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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 

COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS 

EDWARD M. KENNEDY, Massachusetts, Chairman 

CHRISTOPHER J. DODD, Connecticut 

TOM HARKIN, Iowa 

BARBARA A. MIKULSKI, Maryland 

JEFF BINGAMAN, New Mexico 

PATTY MURRAY, Washington 

JACK REED, Rhode Island 

HILLARY RODHAM CLINTON, New York 

BARACK OBAMA, Illinois 

BERNARD SANDERS (I), Vermont 

SHERROD BROWN, Ohio 

MICHAEL B. ENZI, Wyoming, 

JUDD GREGG, New Hampshire 

LAMAR ALEXANDER, Tennessee 

RICHARD BURR, North Carolina 

JOHNNY ISAKSON, Georgia 

LISA MURKOWSKI, Alaska 

ORRIN G. HATCH, Utah 

PAT ROBERTS, Kansas 

WAYNE ALLARD, Colorado 

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 

JEFF BINGAMAN, New Mexico 

JACK REED, Rhode Island 

BERNARD SANDERS (I), Vermont 

SHERROD BROWN, Ohio 

EDWARD M. KENNEDY (ex officio), 

Massachusetts 

RICHARD BURR, North Carolina 

JUDD GREGG, New Hampshire 

LAMAR ALEXANDER, Tennessee 

JOHNNY ISAKSON, Georgia 

ORRIN G. HATCH, Utah 

MICHAEL ENZI (ex officio), Wyoming 

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) 

(1)

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 

2

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 

3

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 AntiImpoverishment 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. 

4

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 longterm 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. 

5

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 WinstonSalem-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. 

6

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 

7

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 

8

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 enVerDate 0ct 09 2002 12:43 Feb 15, 2008 Jkt 000000 PO 00000 Frm 00012 Fmt 6633 Sfmt 6601 S:\DOCS\34318.TXT SLABOR1 PsN: DENISE
9

thusiastic. 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 stretchout. 

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 

10

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 underinvested 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. 

11

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:

12

1. To provide access to effective treatments, increase funding for Alzheimer re- search 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-yearVerDate 0ct 09 2002 12:43 Feb 15, 2008 Jkt 000000 PO 00000 Frm 00016 Fmt 6633 Sfmt 6621 S:\DOCS\34318.TXT SLABOR1 PsN: DENISE
13

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 

14

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. 

15

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. 

16

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 genVerDate 0ct 09 2002 12:43 Feb 15, 2008 Jkt 000000 PO 00000 Frm 00020 Fmt 6633 Sfmt 6621 S:\DOCS\34318.TXT SLABOR1 PsN: DENISE
17

eration 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, workVerDate 0ct 09 2002 12:43 Feb 15, 2008 Jkt 000000 PO 00000 Frm 00021 Fmt 6633 Sfmt 6601 S:\DOCS\34318.TXT SLABOR1 PsN: DENISE
18

shops 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 enVerDate 0ct 09 2002 12:43 Feb 15, 2008 Jkt 000000 PO 00000 Frm 00022 Fmt 6633 Sfmt 6621 S:\DOCS\34318.TXT SLABOR1 PsN: DENISE
19

gagement, 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 

20

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 

21

in a Latino community in Los Angeles and then adapting the program for AfricanAmerican 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 

22

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 mid1980s, 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. 

23

1 Alzheimer’s Association, (2007), Alzheimer’s Disease Facts and Figures. 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. 3 Comer (2007) 59.

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. 5Koppel, R, (2002). ‘‘Alzheimer’s Disease: The Costs to US Businesses in 2002.’’ An Alzheimer’s Association commissioned report. 

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

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: 

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

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

Because Alzheimer’s steals independence and complicates the treatment of comorbidities, it is already America’s third most expensive disease.5 Claims for MediVerDate 0ct 09 2002 12:43 Feb 15, 2008 Jkt 000000 PO 00000 Frm 00027 Fmt 6633 Sfmt 6621 S:\DOCS\34318.TXT SLABOR1 PsN: DENISE
24

6Lewin Group, (2004). ‘‘Saving Lives, Saving Money: Dividends for Americans Investing in 

Alzheimer’s Research.’’ An Alzheimer’s Association commissioned report. 7Lewin Group, (2004). 

8Lewin Group, (2004). 

9 National Center for Health Statistics, (http://209.217.72.34/aging/TableViewer/

tableView.aspx?ReportId=357). 10Minin ̃ o, 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. 11 Ballon, Daniel, Ph.D., (2007). Correspondence. 

care 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

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. 

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

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

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

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. 

25

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. 14Oddo S et al. Triple-Transgenic Model of Alzheimer’s Disease with Plaques and Tangles: 

Intracellular Ab and Synaptic Dysfunction. Neuron, 2003;39:409–421. 15http://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). 

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

• 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. 

• 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

26

17Kola I and Landis J. Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery, 2004;3:711–715. 18 Health Affairs, 25, no. 3 (2006): w94–w103. 

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 highrisk 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. 

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 

27

19http://olpa.od.nih.gov/hearings/109/session2/testimonies/nihbudget.asp. 20 [Complete remarks available at www.healthtransformation.net] 

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 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. 

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? ’’ 

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. 

28

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 industrialera 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. 

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21 [Complete remarks available at www.healthtransformation.net] 

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 RE- MARKS) 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. 

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 shortterm 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 

30

22 [Complete remarks available at www.healthtransformation.net] 

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. 

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 

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23 [Complete remarks available at www.healthtransformation.nets] 

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. 

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 

32

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 

33

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 

34

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. 

35

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 dayto-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 

36

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, 

37

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, 

38

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. 

39

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. 

40

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. 

41

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 

42

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? 

43

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 betasecretase. 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 betasecretase 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 

44

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 

45

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 

46

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. 

47

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 innovationfriendly 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:]

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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.]

49

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. 

50

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 

51

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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