[Senate Hearing 113-798]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 113-798

 THE NATIONAL PLAN TO ADDRESS ALZHEIMER'S DISEASE: ARE WE ON TRACK TO 
                                 2025?

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

                                HEARING

                               BEFORE THE

                       SPECIAL COMMITTEE ON AGING

                          UNITED STATES SENATE

                    ONE HUNDRED THIRTEENTH CONGRESS


                             FIRST SESSION

                               __________

                             WASHINGTON, DC

                               __________

                       WEDNESDAY, APRIL 24, 2013

                               __________

                            Serial No. 113-4

         Printed for the use of the Special Committee on Aging


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


         Available via the World Wide Web: http://www.fdsys.gov
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                       SPECIAL COMMITTEE ON AGING

                     BILL NELSON, Florida, Chairman

RON WYDEN, Oregon                    SUSAN M. COLLINS, Maine
ROBERT P. CASEY JR, Pennsylvania     BOB CORKER, Tennessee
CLAIRE McCASKILL, Missouri           ORRIN HATCH, Utah
SHELDON WHITEHOUSE, Rhode Island     MARK KIRK, Illinois
KIRSTEN E. GILLIBRAND, New York      DEAN HELLER, Nevada
JOE MANCHIN III, West Virginia       JEFF FLAKE, Arizona
RICHARD BLUMENTHAL, Connecticut      KELLY AYOTTE, New Hampshire
TAMMY BALDWIN, Wisconsin             TIM SCOTT, South Carolina
JOE DONNELLY Indiana                 TED CRUZ, Texas
ELIZABETH WARREN, Massachusetts
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                  Kim Lipsky, Majority Staff Director
               Priscilla Hanley, Minority Staff Director
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
                                CONTENTS

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                                                                   Page

Opening Statement of Chairman Bill Nelson........................     1
    Prepared Statement...........................................    58
Opening Statement of Ranking Member Susan M. Collins.............     1
    Prepared Statement...........................................    60

                           PANEL OF WITNESSES

Ashley Campbell, Testifying on Behalf of Glen Campbell and Family     3
Don Moulds, Ph.D., Acting Assistant Secretary of Planning and 
  Evaluation, United States Department of Health and Human 
  Services.......................................................    11
Ronald Petersen, MD, Ph.D., Cadieux Director of the Mayo 
  Alzheimer's Disease Research Center and the Mayo Clinic Study 
  of Aging.......................................................    23
Michael D. Hurd, Ph.D., Director, RAND Center for the Study of 
  Aging..........................................................    34

                                APPENDIX
        Prepared Witness Statements and Questions for the Record

Ashley Campbell, Testifying on Behalf of Glen Campbell and Family     6
Don Moulds, Ph.D., Acting Assistant Secretary of Planning and 
  Evaluation, United States Department of Health and Human 
  Services.......................................................    13
Ronald Petersen, MD, Ph.D., Cadieux Director of the Mayo 
  Alzheimer's Disease Research Center and the Mayo Clinic Study 
  of Aging.......................................................    25
    Questions submitted for Dr. Petersen.........................    62
Michael D. Hurd, Ph.D., Director, RAND Center for the Study of 
  Aging..........................................................    36
    Questions submitted for Dr. Hurd.............................    64

                  ADDITIONAL STATEMENTS FOR THE RECORD

Alzheimer's Association..........................................    69
Alzheimer's Foundation of America................................    74
Jeffrey L. Cummings, M.D., Sc.D., Director, Cleveland Clinic Lou 
  Ruvo Center for Brain Health, Camille and Larry Ruvo Chair for 
  Brain Health, Cleveland, OH....................................    82
George Vradenburg, Chairman, USAgainstAlzheimer's................    84
 
                      THE NATIONAL PLAN TO ADDRESS
             ALZHEIMER'S DISEASE: ARE WE ON TRACK TO 2025?

                              ----------                              


                       WEDNESDAY, APRIL 24, 2013

                                       U.S. Senate,
                                Special Committee on Aging,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 2:11 p.m., in 
Room 106, Dirksen Senate Office Building, Hon. Bill Nelson, 
Chairman of the Committee, presiding.
    Present: Senators Nelson, Whitehouse, Manchin, Blumenthal, 
Donnelly, Collins, and Ayotte.

       OPENING STATEMENT OF SENATOR BILL NELSON, CHAIRMAN

    The Chairman. Good afternoon. We are going to do things a 
little bit different here today. Ms. Campbell, if you would 
come on up, after the opening statements, in order to 
accommodate the Campbells' schedule, we will have them testify 
first and answer questions so that they can get on to the 
airport. I certainly hope you are not experiencing a lot of the 
delays at the airport like everybody else is.
    I want to really thank everybody for being here and this 
show of support and the enthusiasm that has been generated and 
for all of the purple that is displayed today, we want you to 
know how much we appreciate it.
    I want to turn to our Ranking Member, Senator Collins, for 
her to make the opening statement.

         OPENING STATEMENT OF SENATOR SUSAN M. COLLINS

    Senator Collins. Mr. Chairman, first of all, I cannot tell 
you how grateful I am that you have called this very important 
hearing to examine the enormous toll that Alzheimer's disease 
is taking on our nation and to assess the progress since the 
enactment of the National Alzheimer's Project Act in 2011. 
Along with former Senator Evan Bayh, I am proud to have been 
the sponsor of that law, known as NAPA.
    Alzheimer's is a terrible disease that exacts a tremendous 
personal and economic toll on both the individual and the 
family. As someone whose family has experienced the pain of 
Alzheimer's time and time again, I know there is no more 
helpless feeling than to watch the progression of this 
devastating disease. It is an agonizing experience to look into 
the eyes of a loved one and receive only a confused look in 
return. It is equally painful to witness the emotional and 
physical damage inflicted on many family caregivers, exhausted 
by an endless series of 36-hour days.
    And my family is by no means alone. An estimated 5.2 
million Americans have Alzheimer's, more than double the number 
in 1980. Based on the current trajectory, as many as 16 million 
Americans over the age of 65 will have Alzheimer's disease by 
the year 2050.
    Moreover, in addition to the human suffering it causes, 
Alzheimer's costs the United States more than $200 billion a 
year, including $142 billion in costs to Medicare and Medicaid. 
This price tag will increase exponentially as the baby boom 
generation ages. If nothing is done to stop or slow this 
disease, Alzheimer's will cost the United States an astonishing 
$20 trillion over the next 40 years, according to the 
Alzheimer's Association.
    It is estimated that nearly one in two of the baby boomers 
reaching 85 will develop Alzheimer's. As a consequence, chances 
are that the members of the baby boom generation will either be 
spending their/our golden years with Alzheimer's or caring for 
someone dear to them who has it. In many ways, Alzheimer's has 
become the defining disease of my generation.
    A strong and sustained research effort is our best tool to 
slow the progression and ultimately prevent the onset of this 
disease. If we fail to change the current trajectory of 
Alzheimer's disease, our country will face not only a mounting 
national health care crisis, but an economic one, as well.
    Despite all the alarming statistics, until now, there has 
been no national strategy to defeat Alzheimer's and our efforts 
to combat the disease have lacked coordination and focus, and 
that is why the National Alzheimer's Project Act, or NAPA, 
creates a strategic National Plan for combating Alzheimer's. 
This National Plan, which will be updated annually, will help 
us focus our efforts and accelerate our progress toward better 
treatments, a means of prevention, and ultimately even a cure.
    The annual review process required by the law is intended 
to help us answer an important straightforward question: Have 
we made satisfactory progress this year in the fight against 
Alzheimer's? And that is why we are here today and why I am so 
grateful to our Chairman.
    The primary goal of this hearing is to assess the progress 
that we are making. The goal of the National Plan to Address 
Alzheimer's Disease, the plan which was released last May, was 
to, quote, ``prevent and effectively treat Alzheimer's disease 
by the year 2025.'' It is my understanding that the next 
version of the National Plan will be released next month. So 
this is the perfect time for a progress check. I personally am 
convinced that we need to more than double the amount of money 
that we are investing in Alzheimer's research in order to 
achieve significant progress.
    I want to thank all of our witnesses who are here today, 
but particularly Glen Campbell and his family. It was wonderful 
to hear him play many of my favorite songs. His guitar skills 
are second to none and he still has that wonderful voice. And 
it was wonderful to be honored to meet him, his wife, and 
daughter. And I am also grateful to the other experts who have 
joined us today. Issues related to Alzheimer's clearly are near 
and dear to my heart and I look forward to hearing from our 
witnesses.
    Thank you, Mr. Chairman.
    The Chairman. Well, and Senator Collins, thank you for all 
your hard work in this area.
    It is shocking that, today, one in three seniors will die 
with Alzheimer's. And as the baby boomers age, this fact is 
going to confront us all the more. You take a State like mine, 
Florida, where we have a higher percentage of the population is 
elderly, it all the more will be accentuated.
    And we have got places all over the country that are 
working on this disease. Senator Collins and I want to focus in 
on this today, and we want to give some additional heft and 
lift to what all of you out there are doing.
    Now, today, there are over 900 of you fanning out across 
Capitol Hill and we are very grateful for your tireless efforts 
on behalf of this issue. And for the Alzheimer's Association, 
including former Congressman Dennis Moore, we are grateful for 
all of you being here today.
    Now, I said we are going to do this differently to 
accommodate the Campbell family so they can get to the airport. 
So, first, we are going to hear from Ms. Ashley Campbell, the 
daughter of Glen and Kim. She is a recent graduate of 
Pepperdine. Her father is a five-time Grammy winning country 
singer. During his 50 years of show business, he has recorded 
some of the most beloved songs of his generation: ``Gentle on 
My Mind,'' ``Rhinestone Cowboy,'' more than 70 albums. And he 
has won numerous accolades for his music: The Academy of 
Country Music's Entertainer of the Year Award, three Grammy 
Hall of Fame Awards, and a Grammy Lifetime Achievement Award. 
He was also inducted into the Country Music Hall of Fame in 
2005.
    A couple of years ago, Mr. Campbell was diagnosed with 
Alzheimer's. Mr. Campbell, with his wife, Kim, who is with us, 
and his children, Ashley, Cal, and Shannon, have decided to 
face his illness head on. And so we want to hear from Ms. 
Ashley Campbell first.

 STATEMENT OF ASHLEY CAMPBELL, ON BEHALF OF GLEN CAMPBELL AND 
                             FAMILY

    Ms. Campbell. Thank you, Chairman Nelson and Senator 
Collins and members of the committee for the opportunity to 
testify today, and thank you for holding this hearing on 
Alzheimer's disease and the National Plan.
    Before my dad was diagnosed, I did not realize what a 
serious disease Alzheimer's is or how many people were affected 
by it. Over the past few years, here is some of what I have 
learned.
    Over five million Americans are living with Alzheimer's 
today. As many as 16 million will have Alzheimer's disease by 
2050. This year, our country will spend $203 billion in direct 
costs for those with Alzheimer's, including $142 billion in 
government costs to Medicare and Medicaid. Those costs are 
expected to exceed $1.2 trillion by 2050. In fact, a recent 
study in the New England Journal of Medicine confirmed that 
Alzheimer's is the most expensive disease in America.
    Because the costs are set to skyrocket and so much of this 
is paid by government, overcoming Alzheimer's is the key to 
fixing the country's growing fiscal challenges. For example, if 
a new medicine was developed to delay the onset of the disease 
by just five years, we could cut government Alzheimer's costs 
nearly in half by 2050, if only we fund the research needed to 
get there.
    What all of these numbers cannot tell you is the cost of 
the disease to the families. Since we announced that my dad has 
Alzheimer's, perfect strangers have been coming up to me and 
crying to tell me about Alzheimer's in their family. In fact, 
there are a thousand advocates on Capitol Hill today, hundreds 
in this hearing room now, who have been touched by Alzheimer's, 
and I have been honored to hear many of their stories, and 
today, I am honored to share my family's story with you.
    In June of 2011, my dad announced that he had been 
diagnosed with Alzheimer's disease. I was 24 years old at the 
time. I met a young man last night who was in sixth grade when 
he heard his father was diagnosed, and a little girl who could 
not have been more than 12 years old whose father just passed 
away from Alzheimer's. Dad thought it was important for people 
to know that you can keep doing what you love and that life 
does not end right away when you get Alzheimer's. It was also 
so important for my dad to take action and help spread the word 
about the need to find a cure for Alzheimer's.
    Shortly after my dad's announcement, my brothers and I 
joined my dad for the Glen Campbell Goodbye Tour. My mom was by 
my dad's side, of course, and we were also joined by the 
filmmakers who are doing a documentary about my dad. For dad, 
music has been therapeutic, and being public about his 
diagnosis was really helpful, because he did not want people to 
get the wrong idea at concerts if something appeared to go 
wrong.
    While there were a few challenges on stage during some of 
the shows, we always smoothed things out quickly. It helped to 
have my brothers and me on stage with him, and it helped to 
have such amazing support from my dad's fans. And it helped 
that my dad has been playing and touring for so long that the 
stage for him feels like home. That is where he is most 
comfortable, I think.
    One highlight of the Glen Campbell Goodbye Tour was playing 
at the Grammys last year and getting to meet Paul McCartney 
there. And another highlight was our visit to Capitol Hill last 
year. My family and I came to Washington, D.C., last May when 
the first National Alzheimer's Plan had just been released. We 
spent a few days meeting with members of Congress to ask for 
funding for the plan. We also played a special performance for 
members of Congress during a briefing put on by the Alzheimer's 
Association. I was so grateful to see Senators and 
Representatives singing along with dad and to know that they 
were fighting to end this terrible disease.
    Dad has been really committed to this fight, and we all 
have, and we are committed to doing more about it, which is why 
we are here today.
    Senators, there is something that my family and this whole 
community needs you to do. Congress passed a bill two years ago 
which resulted in the first ever National Alzheimer's Plan. The 
plan is strong and so is its goal to prevent and effectively 
treat Alzheimer's by 2025. As our nation's leaders, I 
respectfully ask that you support the implementation of the 
National Alzheimer's Plan and that you fund the President's 
budget request of an additional $100 million for Alzheimer's 
this year.
    In my family, music was always a part of our home and we 
are still playing. We knew at the beginning that Alzheimer's 
does not rob you of the things you love right away, but the 
disease will keep getting worse and there are not any 
medications today that can stop it.
    Alzheimer's is a disease that robs people of their lives 
while they are still living it, and it robs families of the 
people they love while they are still standing right in front 
of their eyes. I think a person's life is comprised of 
memories, and that is exactly what this disease takes away from 
you, like a memory of my dad taking me fishing in Flagstaff 
when I was a little girl, or playing banjo with my dad while he 
plays guitar. Now, when I play banjo with my dad, it is getting 
harder for him to follow along and it is getting harder for him 
to recall my name. It is hard to come to the realization that, 
someday, my dad might look at me and I will be absolutely 
nothing to him.
    We need to find a cure for this because we are not the only 
family affected. So much pain should not exist in the world. 
Let us work together to end Alzheimer's. Thank you.
    [The prepared statement of Ms. Campbell follows:]
    
  [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]  
    
    
    The Chairman. Thank you very much.
    [Applause.]
    Do any of the members, before we excuse the Campbell 
family, have any questions? Any additional comments?
    Senator Collins. I just want to thank Ashley for her very 
moving and compelling testimony. It is so important that we put 
a human face on this, and I admire the decision of your entire 
family to step forward out of the shadows and shine a spotlight 
on this devastating disease, so thank you so much for being 
here today.
    Ms. Campbell. Thank you.
    Senator Whitehouse. I just want to join my colleagues in 
thanking the Campbell family, thanking Ashley for her wonderful 
testimony, and thanking Mr. Campbell for the many years of 
pleasure that I got listening to him as I was growing up.
    The Chairman. Courage is an American characteristic that is 
embraced by the American people. You clearly have shown that 
courage, as have your mom and dad, and we want to thank you for 
sharing your story. This wretched disease has touched almost 
every one of us in this room one way or another, and you have 
stood tall to bring the focus all the more on this issue of 
monumental consequence. So we are deeply grateful.
    And I know you have to get to the airport, so at your 
pleasure, you all just excuse yourselves whenever you would 
like.
    Ms. Campbell. Thank you.
    The Chairman. Next, we are going to hear from Dr. Don 
Moulds. He is the Acting Assistant Secretary of Planning and 
Evaluation at the Department of Health and Human Services, and 
in this capacity, Dr. Moulds is overseeing the development of 
the national strategy to end Alzheimer's disease. He is also a 
member of the Federal Advisory Council on Alzheimer's Research, 
Care, and Services.
    We also have Dr. Ronald Petersen. Dr. Petersen is the 
Director of the world-renowned Mayo Clinic's Alzheimer's 
Disease Research Center and the Mayo Clinic Study of Aging. He 
has authored over 400 peer-reviewed articles on memory 
disorders, aging, and Alzheimer's disease. Dr. Petersen's most 
recent research focuses on the study of normal aging, mild 
cognitive impairment, dementia, and Alzheimer's.
    And then we will hear from Dr. Michael Hurd. Dr. Hurd is 
the senior principal researcher at the RAND Corporation, where 
he directs the RAND Center for the Study of Aging. His research 
focuses on the economies of retirement as well as other topics 
related to aging and the elderly. Dr. Hurd recently wrote a New 
England Journal of Medicine Study on the economic cost of 
Alzheimer's entitled, ``Monetary Cost of Dementia in the United 
States.''
    Gentlemen, welcome. We will take you in the order in which 
I introduced you and then we will get into the questions after 
all three of you have testified. Your formal statement is 
entered into the record, and so we would ask you to summarize 
your comments.
    Dr. Moulds.

    STATEMENT OF DONALD B. MOULDS, PH.D., ACTING ASSISTANT 
   SECRETARY FOR PLANNING AND EVALUATION, U.S. DEPARTMENT OF 
                   HEALTH AND HUMAN SERVICES

    Mr. Moulds. Mr. Chairman and members of the committee, my 
name is Don Moulds and I am the Acting Assistant Secretary for 
Planning and Evaluation in the Office of the Secretary of the 
Department of Health and Human Services. I am honored to come 
before you today to talk about the implementation of the 
National Alzheimer's Project Act, or NAPA, and the National 
Plan to Address Alzheimer's Disease.
    We have an historic opportunity to influence the way we 
address Alzheimer's disease, its impact on those who have it 
and their families, and perhaps reduce the incidence and the 
devastation it causes in the future. President Obama and 
Secretary Sebelius have made it abundantly clear that we cannot 
wait to act on this urgent national priority.
    In my testimony, I refer to Alzheimer's disease under this 
term. I include related dementias, consistent with the approach 
Congress used in the crafting of the law.
    As many as five million people in the United States have 
Alzheimer's disease. The effects of Alzheimer's can be 
devastating for both individuals with the disease and their 
families. As Dr. Hurd will testify, the annual cost of care for 
people with AD is estimated to be between $160 and $215 billion 
annually. There is no treatment for AD and eventually it is 
fatal. It is the fifth leading cause of death among people aged 
65 and older. As we have made progress fighting other diseases 
and the population has aged, mortality from Alzheimer's has 
risen.
    The National Alzheimer's Project Act establishes an 
Advisory Council on Alzheimer's Research, Care, and Services, 
which brings together some of the nation's foremost experts on 
Alzheimer's disease. Ron Petersen, the Chair of the Advisory 
Council, will speak about their work in just a few moments.
    Our work on the National Plan began in 2011 with the 
establishment of an Interagency Group on Alzheimer's Disease 
and Related Dementias. The group included the Departments of 
Veterans Affairs and Defense, the National Science Foundation, 
and over a dozen HHS agencies. The Interagency Group 
inventoried Federal programs, including research, clinical 
care, and services and supports. It then identified areas of 
overlap, opportunities for collaboration, and gaps, forming the 
basis of the initial work for the National Plan.
    In early 2012, we shared a framework and drafted the 
National Plan to Address Alzheimer's Disease with the Advisory 
Council and with the public. We incorporated the input received 
from the Advisory Council and thousands of stakeholders. We 
built off the President's historic ``We Can't Wait'' 
investments in Alzheimer's and identified concrete steps to 
address the disease. The National Plan was released on May 15, 
2012. As Secretary Sebelius said, it provides the cornerstone 
of an historic effort to fight Alzheimer's.
    The National Plan addresses five ambitious goals. First, to 
prevent and effectively treat Alzheimer's disease by 2025. 
Second, to optimize care quality and efficiency. Third, to 
expand supports for people with Alzheimer's disease and their 
families. Fourth, to enhance public awareness and engagement. 
And finally, to track progress and drive improvement.
    In the 11 short months since the National Plan was 
released, we have already made significant progress. In May of 
2012, the National Institutes of Health convened an Alzheimer's 
Disease Research Summit, which brought together national and 
international researchers to develop recommendations on how to 
best advance Alzheimer's research. The summit recommendations, 
which are designed to capitalize on current scientific 
opportunities, will inform Alzheimer's research for years to 
come.
    The administration's Alzheimer's commitment of $50 million 
in 2012 supported some exciting research projects, including a 
clinical trial of an insulin nasal spray that could prevent 
memory impairment and improve cognition during the initial 
period of the disease. This funding supported the first 
clinical trial of a treatment to prevent the disease by 
targeting amyloid, a brain hallmark of AD, among a unique 
family in Colombia whose otherwise healthy members share a 
genetic mutation that causes early onset of Alzheimer's 
disease.
    We have also taken steps to improve the care received by 
people with AD. The Network of Geriatric Education Centers 
funded by HRSA have provided training to over 10,000 doctors, 
nurses, and direct care workers to better recognize the 
symptoms of AD and provide screening and help consumers and 
families who are living with the disease.
    The Administration on Community Living has partnered with 
the National Family Caregiver Alliance to create a resource 
with assessment measures that providers can also use to help 
identify caregiver needs and create a care plan to address 
them.
    HHS launched Alzheimers.gov, a one-stop resource for 
families and caregivers. There were over 200,000 visits to 
Alzheimers.gov in the first ten months.
    Despite all of the progress, we still have a long way to go 
in our fight against Alzheimer's disease. We are finalizing the 
2013 update of the National Plan, which will add additional 
steps we take to beat this disease. The President's fiscal year 
2014 budget includes a $100 million initiative to fight the 
disorder through expanded research, improve supports for 
caregivers, and enhance provider education and public 
awareness.
    In addition, the President's Brain Initiative will 
complement our research by giving us insight into healthy brain 
functioning and the impact of Alzheimer's disease. It may also 
help pinpoint interventions to treat the disease.
    With many partners, the administration has taken 
significant steps to fight Alzheimer's over the past two years, 
but much work remains. I look forward to working with you to 
improve the care received by millions of people with the 
disease, better support their families and caregivers, and 
prevent and effectively treat AD by 2025.
    [The prepared statement of Mr. Moulds follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    
    The Chairman. Dr. Petersen.

 STATEMENT OF RONALD C. PETERSEN, M.D., PH.D., DIRECTOR, MAYO 
 ALZHEIMER'S DISEASE RESEARCH CENTER, MAYO CLINIC, ROCHESTER, 
    MN, AND CHAIR, ADVISORY COUNCIL ON RESEARCH, CARE, AND 
           SERVICES, NATIONAL ALZHEIMER'S PROJECT ACT

    Dr. Petersen. Good afternoon, Chairman Nelson, Senator 
Collins, and distinguished members of the Senate Special 
Committee on Aging. My name is Ron Petersen. I serve as the 
Chair of the Advisory Council on Research, Care, and Services 
for the National Alzheimer's Project Act. I am also a professor 
of neurology and Director of the Mayo Alzheimer's Disease 
Research Center at the Mayo Clinic at Rochester, Minnesota.
    The first United States Plan to Address Alzheimer's Disease 
was released in May of 2012 and represents a major step forward 
toward accomplishing the primary goal of the plan, to prevent 
and effectively treat Alzheimer's disease by 2025. My 
colleague, Dr. Don Moulds, has nicely outlined the structure of 
the plan and the accomplishments of the Federal Government.
    The National Alzheimer's Project Act charged the Secretary 
of Health and Human Services with developing the National Plan, 
but in addition, the law charged the Advisory Council with 
generating recommendations to the Secretary and directly to 
Congress. I would like to take a couple moments to highlight 
some of the more salient recommendations.
    The research community is poised to make key contributions. 
However, insufficient resources are impeding progress towards 
overcoming the disease. Therefore, the Advisory Council states 
that there is an urgent need for annual Federal research 
funding to be increased to the level needed to fund a strategic 
research plan and to achieve the breakthroughs required to meet 
the 2025 goal. Initial estimates of that level are $2 billion 
per year or more.
    Other research endeavors funded by the National Institutes 
of Health are of similar or greater magnitude. Currently, the 
NIH spends approximately $6 billion on cancer research, $3 
billion on HIV/AIDS research, and a little over $2 billion on 
cardiovascular disease. Yet, at present, the Federal research 
budget for Alzheimer's disease is less than one-half-billion 
dollars. Yet Alzheimer's disease may be the defining disease of 
our generation. In order to keep it from being the defining 
disease of the next generation, it is incumbent upon us to make 
the appropriate investments now to enable the research 
community to carry out effective studies to halt the disease.
    Several other recommendations are worth noting. One 
involves the therapeutic pipeline. Another recommendation from 
the Advisory Council pertains to the compression of the 
therapeutic pipeline, or shortening of the extended period of 
time--often over ten years--it takes from the discovery of a 
molecule to the production of a drug for treatment.
    This being a National Plan, along the same theme, the 
Advisory Council realizes that this is a National Plan and not 
a Federal plan. As such, we need to invoke assistance of many 
private partners to come together to develop a therapeutic 
approach for the disease.
    This is a global disease. We realize that Alzheimer's 
disease is not unique to the United States. It is a global 
disease and we have a great deal both to learn from and to 
share with other countries that have developed national plans 
prior to ours.
    With the aging of America, we realize that the front line 
of evaluations for individuals at the early stage of 
Alzheimer's disease will likely be primary care practitioners. 
As such, the Advisory Council has recommended the development 
of a unified curriculum for primary care practitioners to 
become more knowledgeable about Alzheimer's disease and other 
dementias to enhance the skills necessary to deliver dementia-
capable care. In addition, curricula designed for caring for 
individuals with Alzheimer's disease needs to be developed at 
all levels of care, including physicians' assistants, nurses, 
allied health care workers in skilled nursing facilities, and 
emergency department personnel to ensure uniform practices are 
undertaken for those affected with the disease.
    I would like to close by thanking Congress and the 
President for the initial steps at increasing funding for 
Alzheimer's disease research. As Dr. Moulds indicated, the 
initial redirection of funds in fiscal year 2012 yielded two 
large clinical trials, one for prevention and one for 
treatment.
    While we all recognize that these are very difficult times 
for the Federal budget, this is an issue that cannot wait. With 
the aging of the baby boomers, individuals turning age 65 at a 
rate of 10,000 persons per day, it is easy to see why this will 
be the defining disease of our generation. It will swamp other 
diseases and be the single most salient condition of aging. It 
is likely that everyone in this room has or will be impacted by 
this disease in one form or another, and it is our obligation 
to do everything we can to be certain that our children will 
not have to face the same situation. It will take a few 
courageous people, likely this committee, to make bold 
statements necessary to make it possible for us to achieve the 
goal of the National Plan to Address Alzheimer's Disease, to 
prevent and effectively treat Alzheimer's disease by 2025.
    Thank you for the opportunity to represent the Council.
    [The prepared statement of Dr. Petersen follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    
    
    The Chairman. Dr. Hurd.

STATEMENT OF MICHAEL D. HURD, PH.D., DIRECTOR, RAND CENTER FOR 
                       THE STUDY OF AGING

    Mr. Hurd. Chairman Nelson, Ranking Member Collins, members 
of the committee, thank you for the opportunity to testify 
before you today on a critically important topic, the monetary 
costs of dementia in the United States.
    My testimony will be based upon work performed at the RAND 
Corporation and the University of Michigan by me, Paco 
Martorell, Adeline Delavande, Kathleen Mullen, and Kenneth 
Langa. It was published in the New England Journal of Medicine 
on April 4 of this year.
    While our work is about the monetary costs of dementia, my 
coauthors and I recognized that the emotional costs of dementia 
are vast, indeed, as we have heard today. But in our data, we 
have no good way of measuring those emotional costs. However, 
even with the more modest goal of measuring the monetary costs, 
there are a number of challenges.
    First, most people with dementia have a coexisting health 
problem, such as a history of stroke or a heart condition. 
These health problems would, by themselves, lead to higher 
costs. We wanted to separate out those costs so as to find the 
costs attributable to dementia, not the costs of health care of 
people with dementia.
    A second difficult aspect concerns informal care, that is, 
unpaid care performed by a spouse, daughter, or other family 
member, or others. We already knew that the amount of informal 
care was substantial, so that the method of placing a monetary 
value on that care could cause our estimates to vary by a great 
deal.
    We used the Health and Retirement Study. The HRS was first 
fielded in 1992, and since then, it has become the preeminent 
data source for general population representative studies of 
aging. Funded by the National Institute on Aging and the Social 
Security Administration, it provides a wide variety of data, 
including cognition, health care use, and costs and informal 
caregiving.
    We estimated that the prevalence of dementia in the 
population 71 or older was 14.7 percent in 2010. We found that 
persons with dementia had about $29,000 more in annual spending 
for health care than persons without dementia, after adjusting 
for coexisting conditions and demographic characteristics. The 
great majority of those costs were for nursing home stays and 
in-home care that was paid for. Adding in the costs of informal 
care increased the total annual costs due to dementia 
substantially. Depending upon the method of valuing informal 
care, the costs per person with dementia were between $42,000 
per year and $56,000 per year.
    We then used Census estimates of the age distribution of 
the population to estimate the total cost of dementia, that is, 
the total cost in the population. We found that attributable 
actual spending was $109 billion in 2010. This cost places 
dementia as the most costly disease in the United States in 
terms of actual spending. Adding in costs for informal care 
increased this estimate to the range of $160 billion to $250 
billion per year.
    Because the prevalence of dementia sharply increases with 
age, the aging of the population itself, particularly when the 
baby boom generation reaches advanced old age, will increase 
future costs. We calculated that by 2040, the costs for care 
purchased in the marketplace will more than double, from $109 
billion to $260 billion in real terms. Adding in the costs of 
informal care increases the cost in 2040 to between $380 
billion and $510 billion, depending upon the method of valuing 
informal care.
    Our research shows that dementia is costly and that the 
costs will increase sharply, but we did not estimate the 
distribution of costs across households. Even within a year, 
these costs are unequally distributed, with some households 
spending nothing and others as much as $100,000 per year.
    We suspect that the costs are even more skewed when 
accumulated over many years because some people with dementia 
can be in nursing homes for five years or even more, or as Dr. 
Petersen suggested, even ten years. The accumulated costs can 
be financially devastating to some families. In principle, this 
risk could be reduced by long-term care insurance, but the 
products on the market are apparently not well designed. Only 
about 13 percent of persons age 55 or older hold this type of 
insurance.
    In summary, dementia is very costly and will grow more 
costly unless we find ways of delaying onset. In the meantime, 
well-designed long-term care insurance could reduce the risk of 
catastrophic out-of-pocket spending.
    Thank you for your attention.
    [The prepared statement of Mr. Hurd follows:]
   
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    The Chairman. Thank you, gentlemen.
    Before I turn to Senator Collins, Dr. Petersen, would you 
explain what happens to the brain from a medical standpoint--
the build-up of plaque, why do the neurons not fire, et cetera.
    Dr. Petersen. In general, we call Alzheimer's disease a 
degenerative disease of the brain, and that means that the 
nerve cells are not working as well as they formerly did. We 
think that a leading hypothesis right now is this protein that 
you mentioned, Senator. Amyloid gets deposited in the brain and 
causes destruction to the nearby nerve cells. Then there is a 
cascade of events that occur. Inflammation, other proteins 
become involved.
    And when that process begins in the memory part of the 
brain, so called the temporal lobe or the hippocampus, the 
person becomes forgetful. Then as the disease progresses that 
process spreads to other regions of the brain, those involved 
with language, ability to pay attention, concentrate, problem 
solve. And as that starts to spread, then other behaviors start 
to deteriorate. The person loses an ability to care for him or 
herself and the function deteriorates.
    So it is a slow process that begins many, many years, maybe 
decades before the symptoms actually present themselves, and 
this degenerative process gradually progresses over time.
    The Chairman. Is there a trigger that we know of that 
causes the build-up of the protein?
    Dr. Petersen. It is a good question. In some instances, 
yes. In one form of the disease, so-called familial or truly 
inherited Alzheimer's disease, there is a genetic mutation. Dr. 
Moulds mentioned the study that is now being funded by the NIH 
to look at a family who has this particular genetic tendency. 
In those instances, the genetic tendency leads to the build-up 
of this amyloid protein. But that is perhaps only one percent 
of the disease.
    In the much larger proportion, sort of late onset, more 
typical Alzheimer's disease, there still may be a familial 
tendency, meaning that it sort of runs in families. So there 
are what are called genetic susceptibility polymorphisms, a big 
term that means you just a risk, an increased risk because of a 
contribution of a variety of genes that will lead you to 
misprocess these proteins and develop the disease.
    There still might be some environmental triggers that 
accentuate that, head trauma being one of them. So there are 
some environmental factors that bring it on, as well. But we do 
not fully understand why one person with the same genetic make-
up may develop the disease, the next person not. So research 
underway.
    The Chairman. Do we know the molecular structure of the 
protein?
    Dr. Petersen. Absolutely. We know a great deal about the 
amyloid protein, the tile protein. Amyloid makes up the plaques 
in the brain. The tile protein makes up the tangles in the 
brain. The defining characteristics of the disease in the 
brain, plaques and tangles. So when someone passes away, has an 
autopsy, you look at the brain under the microscope. To call it 
Alzheimer's disease, they have to have these plaques and 
tangles.
    We know a great deal about the make-up of these proteins, 
the genetic sequencing of them, when things get misprocessed, 
how they get misprocessed, the enzymes that cause the 
misprocessing, et cetera. So we know a great deal about it, and 
that has resulted in many therapeutic attempts aimed at various 
aspects of that process. So we do know a lot about the basic 
biology of the disease.
    The Chairman. But we have not found the molecules or the 
genes or the proteins that could reverse the process of the 
build-up of this plaque.
    Dr. Petersen. Essentially, that is correct, meaning that we 
do not have a disease modifying therapy, meaning we do not--we 
are unable to get at the underlying plaque and tangle process 
and stop it. But that is a rich area of research right now. 
Many trials are underway, many approaches to doing that, either 
blocking the building up of the protein or enhancing the 
removal of the protein. All of these are possibilities, but we 
are not there yet.
    The Chairman. Thank you for that explanation.
    Senator Collins.
    Senator Collins. Thank you, Mr. Chairman.
    Dr. Petersen, noted neurologist and author Dr. Oliver Sacks 
has written about music's role and impact on patients with 
neurological disorders like Alzheimer's. I could not help but 
be struck by Ashley's poignant comment when she said her father 
is having a hard time remembering her name, and yet just a few 
moments before the hearing, I heard him playing the guitar, 
remembering very complicated musical sequences, singing with 
his daughter, and able to change chords and play significant 
portions of several of his songs.
    Is there a neurological reason why music can have such a 
powerful effect on a patient with dementia and why the ability 
to remember and respond to music is retained even when the 
ability to remember the name of your daughter is not?
    Dr. Petersen. It is a striking contrast in Mr. Campbell, 
his dense memory problem, as we have all seen, even manifesting 
in his inability to remember Ashley's name, and yet his ability 
to perform on stage. And, in part, there are neurologic 
explanations because of the parts of the brain that are 
involved in those different activities.
    So, as I was mentioning to Senator Nelson that the brain--
the disease starts in the memory part of the brain, and that is 
the part of the brain that sort of allows us to learn new 
information and recall recent information. Very old 
information--where we grew up, where we went to school--those 
kinds of events are often retained well into the disease.
    In addition, the ability to play the guitar, which 
neurologists sometimes call procedural memory, motor skill 
memory, can be relatively preserved far into the disease 
process. So it is not an equal opportunity. The brain is not an 
equal opportunity organ to be affected by the disease. Certain 
regions are more susceptible to others.
    So it is quite astounding that Mr. Campbell can be on the 
stage, can play music apparently fairly normally, really, 
things he has done many, many times going back literally 
decades. And if you prompt him with the lyrics of some of the 
songs with a teleprompter, it is business as usual. Mr. 
Campbell looks like the Mr. Campbell of years ago. Yet between 
songs, he may, as Ashley was indicating, he may wander around 
and then it becomes a little bit of freeform as to what is 
going to happen next and we cannot necessarily predict, and he 
will have trouble with where he is going and what is happening 
next.
    So it really involves the regions of the brain and the way 
the disease evolves over time.
    Senator Collins. Thank you.
    In addition to your role as a physician and as the Chair of 
the Advisory Council, you are one of the world's leading 
researchers on Alzheimer's through the Mayo Clinic. Could you 
tell us a little bit more about promising research that you are 
undertaking? I am hoping for everyone here, for all of us, that 
there are some promising developments or good news on the 
horizon. It has been a long time since there has been a 
breakthrough. I think it goes back to 2003, as I recall.
    Dr. Petersen. Thank you, Senator. You have given me too 
much credit. I tend to work around a lot of bright people and 
they are the ones who are responsible for much of the progress 
in the disease.
    I think there are some bright areas with respect to the 
disease itself and what we understand about it and getting 
ready to intervene. Some of the work that we are doing at the 
Mayo Clinic involves what we call the Mayo Clinic Study of 
Aging. Very briefly, this is a random sample of people who live 
in our region who are aging fairly normally. We have been able 
to evaluate these people ages 50 to 90, randomly sample them, 
bring them in, and study them thoroughly clinically. But we are 
also able to look at them with respect to what are called 
biomarkers, and by biomarkers, I mean images of the brain, MRI 
scans, PET scans. We can even image this protein in the brain 
called amyloid now when people are normal.
    So we are poised to be able to characterize people, perhaps 
it is an overstatement to say a prediction formula, but that 
type of approach, risk profile of people based on their age, 
maybe their education, family history, some genetic features, 
maybe some of these biomarkers, that we will be able to say, 
you have a thus and so probability of developing the symptoms 
of Alzheimer's disease by a certain age.
    That helps us, then, to have these individuals ready and 
poised to be able to take a therapy when that therapy--and I 
think it is ``when,'' not ``if''--that therapy is, in fact, 
developed, so that we will be able to use that information 
regarding an individual's risk to dictate what kinds of 
therapies we use.
    For example, what if an immunotherapy, an antibody or a 
vaccine, is developed? That is very promising, under 
investigation right now. It is likely to be expensive and maybe 
a little risky. So it may not be completely benign to give 
this. So we are going to need to know who is at the top third 
of the risk, who is in the middle, and who is in the bottom 
because we may want to expend those resources on individuals at 
the top end of it before they express the symptoms of the 
disease.
    So I think that that type of work is out there. There is a 
great deal of work going on regarding the clinical 
characteristics and understanding of the disease. The therapy 
side is getting there but has not reached that pinnacle right 
now. But as soon as that happens, these two will merge and, 
hopefully, we will be able to have an impact on that disease.
    Senator Collins. Thank you.
    The Chairman. It is just amazing to me that with all of our 
ability to understand, that we cannot make the breakthrough 
here. We have not been able, for example, in others, such as 
ALS, Amyotrophic lateral sclerosis, Lou Gehrig's disease. And 
yet I think we are right on the cusp of the big breakthrough.
    Dr. Petersen. I could not agree more, Senator, that I think 
we are just poised. The research community is anxious to be 
able to make those contributions. We cannot say yet today, 
tomorrow, where it is going to be. But I think so, and it is 
going to be a huge breakthrough when it happens.
    The Chairman. Senator Whitehouse.
    Senator Whitehouse. First, let me thank Chairman Nelson for 
holding this hearing. This is such an important topic and I 
think you have done a really wonderful job of bringing very 
effective witnesses here. I also wanted--and the Ranking 
Member, as well. Thank you, Senator Collins.
    I also wanted to thank the advocates who have been here 
today and compliment them on what I think is a really 
impressive piece of demonstrative literature that they brought 
with them. Donna McGowan and her husband, Bill, from Rhode 
Island came to visit me and they showed the graphic that you 
all have been handing out all day today, and it is really 
extraordinary when you look at the cost piled up in this huge 
line that Medicare and Medicaid will spend on this, not private 
insurance but just the Federal Government through Medicare and 
Medicaid, and then you compare what we are spending on research 
to try to avoid those costs. And if you do, you have got to 
look down to this little thing which you cannot even see out 
there. It is about as wide as my fingernail. This little speck 
is the amount that we are spending on NIH research to combat an 
illness that is creating that much cost.
    As Ashley demonstrated so clearly, the cost of Alzheimer's 
is measured in a great deal more than dollars. But I think the 
case that has been made with this kind of material is really 
terrific and I look forward to working with my colleagues to 
make sure that that funding is protected and increased and we 
have a chance to get ahead of this illness.
    One of the situations that emerges when a family is faced 
with this illness is the question of decisions that are going 
to be made as the illness progresses and how people wish to be 
treated. And it is incredibly important to make those decisions 
early on while the individual suffering from the disease still 
has the ability to make those decisions and determine what they 
want. And there are a great number of us on this committee--I 
know Senator Collins and Senator Nelson have been very active 
in this area--who want to improve the way in which Americans 
express their wishes about how they wish to be treated when 
their illnesses are advanced and make sure that living wills 
and advance directives and things like that are honored.
    I would love to ask the panel what your experience has been 
at how effectively we are treating that goal with patients who 
have this illness and what kind of progress should we be making 
to make sure that those choices are being driven by the wishes 
of the patient and the family and not just the grind of the 
health care system.
    Mr. Moulds. So, why don't I start and then Dr. Petersen, 
because he has obviously encountered this with patients in the 
course of his career, both as a researcher but also as someone 
providing care, medical care.
    But there are a number of steps that are taken in the plan 
to provide information and encourage health care providers to 
have just the conversations that you are alluding to right now 
earlier on in the process. So care, planning, and coordination 
is incredibly important to this population. If ever there is a 
population where the case can be made that you need those 
elements in the provision of care, it is with patients with 
dementia.
    We are pushing out through HRSA's Geriatric Education 
Centers--there are 45 of them over the country--as part of NAPA 
information to try to educate health care providers about best 
practices in dementia care, and part of that is having these 
care planning and coordination conversations in the doctor's 
office earlier in the process.
    As for the question, the second part of the question, which 
is the question about advanced dementia care planning, that 
was, in fact, one of the recommendations that was made by the 
Advisory Council to the Secretary for inclusion in the 2014 
Plan, so the second iteration of the Plan. All of those 
proposals or recommendations are before the Secretary at the 
moment. She is taking all of them very seriously, and we are 
happy to report back out, we expect that the second iteration 
of the Plan will be made public in May sometime, probably mid-
May. There will be some discussion at the Advisory Council 
meeting on Monday, but we are happy to report further when she 
has made her decisions about the second iteration of the Plan.
    Senator Whitehouse. Thanks.
    Dr. Petersen, anything to add in my remaining 38 seconds?
    Dr. Petersen. Just a quick comment that it is increasingly 
important to do this. And I think our recommendations in the 
Plan have suggested that in geriatric education, because it is 
particularly important in this disease to do it earlier rather 
than later, because by the process of the disease itself, 
people lose the insight as to what is going on, because when 
the parts of the brain become involved with the disease that 
allow us to introspect and look at ourself, the people are no 
longer able to make those kinds of decisions. So emphasizing 
the importance of doing it early.
    Senator Whitehouse. Thank you.
    The Chairman. Senator Donnelly.
    Senator Donnelly. Thank you, Mr. Chairman, and I want to 
thank all of our witnesses for all your hard work on this 
issue.
    I also want to mention my former colleague in the House, 
Dennis Moore, who is dealing with this now, who is an 
extraordinary leader, extraordinary person, and so many 
Hoosiers who are here today for Alzheimer's.
    Dr. Moulds, I wanted to ask, FDA recently approved a new 
diagnostic technology and it helps diagnose Alzheimer's. CMS is 
in the process of deciding whether it should be considered for 
national coverage under Medicare and Medicaid. And I was 
wondering if you are working with CMS to ensure that all 
appropriate Medicare patients have access to technologies that 
can help with early diagnosis of Alzheimer's.
    Mr. Moulds. Sure. The short answer is that CMS has been 
quite engaged in this process. We have--I mentioned earlier in 
my opening remarks about the Interagency Working Groups that we 
established very early on. They are in three general areas, on 
the research side, clinical care, and then long-term care 
services and supports. CMS is chairing the clinical care 
subcommittee. There has been a good amount of conversation 
about diagnostics at CMS.
    And more to the question about how to expedite the review 
of potentially helpful both diagnostics and, hopefully, going 
forward, therapeutics, there is a process that exists where 
that work can go on concurrently. CMS is reviewing, I believe, 
a number of diagnostic tools at the moment. I cannot speak to 
decisions----
    Senator Donnelly. Sure.
    Mr. Moulds [continuing]. But they go through the normal 
channels where they are reviewed by an external committee for 
efficacy and for the other considerations that go into making 
those decisions.
    Senator Donnelly. Thank you.
    Dr. Petersen, I recently heard about an area called 
epigenetics and was wondering what you have seen in this area 
of almost--seeing its potential for treating Alzheimer's, what 
you think of it, what you know of it, and is this a path that 
seems to show promise.
    Dr. Petersen. I think it might very well be promising 
insofar as that epigenetics refers to a trait of a particular 
disease that before the full expression of the disease appears. 
So, for example, if somebody has a genetic tendency to develop 
Alzheimer's disease by virtue of their genetic make-up, there 
may be signs that the disease is manifesting itself early.
    So, for example, take imaging. Imaging--certain regions of 
the brain, as I was mentioning earlier, are preferentially 
affected by the disease. So there may be some signatures in the 
brain with shrinkage in certain parts of the brain that can be 
related to the genetic make-up of that individual and imply 
that this person is on the road to developing the disease.
    Senator Donnelly. And I certainly do not have your level of 
knowledge, obviously, but is that an area that could, in 
effect, turn it off at that point, turn off the Alzheimer's?
    Dr. Petersen. It gives us an opportunity to pick up the 
disease process at an earlier point in time. So if we have 
effective therapeutics, we could intervene at that earlier 
point in time when that genetic signal, that epigenetic signal 
is there, and it gets to the issue of certain markers that 
characterize the disease and are they going to be therapeutic 
targets for the disease. We are not there yet, but that is 
where we are going.
    Senator Donnelly. And as we look at Alzheimer's and talk 
about 2025, do you have milestones that, as we look forward, 
here is where we hope to be by this time, here is where we hope 
to be by this time, so that we know either we are making 
progress or we are starting to fall behind from where we hope 
to be?
    Dr. Petersen. A very timely question. With the Advisory 
Council meeting that is coming up on Monday that Dr. Moulds 
just referred to, we are going to be discussing just that 
issue, and our colleagues at the National Institute on Aging, 
Dr. Richard Hodes and his team, have developed a rather 
extensive chart of milestones mapping the plan, the plan that 
was translated into the research summit that was held at NIH 
last May, the recommendations coming out of that summit insofar 
as what are actual items that are actionable and when. So the 
grid has been divided into short-term goals, intermediate 
goals, long-term goals.
    Senator Donnelly. And I do not mean to interrupt you. I 
have ten seconds left. I just want to ask you, is the most 
important thing we can do to continue with the research 
funding?
    Dr. Petersen. I am a little biased, but absolutely.
    Senator Donnelly. Okay. Thank you.
    Thank you, Mr. Chairman.
    The Chairman. Senator Blumenthal.
    Senator Blumenthal. Thank you, and I want to join in 
thanking our Chairman and Ranking Member for having this 
hearing and also the advocates from all around the country who 
have been so steadfast and vigorous in championing this cause 
and also advocating for the kind of research that is necessary 
and caregiving to address this problem.
    I want to begin with your testimony, Dr. Moulds, saying 
that the President's fiscal year 2014 budget includes a $100 
million initiative to fight this disorder through expanded 
research, improved supports for caregivers, and enhanced 
provider education and public awareness.
    We have seen the charts. You know the numbers better than 
I. Is $100 million really enough? I mean, does it even come 
close to being enough?
    Mr. Moulds. That is obviously a very difficult question to 
answer. What I can tell you is that the things that we are able 
to do with the investments that the President has identified, 
that we were able to do in 2012 and moving forward with both 
the insulin nasal spray trial and the trial in Colombia for 
early onset, were tremendously important activities.
    I think if you were to ask anybody in the research 
community whether there are things beyond what you could fund 
with $100 million that would be worthwhile research, the answer 
would almost certainly be yes. But if you think about the NIH 
budget and the way that it has been affected by sequester, the 
fact that we are moving forward with the research agenda this 
year, that the President has identified funds in 2014 reflects 
a tremendous commitment to fighting this disease.
    Senator Blumenthal. But I take it that if you had double or 
triple or a lot more money, there would be worthwhile research 
to be done.
    Mr. Moulds. So, to be clear, I am not an Alzheimer's 
researcher, so I would defer to people who are.
    Senator Blumenthal. I am happy for you to defer, but I 
think you know enough----
    Mr. Moulds. Yes.
    Senator Blumenthal [continuing]. I think almost everyone in 
this room knows enough to say, yes.
    Mr. Moulds. So, I would reiterate the answer that I gave 
earlier, which is that when you talk to researchers in the 
community and ask the question that you just put, the answer 
is, yes, there is more that can be done. There is a lot that 
can be done. We are making tremendous efforts to move this 
agenda forward. We did it last year. We are doing it this year. 
We will be doing it in 2014.
    Senator Blumenthal. Dr. Petersen, did you have anything you 
wanted to add?
    Dr. Petersen. In my remarks, I indicated that the Advisory 
Council has recommended a research budget of about $2 billion a 
year. A reasonable question, where did that number come from? 
Well, in fact, the Alzheimer's Association undertook an 
exercise during the development of the first plan and the 
recommendations surrounding the first plan asking experts in 
the research community, in your area of research, what are 
short-term goals, what are medium goals, and can you put a 
price tag on that?
    As difficult as that is, in fact, many researchers came 
together throughout the entire spectrum of the disease, basic 
biology to treating patients, put numbers on their goal, what 
time frame and all, and, in fact, generated this $2 billion. So 
I think, again, the community really can be receptive of that 
figure as being relatively solid.
    Senator Blumenthal. Thank you.
    Well, I understand, Dr. Moulds, the limitations of what you 
can say and what your role is here. My question to Dr. Petersen 
was going to be about how that $2 billion number is derived. 
You know, it could be $20 billion. It could be $100 billion. 
But $2 billion seems to be the consensus number that the 
research community would pinpoint.
    Mr. Moulds. I mean, I think so. And, again, it is $2 
billion or more, because, in fact, to do a clinical trial in 
Alzheimer's disease may be $100 million-plus to run it out. 
This is a chronic disease. It takes many people to test a 
particular therapeutic. So that is just one aspect. But there 
are a lot of other basic science questions that need to be 
answered, as well as clinical questions regarding the 
characterization of the disease. So I think that is a realistic 
number.
    Senator Blumenthal. Thank you.
    One last question, if I may ask you, Dr. Hurd. We have not, 
in my view, developed the kind of private insurance tools that 
families need to deal with this problem. Could you give us some 
thoughts about whether you believe that there are private 
insurance policies and products available now to help families 
address the huge, humongous, often heartbreaking costs 
financially that they need to face in dealing with a family 
member afflicted with this disease.
    Mr. Hurd. Well, I think, indeed, it is a big lack in the 
insurance market and it exposes some families to tremendous 
financial risk, catastrophic risk, because of the chances--
there are not large chances, but there are chances that they 
might have to support a family member in a nursing home for ten 
years, and we know the costs of one year in a nursing home are 
approaching $100,000 per year. So you can see what the numbers 
are.
    The main risky group would be where one spouse remains in 
the community and the other spouse is in the nursing home, 
because then the spending will come out of the family's 
resources and impoverish the person in the community.
    Why are there not? So, we know that the products that are 
there are not satisfying to families because the take-up rate, 
as I mentioned, is 13 percent. Why are the policies 
unsatisfactory? It is difficult for the insurance companies to 
write kind of correct kind of policies. So the typical 
insurance policy has caps on the daily rate. It has caps on the 
lifetime amount that will be paid out. So the insurance 
policies do not address the extreme upper tail of costs, 
leaving families exposed to that cost.
    That is the part that needs to be covered, because, after 
all, you do not need insurance--well, we have insurance for 
eyeglasses, but you really do not need insurance for 
eyeglasses. You need insurance when your house burns down, not 
when you scorch your rug. And that is the analogy.
    But insurance companies do not know what that long-term, 
what that tail risk is, either, because, for example, suppose 
we have improvements in the ability to keep people alive with 
Alzheimer's. So rather than having ten years in a nursing home, 
it now goes up to 15 or 20. The insurance companies do not know 
how to price that. They do not know what the actuarial value is 
of that and they do not know what the risk of that happening 
is.
    So there is a risk out there that nobody is willing to pick 
up and to bear, and we do not know the price of that risk. That 
was--the CLASS Act was supposed to address that issue, and, of 
course, the CLASS Act was not successful. But that is a gap in 
the insurance market that possibly public policy should be 
addressing.
    Senator Blumenthal. Thank you very much, and again, my 
thanks to the panel and to our Chairman.
    The Chairman. And just to underscore what Senator 
Blumenthal has said, right now, this is about a $140 billion a 
year problem, and in another 30 years, it is going to be a 
trillion dollar problem. And of that trillion per year, it is 
going to be about two-thirds of that paid by Medicare and 
Medicaid. So, Dr. Petersen, another reason for you all to find 
a cure, not even to speak of the heartbreak and the personal 
stories, the cost.
    Now, Dr. Hurd, I want to ask you cost, but from a different 
angle. To take care of an Alzheimer's patient, it is usually 
about $28,000 a year. A lot of the caregivers are the family 
members that are the same age, and the average household income 
of that age group over 65 is about $35,000 a year. So how are 
the families going to manage the cost? Until we find the cure, 
is it that we are looking at bankruptcy?
    Mr. Hurd. The cost, of course, is spread over a number of 
payers, and families spend what they are able to. But we--
families are facing bankruptcy. Families are facing 
catastrophic out-of-pocket spending for reasons that I 
mentioned previously. Right now, there is no effective way for 
families in particular situations to avoid that. There are no 
insurance products. There is really nothing that those families 
can do except do the best they can, and it is a situation--it 
is an insurable situation in principle where costs are enormous 
for small numbers of people, less enormous for larger numbers 
of people. But we do not have those insurance products.
    The Chairman. To underscore what Senator Whitehouse had 
said, we are spending over close to $6 billion a year on cancer 
research and, of course, the budgets have been going backwards 
on Alzheimer's research. It was about a half-a-billion dollars. 
In the sequester, that was cut back. The President has come out 
with his proposal, which is about a $100 million increase, 
which should take it somewhere in the range of $600 million. 
But that is a far cry.
    Some experts have said that if you really want to make some 
advances in finding the cure, that we ought to be spending $2 
billion a year on research. Does anybody want to comment on 
that?
    Dr. Petersen. Well, I think that this is an appropriate 
observation, and the funding that has been expended on cancer 
research, on HIV/AIDS, on heart disease, presumably has been 
effective, because the annual mortality, number of deaths per 
year, in all of those disorders is, in fact, decreasing while 
the number of deaths due to Alzheimer's disease, related to 
Alzheimer's disease, is skyrocketing in the opposite direction.
    So one would think that--again, I am not an economist, but 
the investment of around $2 billion a year for research now 
would pay back so many times over in terms of the savings that 
Dr. Hurd has alluded to if, in fact, these costs could be 
reduced. It makes sense that this is the investment that needs 
to be made now.
    The trouble is, this is a difficult time--you know better 
than I--to make these kinds of statements. But, in fact, the 
investment has to be made right now.
    The Chairman. Presently, we have some assisted living 
facilities that offer specialized memory care units. Dr. Hurd, 
how do we go about having them properly regulated and how do we 
let people know what is appropriate?
    Mr. Hurd. Well, I wish I had the answer to that. You have 
asked me something out of my area of scientific expertise. I 
could give you an answer as an informed reader of the New York 
Times or Wall Street Journal, but not as a scientific effort, 
so maybe I should pass to Dr. Petersen or Dr. Moulds on that 
one.
    Mr. Moulds. I can take a little bit of a stab at it. So, 
assisted living facilities are regulated by States, which 
limits to a significant degree the Federal Government's ability 
to intervene in the way that they are run. We certainly engage 
in research in my office, for example, at the Administration on 
Community Living, looking at best practices in these 
facilities, looking at model regulatory policy. We share 
practices across States. So there are those possibilities, but 
it is one of those things that is largely controlled by States.
    The Chairman. Do you think there is a Federal role for us 
to try to ensure that these residential facilities are 
providing the high-quality care?
    Mr. Moulds. I would say that, certainly, where we have 
levers, it would be an important area to be using those levers. 
As I said, we have limited levers available to us now. We can 
certainly share and push information and have not been shy 
about doing that.
    The Chairman. Do we have any leverage?
    Mr. Moulds. As regulators, no, and there are--I mean, 
insofar as they are Medicaid beneficiaries and Medicare 
beneficiaries that live in some of these cases, we have--there 
are potentially some hooks there. But, again, the facilities 
themselves are regulated by the State.
    The Chairman. Senator Collins.
    Senator Collins. Thank you, Mr. Chairman.
    Dr. Hurd, I am very interested in the research that you 
have done on the costs, since many of us are aware of the 
emotional toll that Alzheimer's takes and the horrible 
suffering that the victims and their families endure. Around 
here, you also have to look at the economics of a disease.
    Now, given that cancer and heart disease, cardiovascular 
diseases, are also age-related, could you give us a comparison 
of the trend lines for those diseases in terms of costs versus 
Alzheimer's.
    Mr. Hurd. I cannot give those directly. The cancer and the 
heart numbers that we came up with and cite in our paper come 
from studies of the medical expenditure panel survey, and I 
have not seen equivalent trends on those. But the defining 
aspect, of course, of the cost associated with Alzheimer's and 
dementia is it is age-related. Roughly speaking, the prevalence 
doubles every five years beginning among people in their 70s, 
and as the baby boom generation reaches those advanced old 
ages, then we see the very large increases in prevalence and, 
therefore, costs.
    I would not think those same trends would pertain to cancer 
and heart, where the age prevalence is not nearly so strong and 
so striking, firstly. And, secondly, the baby boom generation, 
the extremely large generation associated with those birth 
years, will have passed through those critical years and now 
are approaching the ages when Alzheimer's and dementia is so 
prevalent.
    Senator Collins. And, fortunately, and in part due to the 
investments that we have made in research for those diseases, 
we do have some treatments, means of delaying the onset, even 
in some cases cures, and that is what is so troubling on the 
Alzheimer's side, is that we can do so little.
    Dr. Moulds, I cannot help but think that this is one of 
those classic cases where an investment up front is going to 
save our nation so much money in the long term, and when we 
have Federal health programs like Medicare and Medicaid already 
in financial trouble, already teetering in some cases, does it 
not make sense to make that kind of investment in the hopes 
that we can save money later in Medicare and Medicaid? I am 
just talking about the economics. I am putting aside the 
terrible human suffering right now.
    Mr. Moulds. Sure, and absolutely, and you would get a 
wholehearted agreement from both the President and the 
Secretary on that statement. It does make sense to invest in 
this now, which is why the President put forth the initiative a 
year and a half ago now and reiterated it in his 2014 budget.
    I will also add that there are, in addition to investments 
in the research side, there are key investments on the 
caregiver side that are incredibly important. One of the things 
that we know, that the research has shown about caregivers--and 
keep in mind that the best outcome for everyone, for a person 
with Alzheimer's, for their loved ones and for the government, 
is to enable a person with the disease to stay in their home, 
be cared for by their family or other loved ones as long as 
possible.
    But what the research shows is that it is often fairly 
small things that make those arrangements impossible, that lead 
to a person with Alzheimer's disease needing to go into a 
nursing home. So it is a sprained ankle or a thrown back or the 
fact that they could not quite accommodate the job that they 
are doing at the same time. So strategically placed 
reinforcements for the people who are providing the care, very, 
very important, as well.
    Senator Collins. Well, it is also why we should not be 
cutting home health care, because that can help people stay in 
their homes and avoid far more expensive institutional care, as 
well.
    I guess my concern today is while I completely commend the 
President for increasing Alzheimer's research by $100 million 
in his budget and paying attention to the caregiver side, as 
well, when we hear that the Council has advised that at least 
$2 billion be spent, and I believe the number in the 
President's budget is $564 million, we are a long ways away 
from the recommended amount.
    Now, I am also very cognizant of the budget constraints 
that we are living under. But does the administration have a 
plan for ramping up the amount, the investment in Alzheimer's 
so that it is more on a pure level with the amount that we are 
investing in AIDS or cancer or other serious diseases?
    Mr. Moulds. I think you framed the challenges very well. 
Certainly, the President and the Secretary recognize that this 
is important on many different levels. They are absolutely 
committed to funding this research going forward. I cannot 
speak to Presidential budgets beyond the 2014 budget, 
obviously, but I can testify about the imperativeness that both 
of them see in moving forward with this agenda.
    Senator Collins. When I look at the research levels, it 
seems to me that there are two areas that are really 
underfunded, and diabetes is one and Alzheimer's is another, 
when you look at the costs that they are imposing on Federal 
health care programs, not to mention the suffering they are 
imposing on families across this country.
    Let me just ask a couple more questions, if I have the 
Chairman's indulgence.
    The Chairman. Take your time.
    Senator Collins. Thank you.
    Dr. Petersen, one thing that we are going to hear is that, 
let us say we could magically wave a wand and produce the $2 
billion that has been recommended, which I would love to do. 
What we are going to hear is the question, can it be spent 
wisely? If the current funding level is around $470 million, 
that is a huge leap, and we do not have--we cannot waste a 
single dollar nowadays. Are the projects out there? Are the 
clinical trials available? Would the money be well spent, or 
would it be more productive to have the money ramp up and have 
a plan over the next five years for what the funding level 
should be so that researchers like you can know what is coming 
and be prepared to spend this money very wisely?
    Dr. Petersen. Well, I think that the research community is 
ready to be able to absorb that and move ahead. But toward that 
exercise, with the summit that was held at the NIH last May for 
Alzheimer's disease, as I was indicating earlier, there was a 
prioritization and a categorization of research areas and what 
it would take in each of those fields. That has been translated 
at the National Institute on Aging into certain concepts that 
would be appropriate for research. That was approved by the 
National Council on Aging, the National Advisory Council on 
Aging, and that has been translated into RFAs, requests for 
applications to the research community. They have been put out 
and now there have been research grant applications that have 
come in in response to that.
    On May 1 and 2 this year, there is going to be a similar 
summit for the non-Alzheimer's dementias, the frontal temporal, 
the dementia with Lewy bodies, vascular disease. The same 
exercise will be undertaken then, where the disease areas are 
being brought out, categorized, the experts are coming 
together, and a prioritization of research undertakings will be 
made such that if the funding were available, here is where it 
would go.
    So I think the NIA is acting and the NIH is acting 
proactively as if. Now, if that does not come to be, we have 
got a problem. But I think people are thinking ahead because 
there is the hope that either the ramping up or a large bolus 
will come forward, and I think the research community would be 
able to march forward very rapidly.
    Senator Collins. Thank you.
    My final question, Dr. Moulds, Dr. Petersen referred to the 
international--I think there was an international conference 
that was held. If we can coordinate efforts around the globe 
for research, we have the potential to ensure that there is 
faster progress. Could you update us on what is being done to 
coordinate Alzheimer's research around the world as the 
National Alzheimer's Plan Act envisioned?
    Mr. Moulds. I would be happy to. As you know, because you 
were instrumental in its passage, the NAPA legislation directed 
us to develop structures to better coordinate these efforts 
internationally.
    There are a couple of different efforts underway at the 
National Institutes on Aging. The first was the one that Dr. 
Petersen referred to, which was the symposium where we did 
international planning and looked at priorities in funding 
projects moving forward. They have also developed a tool that 
effectively allows countries and non-governmental entities to 
input work globally that is going on so that everyone is aware 
of work going on internationally.
    There are a number of countries that have plans in place, 
so in England, it is the Prime Minister's Dementia Challenge. 
There has been an ongoing initiative in France. We have been 
contacted by the Japanese, who are working on a plan. The 
Koreans are working on a plan. This is an issue that is not 
constrained to our borders. Many of those plans also include 
research components and dollars that are dedicated to research.
    So we are engaging at a couple of different levels. One is 
a multilateral level, which are the planning activities that I 
mentioned and the tools for engaging multilaterally. But we are 
also engaging in a bilateral way. So we have frequent 
conversations with the leaders of the plan.
    In Britain, for example, many of the initiatives that are 
part of their initiatives are starting--they are doing both 
demonstrations and evaluations, so we share early results from 
initiatives that are underway. We have the leader of the 
British plan and the leader of the Canadian plan who are coming 
to testify at the Advisory Council on Monday.
    So this is a very global effort. This type of coordination 
is going to be absolutely essential to maximize limited 
resources. But there are many partners in this because as 
populations age globally, this becomes more epidemic in all of 
the nations that are facing these aging challenges.
    Senator Collins. Thank you.
    I want to thank our witnesses today. You were all very 
illuminating and helpful to us. And most of all, I want to 
thank our Chairman for holding this very important hearing. I 
think it has been so heartening for the advocates who are here 
today to get this update on the plan and on our personal 
commitment, as well. I have worn this purple suit for many 
years during the annual day that the Alzheimer's advocates come 
to town, and I fear I am going to have to keep it around for 
many, many more years and I would like us to get a cure so that 
I can retire it once and for all.
    [Laughter and applause.]
    The Chairman. Well, it is very becoming.
    Senator Collins. Thank you.
    [Laughter.]
    The Chairman. Dr. Moulds, we look forward to the receipt of 
the new plan. When do you think that will be coming?
    Mr. Moulds. So, we anticipate probably mid-May, but almost 
assuredly sometime in May. As I mentioned, the second--this is 
an annual process, so we are required by the statute to update 
on an annual basis. The Advisory Council is charged with 
providing recommendations to the Secretary, which we share with 
Congress, as well, and post on our Web site. We have tried to 
make this as both transparent and as public a process as 
possible for numerous reasons.
    So the recommendations are with the Secretary. We are 
making great progress on the second iteration of the plan and 
we anticipate that it would come out shortly after the Advisory 
Council meeting, which is next week.
    The Chairman. Well, we look forward to it, and if you would 
rap the knuckles of OMB for delaying your testimony to me for 
this hearing, I would appreciate it.
    We are going to hold the record open for one week. There 
are many advocates that I know want statements entered into the 
record.
    Anything more, Senator Collins?
    Senator Collins. No. Thank you again, Mr. Chairman.
    The Chairman. All right. Thank you.
    The meeting is adjourned.
    [Whereupon, at 3:43 p.m., the committee was adjourned.]

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