatment in 
time to prevent development of dementia altogether.
    All of this good news is the direct result of your decision to 
double funding for the National Institutes of Health. The influx of 
resources moved Alzheimer research from a backwater of obscurity to 
perhaps the single most visible, most competitive, and most exciting 
field in the neurosciences. This is the key to drug discovery.
    Drug development does not start or end with pharmaceutical 
companies. It begins at NIH-funded laboratories at academic health 
centers, where scientists uncover the molecular basis of the disease, 
identify treatment strategies, and develop the research methods and 
techniques that make clinical investigation possible. Clinical trials 
depend on the expertise of NIH-funded investigators, and many require 
direct NIH funding because the drugs under investigation are not 
protected by patent.
    I emphasize this fundamental role of NIH funding because there is 
still so much work to be done. We are right to be excited about 
treatments that attack the amyloid plaques. But they will not likely be 
the complete answer. Like cancer and heart disease, Alzheimer's is a 
complex puzzle. Solving it will involve multiple strategies. We already 
have a number of other potential targets for intervention--including 
the chemical basic of the tangles in the brain that are the other 
hallmark of Alzheimer's, the relationship between heart and vascular 
disease and Alzheimer's, the connection to Type 2 diabetes, the role of 
nerve growth factors, and the interaction of environment, life style 
choices, and genetics in the development of disease.
    If we can validate the prevailing wisdom about amyloid, and if we 
can refine these other theories, then every major pharmaceutical 
company will begin bringing new drugs into human clinical trials. That 
will not happen, however, unless Congress provides the funds to sustain 
the Alzheimer research enterprise.
    In 2003, annual NIH funding of Alzheimer research peaked at $658 
million. We are living off the results of that investment, but we now 
risk losing our momentum. Since 2003, we have seen a slow steady 
decline in funding--down to $643 million this year and even less if 
Congress approves the President's fiscal 2008 budget request. In 
constant dollars, the drop is devastating--a 14 percent decline in 
overall funding at the National Institute on Aging (NIA.)
    This is happening at a time when the scientific opportunities have 
never been greater. There are more highly promising avenues of inquiry 
to explore than ever before. And we now have research tools at our 
disposal, involving genetics and imaging, that can help us get better, 
quicker answers. But we cannot use those tools without adding funds to 
existing projects.
    The slow down in funding is already having an impact in the 
Alzheimer research community. NIA is funding less than 18 percent of 
the most highly rated investigator-initiated projects it receives--down 
from a 30 percent success rate in 2003. What is more, the first-year 
grants that are awarded are funded at 18 percent below the level 
recommended by NIA's own independent review panels. There are no 
inflationary adjustments in the out-years or for existing projects. 
This means that most scientific opportunities are left on the table, 
and the successful ones are being seriously under-funded. It also means 
that some of the most promising clinical trials--the way to translate 
basic research findings into effective treatments--will be delayed or 
scrapped altogether. And I can say with certainty that we are losing a 
generation of scientists, who are either choosing less traditional 
careers or else are leaving research altogether. These brilliant minds 
are our greatest resource, and we should be applying them to our most 
difficult problems.
    Only money will bring them back.
    These budget cuts are not just killing research projects. They are 
killing the minds of millions of Americans. And they are killing your 
chances of getting health care spending under control. If we let the 
disease continue on its current trajectory, in less than 25 years 
Medicare will be spending almost $400 billion on 10 percent of its 
beneficiaries--those with Alzheimer's. That is almost as much as we are 
spending in the entire Medicare program today. Medicaid will be 
spending another $50 billion on people with Alzheimer's disease.
    We can cut that spending in half--saving over $200 billion 
annually--with treatments to delay the onset of Alzheimer's and slow 
its progression. And we can also save millions of families from 
devastation. By 2030, there would be 1 million fewer cases of 
Alzheimer's in the United States than there are today--in spite of the 
rapid aging of the baby boomers. And among those of us who would still 
get it, most would never progress beyond the mild stages of the disease 
and could continue to live productively with our families in the 
community.
    Senators, we are in a race against time. With every year that 
passes, we risk losing that race. We urge Congress to add the funding 
we need to break through the finish line ahead of the baby boomers who 
are nipping at our heels. Thank you.
    Senator Mikulski. Thank you very much, Dr. Gandy.
    Dr. Albert.

   STATEMENT OF MARILYN ALBERT, Ph.D., DIRECTOR, DIVISION OF 
COGNITIVE NEUROSCIENCE, DEPARTMENT OF NEUROLOGY, JOHNS HOPKINS 
UNIVERSITY SCHOOL OF MEDICINE, CO-DIRECTOR OF THE JOHNS HOPKINS 
    ALZHEIMER'S DISEASE RESEARCH CENTER, BALTIMORE, MARYLAND

    Dr. Albert. Good morning, Madam Chair and Senator Burr and 
other members of the committee. I speak to you today both as a 
scientist and as someone who has worked with hundreds of 
patients with Alzheimer's Disease and their families for over 
25 years.
    This morning, I want to talk to you specifically about two 
important areas of Alzheimer's research: scientific progress 
and understanding lifestyle factors that may reduce the risk of 
developing Alzheimer's disease and evidence-based strategies to 
reduce the impact of Alzheimer's disease on patients and 
families, once it is developed.
    At the last hearing on Alzheimer's disease before this 
subcommittee, you heard about the rapidly growing body of 
knowledge concerning the links between lifestyle factors and 
the risk of developing Alzheimer's disease, factors such as 
mental activity, physical activity, social engagement and risks 
for vascular disease.
    There is great interest in this topic in the general 
community because most people now understand the awful 
consequences of having Alzheimer's disease and would like to 
reduce their risk for developing it. Based on what we know 
today, we can offer some general guidelines but we still don't 
know many important details. For example, what types of 
physical activity to recommend or when in the lifespan physical 
activity would be most effective at lowering risk.
    Our challenge now is to continue this research so we can 
better understand how to lower risk for developing Alzheimer's 
disease. At the same time, it is important to educate the 
public and healthcare practitioners on what we've learned so 
far and we've begun to make some progress in this area. Just 
last year, workshops given by the Alzheimer's Association, 
known as Maintain Your Brain workshops, educated over 26,000 
people across the country on this topic. Interestingly, many 
were baby boomers and nearly half came to these workshops with 
no prior, or family, or other experience with Alzheimer's 
disease. This confirms our impression that there is a great 
interest in brain health in the population at large.
    A particularly important part of our educational efforts is 
the recent collaboration between the Alzheimer's Association 
and the Centers for Disease Control and Prevention. This 
collaboration, which began about a year and a half ago, was 
initiated by a small, Federal appropriation. This funding has 
permitted working groups organized by the CDC and the 
Alzheimer's Association to develop what is being called A 
National Public Health Roadmap on Cognitive Health. In 
addition, with support from the CDC, the Alzheimer's 
Association is now testing a program on brain health in two 
communities, a program particularly targeted to African-
Americans. African-Americans were chosen because they have high 
rates of vascular risk factors such as high blood pressure, 
diabetes and obesity and these factors are now known to 
increase the likelihood of cognitive decline. A larger program 
along these lines could clearly have enormous benefits for 
public health.
    At the same time that we're seeking to improve strategies 
for preventing Alzheimer's disease, we're also committed to 
reducing its impact on patients and families who are dealing 
with the disease now. A number of NIH funded studies have shown 
that relatively simple interventions, such as caregiver 
education, can reduce the behavioral and psychological symptoms 
of the patients. These programs also teach strategies for 
reducing stress and depression and have been shown to improve 
quality of life for both the patient and the caregiver. In 
fact, these strategies can even delay nursing home placement. 
One study found that the delay could be by as much as a year 
and a half.
    The Alzheimer's Breakthrough Act, which you've sponsored, 
Senator Mikulski, is critical for all the ongoing efforts in 
Alzheimer's disease I've been talking about. It will lay the 
groundwork to increase funding at the NIH to pursue promising 
avenues in the prevention and treatment of Alzheimer's disease. 
It will also expand current efforts to translate research into 
practice. All of us who care for Alzheimer's patients and 
conduct research in the area believe that the scientific 
community is on the brink of finding answers to creating a 
world without Alzheimer's disease. We need your leadership and 
your support to make that goal a reality.
    [The prepared statement of Dr. Albert follows:]
                  Prepared Statement of Marilyn Albert
                                summary
    At Johns Hopkins, with Federal funding from the National Institutes 
of Health, we are proud to be on the forefront of Alzheimer's research 
and we are as optimistic about the breakthrough drugs on the horizon. 
We are also just as concerned about reductions in NIH funding.
    There is a rapidly growing body of knowledge about the links 
between cardiovascular risk and Alzheimer's and about the possibilities 
that exercise, diet and even social engagement might help reduce the 
risks of Alzheimer's and cognitive decline. However, we still don't 
know how much exercise, or which kinds of social engagement, or which 
specific dietary changes will have the greatest impact on the disease. 
But, the findings are strong enough that the Alzheimer's Association 
has launched its Maintain Your Brain Campaign and in partnership with 
the Centers for Disease Control has initiated a new effort to address 
cognitive health. Maintain Your Brain workshops educated 26,000 people 
in communities across the Nation last year. The average age of 
participants was 61 and many were baby boomers--program's target 
audience.
    Another exciting development is the collaboration between the 
Alzheimer's Association and the Centers for Disease Control and 
Prevention. A National Public Health Roadmap to Cognitive Health is 
being developed which will provide guidance to government and the 
private sector on key steps to communicate the latest scientifically 
sound information, conduct and translate research on risk factors and 
strategies to maintain and improve brain health, on policy changes 
needed to support brain healthy behavior, and on better surveillance 
techniques to assess the burden of Alzheimer's disease and cognitive 
decline in communities nationwide. In addition, with support from the 
CDC, the Alzheimer's Association is now testing a program on brain 
health in two communities--southern California and the Greater Atlanta 
area--targeted to African-American baby boomers. Given the higher rates 
among African-Americans of cardiovascular disease, diabetes, obesity 
and high blood pressure, all of which are risks for Alzheimer's, a 
program targeted to this population could have enormous benefit for 
public health.
    While we continue our work on strategies to prevent Alzheimer's 
disease, we are also learning a great deal about how to reduce its 
impact on patients and families. NIH-funded studies have shown that 
relatively simple interventions, such as caregiver education, can 
reduce the behavioral and psychological symptoms in people with the 
disease that create the greatest challenges for family caregivers and 
our health and long-term care systems. They can reduce depression, 
stress, burden and unmet needs in caregivers. They can improve quality 
of life for both the person with the disease and the caregiver. And 
they can delay nursing home placement, in one study by more than a year 
and a half.
    The most exciting research findings are meaningful only if they are 
translated into practice, and if the benefits offered by State and 
Federal programs like Medicaid and Medicare are updated to incorporate 
these new and successful care strategies. That is why your proposed 
Alzheimer's Breakthrough Act is so important, Senator Mikulski. We have 
a strong foundation and the scientific community is well on its way to 
the answers needed to change a diagnosis of Alzheimer's disease from a 
death sentence to one of hope for generations to come.

    Good morning Madame Chair and Senator Burr. My name is Marilyn 
Albert, and I am Director of the Division of Cognitive Neuroscience in 
the Department of Neurology at Johns Hopkins University School of 
Medicine and Co-Director of the Johns Hopkins Alzheimer's Disease 
Research Center. I am also a member of the national board of the 
Alzheimer's Association and former chair of the Association's Medical 
and Scientific Advisory Council. I speak to you today as a scientist 
and as someone who has worked with hundreds of people with Alzheimer's 
disease and their families for over 20 years.
    At Johns Hopkins, with Federal funding from the National Institutes 
of Health, we are proud to be on the forefront of the research just 
discussed by Dr. Gandy. We are as optimistic as he is about the 
breakthrough drugs on the horizon. We are also just as concerned about 
reductions in NIH funding. Senator Mikulski, thank you for your support 
of Alzheimer's disease research and our efforts at Hopkins.
    My reason for being here is to report ground-breaking results in 
two exciting areas of Alzheimer research: (1) scientific breakthroughs 
on lifestyle factors that could reduce the risk of developing 
Alzheimer's disease; and (2) evidence-based strategies to reduce the 
impact of Alzheimer's disease on individuals, families and our health 
care system. This progress is a direct result of prior investments 
Congress has made at the National Institutes of Health (NIH) and 
research supported by the Alzheimer's Association.
                reducing the risk of alzheimer's disease
    At this subcommittee's last hearing on Alzheimer's, you learned 
about a rapidly growing body of knowledge about the links between 
cardiovascular risk and Alzheimer's. About the possibilities that 
exercise, diet and even social engagement might help reduce the risks 
of Alzheimer's and cognitive decline. We have only scratched the 
surface of these issues and we still don't know, for example, how much 
exercise, or which kinds of social engagement, or which specific 
dietary changes will have the greatest impact on the disease. But, the 
findings are strong enough that the Alzheimer's Association has 
launched its Maintain Your Brain Campaign and in partnership with the 
Centers for Disease Control has initiated a new effort to address 
cognitive health. All of these public health initiatives are based on 
solid science. And, all provide hope that we may be able to someday 
prevent this terrible disease through lifestyle changes and 
pharmaceutical interventions.
    Our challenge now is to continue the research and to educate the 
public and health care practitioners to act on this information. We 
have a lot of work to do. A recent national survey by the Alzheimer's 
Association found that most Americans are not aware of the progress 
being made against Alzheimer's and that only 14 percent are taking any 
action to reduce their risk for Alzheimer's disease.
    We've begun to make some progress in this area. Just last year, the 
Alzheimer's Association's Maintain Your Brain workshops educated 
26,000 people in communities across the Nation. The average age of 
participants was 61 and many were baby boomers, the target audience for 
the program. Nearly half came to the workshops with no prior family or 
other experience with Alzheimer's disease, which means there is 
interest in brain health in the general population. We don't know 
whether participation in the Maintain Your Brain workshops have lead to 
changes in lifestyle or improvements in brain healthy behavior, but the 
first step in behavior change is knowledge and 90 percent said they 
learned something new and could apply this new knowledge.
    But, the most exciting development began a year and a half ago with 
the collaboration between the Alzheimer's Association and the Centers 
for Disease Control and Prevention. With a small Federal appropriation, 
some big things have begun to happen. Most notable is the development 
of a National Public Health Roadmap to Cognitive Health, which will 
provide guidance to government and the private sector on key steps to 
communicate the latest scientifically sound information, conduct and 
translate research on risk factors and strategies to maintain and 
improve brain health, on policy changes needed to support brain healthy 
behavior, and on better surveillance techniques to assess the burden of 
Alzheimer's disease and cognitive decline in communities nationwide. 
This report will be released in June at the Alzheimer's Association's 
International Prevention of Alzheimer's Disease Conference here in 
Washington, DC.
    In addition, with support from the CDC, the Alzheimer's Association 
is now testing a program on brain health in two communities--southern 
California and the Greater Atlanta area--targeted to African-American 
baby boomers. Given the higher rates among African Americans of 
cardiovascular disease, diabetes, obesity and high blood pressure, all 
of which are risks for Alzheimer's, a program targeted to this 
population could have enormous benefit for public health. At this time 
next year, this exciting demonstration project will be reporting 
initial results.
    The CDC is also working with organizations, such as the AARP, the 
American Society on Aging and National Council on the Aging to educate 
professionals and the public about cognitive health. Some programs are 
targeted to school age populations in the hopes of starting at the 
youngest age to address brain healthy behavior.
               reducing the impact of alzheimer's disease
    While we continue our work on strategies to prevent Alzheimer's 
disease, we are also learning a great deal about how to reduce its 
impact on patients and families. We now have strong evidence from 
randomized clinical trials that coordinated medical and community care 
for people with dementia and counseling and support for family 
caregivers can stretch out the time that people with Alzheimer's can 
live successfully in the community.
    These NIH-funded studies have shown that relatively simple 
interventions, such as caregiver education, can reduce the behavioral 
and psychological symptoms in people with the disease that create the 
greatest challenges for family caregivers and our health and long-term 
care systems. They can reduce depression, stress, burden and unmet 
needs in caregivers. They can improve quality of life for both the 
person with the disease and the caregiver. And they can delay nursing 
home placement, in one study by more than a year and a half.
    Through the Alzheimer Demonstration Grant Program at the 
Administration on Aging, States are matching modest Federal grants and 
are developing practical ways to incorporate evidence-based programs to 
help patients and caregivers into their health and long-term care 
systems. For example, North Carolina developed a guide for families and 
a companion manual for nurses to improve hospital care for people with 
dementia. Georgia developed a mobile day care program to bring these 
important services to rural areas that did not have the resources to 
support a full program on their own. Maryland extended caregiver 
outreach services into rural and underserved minority communities. 
California developed a model to mobilize community resources to support 
Alzheimer families in underserved areas, starting first in a Latino 
community in Los Angeles and then adapting the program for African-
American and Asian communities.
                    translating research to practice
    In the end, the most exciting research findings are meaningful only 
if they are translated into practice, and if the benefits offered by 
State and Federal programs like Medicaid and Medicare are updated to 
incorporate these new and successful care strategies.
    That is why your proposed Alzheimer's Breakthrough Act is so 
important, Senator Mikulski. It would provide the authority and 
resources to deliver on the exciting promise of the Alzheimer's 
Association/CDC Brain Health Initiative, the Maintain Your Brain, and 
the community demonstrations with African-American baby boomers. And it 
would extend the opportunity to develop innovative Alzheimer programs 
under AOA's Demonstration Grant Program to all 50 States. And, perhaps 
most important, it will lay the groundwork to increase funding at NIH 
to pursue the many promising avenues in Alzheimer research.
    We have a strong foundation and the scientific community is well on 
its way to the answers needed to change a diagnosis of Alzheimer's 
disease from a death sentence to one of hope for generations to come. 
With your continued support and leadership, we can create a world 
without Alzheimer's.

    Senator Mikulski. You know, that's what all of you said so 
far but particularly focusing on Drs. Albert and Gandy. What 
amazing gains have been made, even in the last 5 years and this 
is why, I think, the impetus of the breakthrough is so 
important.
    Let's turn to Mr. Egge because I know you have ideas on 
promoting research and also the affordability aspects of this 
as well.

 STATEMENT OF ROBERT EGGE, PROJECT DIRECTOR, CENTER FOR HEALTH 
                TRANSFORMATION, WASHINGTON, DC.

    Mr. Egge. Thank you very much, Madam Chair, Senator Burr, 
members of the subcommittee. Thank you for this opportunity to 
testify regarding the significant challenge that Alzheimer's 
disease poses to our Nation and to the importance of responding 
to this growing crisis with a bold strategy that emphasizes 
research and innovation.
    My name is Robert Egge. I am a Project Director at the 
Center for Health Transformation, where I lead the Center's 
Alzheimer's Disease Project. The Center is a collaboration of 
more than 90 organizations from all segments of the health 
sector, including some of America's largest healthcare 
providers and employers.
    As we have already heard this morning, every 72 seconds, 
another American develops Alzheimer's disease. That's 50 more 
Americans during the course of this hearing, five more in the 
course of my remarks. Based on this present reality and future 
projects, that's certainly a cause for grave concern. But as we 
have also heard, when we survey the exciting progress being 
made in our Nation's laboratories, we find reason for cautious 
optimism. What we will not find anywhere, however, is an excuse 
for complacency. America must work both quickly and effectively 
to meet the challenge Alzheimer's poses to our country and to 
do so, our efforts must be guided by a comprehensive, coherent 
strategy. What is alarming is that based even on a cursory 
review of our current Federal efforts, the evidence suggests 
that such a strategy is now lacking.
    America has two fundamental objectives with respect to 
Alzheimer's. The first objective, as we heard and as I've 
described in greater length in my written testimony, is to 
develop therapies that will end this epidemic.
    The second objective is to support those now coping with 
Alzheimer's devastating impact, to help reduce the pain and 
exhaustion they face daily until the day comes when medical 
advances make Alzheimer's care giving no longer necessary.
    Both are essential goals and one might reasonably assume 
that the Federal Government is putting roughly comparable 
resources behind each of them. In fact, however, the current 
imbalances in investment are startling. For every dollar the 
government now spends through Medicare and Medicaid to help 
Americans cope with Alzheimer's impact, it invests less than a 
penny to find a cure through the work of the NIH and the FDA.
    This penny on the dollar approach might be called America's 
Katrina strategy for Alzheimer's disease. As we now know, 
policymakers long neglected funding the work required to repair 
and to strengthen the levies that might have saved New Orleans 
from the worst of Katrina's impact. And so, after the 
hurricane, more than 100 times this amount will have to be 
spent to repair the damage done to the city after the levies 
failed.
    So long as the government's current reactive posture toward 
Alzheimer's continues, we are at risk of repeating this tragic 
misjudgment of Katrina every 72 seconds, as another American 
braces their personal hurricane with no levies, no disease 
disrupting therapies to shield them.
    Far from sensationalizing the present situation, in one 
very significant regard, this Katrina analogy still understates 
the deficiency of current Federal approach toward Alzheimer's 
disease. For however slowly, the fact remains that New Orleans 
is now being rebuilt. That city is recovering from the mistake 
of neglect of its levies but until effective therapies are in 
hand, we simply have no way to even begin to restore the lives 
that are now being lost to Alzheimer's.
    However, we do know how to go about this the right way. Our 
national response to HIV/AIDS, for instance, shows what can be 
accomplished when our Federal Government mobilizes around a 
coherent, aggressive, innovation-oriented strategy. In the mid-
1980s, projections for the future impact of the AIDS epidemic 
were of a scale that is now similar to what we face from 
Alzheimer's disease. In a recent interview in Health Affairs, 
NIH Director Zerhouni recalled his experience as a doctor at 
Johns Hopkins in the mid-1980s, a time when there was not yet, 
like now with Alzheimer's, an effective treatment available for 
the disease. Half of all beds at that time were being used to 
care for terminally ill AIDS patients and Dr. Zerhouni and his 
colleagues projected that within a decade, 80 percent of their 
beds would be used to care for those dying from HIV/AIDS. 
However, through a combination of strong research funding and 
accelerated FDA review, a pre-emption strategy has yielded 
dramatic results. In just 5 years, between 1995 and 2000, 
deaths fell 70 percent and survival rates increased by 10 
years. Results continue to improve this decade. While much more 
remains to be done within the United States, HIV/AIDS diagnosis 
is increasingly regarded as a chronic disease rather than death 
sentence.
    The fiscal impact of these new therapies have been equally 
dramatic. In his testimony before both the Senate and the House 
last year, Dr. Zerhouni explained how a $10 billion investment 
in basic HIV/AIDS research between 1985 and 1995 has saved $1.4 
trillion in healthcare expenditures, a return of $140 for every 
dollar invested.
    It is time for America to learn from our past successes and 
to act in similarly bold, strategic and compassionate manner, 
revitalizing our commitment to defeating Alzheimer's disease 
through research and innovation. If we do, I'm hopeful that in 
20 years time, a future NIH director will use Alzheimer's 
disease to illustrate how smart, aggressive action changed the 
course of the Nation and immeasurably improved the lives of 
millions of Americans. Thank you.
    [The prepared statement of Mr. Egge follows:]
                   Prepared Statement of Robert Egge
    Chairwoman Mikulski, Senator Burr, and members of the Senate 
Subcommittee on Aging and Retirement, thank you for this opportunity to 
testify regarding the significant challenge that Alzheimer's disease 
(AD) poses to our Nation, and to the importance of responding to this 
growing crisis with a bold strategy that emphasizes the role of 
research and innovation.
    My name is Robert Egge. I am a project director at the Center for 
Health Transformation, where I lead the Center's Alzheimer's Disease 
Project. The Center is a collaboration of more than 90 organizations 
from all segments of the health sector, including some of America's 
largest healthcare providers and employers.
               the mounting impact of alzheimer's disease
    As documented in the Alzheimer's Association's Alzheimer's Disease 
Facts and Figures 2007 report released today, Alzheimer's strikes 1-in-
8 Americans over age 65 and almost half of Americans over 85. The 
likelihood of developing Alzheimer's essentially doubles every 5 years 
beyond age 65. Every 72 seconds another American develops Alzheimer's 
disease--50 more Americans during the course of this hearing.\1\
---------------------------------------------------------------------------
    \1\ Alzheimer's Association, (2007), Alzheimer's Disease Facts and 
Figures.
---------------------------------------------------------------------------
    There are no cures for Alzheimer's and no remissions. It is a 
condition that, once begun, always leads inexorably to death--on 
average within 8 years. These are long, exhausting, and painful years, 
described as ``the funeral that never ends.'' \2\ One caregiver 
recounted her experience since the onset of her husband's condition:
---------------------------------------------------------------------------
    \2\ Ballenger, J., (2006). Self, Senility, and Alzheimer's Disease 
in Modern America: a History. Baltimore: The Johns Hopkins University 
Press, as cited in, Comer, Meryl, ``Be Heard Here First: A Strategic 
Voice for Alzheimer's Advocacy,'' Alzheimer's & Dementia 3 (2007) 58-
61.

          Twelve years later, my own vision has forever been clouded by 
        seeing my husband's brilliant mind unravel, his eloquence turn 
        to gibberish, my name and our life together lost in the tangles 
        and plaques that clog his brain. His identity has been stolen 
        forever by this cruelest of disease, yet his body lingers 
        intact because it never got the message from the brain that it 
        is time to shut down. So together we are trapped in the endless 
        wasteland of Alzheimer's disease that offers no mercy to its 
        victim or the caregiver or the family.\3\
---------------------------------------------------------------------------
    \3\ Comer (2007) 59.

    The impact of Alzheimer's, on a national scale, is just as 
alarming. The Alzheimer's Association now estimates that more than 5 
million Americans suffer from this brain-crippling disease. With the 
aging of the baby boomers, this number is set to nearly triple in 
little more than a generation.\4\
---------------------------------------------------------------------------
    \4\ Hebert, LE; Scherr, PA; Bienias, JL; Bennett, DA; Evans, DA, 
(2003) ``Alzheimer Disease in the U.S. population; Prevalence Estimates 
Using the 2000 Census.'' Archives of Neurology. 60 (8): 1119-1122.
---------------------------------------------------------------------------
    Because Alzheimer's steals independence and complicates the 
treatment of co-morbidities, it is already America's third most 
expensive disease.\5\ Claims for Medicare beneficiaries with 
Alzheimer's disease, for instance, are three times larger than the 
claims of those without.\6\ Estimates of the disease's current cost to 
the Nation range as high as $200 billion per year. This year the 
Federal Government will likely spend more than $120 billion of this 
amount through the Centers for Medicare and Medicaid Services (CMS).\7\
---------------------------------------------------------------------------
    \5\ Koppel, R, (2002). ``Alzheimer's Disease: The Costs to US 
Businesses in 2002.'' An Alzheimer's Association commissioned report.
    \6\ Lewin Group, (2004). ``Saving Lives, Saving Money: Dividends 
for Americans Investing in Alzheimer's Research.'' An Alzheimer's 
Association commissioned report.
    \7\ Lewin Group, (2004).
---------------------------------------------------------------------------
    Looking ahead, however, this $120 billion tab is only a fraction of 
what awaits our Nation. Without medical breakthroughs, as the boomers 
pass through their elder years Federal spending on Alzheimer's care 
will increase to more than $1 trillion per year by 2050 in today's 
dollars.\8\ That's more than 10 percent of America's current gross 
domestic product. With this amount of money on the table, the 
Government simply will not be able to solve its looming fiscal problems 
if it fails to address this growing epidemic.
---------------------------------------------------------------------------
    \8\ Lewin Group, (2004).
---------------------------------------------------------------------------
    Yet as daunting--and, in personal terms, tragic--as this portrait 
is, we also have sound reason for optimism about what can be 
accomplished if our Nation commits to supporting the development of 
more effective therapies, guided by a bold but balanced Alzheimer's 
strategy. This optimism is important, because while complacency is a 
grave danger, so is resignation.
         a record of u.s. biomedical progress: past and present
    Our Nation's mounting Alzheimer's crisis is largely a result of our 
past biomedical accomplishments. Alzheimer's grows more common with 
age, and we have been remarkably successful at extending the average 
American's lifespan. The life expectancy of Americans expanded by three 
decades over the course of the 20th century alone, increasing from 47 
to 77 years of age.\9\
---------------------------------------------------------------------------
    \9\ National Center for Health Statistics, (http://209.217.72.34/
aging/TableViewer/tableView.aspx?ReportId=357).
---------------------------------------------------------------------------
    Steady progress has continued in recent decades even as the 
biomedical community has shifted its attention to the more complicated 
constellation of diseases associated with aging. In fact, according to 
the most recent statistics available from the CDC, the age-adjusted 
death rate for 9 of the top 10 causes of death in America fell from the 
prior year, including for cardiovascular disease and cancer.\10\
---------------------------------------------------------------------------
    \10\ Minino, Arialdi M., M.P.H.; Melonie P. Heron, Ph.D.; and Betty 
L. Smith, B.S. Ed., (2006). ``Deaths: Preliminary Data for 2004,'' 
National Vital Statistics Reports, Vol 54, No 19.
---------------------------------------------------------------------------
    As it happens, the only one of these top 10 causes of death to 
increase was Alzheimer's disease. And it will continue to increase, in 
step with our aging population, unless and until an effective, disease-
modifying therapy becomes available.
    The good news is that Alzheimer's disease is now receiving steadily 
increasing attention from our biomedical research community. One 
accepted way to gauge the growth of scientific activity within a field 
is through the volume of studies on the subject published in research 
journals. Less than 100 articles were published on Alzheimer's disease 
during the 1960s. During the 1990s, almost 25,000 such articles were 
published. This represents a seven-fold increase, decade on decade, 
over the latter half of the 20th century.\11\
---------------------------------------------------------------------------
    \11\ Ballon, Daniel, Ph.D., (2007). Correspondence.
---------------------------------------------------------------------------
    This rapid increase in research activity continues. Nearly 52,000 
scientific articles related to AD have been indexed in the PubMed 
database since the first such publication in 1949. Remarkably, about 
half of these articles have been published since the start of the new 
millennium, vividly illustrating the stunning acceleration of AD 
research.
    Alzheimer's research is not just rapidly expanding in its own 
right. It is also beginning to close a once large gap with other 
biomedical research fields. The comparison with cancer research is 
typical. From 1950 to 1980, oncology researchers published 
approximately 1,000 papers for every one on Alzheimer's disease. By the 
1990s, however, that gap had closed to a much closer ratio of 25 to 1, 
and so far this decade the ratio is just under 20 to 1.
    This upswing in Alzheimer's disease research activity tracks 
closely with the commitment to significantly expand support for 
Alzheimer's research through the National Institutes of Health. In 
particular, the rapid ``catching up'' in the 1980s corresponds with 
President Reagan's initiation of a serious, directed effort to fund AD 
research through the NIH. This linkage suggests that Federal Government 
support for basic research can indeed trigger a dramatic expansion of 
research activity and of new knowledge.
    For all the increased effort, however, AD research has not been 
easy work, and it's not likely to become so anytime soon. Like many 
other neurodegenerative conditions, Alzheimer's disease is extremely 
complex. Our neuroscience community has learned much about the brain, 
the central role it plays in regulating almost all aspects of health, 
and the profound disruptions to its activity associated with plaques 
and tangles. But those discoveries only skim the surface of the 
mysteries that remain.
    Nevertheless, our neuroscientists are meeting this challenge, 
systematically unlocking the brain's complexities with ever greater 
strides in scientific capabilities and sophistication. Never before in 
human history have so many scientists worked so productively, routinely 
employed such sophisticated instrumentation, collaborated worldwide so 
effectively, and developed their discoveries so efficiently.
    One result of the rapid expansion of research described above has 
been a series of specific, cumulative breakthroughs in our 
understanding of Alzheimer's mechanisms, and in the creation of novel 
strategies to disrupt them--with almost all these advances occurring 
within just the past 20 years. At the moment there are more than 250 
active Alzheimer's disease trials underway as listed on 
clinicaltrials.gov. These trials are all designed to test critical 
aspects of our understanding of AD, helping us to put together the 
pieces of the puzzle that explain this disease.
    These trials, as well as the underlying research strategies, have 
been supported by rapid advances in instrumentation and platform 
technologies. Some of these essential tools and methods include:

     Imaging. Advances in brain imaging technology--in 
particular, functional magnetic resonance imaging (fMRI) and positron 
emission tomography (PET)--are providing important clinical diagnostic 
aids for AD research. Particularly encouraging is the development of 
novel PET scan probes/tracers that permit real-time visualization. 
Similar tracers are under development for use with fMRI.\12\ \13\
---------------------------------------------------------------------------
    \12\ It is important to note that the development of these tracers, 
however, is comparable in process, time scale, and financial investment 
to the development of AD therapies themselves.
    \13\ Not only are these advances in imaging technology extremely 
important for research, but continued increases in capabilities with 
declining costs may eventually enable wide-scale, routine screening to 
detect AD upon onset when therapies are likely to be more effective.
---------------------------------------------------------------------------
     Biomarkers. Extensive efforts are underway to identify AD-
specific biomarkers that reliably and non-invasively track AD onset and 
progression so that, among other uses, these markers can indirectly 
measure drug response and help optimize treatment regimens. Researchers 
are currently working to identify superior markers using technologies 
from genomics, proteomics, metabolomics, computational and systems 
biology, and mathematical modeling.
     Screening Methodologies. A candidate therapy's performance 
is routinely measured using a variety of techniques including cell-
based (in vitro) assays and animal models (in vivo assays). While the 
animal models are the gold standard, they are time consuming and 
extremely costly. Recently, the development of automated, high-
throughput assays has greatly enhanced in vitro approaches to 
screening. Scientists are currently developing new computer-assisted 
(in silico) or virtual techniques to analyze and model the 
physiochemical properties of a compound in order to predict how it 
would behave in a complex system like the human body.
     Animal Models. Better understanding of the mechanisms 
underlying AD, coupled with advances in the fields of genetics, 
bioinformatics, and molecular biology, has led to substantially 
improved AD animal models. A major limitation of the early mouse models 
of AD was that the mice only developed some of the hallmark pathologies 
of the disease. Researchers recently addressed this problem by creating 
a triple transgenic mouse model that progressively developed both 
plaques and tangles, and demonstrated cognitive defects.\14\ This 
particular transgenic mouse promises to be a valuable animal model for 
evaluating potential AD therapeutics.
---------------------------------------------------------------------------
    \14\ Oddo S et al. Triple-Transgenic Model of Alzheimer's Disease 
with Plaques and Tangles: Intracellular Ab and Synaptic Dysfunction. 
Neuron, 2003;39:409-421.
---------------------------------------------------------------------------
     Genome-Wide Association Studies. Rapidly evolving 
technologies--such as computerized databases containing reference human 
genome sequences and tools that can rapidly identify genetic 
variations--are equipping neuroscientists to employ new investigative 
methods such as genome-wide association studies (GWAS).\15\ For 
instance, one such study reported earlier this year uncovered that 
faults in the SORL1 gene are associated with an increased risk of late-
onset AD, providing promising new avenues for follow-on research.\16\
---------------------------------------------------------------------------
    \15\ http://www.genome.gov/20019523.
    \16\ ``The neuronal sortilin-related receptor SORL1 is genetically 
associated with Alzheimer disease.'' Nature Genetics 39, 168-177 (01 
Feb 2007).
---------------------------------------------------------------------------
    The range of these research breakthroughs and others like them 
indicates the complexity of the task we have set before the 
neuroscientists in our research institutes and industry laboratories. 
It's as if we've asked them to build a house, but to do so they also 
have had to invent and fabricate all the tools needed for construction 
along the way. They are proving more than equal to this challenge.
    Even with rapid advances in our understanding of the disease and in 
the tools available to neuroscience researchers, though, the 
development of therapies--bringing them from the point of discovery to 
the moment of delivery--remains a high-risk enterprise. AD drugs have 
low clinical success rates, similar to those of other central nervous 
system (CNS) drugs ( 8 percent).\17\ Approximately 60 percent of drugs 
targeting the CNS successfully complete phase I clinical trials. Of 
these,  40 percent successfully complete phase II clinical trials, and 
 50 percent of these successfully complete phase III clinical trials. 
Finally, only  70 percent of those that progress past phase III trials 
will become registered.
---------------------------------------------------------------------------
    \17\ Kola I and Landis J. Can the pharmaceutical industry reduce 
attrition rates? Nature Reviews Drug Discovery, 2004;3:711-715.
---------------------------------------------------------------------------
    The new instrumentation and methodological options described above 
should improve these attrition levels. However, AD therapy development 
will remain daunting for the foreseeable future. It will continue to 
require substantial investments to be made by biopharma and medical 
device companies far in advance of what are, at best, uncertain 
prospects at the close of their development cycles.
    still needed: a roadmap to guide our alzheimer's disease efforts
    So today, as we look at the national projections for Alzheimer's 
disease, we find cause for grave concern. As we survey the progress 
being made in our Nation's laboratories, we find reason for cautious 
optimism. What we will not find anywhere, however, is an excuse for 
complacency.
    America must work both quickly and effectively to meet the 
challenge Alzheimer's poses to the country. And to do so, our efforts 
must be guided by a comprehensive, coherent strategy. What's alarming 
is that based even on a cursory review of our current Federal efforts, 
the evidence suggests such a strategy is lacking.
    We have two fundamental objectives with respect to Alzheimer's. One 
objective, as described above, is to find therapies that will derail 
this disease. The second objective is to support those coping with 
Alzheimer's devastating impact. The first is to deliver a decisive 
medical solution. The second is to help reduce the pain and exhaustion, 
however inadequately, until medical advances make caregiving no longer 
necessary.
    Both are essential goals and one might reasonably assume that the 
Federal Government is putting roughly comparable resources behind each 
of them. In fact, however, the imbalance in investment is startling. 
For every dollar the Government spends through Medicare and Medicaid to 
help Americans cope with Alzheimer's impact, it invests less than a 
penny to find a cure through the work of the National Institutes of 
Health and the Food & Drug Administration.
    This penny-on-the-dollar approach might be called America's Katrina 
Strategy for Alzheimer's disease. As we now know, policymakers long 
neglected funding the work required to repair and strengthen the levees 
that might have saved New Orleans from the worst of Katrina's impact. 
And so, after the hurricane, a hundred-fold more had to be spent to 
rebuild the devastated city after the levees failed.
    So long as the Government's current, reactive posture continues, we 
are repeating the tragic misjudgment of Katrina every 72 seconds as 
another American faces their personal hurricane with no levees to 
shield them.
    Far from sensationalizing the present situation, in one very 
significant regard this Katrina analogy understates the deficiency of 
our current Federal approach toward AD. For, however slowly, the fact 
remains that New Orleans is now being rebuilt. That city is recovering 
from the mistake of neglecting its levees. But until effective 
therapies are in hand, we simply have no way to even begin to restore 
the lives of those now gripped by Alzheimer's.
    However, we do know how to go about this the right way. Our 
national response to HIV/AIDS shows what can be accomplished when our 
Federal Government mobilizes around a coherent, aggressive, innovation-
oriented strategy. In the mid-1980s, projections for the future impact 
of the AIDS epidemic, absent effective treatments, were of a scale 
similar to what we now face from Alzheimer's disease.
    In a recent interview in Health Affairs, NIH Director Elias 
Zerhouni recalled his experience as a doctor at Johns Hopkins during 
the mid-1980s, a time when there was not yet an effective treatment 
available for the disease.\18\ Half of all beds were being used to care 
for terminally ill AIDS patients, and Dr. Zerhouni and his colleagues 
projected that within a decade, 80 percent of their beds would be used 
to care for those dying from HIV/AIDS.
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    \18\ Health Affairs, 25, no. 3 (2006): w94-w103.
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    However, through a combination of strong research funding and 
accelerated FDA review, a preemption strategy yielded dramatic results. 
In just 5 years between 1995 and 2000, deaths fell 70 percent and 
survival rates increased by 10 years. Results continue to improve this 
decade. While much more remains to be done, within the United States an 
HIV/AIDS diagnosis is increasingly regarded as a chronic disease rather 
than a death sentence.
    The fiscal impact of these new therapies has been equally dramatic. 
In his testimony before both the Senate and the House last year, Dr. 
Zerhouni explained how this innovation-focused strategy has saved $1.4 
trillion in healthcare expenditures,\19\ on the basis of $10 billion 
invested in basic research between 1985 and 1995; a return on 
investment of 140 to 1.
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    \19\ http://olpa.od.nih.gov/hearings/109/session2/testimonies/
nihbudget.asp.
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    It is time for America to once again act in a similarly bold, 
strategic manner, revitalizing our commitment to defeating Alzheimer's 
disease. If we do so, I am hopeful that in 20 years' time a future NIH 
Director will use Alzheimer's disease to illustrate how smart, 
aggressive action changed the course of the Nation and immeasurably 
improved the lives of millions of Americans.
    Thank you.
Appendix 1.--Preparing the Country for the Alzheimer's Epidemic: A View 
  from Science, Business, Government, and Caregivers; Newt Gingrich, 
 Founder, The Center for Health Transformation (Excerpted Remarks) \20\
    This particular conference was inspired in part by an article in 
the Washington Post called ``Open the Door to Curing Alzheimer's: Why 
this Research Must Become an Urgent Priority,'' by Bob Essner at Wyeth. 
It really led me to ask the question, ``Are we at a turning point where 
the scientific knowledge base makes it plausible that you could design 
a roadmap of extraordinary power that could in fact provide 
dramatically better futures for people? ''
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    \20\ [Complete remarks available at www.healthtransformation.net]
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    The breakthroughs for this disease are real and they're 
extraordinarily exciting, and they are driven by fundamental 
breakthroughs in science. I want to suggest to you that we are at the 
edge of an opportunity that is truly extraordinary, but that requires a 
willingness to think beyond the normal.
    If you were to look at what the cost would have been to have fixed 
the levees prior to Katrina and what the cost has been since then, you 
would see a perfect case study of prevention and failure. And one of 
the great challenges for the Congress and the President to confront is 
that if we allow annual budgeting to define our investment strategies, 
we guarantee in the baby-boomer retirement years catastrophic 
disasters, because you never generate the resources to make the 
breakthroughs to avoid the catastrophes, and this has been very evident 
in the last 5 or 6 years. I mean, it is a process; it literally fits 
the model of penny wise and pound foolish from the 18th century phrase 
that you should never try to save a penny if it cost you a pound in 
British terms. In our case, it is million-dollar wise and trillion-
dollar foolish. And it's just utterly irrational. And yet it requires 
you to say, ``okay, what would an investment strategy approach look 
like? ''
    Let me also say that one of the things that is most stunning--if 
you take the 5-year cost of a breakthrough--if you could get a research 
advance that would delay the onset of Alzheimer's by 5 years, which is 
not complete victory, but a non-trivial breakthrough, the difference 
would be a 40 percent reduction and prevalence--5.3 million lives 
saved, a $444 billion annual Medicare saving, a $70 billion annual 
Medicaid savings, and a total $515 billion savings for the Center for 
Medicaid and Medicare services. You can multiply that number by about 
seven to get the private savings for human beings who are using their 
own money today to deal with the challenge of Alzheimer's in their 
family. That's what just a 5-year delay means as a difference.
    I believe that the scale of change we need--and I'm just going to 
go over this very briefly but I want to set a stage here--the scale of 
change we need starts with how do you maximize the evolution of imaging 
capabilities so that you can have a very inexpensive real-time 
capability on a routine basis. Ultimately, in the long-run, you want 
brain scans to be comparable to getting your teeth X-rays, and that's 
largely a research--it's a combination of the National Science 
Foundation, NIH, Siemens, General Electric, and other systems that 
focus on it. But that's a box that has to be dealt with.
    The second box is to design both basic and applied research tracks 
to essentially try to figure out what are the six or eight or nine 
biggest breakthroughs we need? And what level of resourcing does that 
require, and what level of access to data does that require? We're 
entering a world where if you look at Kaiser Permanente, the Veterans 
Administration, a number of other fairly large systems, we have over 
30-million electronic health records today. We have a potential 
capacity to build Framingham-style studies to give you the epidemiology 
of a wide range of things, and we don't use them very well because we 
don't think like that. And so you want to look at could you identify 
every person who is in an early onset Alzheimer's situation out of the 
30 million we already have electronic health records for and how could 
you knit them together into a learning system?
    But this whole notion, we have to fundamentally reassess what do we 
mean by basic and applied research in the information age. And how do 
we maximize the rate of change and maximize the rate of discovery? And 
how do we bring together--it's very parallel to what Andy began doing 
at the National Cancer Institute in trying to accelerate the evolution 
with cancer. We need the same kind of pattern and we need to recognize, 
because of the emergent nature of brain science, which is at a much 
earlier stage than oncology, that you really want a lot more National 
Science Foundation involvement, because a fair amount of this is 
physics and mathematics; and you want NIH involvement and you want the 
corporations. And you want some kind of public/private research 
partnership to build a very high-tempo process.
    The third thing you want to do, frankly, if I can take a few 
seconds to preach in public here, is we need an FDA brain science model 
of operation. Brain sciences are different. They're going to cut across 
all sorts of existing FDA systems. They require a level of sensitivity 
and intuitiveness, because today, it is my understanding as a non-
scientist, we actually determine for sure you have Alzheimer's during 
the autopsy. Well, that defies all the FDA requirements for figuring 
out who the subjects are. And so we really need to fundamentally from 
the ground up erase the blackboard and say, ``okay, in this newly 
emergent science involving one of the two or three largest items facing 
the American people, what is it we need to understand to maximize the 
rate of testing and maximize the rate''--and again, I want total 
Federal testing from a human safety standpoint, but I want it done in a 
brand new kind of framework.
    This is particularly important because--my sense, again, as a non-
scientist but as a historian who looks at the evolution of technology--
my sense is you're going to see three parallel patterns going on 
simultaneously. You're going to see symptom management where you get a 
breakthrough that is partially palliative. It makes a huge difference 
if you can manage the symptom. You're going to get actual disease 
management. How can you in fact suppress the effect of it, make it 
better? And third, you are eventually going to start getting disease 
prevention or literally disease suppression. Now, those three tracks 
need to simultaneously be coordinated because you want to make progress 
on all three, and you don't want to give up any one of those waiting 
for some kind of magic breakthrough.
    Fourth, I think the Center for Medicare and Medicaid Services and 
public policy in general, including the Veterans Administration and the 
Federal employee health benefit plan and Tricare should all be looking 
from the [caregiver] side back. What is the optimum way to help people 
be good caregivers? What is the optimum public policy to maximize the 
opportunity for families to have decent lives while struggling with 
this terrible disease? What is it we can do, for example, we should 
have a center which is developing the maximum number of tools that 
would help people who are caregivers.
    Alzheimers Disease is a newly emergent problem that is no different 
than the epidemics of the 19th century or the famines of the 18th 
century or the industrial-era diseases of the 20th century. It's 
something we're going to have to learn to solve. We have to be 
practical about it. And the more aggressive we are and the more 
innovative we are, the faster we'll be successful.
    And so I'm thrilled to have a chance on behalf of the Center for 
Health Transformation to thank all of you for being involved and to say 
that we very much want to work with you.
Appendix 2.--Preparing the Country for the Alzheimer's Epidemic: A View 
from Science, Business, Government, and Caregivers; Samuel Gandy, M.D., 
Ph.D., Director, Farber Institute for Neurosciences (Excerpted Remarks) 
                                  \21\
    This is the first time in medical history we can actually 
contemplate rational therapy for Alzheimer's disease. One of the 
numbers that you might or might not have heard before, but just to 
reinforce--half of the over-85 population has a dementing illness. That 
is, if both parents live to 85, statistically the likelihood is that 
they will--one of them will have Alzheimer's disease; will have a 
dementia, usually Alzheimer's disease.
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    \21\ [Complete remarks available at www.healthtransformation.net]
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    So here's my title, ``A Pivotal Moment is Within Reach'' and that's 
absolutely certain; there's no doubt about that. We are now entering 
human clinical trials that will tell us if what we are fairly certain 
is true about Alzheimer's disease is in fact provable in humans.
    Alzheimer's is really characterized by three key criteria. The 
first is the characteristic change in memory, typically the inability 
to form and retrieve new short-term memories. Equally frequent, 
patients with Alzheimer's may present with changes in personality. 
Eventually, all of the outside surface of the brain, all of the 
cerebral cortex, the part that's responsible for thinking, all of that 
part of the brain degenerates and patients die bed bound in what we 
call a vegetative state.
    There is very early on a profound loss of a chemical called 
acetylcholine. This is a chemical that nerve cells use to talk to each 
other called a neurotransmitter. The currently approved medicines, at 
least three of the four, all target this deficiency; that is, they help 
the brain to compensate at the very earliest stages of the disease. 
However, for these medicines to be effective, intact nerve cells are 
required. So once nerve cells become impaired to the point of 
degenerating, those medicines that we currently have wear off. So these 
medicines don't appreciably slow the progression of the disease and 
don't really attack the underlying pathology. And that's what I'm going 
to talk about--the accumulation of the abnormal, gummy structures. This 
is really what's been the heart of the advances in Alzheimer's science.
    This is what has the scientific community so excited about 
Alzheimer's disease--amyloid plaque, a clump, a build-up of a gooey 
material in between nerve cells. These plaques are composed of a 
protein called the beta amyloid peptide. So the real problem in 
Alzheimer's disease, in particular, and in other aggregation diseases, 
is that normal proteins, proteins that are always with you all 
throughout life, somehow, for reasons that are often mysterious--not 
always--change their shape, and in this altered shape, they then clump. 
And that's really the bottom line.
    Within the past few years, we've now been able to develop--we the 
field; we, not me--have been able to develop PET scans that allow the 
visualization of amyloid buildup in the brain during life. So for the 
first time in a living human, you can watch amyloid buildup.
    This is an incredibly important breakthrough and is being evaluated 
worldwide now, especially for the testing of new medications because 
now, for the first time, we can see the target; we can see what we are 
aiming our drugs at because we're developing these anti-amyloid drugs, 
and most peripheral markers have not been satisfactory. This particular 
imaging tool is being added to a large international initiative called 
the Alzheimer's Disease Neuroimaging Initiative and these particular 
scans are supported by a project from the Alzheimer's Association.
    You will hear that there's a controversy over amyloid. Is this a 
cause or an effect? And the likely answer is both, because we know 
there is some instances in which the disease begins with amyloid and we 
know that there are other forms in which we can't trace the exact 
beginning. But all the evidence indicates we are better off without 
this misfolded form.
    Even if amyloid is not the whole story in common Alzheimer's, we 
know very well that these clumps in nerves, and if we look at nerve 
cells in a dish, are poisonous. So this is not good. The only way now 
we can really resolve how much of the dysfunction in Alzheimer's 
disease is due to amyloid is in human clinical trials in which we 
develop successfully anti-amyloid agents, purge the brains of humans so 
there's no amyloid left, and see what happens cognitively. Ideally, 
we'd like to actually be in the prevention mode so that we identify 
ways to screen people, begin anti-amyloid interventions, and prevent 
the scenario from ever happening. But we won't know how bad amyloid 
really is until we purge it completely and follow the clinical outcome.
    All the strategies that are currently being tested really fall into 
one of three categories. The first is the immunotherapeutic approach, 
the vaccine. The second is a new group of compounds called plaque 
busters (anti-aggregation drugs) And the third category are drug-like 
structures that could totally block amyloid formation.
    This is really the state of Alzheimer's research. Mouse models of 
Alzheimer's amyloid can be caused with these amyloid-parent protein 
genes and cured with either vaccines, anti-aggregates, or these 
scissors modifiers. The real question that we're now answering in 
clinical trials, because these medicines are already being given to 
humans, is will (what we've seen in the mouse model) arrest or prevent 
the dementia with humans with Alzheimer's?
    So I think that gives you a bit of an overview of the dramatic 
progress we've been able to make in the last 20 years in Alzheimer's. 
And the pivotal moment now is having these anti-amyloid medicines in 
human trials, washing the humans with these plaque-low PET scans to see 
if the anti-amyloid medicines work and following them with cognitive 
exams to see if they will stabilize or ideally, improve. And this is 
exactly where we are at this moment.
Appendix 3.--Preparing the Country for the Alzheimer's Epidemic: A View 
from Science, Business, Government, and Caregivers; Robert Essner, CEO 
              and Chairman, Wyeth (Excerpted Remarks) \22\
    It's really a pleasure for me to be here today and share some 
thoughts on the intersection between science and patient care--in other 
words, how Wyeth and the private sector research-based pharmaceutical 
industry are trying to harness science to overcome Alzheimer's disease.
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    \22\ [Complete remarks available at www.healthtransformation.net]
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    I'm pretty certain that still the population at large does not 
really see Alzheimer's disease as an epidemic, at least not yet. Last 
year, I spoke at the White House Conference on Aging, and pointed out 
that if you were to say the word epidemic then--and maybe still today--
I bet most people would immediately think about avian flu, the so-
called bird flu that's on the front pages of newspapers still all the 
time. And it's received massive attention in the media and people are 
genuinely and understandably frightened about the possibility of this 
new disease sweeping the world. But with all the intense interest 
around avian influenza, I sometimes think we've lost sight of the fact 
that this disease or potential disease, scary as it is, is only a 
potential threat, and that we may or may not actually have to deal with 
it.
    The next disease probably most people would think about as an 
epidemic is HIV/AIDS. Reports in the 1980s of the devastation of AIDS 
quickly garnered widespread attention. The fear factor of this new 
disease with dramatic mortality rates was extraordinary. Scientific 
advances and a significant amount of effort across a multiplicity of 
stakeholders have rendered the threat of AIDS today to be very 
different than the way it was 10 or 20 years ago. While AIDS does 
continue to ravage many developing countries, in many parts of the 
world today, a diagnosis is no longer an automatic death sentence. 
Although much remains to be done in that field, in many ways, this is 
kind of a miraculous fact. And I think it feeds the imagination of a 
world in which AIDS is no longer an epidemic, but a manageable chronic 
illness. Unfortunately, obviously the same cannot be said about 
Alzheimer's disease.
    Many people do not know that Alzheimer's disease is the third-most 
costly disease to treat in the United States right now, and most do not 
know that annual medical care costs for beneficiaries with Alzheimer's 
are expected to increase 75 percent over the next 5 years, and that 
Federal and State Medicaid spending for nursing home care alone for 
Alzheimer's patients is expected to nearly double by the year 2025.
    The costs of Alzheimer's disease don't strike governments alone; 
they also strike individual families and businesses like ours. Over the 
course of the disease, Alzheimer's patients and their families spend 
more than $200,000 on healthcare for a patient, and employer's use 
approximately $60 billion a year on lost productivity as adult 
caregivers are forced to leave their jobs, either permanently or on a 
temporary basis to care for a family member with the disease. I think 
you get the picture.
    What is so horrifying about Alzheimer's is not just that it kills, 
but that it is debilitating and dehumanizing. Alzheimer's essentially 
eats away at the very essence of its victims, not just their physical 
and mental capabilities, but also, as you saw, their personalities and 
the qualities that I think we all believe make us human. Yet the 
general public still does not, by and large, consider Alzheimer's 
disease to be an epidemic, but the world's scientists are not just 
sitting by and watching the devastation approach. Efforts to respond to 
the epidemic of Alzheimer's are underway across academia, industry, and 
government.
    We at Wyeth are trying to do our part. Wyeth has been researching 
innovative treatments for Alzheimer's for more than 15 years now. We 
have more than two dozen projects in our pipeline, and have over 350 
people in our research group who work exclusively on Alzheimer's 
disease today. And we have projects ranging from very early development 
through later-stage clinical trials. Our projects today use all of our 
available technology platforms, drugs, biotech skills, and vaccines 
because we want to explore every option available to us.
    Wyeth is not alone obviously on this path to trying to find a 
solution to Alzheimer's. There are other companies at work, as well as 
scientists and academia and research institutes, who are making their 
strong contributions. The scientific, pharmaceutical, and research 
communities have been seeking to identify and develop new therapeutic 
targets that could dramatically alter the treatment for Alzheimer's. 
There are a lot of people on this path, and a few dozen programs each 
have the potential to fundamentally transform the treatment of this 
disease.
    So why, given all the attention across various stakeholders, does 
the war against Alzheimer's disease continue to progress so slowly? I 
consider the greatest challenge facing Alzheimer's is the lack of a 
coherent strategy to respond to this disease. Unlike my examples of 
AIDS and avian flu, there is no global or even national focus on 
Alzheimer's. Scientific work and drug development go on, but at too 
slow a pace. Public health agencies are perhaps understandably engaged 
in dealing with the current devastation of the disease as much as 
working towards its cure, and regulatory agencies sometimes deal with 
Alzheimer's in the cautious way they do with diseases where major 
therapeutic options already exist. On the regulatory front alone, 
worldwide cooperation between reviewers and researchers could 
significantly improve the probability that we will succeed and reduce 
development times by years.
    The reality is that our efforts against Alzheimer's are moving at a 
pace that is in no way commensurate with the problem that we're all 
trying to solve. What we need is a sense of urgency analogous to what 
arose around AIDS.
    What we also need is a sense of urgency driving a coordinated 
response to this disease. Scientists and academia, government and 
industry must work hand in hand with regulators, healthcare providers, 
and patients and caregivers. We need the kind of bold innovative effort 
that has been generated in the past, and the AIDS story I think is 
instructive and inspirational. If we approach Alzheimer's with the same 
fervor, we'll be able to harness the potential of scientific advances 
and truly alter the course of this epidemic.
Appendix 4.--Preparing the Country for the Alzheimer's Epidemic: A View 
   from Science, Business, Government, and Caregivers; Andrew C. Von 
Eschenbach, M.D., Commissioner of the U.S. Food and Drug Administration 
                        (Excerpted Remarks) \23\
    Listening to the Video and Dr. Gandy's scientific presentation took 
me back to my roots. My roots at M.D. Anderson, where I spent 26 years 
living with this dual reality, which on one hand allowed me to be a 
part of what have been some of the most profound breakthroughs in 
biomedical research in science and in technology, and yet at the same 
time every single day being confronted with the suffering and death and 
the ravages due to a disease like cancer.
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    \23\ [Complete remarks available at www.healthtransformation.nets]
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    And I knew that those two realities needed to be and could be 
reconciled; that all of that progress, the kind of progress that Dr. 
Gandy talked about this morning, could now lead us to a point where we 
no longer had to witness and tolerate that suffering and death, whether 
it was a disease like cancer or the ravages of Alzheimer's. That is 
within our grasp. That is our opportunity. That is why this meeting and 
your involvement and participation are so important.
    Almost 5 years ago, I had the privilege to come to Washington to 
lead the National Cancer Institute with that vision, with that passion 
and with that commitment, and set a goal that we would focus and commit 
our effort to eliminate the suffering and death due to cancer, and 
bring that about by the year 2015.
    I would present that same perspective to you this morning, that as 
you are engaged passionately and appropriately in seeking and driving 
for a solution to the problem of Alzheimer's, you also are involved and 
a part of a larger transformation, a transformation in health, in 
healthcare, and in fact in our healthcare delivery system.
    We are together collectively cooperatively in the midst of being 
able to change the entire future of health and healthcare. By embracing 
and fully developing across the continuum of discovery, development, 
and delivery the new molecular reality and the molecular opportunity. 
And it holds the promise for being able to radically conquer diseases 
like Alzheimer's. Not only is the magnitude of change that significant, 
but the pace of change is equally significant, such that we no longer 
need to think of time horizons that are something in decades and 
centuries away as we did in the past, but to see this as not evolution 
but revolution in medicine.
    As we look at this new future of discovery and development and 
delivery, I now have the privilege to have moved from the National 
Cancer Institute, where we had the opportunity to drive the agenda of 
our understanding of molecular mechanisms of a disease process like 
cancer, and begin to think about that disease not as an event but as a 
process in which those genetic and molecular and cellular events 
occurred over a period of time, and offered us ample targets for 
intervention that could preempt its outcome, the suffering and death.
    And one listens to this morning's presentations and recognizes that 
that is exactly the same paradigm for Alzheimer's. It is a disease 
process that occurs over time, and as we understand the fundamental 
mechanisms, as outlined by Dr. Gandy, we can begin to develop 
interventions, as presented by Bob Essner, that could be prevent or 
preempt, or modulate that disease process in a way that we eliminate 
the outcome, that tragic, horrible outcome that we witnessed on that 
video.
    The FDA is positioned as the bridge that needs to be responsible 
for making certain that all of the fruits of that discovery and that 
development come to be applied to patients who are in need. And it is 
the FDA's commitment to be that bridge, to be that bridge not of the 
past, but to be that bridge of the future. And for that, like you, and 
like every other part of this equation, FDA must change. It has a proud 
record over the past hundred years of being the world's gold standard, 
but the FDA of the past is not adequate or equipped for this new 
reality, and therefore it must change, and it must change not in 
isolation, but in context and in collaboration and integration with all 
of the other parts and pieces of the equation.
    And so we have embarked upon an opportunity to look internally 
about what those transformations are that must occur within the agency 
itself, and what those opportunities are to collaborate and integrate 
both on the discovery and development end of the continuum, as well as 
on the delivery end of the continuum to bring that process about.
    For example,

     Critical path--and the need to fully implement many of the 
strategic initiatives in critical path so that we bring the new science 
that is making possible discovery and development into the regulatory 
process;
     The use of biomarkers instead of simply waiting for the 
kinds of outcomes that were alluded to earlier this morning having to 
do with autopsy findings;
     The ability to completely revamp our clinical trials 
process and to begin to look at different adaptive trial designs and 
models that are adapted to the new realities;
     To begin to bring tools of modern information technology 
and bio-informatics into the regulatory process; and
     To collaborate and cooperate with the industry in being 
able to assure that we are effectively, proactively facilitating the 
development of these new interventions in ways that assure not just 
their efficacy but their safety, and to be able to stay invested not 
only on the front end of their development, but also to continue to 
monitor and modulate the behavior once they are being applied to much 
larger populations.

    One of the things that we have done is to begin to look at ways in 
which we can bring the advocacy groups more actively into the process. 
The patient consultant program will of course include the ability to 
bring advocate participation into FDA's regulation and development of 
new treatments for serious neurological diseases, and the patient 
representative program will welcome your participation in advisory 
committees.
    We have created an FDA interagency, neurology working group that 
will enable us to integrate across the entire portfolio of the FDA--our 
opportunities to begin to look at use of neurologic diseases, like 
Alzheimer's, as a model, just like we can look at cancer as a model 
through the activities that we have around the interagency oncology 
taskforce to drive this integrative and collaborative process.
    There is much for us to change and much for us to do. This meeting 
typifies what we need. We need knowledge coming from scientists. We 
need commitment coming from the developers of these interventions. We 
need visions coming from public leaders, like the Center for Health 
Transformation, and we need leadership, and advocacy, and passion 
coming from you. And collectively, cooperatively, together, we will 
create a new world, not just for Alzheimer's or cancer, but also for 
everyone. You have the opportunity to help make that happen.

    Senator Mikulski. Well done. Now we'd like to turn to 
Marilyn Blum of Owings Mills, Maryland, because as we've heard 
now from the experts, the real expert is always the family who 
must live through this. We really thank you for speaking to so 
many people in the room because so much of the advocacy comes 
from people who have been touched by this disease. So there are 
several hundred here and we're gratified for that but we'd like 
you to give voice to what you think, as policymakers, we need 
to hear from the family.

       STATEMENT OF MARILYN BLUM, OWINGS MILLS, MARYLAND

    Ms. Blum. Good morning, Senator Mikulski and Senator Burr. 
My name is Marilyn Blum and I represent one of the millions of 
family caregivers who struggle daily with the challenges of 
Alzheimer's disease. I am also here to tell you that 
Alzheimer's disease is no longer just our parents' disease. It 
has hit the baby boomers and it is not going away.
    My husband, Steve, is just one of the people under age 65 
with early onset Alzheimer's disease. He was diagnosed at age 
60, a diagnosis that was not a surprise, given his family 
history. His father was diagnosed with dementia in his forties 
and died about 10 years later.
    Steve's memory problems began when he was a very successful 
CPA, employed as the Chief Financial Officer of a Public 
Relations firm. The CFO job was demanding but Steve had always 
been able to handle the job. Suddenly, he started going to the 
office 7 days a week because he said his assistant had been let 
go.
    He also got lost in familiar places. When we drove 
somewhere together, I had to give him specific directions like 
turn right at the stop sign or watch out for the red light. He 
gave wrong answers when asked about money, which was odd for a 
CPA. He also stopped doing maintenance on the house and cars, 
which was unusual. That led to later challenges for me because 
I had to play catch-up on things that weren't done timely, one 
of which caused our basement to flood.
    Eventually, Steve's company was bought by a larger company 
and he was laid off. It was a blessing because in reality, he 
could not do the job. This gave us a chance to focus on dealing 
with his memory problems. We made an appointment with his 
internist and mentioned that Steve's father had been diagnosed 
with dementia at a young age but the internist repeatedly 
dismissed our concerns. The internist diagnosed depression and 
put Steve on anti-depressants. I wasn't happy with the doctor's 
diagnosis so I found a good therapist through a friend.
    Steve began seeing the psychotherapist who suggested he get 
further tests. Numerous tests followed and then the diagnosis 
of cognitive impairment with probable AD. The diagnosis turned 
our lives upside down. Steve had to relinquish responsibility 
for our checkbook, a major blow to the CPA who had always 
handled our finances. He also had to give up driving, which was 
perhaps the most painful loss.
    We were referred to the local Alzheimer's Association 
Chapter, which has been terrific. No matter how many friends 
and family members you have to help, no one can give you 
support like the Alzheimer's Association.
    Through the Association, we attended four different support 
groups before we finally found one that focused on the issues 
we were facing, including loss of income, social isolation and 
lack of meaningful activities for younger persons. We enrolled 
in an 8-week pilot program for individuals with early onset AD. 
The program was a lifesaver for both of us. I learned from 
other caregivers how to tackle the daily challenges of being an 
Alzheimer's caregiver. Steve spent time with people like 
himself and made new friends. I also heard about the 
Association's Help Line that is available 24 hours a day, 7 
days a week to offer counseling in crisis situations or just 
listen if I need someone to talk to. Doctors can help deal with 
the medical aspects of Alzheimer's but you can't call them at 
11 p.m. when your husband is yelling at you because he can't 
remember where he put the television remote.
    I also learned what I could do to help keep Steve occupied. 
Being with him 24 hours a day, 7 days a week was emotionally 
and physically draining. The Association suggested I enroll him 
in an adult daycare program. He now goes to daycare 5 days a 
week and thinks of it as his volunteer job. With Steve at the 
daycare center, I don't have to worry that he is home alone and 
I can continue looking after my 92-year-old father who has 
health problems of his own. But I'm very aware that our future 
is uncertain so I applied for the Maryland Respite Care 
Program. I recently learned that unfortunately, there is a 
greater demand for respite services than funds available so I'm 
on a waiting list.
    I am determined to keep Steve at home but I can't do it 
alone. We must continue programs that support caregivers. We 
have to increase funding for research to find better treatments 
and we need greater awareness about early onset AD and better 
tests to identify the disease at the earliest stages.
    I'm so grateful to you, Senator Mikulski, for introducing 
the Alzheimer's Breakthrough and Family Assistance Act and for 
your outstanding leadership on Alzheimer's issues. I want 
Congress to pass your bill as soon as possible so I can tell 
Steve that his daughter, granddaughter and grandson on the way 
will not have to confront what I'm dealing with today. Congress 
should pass this bill, not just for my family but also for the 
millions of other families who are represented in this room. 
Thank you.
    [Applause.]
    [The prepared statement of Ms. Blum follows:]
                   Prepared Statement of Marilyn Blum
                                summary
    My husband Steve is one of as many as half a million people under 
age 65 who have early onset dementia. He was diagnosed 2 years ago at 
age 60, although his memory problems started even earlier. Steve's 
father was diagnosed with dementia in his forties and died in a State 
mental institution 10 years later, while Steve was still in college.
    Steve had been a very successful CPA and chief financial officer of 
a public relations firm. His memory problems were already noticeable 
when his firm was downsized and he was laid off. He declined 
considerably after he retired.
    Steve's internist dismissed our concerns about Alzheimer's, even 
when we told him about Steve's father. He diagnosed depression and 
prescribed antidepressants. I wasn't satisfied. We found a 
psychotherapist who agreed this was not depression. After extensive 
tests, we got the diagnosis of probable Alzheimer's.
    Steve has suffered huge personal loss because of his Alzheimer's. 
He had to give up our personal finances--a major blow to a successful 
CPA. He had to give up driving. Because we were younger than most 
couples dealing with Alzheimer's, we faced unique problems--loss of 
income, social isolation, and lack of meaningful activities.
    Our best source of help has been the Alzheimer's Association. 
Through them we found a program organized for people with early-onset 
disease, which included educational sessions and separate counseling 
sessions. Both Steve and I found new friends there who understand what 
we are going through and share ideas about how to tackle our daily 
challenges.
    The 24/7 helpline has been a godsend. Doctors can help with medical 
issues, but they are not available at 11 at night when your husband is 
yelling at you. The Alzheimer's Association's Call Center is.
    It was not safe for Steve to be at home alone. For nearly 2 years, 
I was working 24 hours a day, 7 days a week to keep him socially 
stimulated and engaged in day-to-day activities. At the same time, I 
was looking after my 92-year-old father who has health problems of his 
own. When I reached the end of my rope, I enrolled him in an adult day 
program, which he attends 5 days a week. He thinks about it as his 
volunteer ``job.''
    I am determined to keep Steve at home as long as possible but like 
all caregivers, I need help. I urge Congress to continue its support of 
programs like the 24/7 helpline. We also need greater awareness, 
standard procedures to recognize early onset Alzheimer's and better 
tests to diagnose the disease at its earliest stages.
    I urge you to increase funding for Alzheimer research to find 
better treatment and prevention. I want to be able to tell Steve that 
his daughter, his granddaughter, and the grandson on the way will not 
have to face what I am dealing with today.
                                 ______
                                 
    Good morning Senator Mikulski and other distinguished guests. It is 
an honor to be here. My name is Marilyn Blum and I live in Owings 
Mills, Maryland. I represent one of the millions of family caregivers 
who struggle daily to confront the challenges of this terrible disease. 
I am also here to tell you that Alzheimer's is no longer just our 
parent's disease. It has hit the baby boomers and it is not going away.
    My husband Steve is one of the 200,000 to 500,000 people under age 
65 with early onset Alzheimer's disease or other dementias. We found 
out that he had probable Alzheimer's disease 2 years ago at age 60 a 
diagnosis that was not a surprise given Steve's family history. His 
father was diagnosed with dementia in his 40's and was eventually 
placed in a State mental hospital after he became violent. He died in 
the State institution about 10 years later, while Steve was still in 
college.
    When Steve's memory problems first started, he was a very 
successful CPA employed as the chief financial officer of a public 
relations firm. The CFO job was demanding but Steve had always been 
able to handle the workload. Suddenly he started going to the office 7 
days a week. He said it was because his assistant had been let go and 
he had to do her work as well as his. He also started getting lost in 
familiar places. Whenever we drove somewhere together I had to give him 
specific directions like ``turn right at the stop sign'' or ``watch out 
for the red light''. He gave wrong answers when asked questions--
particularly about money--which was odd for a CPA. Although I didn't 
know it at the time, he also stopped doing maintenance on the house and 
cars, which was not normal for him. That led to later challenges for 
me, because I had to play ``catch up'' on things that weren't done 
timely, one of which caused our basement to flood.
    Steve's memory problems continued for several months. Eventually 
the PR firm was bought by a larger company who downsized the firm. 
Steve was laid off--a development that turned out to be a blessing 
because it was becoming increasingly obvious to Steve's superiors that 
he could not perform the duties of his job. The layoff allowed Steve to 
end his career with dignity and helped him accept that retirement was 
the next logical step.
    Steve declined considerably after he lost his job. We immediately 
made an appointment with Steve's internist. During the consultation we 
mentioned that Steve's father had been diagnosed with dementia at a 
young age but the internist repeatedly dismissed our concerns. The 
internist diagnosed depression and put Steve on antidepressants. I 
wasn't happy with the doctor's diagnosis so I found a good therapist 
through a friend. Steve began seeing the psychotherapist who realized 
that the memory problems were not depression. After an extensive round 
of tests, we found out that Steve had cognitive impairment with 
probable Alzheimer's disease.
    The diagnosis turned our lives upside down. I had to convince him 
to relinquish responsibility for our personal finances. That was a 
major blow because as a CPA he was always on top of our financial 
situation and suddenly we had to hire an accountant for the first time 
in our lives. He also had to give up driving which was perhaps the most 
painful loss. We always loved to drive and kept our cars in spotless 
condition--we joked about what good prices we got when we sold cars, 
because he kept them so well. He has gradually come to accept that I 
don't want him to drive, but we have daily conversations about him 
buying a new car.
    We were referred to the local Alzheimer's Association chapter which 
has been the absolute best source of help and support over the last few 
years. No matter how many friends and family members there are to help, 
no one can give you support like the Alzheimer's Association because 
they are the experts. Through the Alzheimer's Association we attended 
four different support groups before we finally found one that met our 
needs. Most of the support groups were geared toward older people who 
were not dealing with the same issues that we were facing including 
loss of income, social isolation and lack of meaningful activities for 
younger persons. We eventually enrolled in an 8-week pilot program for 
individuals with early-onset Alzheimer's. The program included 
educational seminars about the basics of Alzheimer's disease, as well 
as separate counseling sessions for caregivers and individuals with the 
disease. The program was a lifesaver for both of us. Steve got to spend 
time with people like him and make new friends. I met people who knew 
what I was going through and learned from other caregivers how to 
tackle the daily challenges of being an Alzheimer caregiver. I heard 
about the Association's helpline that is available 24 hours a day, 7 
days a week to answer questions about the disease, provide information 
about available services, offer counseling in crisis situations or just 
listen if I need someone to talk to about my fears and frustrations. 
Doctors can help deal with the medical aspects of Alzheimer's but you 
can't call them at 11 p.m. when your husband is agitated and yelling at 
you because he can't remember where he put the television remote.
    I also learned what I could do to help keep Steve socially 
stimulated and engaged in day-to-day activities. When I reached the end 
of my rope after being with Steve 24 hours a day, 7 days a week for 
nearly 2 years, the Association suggested I enroll Steve in an adult 
daycare program. At first, Steve refused to participate. However, I 
read a book that said to tell Steve that going to the daycare center 
was a volunteer job. Steve now volunteers at the daycare center 5 days 
a week and it makes him feel like he still has a job. With Steve at the 
daycare center I don't have to worry that he's home alone and I can 
continue looking after my 92-year-old father who has health problems of 
his own. However, I'm very aware that our future is uncertain so I 
applied for the Maryland respite care program. I recently learned that 
unfortunately there is a greater demand for respite services than funds 
available so I am now on a waiting list.
    I am determined to keep Steve at home as long as possible but I 
can't do it alone. We must continue programs that support caregivers, 
including the Alzheimer's 
24/7 helpline and we have to increase funding for research to find 
better treatments. We also need greater awareness and standard 
procedures in place to recognize early-onset Alzheimer's disease and 
better tests to identify the disease at the earliest stages. That is 
why I'm so grateful to you, Senator Mikulski, for introducing the 
``Alzheimer's Breakthrough Act'' and for your outstanding leadership on 
Alzheimer's issues in the Senate. I want Congress to pass the 
``Alzheimer's Breakthrough Act'' as soon as possible so I can tell 
Steve that his daughter, granddaughter and grandson on the way will not 
have to confront what I'm dealing with today. Congress should pass this 
bill not just for my family but also for the millions of other families 
who are represented in this room. Unless we act now, another generation 
of Americans will become the newest set of statistics to fill the pages 
of a report about Alzheimer's. We can avoid this horrible scenario but 
only if policymakers make Alzheimer's an urgent national priority. 
Thank you again for inviting me here today.

    Senator Mikulski. Thank you very much, Mrs. Blum. Thank you 
very much. I'm proud to have you as a constituent and we're 
certainly on the same side here. We're now going to go to 
questions but I would like to just kind of lay out quickly 
where we are and then we'll move into questions.
    For those in the audience, there are two issues here: 
something called an authorization and something called an 
appropriation. Now for all these years and all your years of 
advocacy, we haven't just been sitting on our hands. We have 
been doing things, working to double the funding at NIH, 
looking at strengthening programs like the Call Center, the 
Alzheimer's Demonstration Grant Program and so on. But as Mr. 
Egge said, it's been a bit piecemeal, uneven and even news that 
you could use often does not get out to those in clinical 
practice.
    What we do know, though, is that we need to be focusing on 
two things. One, moving this year's appropriations to make sure 
that there is enough to keep hope and help alive while we work 
on the authorization legislation, which is S. 898, which will 
double the funding at NIH.
    But to talk about doubling the funding is really an 
abstraction. What we face now, though, is that our legislation 
would double what we spend at NIH now, from $640 million to 
$1.3 billion. OK? Then we would also call for a summit to be 
run by NIH to look at breakthrough research. However, while 
we've been busy doubling the funding of NIH, which we completed 
in 2003, what we see is that Alzheimer's research has been 
actually cut since 2003, it has been cut a total of $155 
million. So we've been losing ground while we've been making 
headway in research.
    What I want to do and I think we'll do on a bipartisan 
basis, is remember--look at this year's appropriations but we 
really need your help to go to every single member you know to 
co-sponsor this bill if, in fact, you are in support of it.
    Well, let's go to what money will buy. I'd like to turn to 
Drs. Albert and Gandy because you've talked about the need to 
do more but tell me what you think about passage of this 
legislation, because we're calling it breakthrough legislation. 
Too often we've heard about the melancholy situation where it's 
hopeless, we can't make gains, et cetera. What would the 
increased funding, do you think, enable us to do that we are 
not doing or what would it do to accelerate what we are now 
doing? Dr. Gandy, you're the science advisor to the 
Association.
    Dr. Gandy. Every clinical trial costs about $50 million. So 
that's testing one medicine from start to finish. We believe 
that once we have these disease modifiers, we will now want to 
test medicines in pairs and in trios. We think that a cocktail 
of medicines will be the most effective way to arrest 
Alzheimer's. This is the strategy that has been successful with 
cancer, when we identify several pathways along the way and 
then develop medicines that block them one, two, three, four. 
That's where we need to go now. We need to be able to not only 
test these medicines one by one but in combination.
    Senator Mikulski. Dr. Albert.
    Dr. Albert. In addition, we need to be able to identify 
people as early as possible in the course of the disease when 
we do have effective medicines. We're not going to want to wait 
until the kinds of difficulties that Mrs. Blum has just been 
describing. We're going to want to intervene earlier, when the 
disease is just developing in the brain. So there are lots of 
strategies that need to be explored to improve early diagnosis 
so we can have early treatment. And as I was mentioning 
earlier, we also need to think about lowering risk. We need to 
learn much more about how we can delay the onset of the 
disease, prevent the disease, perhaps entirely by a variety of 
things. Right now, we've been focusing on----
    Senator Mikulski. Could you elaborate on that? Because I 
think what struck Senator Burr and I while you were talking was 
these low-tech approaches. While we're looking for breakthrough 
drugs, which is as you said, $50 million for a trial. It has to 
be tested to be sure it not only has efficacy but it's safe. 
But right now, there seems to be a body of knowledge that is 
coming out of research even like yours, Dr. Albert, that are 
low-tech recommendations, kind of news you can use at the 
family level, at the community center level, on cognitive 
stretch-out, preventive kinds of diet things. Could you tell us 
maybe because not everything is high-tech drugs, though this is 
obviously very promising?
    Dr. Albert. I think the most important thing we know for 
sure is the impact of vascular risks on cognitive decline. We 
all know that high blood pressure, diabetes, obesity, and 
smoking puts us at risk for heart disease and what we now know 
for certain is that it also puts us at greater risk for brain 
disease and cognitive decline. If that kind of information 
could get out to the community with programs such as the 
Alzheimer's Association has been developing with the CDC, that 
could have immediate impacts on public health because I think 
it could convince people that they should engage in these 
strategies of risk protection not only for their heart but for 
their brain.
    In addition, we're learning that things like physical 
activity likely are very beneficial to the brain but we need to 
learn much more about that. So we need to have more research in 
order to know what to recommend to people.
    Senator Mikulski. Mrs. Blum, you've talked about your life 
with your husband who really sounds like one swell guy and he 
still is a swell guy and you've lived the 36-hour day. Could 
you tell us what that means and therefore, what other public 
policies would have been helpful to you? You talked about a 
clinician who couldn't diagnose this. You talked about really, 
it was the Alzheimer's Association that was your friend and 
chief source of information. Then, of course, there is the 
financial stress. Could you share that with us and then we'll 
be turning to others for questions.
    Ms. Blum. I think, for one thing, it would be helpful if 
doctors could be educated that younger people can suffer from 
this type of disease. It just really threw a roadblock into 
Steve's getting a good diagnosis when his internist, whom we 
had confidence in, said that there was basically very little 
wrong with him. She actually said, every time a couple comes in 
here, the wife says the husband can't remember a thing she says 
to him and sort of made a little joke about it and this was no 
joking matter. Fortunately, we did get to see a good 
psychotherapist who recognized maybe there was something more 
serious going on and convinced him to be tested, to have his 
memory tested and then he was diagnosed.
    Another, I think, critical area, as Dr. Albert mentioned, 
is educating caregivers on how to deal with it. This disease is 
like nothing you've ever experienced. Everybody here in this 
room knows that and you can't use your normal coping skills in 
dealing with your loved one because they are not the same 
person that they used to be and you really have to learn a 
whole new way of communicating with them, of dealing with 
crisis situations and I think caregivers need to be educated to 
learn how to do that.
    Senator Mikulski. Where did you get your education? You 
said at this 8-week program that you went to.
    Ms. Blum. Yes. From the Alzheimer's Association, from 
reading everything I could get my hands on, from talking to 
other caregivers but certainly the Association is a major help.
    Senator Mikulski. Was the Office on Aging or the Research 
and Information Service of any help to you?
    Ms. Blum. I don't think I ever used any of their resources.
    Senator Mikulski. Well, you live in Baltimore County----
    Ms. Blum. Yes.
    Senator Mikulski. Which has one of the really most 
outstanding senior programs. They win all kinds of awards but 
we're trying to look at also, how do we get the information 
that we now know out to the broader public? So I think you've 
offered us insights.
    My time has expired. I'd like to now turn to Senator Burr.
    Senator Burr. Thank you, Madam Chairman. Mr. Johns, thank 
you for what the Association does for so many afflicted by the 
disease and their families around the country. Ms. Blum, thank 
you for your very personal testimony today and your willingness 
to share that with us.
    If I could, Dr. Gandy, let me focus on the two disease 
modifying drugs that you talked about. You said that they are 
now safe and effective. Are either one of those drugs on the 
fast track at FDA?
    Dr. Gandy. Well, we're waiting for this summer's 
Alzheimer's Association Prevention Conference for the data to 
be laid out and at that point, the FDA will be able to make a 
decision as to what other information it requires to consider 
fast tracking either of those. I'm giving you sort of a preview 
of what is going to be released this summer.
    Senator Burr. And my hope is that we can work in a 
bipartisan way up here to redefine for the future what fast 
track is. Fast track should start when we identify an epidemic 
and not necessarily at some point in the drug development 
process, do we now say, ``Gee, this might be helpful. Let's 
speed it up.'' We've heard all the numbers from you, from the 
Association and I think from Mr. Egge. Nobody disputes the 
numbers. This is in the best interest of the patient, the 
families and the country that whatever our definition is of 
fast track, it should be let's get it as soon as we possibly 
can and my hope is that we'll work with you to try to achieve 
that.
    How close are we potentially for big pharma, for 
biotechnology firms, for some of the companies independently to 
say, we know enough now that we're willing to invest our 
private sector money and we really begin to leverage that 
Federal investment? Not to diminish what we need to do on the 
Federal side but have we reached that critical mass in the 
private sector yet?
    Dr. Gandy. I would say that every major pharmaceutical 
company has a program in Alzheimer's disease but many--actually 
most, are waiting for the very first effective medicine to be 
proven. Because then, they'll all agree that this is the right 
approach, that we're on the right track and things that are on 
the shelves now will begin to be tested.
    Senator Burr. I think history has proven to us that we 
really need those private sector companies. They are the ones 
that have done most of the research on HIV/AIDS as it relates 
to the combination drug results and outcomes.
    Let me turn to Mr. Egge for a second. In your testimony, 
you described a few recent biomedical advances in Alzheimer's 
disease, including brain imaging technology, animal models, 
specific biomarkers that track the onset and the progression of 
Alzheimer's, but you stated the development of therapies based 
upon these exciting initial discoveries has not been 
successful. Share with us, if you will, what you think the 
Federal Government can do to be a better partner with the 
private sector, to speed up translational advanced research 
that can turn promising basic research into actual therapies 
and treatments.
    Mr. Egge. Thank you, Senator. I think we can learn a lot, 
for instance, from what you did last year with some 
legislation, which was a very interesting look at a very 
pressing problem and it had very distinctive characteristics 
but it looked at how we could integrate it across the different 
functions of government, how we could work with the private 
sector very effectively. I think in the case of Alzheimer's 
disease, it's just the thing that has already been alluded to, 
where we need to look at this as a disease. I think our current 
leadership within HHS is exceptional and the people who oversee 
the different agencies are doing an extremely good job of 
overseeing what they asked to oversee, which is to look at it 
from an organizational or you might call it a horizontal 
perspective. But diseases don't strike that way. They come at 
us across the continuum.
    So I think that's why we need to look at how we can work on 
just this translational point and maybe with some of the work 
we've done with the Cancer Society--the Cancer Society has done 
in working with government. It could point the way in some 
regards. For instance, there was active collaboration between 
NCI, where the current FDA Commissioner was leading the NCI and 
FDA to work on an integrative program so that there was as 
smooth a handoff as possible between the NIH and the FDA. So I 
think it is exactly that kind of approach that would be helpful 
here as well.
    Senator Burr. Well, as we all know, this is not a phenomena 
just of Alzheimer's disease. I guess I would ask this 
question--do any of you share my frustration that eventhough 
innovation and technology has accelerated at a phenomenal rate, 
and the capabilities of bench research and the investment in 
the brain power is beginning to pay off, but we still have a 
system primarily at the FDA that moves at the same pace that it 
did 20 years ago because the designs never change. It is time 
we, in a bipartisan way, begin to look at how the design should 
change while still maintaining our safety and efficacy Gold 
Standard?
    Mr. Johns. I certainly do, Senator. I know in talking to 
Commissioner von Eschenbach, he is interested in that very 
approach because he believes that the FDA needs to modernize to 
address these kinds of technological improvements. As you say, 
across different kinds of medical research, we've seen that 
we've got advancements in technology that can't be absorbed by 
the existing systems. We've used the great brain power and 
ability of the American public and researchers to move these 
things along but now we can't absorb them fast enough because 
of systems at FDA and otherwise.
    But we are gratified by the work we've done with the FDA 
and that they have done with us in terms of including 
Alzheimer's individuals and caregivers on the panels and also 
for putting a focus on Alzheimer's disease neurological issues 
in the FDA. But we would agree with you completely that we need 
a bipartisan approach to advancing those systems to allow those 
technologies to move even faster.
    Senator Burr. Thank you. My time has expired.
    Senator Mikulski. That was an excellent line of questioning 
and I think something this committee will be taking up in the 
FDA reform. I think it is an excellent challenge.
    Let's turn now to Senator Isakson from Georgia, also the 
home of the Center for Disease Control that has played such an 
important role in disseminating information on this.
    Senator Isakson.

                      Statement of Senator Isakson

    Senator Isakson. Thank you very much, Senator. Let me--I 
might break a rule here but I'm going to do it anyway. I want 
to acknowledge--I just noticed a minute ago in the audience, 
Matt McNair is here, right over here at the end of this row. He 
is a special friend to me for a number of reasons. He is a 
distinguished veteran of the U.S. military. He was a Republican 
candidate for governor in 1994 and today, he is the caregiver 
for his beautiful wife. He lives in a facility that my brother 
developed, having gone through the experience that he and I 
went through, taking care of my mother who died of Alzheimer's 
in 1998, which is why I am so supportive of S. 897 in 
particular because of what it does for the caregivers. Mack--
I've seen him on many occasions at Park Springs at Stone 
Mountain, taking care of his lovely wife in an environment 
where he can still do it and everything we can do to promote 
the benefits to allow caregivers to be able to do that, just 
like Mrs. Blum, will be a tremendous advantage for the families 
and a tremendous advantage for those that suffer from what is a 
very devastating and terrible disease. So Mack, thank you for 
being here.
    Senator Mikulski. Why don't you stand up because I think 
it's important we acknowledge the role of men in caregiving 
well----
    [Applause.]
    Senator Isakson. Mr. Johns probably knows this but Mack is 
probably the most significant fundraiser in the State of 
Georgia on behalf of raising money for the Alzheimer's 
Association and does a wonderful job of advocacy in terms of 
doing that.
    As a son to a mother who had Alzheimer's and passed away 
from Alzheimer's, I'm interested in two things. First of all, 
Dr. Gandy, I'm interested in diagnosing those at risk early and 
you made in your comments, statements about advancements that 
are being made in that area. Would you elaborate on that for 
just a second?
    Dr. Gandy. Sure, thank you, Senator. The way we envision 
the future is that there will be brain scans that we're 
beginning to develop now that will be applied the way 
colonoscopies, mammograms, PSAs are applied now in middle life 
so that we can determine whether the changes of Alzheimer's are 
already present. We believe that those changes that we can 
detect certainly under the microscope and we believe, with 
these x-rays, with this brain scans, begin at least 10 years 
before the very first psychological or memory change.
    So the idea is to use these brain scans to identify who is 
at risk or who is already on the way and when we have these 
effective medicines, begin those and that will then prevent 
this person from ever getting the disease. Sequential scans 
will be done to follow and be sure that the medicines are 
working.
    Senator Isakson. That leads to my second question. Dr. 
Albert, you talked about Maintain your Brain exercises. I want 
to get a list of all of those, personally but I would suppose--
--
    Senator Mikulski. We're going to give them out to both 
caucuses.
    [Laughter.]
    Senator Isakson. Yeah, right. I would suppose that as Dr. 
Gandy's early diagnosis bears itself out and is reliable that 
the first prescription in early diagnosis would be things like 
Maintain your Brain exercises, is that correct?
    Dr. Albert. Absolutely. But we would want--we would hope 
that people would do that even without an early diagnosis. What 
we're learning is that the kinds of risk factors that I--the 
kinds of lifestyle changes that I mentioned, such as mental 
activity and physical activity and lowering vascular risks are 
beneficial even if people start doing them in middle age. There 
are large groups of individuals who've been followed from 
middle age to old age and it is clear now that when their 
lifestyle is already in this direction, it lowers their risk 
for developing Alzheimer's disease later on. So I would hope 
that this--we need much more information about specific 
activities that people can engage in to lower risk but my 
ultimate hope would be that all of us would engage in these 
activities starting at a much younger age.
    Senator Isakson. I want to tell Dr. Gandy, who I believe is 
moving to Emory University soon, is that not correct?
    Dr. Gandy. That's correct, yes.
    Senator Isakson. Emory University is where my mother was 
diagnosed--we were very frustrated with her condition in 1992 
and it was Emory that finally diagnosed my mom in 1993 and gave 
her tremendous support and care at that early stage of the 
diagnosis. So we'll welcome you to come to Georgia and come to 
Emory University.
    Dr. Gandy. Thank you.
    Senator Isakson. Thank you, Madam Chairman.
    Senator Mikulski. Very good and again, we thank you for 
your active participation. We'd now like to turn to Senator 
Coburn from Oklahoma. Senator Coburn is also a physician and 
brings great insight into this and we turn to you, Senator.
    Senator Coburn. Thank you, Madam Chairman, and thank you 
for having this hearing. I apologize, I had another hearing so 
I didn't get to hear all of the testimony. I have a couple 
questions for Dr. Gandy and also for Dr. Albert. Would you talk 
a little bit about beta-secretase and the inhibition drugs that 
are out there? I'm very involved with the Oklahoma Medical 
Research Foundation and they have a drug undergoing human 
trials right now. Would you talk about that because I see 
tremendous hope there?
    Dr. Gandy. Absolutely. Beta-secretase is a chemical enzyme 
in the body that is really the rate limiting step that heads 
down the pathway, the bad pathway for creating the amyloid 
peptide. The idea then is to develop a medicine that will 
specifically block beta-secretase. That's been a favorite 
target since that enzyme was discovered in 1999.
    There have been challenges so far for two reasons. One, 
because the catalytic site is very large and it is difficult to 
get something that will permeate the blood brain barrier and 
because the medicines that have been tried so far have been 
toxic. It's a favorite target and using genetic manipulations, 
looks very effective and looks like a safe target. But it has 
been very challenging to get a medicine that will do what we 
want. There are other strategies that seem safer but also are 
moving forward a bit faster than beta-secretase inhibitors.
    Senator Coburn. Dr. Albert, any comment?
    Dr. Albert. I would just reiterate what Sam said earlier, 
that all of the major pharmaceutical companies are trying 
extraordinarily hard to find medicines that will do just what 
he was describing. But they are only putting partial effort 
into this. They are waiting to see whether or not some drug 
will be truly disease modifying and the moment that that 
happens, I think, there will be an explosion.
    Senator Coburn. I think there is no doubt that people in 
this country would love to see us double up our research again 
at NIH, which would imply a much larger portion of money going 
to dementia and Alzheimer's work, but what we often hear is we 
don't have the money for it. The thing that I'm struck by--I'm 
struck by it up here in the political sense but I'm also struck 
by it by all the disease advocacy groups, is that we have 
plenty of money to do it. But Congress doesn't have the courage 
to find the money.
    Let me explain. Last year, we demonstrated in one 
subcommittee of the Homeland Security and Government Affairs, 
$200 billion--$200 billion in waste, fraud, abuse or 
duplication inside the discretionary budget of the Federal 
Government. That's $200 billion out of a trillion. That's 20 
percent waste, fraud, abuse or duplication. And yet, there is 
no action in Congress to eliminate any of that so we could take 
NIH from $28 billion to $56 billion next year.
    What you continually hear is well, it's a matter of 
prioritizing for the money. It's not. It's a matter of priority 
for Congress to do its job to get rid of the waste, fraud, 
abuse and duplications so we can put the money where it needs 
to be. So what I would like to ask each of you, will you help 
me put the pressure on Congress so that we get rid of the 
things that aren't giving us results so we can put money where 
it is truly needed? Any comments on that?
    [Applause.]
    Mr. Johns. Well, certainly Senator, certainly any of us as 
taxpayers favor our dollars going to what are the most 
effective kinds of things that our government can fund for this 
country and we certainly are believers that Alzheimer's disease 
is one of those things and as you indicate, the entirety of the 
medical research enterprise is something that is critical to 
this country going forward. As many of us have stated here 
earlier today, the returns on investments in medical research 
have such huge potential for this country to avoid future costs 
in Medicare costs, in Medicaid costs and again, simply the cost 
in human lives and human suffering that is being endured today 
and will be endured to much more greatly beyond.
    One of the things we haven't said here yet today is that 
today, there are 5 million people who have Alzheimer's disease. 
In the future, by 2050, if we don't check it, there would be as 
many as 16 million people who have Alzheimer's disease and 
again, the potential for that to have a devastating effect on 
not only the Federal budget but the entire American economy is 
significant. So I do believe that anything we can do to invest 
in medical research, as several of you have said, the potential 
of raising the entire NIH budget and doing what we believe is 
correcting an error in under-investment in Alzheimer's disease 
would be much advantageous.
    Senator Coburn. I want to--one last question for Dr. 
Albert. The idea of prevention--Senator Burr and I tomorrow are 
going to be introducing a global healthcare bill and one of the 
hallmarks of that is prevention. We know that when we really 
spend dollars properly on prevention in this country, we save 
tons of money and the money we're going to save is basically 
for our children and our grandchildren. But I'd like to see--
the thoughts of educating the American public on what you can 
do to prevent Alzheimer's--that ought to be out there and it 
ought to be out there in a way where we can receive it. Just 
like what you can do to prevent colon cancer. But we spend 
almost $8 billion a year on prevention in this government in 27 
different agencies and yet, we don't have a good, comprehensive 
message on prevention.
    So I would love to have your help as we try to develop that 
and push this, putting this money all together and saying, 
there's going to be a concentrated, coordinated plan for 
prevention, not just of Alzheimer's but of everything else that 
we know is preventable. That's a legitimate roll for the 
Federal Government, which we have neglected by not putting it 
together and not coordinating it. So I'd love to have your help 
on that.
    Dr. Albert. That's why we think that the collaboration 
between the CDC and the Alzheimer's Association is so 
important. There has never been a campaign by the CDC about 
brain health. This would be the first. We know that there are 
things that people can do and we just need to figure out how to 
inform them and then with the help of the CDC, figure out what 
gaps in knowledge there that we could then provide additional 
funds for.
    Senator Coburn. You know, it doesn't take much in terms of 
national television advertising dollars to get that message 
out. As far as what we're spending on prevention, we could cut 
colon cancer in half, we could markedly reduce the IBs, we 
could prevent Alzheimer's, a good portion of it, if we would 
just market that message. And yet, we're doing it through all 
these government programs, regulations and everything else 
rather than having great consumer advertising saying here's 
what you need to know. So I look forward to working with you. I 
thank the Chairwoman for this hearing. I think it is creeping 
upon us that as we age, prevention is the key for us in terms 
of affording the healthcare in the future but also research is 
the key and I will say today, I'm committing myself to double 
the funding at NIH over the next 5 years from the present 
number to $70 billion so that we can actually put the money 
into the disease prevention and the treatment. And I'm not one 
known for spending a lot of money up here.
    Senator Mikulski. No, you're not.
    [Laughter and applause.]
    I think we all agree that this is really a public 
investment that not only helps families but the cost, as Mr. 
Egge said, we could be heading to a Katrina year.
    I'd like to just summarize a few things and then see if 
colleagues have any followup questions before we break for the 
votes.
    First of all, when we talk about the bill S. 898 that is 
pending, there is an effort in terms of what we call not only 
prevention but news you can use, which would put into an 
authorization a program that is currently in existence at CDC 
for public education about prevention techniques that could 
help people maintain a healthy brain at all ages. It also 
authorizes the Alzheimer's 24/7 Call Center, which provides 
crisis assistance and decisionmaking support.
    Now, I was struck by Mrs. Blum and others who we have 
talked to where they don't often know where to go even to begin 
and even their clinicians sometimes don't know where to go to 
identify a 60-year-old man with lethargy and memory loss--that 
does have some of the same symptomology as depression. Could 
you tell me, Mr. Johns, why you think the funding for the Call 
Center is so important? You've advocated for it in your 
testimony.
    Mr. Johns. Absolutely, Senator Mikulski. It is absolutely 
crucial, we believe, because we know from the research that we 
have done that people across America do not understand 
Alzheimer's disease. When they confront it, as we've heard here 
today, oftentimes docs don't make the diagnosis. We've got a 
lot of work before us at the Alzheimer's Association and we 
think at the Federal Government level, too, to get those 
messages across this country.
    We are about to embark on an advertising campaign to raise 
attention to Alzheimer's disease and to move more people to 
that Call Center so that they can, in fact, get the information 
they need at that critical moment when they need it. Without 
that kind of information, you've heard here today that 
individuals can suffer needlessly, not only the individual with 
the disease but the families who provide the caregiving. I've 
talked to people--you know, I sit on an airplane and I sit next 
to someone who says, ``I just don't know what to do about this 
and I don't understand what to do.'' It's possible for us to 
help them understand what to do and we do that every day, 365 
days a year, 24 hours a day and even at those worst moments 
when people need us most. It's a critical support mechanism for 
people who are suffering from this disease.
    Senator Mikulski. Senator Burr, do you have any further 
questions and Mr. Isakson and then I'll kind of summarize 
before we conclude.
    Senator Burr. Madam Chairman, I want to thank you for 
calling this hearing but more importantly, I want to say to all 
five of our witnesses, we can't thank you enough, not only for 
your testimony today but for the great knowledge that each one 
of you bring to the table. I think that it's evident that we've 
got a lot of work to do and it's not limited to this disease 
category. As Dr. Coburn said, this is about how we change the 
model in America to one where prevention and wellness is the 
first thing that is promoted in healthcare coverage. It is the 
educational piece that we go out with, regardless of what the 
disease is and that we take to the next generation and we 
ingrain in them that prevention and wellness is the focus that 
they must have, relative to their health. We do that at a time 
where we try to provide the breakthroughs that Alzheimer's 
needs, and that other disease categories desperately need. My 
only suggestion today is that we can be successful at the 
research bench and we can still fail, if we can't expedite 
those safe and effective and promising breakthroughs to where 
they are used by patients and they are done quickly because of 
the timelines that we're up against.
    You know, the amazing thing about HIV/AIDS was that the 
commitment was laid beside the timeline and the short timeline 
was one that really was devastating, as Dr. Zarhouni said when 
he was in Baltimore. There is no doubt in my mind that we've 
got to lay a timeline down. That timeline may be different but 
I would suggest to you today, the timeline is not necessarily 
the result of Alzheimer's or the result of HIV/AIDS. It's the 
result of us not changing our healthcare model. It's the 
continued deterioration of healthcare dollars that we've got 
available to treat the entire healthcare system.
    So as Mr. Egge talked about, prize payments--it doesn't 
matter whether it's prize payments in the industry for somebody 
to get a breakthrough, the question is, get the breakthrough. 
We can't be held up at FDA because we haven't determined yet 
whether this meets the classification of fast track, any drug 
that shows safety, any drug that shows efficacy in a disease 
category that we would list as epidemic should be fast track. I 
think that Alzheimer's presents a great opportunity for us to 
implement a lot of these external things that we know have an 
impact today on people who are affected by this disease. I 
thank you, Madam Chairman.
    Senator Mikulski. Mr. Isakson, did you want to have any 
comment?
    Senator Isakson. Yes, thank you very much for your 
leadership, Senator Mikulski and thank all our panelists for 
being here today and especially all the advocates who came to 
support those who testified today. They were just as important.
    Senator Mikulski. I too, want to extend my gratitude to 
both the leadership of the Alzheimer's Association, and their 
organization of an excellent public policy framework but also 
to all of the people who are here today, and those who couldn't 
come because of either the responsibilities of caregiving or 
other demands in their lives.
    We know that many of the advocates in this room, in fact, 
most of you, that you're doing it on your own time and on your 
own dime and we know that you put in three shifts. Many of you 
put in one shift in the marketplace earning a living or 
supporting a family, trying to hope that you have benefits in 
the workplace that would help you with caregiving and then you 
put in another shift with your own family and then the third 
shift here with the Alzheimer's Association. So we really thank 
you for your civic engagement and we need you to really then 
move this legislative framework forward.
    I think what we've learned from both the testimony today 
and also the other experts and the Alzheimer's Associations' 
excellent report and I'd commend it to all that Alzheimer's is 
really a continuum. It's not like you catch it like an 
infectious disease. You don't catch Alzheimer's the way you 
might have malaria. You don't catch it the way you might 
develop polio. You don't catch it, unfortunately but it 
evolves. Therefore, what we need are those strategies that look 
at it as a continuum, pretty much the way we looked at diabetes 
years ago when it was diabetes, yes or no, insulin, yes or no 
but now, thanks to the breakthrough in medication, the whole 
issue of diet and lifestyle, the focus on prevention, then when 
medications--to go from insulin resistance all the way through 
to perhaps being insulin dependent. But there were so many 
interventions along the way. I remember years ago that when my 
own mother, who was a diabetic, was on oral insulin at age 40. 
Yet in a family with that propensity, there are over 300 
medications that help from insulin resistance to others. This 
is where we're heading with Alzheimer's. First of all, 
prevention--diet, exercise certainly affects the vascular and 
other complications. The second thing is, cognitive stretch-
out. We know just as you do physical exercise, you've got to 
use the mind and be active in that way. But these are all those 
wonderful ideas and then to be able to do the breakthrough kind 
of research that would help either with the cure or the memory 
stretch-out and to work on a bipartisan basis to move the 
research into clinical practice.
    We're going to do this together and at the same time, we 
want to focus on the Call Center. We think you need news you 
can use. This is why we want to promote the Call Center and the 
efforts of the Center for Disease Control, to get out those 
kinds of things that help you be you.
    We're going to have two other hearings on this topic. One 
on the further exploring of research, where we'll hear from the 
Head of the Institute on Aging at NIH as well as other 
researchers so that the committee grasps the full range of 
what's going on. This was just a cameo and we thank you. And at 
the same time, to listen to the private sector on how they 
think we can be an innovation-friendly government to move the 
ideas out because it's great to do the research but we can't 
wait 5 years, 10 years, as Mr. Egge said, the levies are 
starting to really crack, and then we will also hold a second 
hearing on the whole issue of caregiving. What do caregivers 
need in terms of again, their continuum? How do you help keep a 
loved one at home and what should government do to be able to 
support that? What about the continuum of care from adult 
daycare to assisted living to other types of help because no 
one family can deal with this all by themselves.
    But you know, each and every one of you is already making a 
difference. We're going to work together and we're going to 
make the change. So God bless you today for your hard work and 
let's keep on fighting.
    [Applause.]
    You're welcome. I also want to acknowledge that Senator 
Jack Reed and Sherrod Brown were here. Senator Brown will have 
a statements for the record.
    [The prepared statement of Senator Brown follows:]

                  Prepared Statement of Senator Brown

    Thank you, Madam Chair.
    And thanks to Senator Collins and our other witnesses for 
joining us this morning.
    Today's news underscored the significance of Alzheimer's 
research: more than 5 million Americans are living with 
Alzheimer's disease today and at least 7.7 million are expected 
to have the disease by 2030. Unless scientists find a way to 
prevent or reverse Alzheimer's, that number could reach 16 
million by 2050.
    According to researchers, the increase in Alzheimer's does 
not reflect an acceleration in the incidence of the disease in 
any particular age group. Instead it's a function of longer 
life expectancies fueled by advances in the prevention and cure 
for other major diseases.
    It's useful to know that longer life expectancies are 
fueling the increase, but it doesn't make the increase in cases 
any less alarming.
    We need to take action.
    There are promising medicines in the pipeline that could 
delay the onset of Alzheimer's, and there are excellent 
programs throughout the country that provide comprehensive, 
state-of-the-art care to Alzheimer's patients--like the 
University Memory and Aging Center, a collaboration between 
University Hospitals and Case Medical Center in Cleveland, 
Ohio.
    But it is clearly in the public interest to redouble our 
efforts to prevent this disease and lessen its symptoms.
    Alzheimer's robs individuals of their identities and 
families of their loved ones.
    The costs--both the human costs and the budgetary impact--
of not addressing Alzheimer's are staggering. As it stands, the 
cost of treating individuals with Alzheimer's and other forms 
of dementia is nearly three times the cost of care for other 
Medicare beneficiaries.
    Medicare spending for these patients is expected to reach 
$189 million by 2015.
    We can predict what the future holds if we don't overcome 
Alzheimer's, Parkinson's Disease and other illnesses, the 
prevelance of which are growing as the population ages.
    More suffering and an increased strain on families, 
communities, the health care system, and public and private 
payers.
    It is in the public interest to invest in embryonic stem 
cell research and other avenues that hold promise for tackling 
medical conditions that undermine human capability and breed 
human suffering.
    I want to commend Senator Mikulski and Senator Bond for 
their hard work on behalf of Alzheimer's patients and families, 
and for introducing the Alzheimer's Breakthrough Act. It is a 
blueprint for progress, and I fully support it.
    I am looking forward to working with colleagues on both 
sides of the aisle to respond to this hearing's call to action.
    Senator Mikulski. That concludes the hearing.
    [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 the current state of 
Alzheimer's disease research, and the pressing need for 
research and program funding. I would also like to express my 
appreciation to the Alzheimer's Association for their continued 
leadership.
    I would like to extend a special thank you to Senator 
Collins for her leadership on issues related to Alzheimer's 
disease and aging more broadly, and for partnering with me on 
numerous pieces of legislation and initiatives related to these 
and other important health issues.
    For the past 3 years, Senator Collins and I have co-chaired 
the Senate Alzheimer's Task Force, hosting six Congressional 
events, which have highlighted a variety of issues, including: 
the importance of early detection of Alzheimer's; helping 
people suffering from Alzheimer's and providing support 
services for their families and caregivers; and 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. I am pleased that today's 
witness panel includes Dr. Marilyn Albert, who has been a 
panelist at several Alzheimer's Task Force events over the 
years and who most recently presented a wonderful overview of 
the current state of research on preventive lifestyle measures 
at a December 2006 Alzheimer's Task Force event.
    But even as our understanding of this disease grows--so 
does the toll of the disease. We cannot lose sight of the 
struggles of approximately 4.5 million Americans suffering from 
Alzheimer's--and the countless husbands, wives, sons, 
daughters, loved ones and caretakers who watch the disease 
unfold in a family member, friend, patient.
    This hearing provides an opportunity to express our 
commitment to providing scientists with the resources needed 
to: identify the factors that contribute to Alzheimer's; 
recognize the warning signs of Alzheimer's; and make strides in 
treatment. I am a long-standing supporter of greater research 
funding at the National Institutes of Health, among other 
steps, to put our best ideas and brightest minds to work on 
this heart rending disease.
    Today's hearing is not only a reminder of the importance of 
committing the resources necessary to both aggressively pursue 
a cure for Alzheimer's, but also as a call to action to 
responsibly provide the care that its present victims 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, the Lifespan Respite Care Act was finally 
enacted after a long, bipartisan effort. This law will have a 
real and meaningful impact on millions of Americans who 
struggle everyday 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. Senator Warner and I, 
along with 22 of our fellow Senators, are currently fighting to 
obtain the authorized funding, which would be nearly $300 
million over 5 years.
    This fight for funding is a bipartisan effort, because all 
of us recognize the financial pressure that will be placed on 
our healthcare system in light of the fact that older adults 
are the fastest growing segment of the U.S. population. And we 
realize that as the Baby Boomer generation ages, there will be 
a dramatic increase in the number of Alzheimer's cases in the 
Nation. By the year 2050, if we do not make headway, up to 16 
million Americans are expected to suffer from this devastating 
disease.
    For the people that will confront this disease in their own 
lives, this increase is more than statistics: the increase 
represents an emotional struggle, a tremendous financial 
burden, a new strain on our already stressed healthcare system, 
particularly for Medicaid and Medicare costs.
    I congratulate Senator Mikulski for her tireless efforts to 
raise awareness and support for Alzheimer's disease. I am proud 
to have been an original co-sponsor of the Ronald Reagan 
Alzheimer's Breakthrough Act last Congress, and now an original 
co-sponsor of both the Alzheimer's Breakthrough Act and the 
Family Assistance Act that Senators Mikulski and Bond 
introduced last week. I am delighted that these bills have 
garnered bipartisan support.
    I also applaud Chairman Mikulski and Ranking Member Burr 
for using this hearing to highlight the importance of programs 
such as the 24/7 Alzheimer's Call Center and the CDC ``Brain 
Health Initiative.'' Last year, I worked with Senators Mikulski 
and Collins to restore funding for critical seniors and 
Alzheimer's programs, and I will continue to advocate for these 
programs' continuation.
    Diseases such as Alzheimer's can contribute to depression 
and anxiety for both those who suffer from the disease as well 
as their caretakers. That is why Senator Collins and I are 
working to improve access to mental health services for our 
Nation's seniors by integrating mental health services into 
primary care and community settings. 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. 
Senator Collins and I will soon introduce the Positive Aging 
Act of 2007, which will support integration of mental health 
services in primary care settings and authorize grants for 
community-based mental health treatment outreach teams, among 
other provisions.
    Again, I would like to thank both Chairman Mikulski and 
Ranking Member Burr for holding this hearing, which reminds us 
that we must remain focused: to ensure we fully explore the 
potential for prevention, treatment, and cure; that we do all 
we can to improve the lives of those suffering; and that we 
take steps now to lessen the future burden and improve the 
quality of life for our Nation's current and future seniors. 
The more we know, the closer we are to achieving a world 
without Alzheimer's--and we know that we cannot afford to wait.
    I look forward to working with my colleagues on the 
committee and the Alzheimer's Task Force to highlight the need 
for more funding for Alzheimer's research and support programs. 
Thank you.

    [Whereupon, at 11:35 a.m., the subcommittee was adjourned.]

                                    

      
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