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36–838 PDF 2009

S. HRG. 110–722 

FEDERAL RESPONSE TO THE 

ALZHEIMER’S EPIDEMIC 

HEARING 

BEFORE THE

SUBCOMMITTEE ON RETIREMENT AND AGING 

OF THE

COMMITTEE ON HEALTH, EDUCATION, 

LABOR, AND PENSIONS 

UNITED STATES SENATE 

ONE HUNDRED TENTH CONGRESS 

FIRST SESSION 

ON

EXAMINING THE FEDERAL RESPONSE AND ADVANCES BEING MADE 

TOWARD DEFEATING THE EPIDEMIC OF ALZHEIMER’S DISEASE 

JULY 17, 2007 

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

( 

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, Massachusetts 

RICHARD BURR, North Carolina 

JUDD GREGG, New Hampshire 

LAMAR ALEXANDER, Tennessee 

JOHNNY ISAKSON, Georgia 

ORRIN G. HATCH, Utah 

MICHAEL B. ENZI, Wyoming 

ELLEN-MARIE WHELAN, Staff Director 

(II) 

C O N T E N T S 

STATEMENTS 

TUESDAY, JULY 17, 2007 

Page 

Mikulski, Hon. Barbara A., Chairman, Subcommittee on Retirement and 

Aging, opening statement .................................................................................... 1 

Burr, Hon. Richard, a U.S. Senator from the State of North Carolina, opening 

statement .............................................................................................................. 2 

Zerhouni, Elias, M.D., Director, National Institutes of Health, U.S. Department of Health and Human Services, Bethesda, MD ....................................... 4 

Prepared statement .......................................................................................... 5 

Hodes, Richard, M.D., Director, National Institute of Aging, National Institute of Health, U.S. Department of Health and Human Services, Bethesda, 

MD ......................................................................................................................... 8 

Prepared statement .......................................................................................... 10 

Gerberding, Julie, M.D., Director, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA .............. 14 

Prepared statement .......................................................................................... 15 

Eschenbach, Andrew von, M.D., Commissioner of Food and Drugs, Food and 

Drug Administration, U.S. Department of Health and Human Services, 

Rockville, MD ....................................................................................................... 19 

Prepared statement .......................................................................................... 21 

Isakson, Hon. Johnny, a U. S. Senator from the State of Georgia, statement ... 26 

ADDITIONAL MATERIAL 

Statements, articles, publications, letters, etc.: 

Clinton, Hon. Hillary Rodham, a U.S. Senator from the State of New 

York, prepared statement ............................................................................ 40 

(III) 

(1) 

FEDERAL RESPONSE TO THE 

ALZHEIMER’S EPIDEMIC 

TUESDAY, JULY 17, 2007 

U.S. SENATE, 

SUBCOMMITTEE ON RETIREMENT AND AGING, 

COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS, 

Washington, DC. 

The subcommittee met, pursuant to notice, at 3:17 p.m., in Room 

628, Dirksen Senate Office Building, Hon. Barbara Mikulski, chairman of the subcommittee, presiding. 

Present: Senators Mikulski, Burr, and Isakson. 

OPENING STATEMENT OF SENATOR MIKULSKI

Senator MIKULSKI. Good afternoon, everyone. This afternoon, the 

Subcommittee on Retirement and Aging is hosting a roundtable on 

the subject of the Federal agency response to the epidemic of Alzheimer’s. This is set up a lot more starchy than what I had originally intended it to be because to me, it looks like a hearing. If it 

looks like a hearing, it is a hearing but we’re not going to act like 

it’s a hearing. We wanted a far more casual, more interactive approach and I hope that we can do this. 

Today, the reason we’re here and I really want to welcome four 

very distinguished Americans who have devoted their life to public 

health, to saving lives and to caring about the people in the United 

States of America. Dr. Zerhouni, the Head of the National Institutes of Health, Dr. Gerberding, our Director for the Center for 

Disease Control and Prevention, Dr. von Eschenbach, our Commissioner for Food and Drug Administration and Dr. Hodes, who is the 

Director of the National Institute of Aging and Dr. Hodes, we had 

a very robust hearing on research a couple of weeks ago. 

But today, where are we heading? Well, everyone knows the data 

about Alzheimer’s. Five million Americans are currently living with 

it. As the baby boomers age, we expect to have more of Alzheimer’s 

in our community, a disease right now for which there is no cure, 

yet the possibility of very realistic cognitive stretch-out. One hundred years ago, it was the first year that Alzheimer’s was diagnosed but we don’t want to wait another 100 years to see what we 

can do. 

In talking about this, what we realized is that was 10 years after 

the first diagnosis of HIV/AIDS that a cocktail was produced that 

enabled people to live longer and to live better. It was a stunning 

time of cooperation. The wonderful work at NIH. Certainly our 

good friend, Dr. Fouche played a lead role working with obscure viVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\DOCS\36838.TXT DENISE
2 

ruses that led the way and paved the way. It was the best of research. The Center for Disease Control mounted this incredible 

medical detective work when young men in San Francisco and 

throughout the country were developing the disease that we began 

to recognize—and FDA worked in this intense and concentrated 

way to see how we could take the best of what we knew in research, what we were noting in epidemiology to come with up 

where we were. 

Well, we wonder if we’re not at this point now, where we need 

to think along the lines of where are we going with the issue of 

Alzheimer’s. What we wanted to discuss with you today is the Federal response. To talk about what is happening in the area of research but knowing where we are with research, how this is being 

transmitted into essentially work that the CDC can troubadour out 

for either prevention or what clinicians can use. We’ve heard stories of one, misunderstanding and misdiagnosis by well-meaning, 

primary care doctors. Patients worry about what’s happening to 

them and their family wonders, what should they do and where 

could they turn? 

At the same time, we know that there are drugs that are being 

developed, drugs that are being explored but we wonder, is there 

a kind of a focal point where, in the issue of speed, we still maintain the very rigorous standards of safety and efficacy and don’t let 

our fear and our hope move things too quickly but then, a sense 

of urgency. 

So what we’re looking for today is to hear where we are in kind 

of much-needed research but at the same time, what we’re looking 

at as we mark up the Alzheimer’s Breakthrough Research Program, what we could be doing to help you be you? We need you. 

We already count on you but what can we do to help you deal with 

the fact that this is an epidemic and we look forward to your 

thoughts and then we hope that we can progress in a conversational way. 

We expect to be able to really have a conversation. We expect 

more of our people to come but we scheduled this meeting in coordination with your very complicated schedules as well and we appreciate your cooperation but there is an intense debate going on, 

on the Iraq War and about the deployment of our troops. 

But we have here Senator Burr, our very wonderful colleague 

from North Carolina whose passion for public health is well known 

and his dedication to research and advancing medical science is 

well known. So why don’t you—and I see you’re wearing the purple 

colors of the Alzheimer’s Association. 

OPENING STATEMENT OF SENATOR BURR

Senator BURR. Well, Madam Chairman, thank you. More importantly, I’d like to also welcome this prestigious group of panelists 

today. As I look down, doctor, doctor, doctor, doctor, I’m not sure 

whether Dr. Gerberding’s sign is indicative of anything other than 

the fact that she brought her own. But it is larger. 

[Laughter.] 

Senator MIKULSKI. It’s kind of the new world order, isn’t it? 

[Laughter.] 

Maybe I ought to get a bigger one. 

3 

Senator BURR. A rose among thorns—Madam Chairman, I commend you for your leadership and your support for Alzheimer’s patients, your passion on the issue and more importantly, what I’ve 

had the opportunity to learn from you in a short period of time. 

Again, I want to thank each of you for taking time out from what 

I know is an incredibly busy schedule and I’ve had the opportunity 

already once today to meet with Dr. Zerhouni on some other issues. 

I believe promising research exists for Alzheimer’s. Each of your 

agencies play an important part of how we treat, how we educate, 

how we care for the 5 million individuals in the United States living with Alzheimer’s disease and the many more who will be added 

as they age or become diagnosed. 

As we know all too well, Alzheimer’s is truly costly to treat and 

quickly becoming a financial burden on the Nation’s health care 

system. Loved ones and family members are feeling the financial 

and emotional burdens of Alzheimer’s disease as well. Ten million 

caregivers are providing 8.5 billion hours of care each year, valued 

at $83 billion. 

Simply put, we must find a disease modifying treatment. There 

are many reasons for optimism. Both the public and the private 

sectors have identified Alzheimer’s as a priority for research and 

development dollars and we’ve learned during our last couple hearings that we’re on the cusp of a number of potential scientific 

breakthroughs, which is exciting. It’s critical that we translate the 

information learned through research and through clinical practice 

and personal experiences into effective public health practices and 

more importantly, medical treatment. 

I look forward to hearing how each of your agencies are advancing in this very, very important research and stand with the Chairman to say we are committed to try to explore any and all avenues 

that provide a better level and quality of care for patients and also 

provide us a way to fill that gap of a disease that is extremely costly, not just to us but to individuals and to their families and I 

thank the Chair. 

Senator MIKULSKI. Thank you. Dr. Zerhouni, we’re going to ask 

you to kick it off. Dr. Zerhouni is the Director of NIH. He’s a respected leader in the field of radiology medicine. He is a well 

known scholar, worked at Johns Hopkins as the Vice Dean in the 

School of Medicine and has a distinguished history. Then we’ll go 

right down the line. 

Dr. Zerhouni, we look forward to what you have to say but it’s 

not only where we are in research but one of our questions is, can 

the Congress either through authorizing more appropriations, do 

something that would really accelerate where we are on breakthroughs, never underestimating the solid, basic research that 

needs to go on. But how do you see this? What are we doing and 

could we do more and what would be the best way to do it? And 

of course, we want to hear from our very wonderful head of the National Institute of Aging. 

4 

STATEMENT OF ELIAS ZERHOUNI, M.D., DIRECTOR, NATIONAL 

INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND 

HUMAN SERVICES, BETHESDA, MD 

Dr. ZERHOUNI. Well, Senator Mikulski and Senator Burr, it’s a 

pleasure to be here and to address your question, I think it would 

be important for us to A, review a little bit of the recent past and 

then tell you where we are and where we intend to be, if we have 

the ability to follow the pathways that I think are becoming very 

clear today. 

Over the past 30 years, Americans have—the average life expectancy of Americans has gone up by 6 years or about 1 year every 

5 years. What that means is that you have a 65-year-old American 

today, their average survival beyond 65 is 18 years. If you’re 85, 

your average length of life is going to be 6 years longer or more. 

And that has changed the demographics of our country, as you 

well know and this is what makes Alzheimer’s a disease that has 

been with us a long time, a current priority and a future urgency, 

if you will, that we need to address. We need to address forthrightly with programs that I think will, at the end, change the paradigm with which we treat chronic diseases and the thing that is 

very obvious to us is that the landscape of disease has changed and 

is continuously changing in the country. As you mentioned, there 

is no doubt that our population continues to age but a striking 

change is the fact that chronic diseases now make up 75 percent 

of health care expenditures and are continuing to grow at a rapid 

pace. 

Alzheimer’s disease is a major component of that, as you said, 

where up to 4.5, 5 million individuals affected with this disease but 

if you really think forward, you’re going to have up to 16 million 

Americans affected by this disease and as Senator Burr mentioned, 

it is a costly disease. 

So how do you change the paradigm? How do you really affect 

the outcome of this disease? What does NIH need to do? What I 

think is obvious is that with the completion of the human genome 

and the discovery of fundamental causes of diseases, especially diseases like Alzheimer’s disease that are long-term diseases where 

it’s obvious that the disease started many, many years before it 

struck the patient. What we need to do is strike the disease before 

it strikes the patient. 

This is what we call the ERO, the Four P’s of the future of medicine. Where we have to go from a paradigm where we wait for the 

patient to get very sick, to intervene to an era where we are much 

more predictive about who, how, when is a patient going to suffer 

from Alzheimer’s disease and that implies, Senator, a different 

kind of research. We need to do research not just on the late effects 

of a disease but on the early effects and the early signs of the disease by developing biomarkers. 

The second is that these conditions require us to understand not 

only the fundamental causes of the disease but also to manage the 

symptoms of the disease and lessen the burden of the disease on 

our patients. For example, we know that patients with Alzheimer’s 

disease suffer from depression. They suffer from cognitive deficits 

and we need to intervene at that level. 

5 

At the end of the process, what will be the ultimate solution for 

us to usher in an era where we will be much more predictive of 

the disease process being there 20 years before it strikes; B, very 

targeted approaches to treating the disease at the stage we find it, 

and; C, if we can pre-empt the disease all together, that would be 

the ideal and we’ve shown that in certain cases, we can. For example, last year we introduced the vaccine to prevent cervical cancer 

and there are areas of research that the National Institute of Aging 

is funding where a vaccine is being entertained for Alzheimer’s disease as well. 

So we have to really cover the entire spectrum of the disease and 

this is what I think needs to be understood. We will not make 

progress unless there is total coordination between all aspects of 

the disease process, remembering that we are seeing correlation 

and associations between—in these patients—between the presence 

of diabetes and the likelihood of developing Alzheimer’s disease, 

heart disease and Alzheimer’s disease. 

We also know that the disease has great impacts on caregivers 

and therefore the delivery of the care has to be thought through 

and it has to be improved. So for researchers today, earlier and 

more accurate diagnosis is going to be critical. That will require a 

better molecular understanding of the disease process in its earliest 

stages. 

It will require us to develop biomarkers, the ability to either 

through imaging or blood tests, to detect who is at risk for Alzheimer’s disease. The completion of the human genome has given 

us hope that we will be able to find genetic signatures of susceptibility for the disease. We are launching a genome environment initiative that will allow us to find out if there are environmental factors that accelerate or provoke the development of Alzheimer’s disease. 

All in all, I think that the key here is the transformation of our 

research from a curative paradigm of the past to the pre-emptive 

paradigm of the future is truly within our grasp and it is the priority that we should sustain and support aggressively. 

I think 10, 15 years ago, we didn’t know what the causes of Alzheimer’s disease at the fundamental level were, we have multiple 

theories of the disease. You will hear from my colleague, Dr. Hodes, 

about the progress we’re making but there are still remaining challenges and the challenges, I think, in this case, are that the opportunities for science to make a difference are many but we will not 

succeed unless we have an all-front attack on Alzheimer’s disease, 

from the very moment it starts, before anybody knows that the disease is there and the patient feels no symptoms, to the moment it 

strikes. We have to be able to do research across that entire spectrum. Thank you very much. 

[The prepared statement of Dr. Zerhouni follows:] 

PREPARED STATEMENT OF ELIAS A. ZERHOUNI, M.D. 

Senator Mikulski and members of the committee, good afternoon. I am Dr. Elias 

Zerhouni, Director of the National Institutes of Health (NIH), an agency of the Department of Health and Human Services, and I am pleased to be here today to talk 

about the advances we are making toward defeating Alzheimer’s disease (AD), a 

devastating condition with a profound impact on individuals, families, the health 

care system, and society as a whole. 

6 

1 Hebert, L.E., et al. Alzheimer Disease in the US Population: Prevalence Estimates Using the 

2000 Census. Archives of Neurology 60: 1119–1122, 2003. 2 Alzheimer’s Association, Alzheimer’s Disease Facts and Figures: 2007. http://alz.org/national/documents/Report 2007lFactAndFigures.pdf. Figure includes Medicare and Medicaid 

costs and the indirect cost to businesses when employees are burdened with the care of persons 

with Alzheimer’s. 

Peer-reviewed reports estimate that up to 4.5 million Americans ages 65 and older 

are currently battling AD. Moreover, the rapid aging of the American population 

threatens to increase this burden significantly in the coming decades: Demographic 

studies suggest that if current trends hold, the incidence of AD will begin to sharply 

increase around the year 2030, when all the baby boomers (born between 1946 and 

1964) will be over age 65. By the year 2050, the number of Americans with AD 

could rise to as many as 16 million.1 In addition to the tremendous emotional and 

physical toll AD exacts upon patients and their caregivers, financial costs of AD are 

high: Some experts estimate direct and indirect costs of Alzheimer’s and other dementias to be more than $148 billion annually.2

AD’s complex pathology and relentless clinical course have presented daunting 

challenges for the medical and research communities. However, the National Institutes of Health is poised to meet these challenges through a comprehensive program 

of research into the underlying causes, diagnosis, prevention, and treatment of AD. 

At the most basic level, our understanding of the brain and cognition in both normal aging and disease states is increasing rapidly and exponentially. Advanced imaging technologies have opened a window into the inner workings of the brain and 

made it possible to visualize the brain’s activity, including changes in the brain that 

could herald the onset of disease, with a specificity that was impossible even a few 

years ago. For example, the development of new tracer compounds such as Pittsburgh Compound B, the first molecule that can be used to map amyloid plaques (one 

of the pathological hallmarks of AD) in the brains of Alzheimer’s patients, could 

allow earlier diagnosis of AD and facilitate the evaluation of new treatments. 

Because research suggests that the earliest AD pathology begins to develop in the 

brain long before clinical symptoms are apparent, scientists are now searching for 

reliable, valid, and easily attainable biological markers that can identify cases very 

early in the course of disease. Early diagnosis of AD benefits affected individuals 

and their families, clinicians, and researchers. For patients and their families, a definitive early diagnosis provides the opportunity to plan for the future while the patient can still take an active role in decisionmaking. For clinicians, accurate early 

diagnosis facilitates the selection of appropriate treatments, particularly as new 

interventions are developed to stop or slow progression of symptoms. And for researchers, earlier and more accurate diagnosis will facilitate clinical studies of new 

therapies and preventive measures by allowing clinical trials on early intervention, 

before cognitive loss becomes significant. We expect programs such as the ongoing 

Alzheimer’s Disease Neuroimaging Initiative (ADNI), a public-private partnership 

which Dr. Hodes discusses in his statement, to provide a wealth of information 

about both brain pathology and biomarkers that can aid us in early diagnosis. 

Successful early diagnosis also depends upon the identification of people who are 

at particular risk for developing the disease. Although we do not yet fully understand what causes AD, it is apparent that genes play an important role, and NIH 

is supporting the development of new techniques to speed the identification of genes 

that are associated with AD. For example, genome-wide association studies (GWAS) 

rely on newly available research tools and technologies to rapidly and cost-effectively analyze genetic differences between people with specific illnesses such as Alzheimer’s disease or diabetes and to healthy individuals. Identifying the differences 

may facilitate our understanding of genetic risk factors that influence the development or progression of disease. 

Several NIH Institutes recently launched, or are planning, GWAS initiatives with 

the expectation that the results will eventually accelerate the development of better 

diagnostic tools and the design of new, safe, and highly effective treatments. NIH 

is also developing a data-sharing policy for GWAS to harmonize the practices NIHwide through which data will be made available for research use. 

As with other chronic diseases and conditions, however, genes are only part of the 

story. In addition to the genetic component, cognitive health can be influenced by 

concurrent medical conditions, environmental factors, and even an individual’s social environment. An ongoing NIH initiative aimed at elucidating the underpinnings 

of cognitive health and preventing disease is the Cognitive and Emotional Health 

Project. The goal of this trans-NIH initiative is to assess the state of epidemiologic 

research on demographic, social, and biologic determinants of cognitive and emotional health in aging populations and the pathways by which cognitive and emoVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00010 Fmt 6633 Sfmt 6621 S:\DOCS\36838.TXT DENISE
7 

3 National Diabetes Statistics.’’ National Institute of Diabetes and Digestive and Kidney Diseases, 2005. http://diabetes.niddk.nih.gov/dm/pubs/statistics/index.htm. 

tional health may reciprocally influence each other so that the most likely interventions for maintenance of cognitive and emotional health may be targeted. As a first 

step, a comprehensive review of measures that are associated with maintenance of 

cognitive health has been published and was a starting point for the development 

of the recently published Centers for Disease Control and Prevention/Alzheimer’s 

Association’s Healthy Brain Initiative: A National Public Health Roadmap to Maintaining Cognitive Health. 

By learning more about the diverse factors that may increase risk of cognitive decline or AD, we hope to identify interventions that could delay or prevent its onset. 

For example, we have learned from epidemiologic studies that diabetes, a condition 

affecting nearly 21 million Americans,3 is associated with cognitive decline in older 

people. ACCORD-MIND, an ongoing substudy of the NIH-supported Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, is currently testing whether 

the rate of cognitive decline and structural brain change in people with diabetes 

treated with standard care guidelines is different than in people with diabetes who 

adhere to more rigorous treatment. 

The translation of findings from basic research into new interventions to prevent 

or treat disease is another major focus of the NIH. In recent years, new insights 

into amyloid, tau, and inflammatory and oxidative stressors have enabled us, for the 

first time, to create highly specific treatments for AD that are targeted at particular 

molecules and processes in the brain; Dr. Hodes describes in his statement some of 

the newer targets that have been identified through this research. Some of those 

compounds have significant proprietary potential and are currently undergoing preclinical and clinical study by pharmaceutical and biotech companies. Others are 

being tested in NIH-supported clinical trials. 

Finally, NIH supports the national infrastructure that makes basic and clinical 

research possible. For example, researchers at NIH-funded Alzheimer’s Disease Centers (ADCs) are working to translate research advances into improved diagnosis and 

care for Alzheimer’s disease patients while at the same time focusing on the program’s long-term goal—finding a way to cure and possibly prevent AD. Areas of investigation range from the basic mechanisms of AD to managing the symptoms and 

helping families cope with the effects of the disease. ADC staff conduct basic, clinical, and behavioral research and train scientists and health care providers who are 

new to AD research. 

The Alzheimer’s Disease Cooperative Study (ADCS) is a major Alzheimer’s disease 

clinical trials effort. Now in its 16th year, the goal of the ADCS is to plan and conduct clinical trials on promising compounds designed to improve cognitive functioning, ameliorate behavioral disturbances, slow the rate of decline, or delay the 

onset of Alzheimer’s disease. In general, the ADCS tests drugs that are not typically 

studied by large pharmaceutical companies, such as drugs that are off patent or 

were patented and marketed for another use but might be useful for treatment of 

AD, or novel compounds from individual investigators or from small companies 

without adequate resources for clinical trials. ADCS studies thus fill an important 

resource gap between the identification of a potentially useful compound and its 

eventual adoption in clinical practice. October 2006, NIH announced a $52 million 

award to the ADCS over the next 6 years to conduct several new clinical trials. Dr. 

Hodes describes some of these upcoming clinical trials in his statement. 

An exciting trans-NIH initiative that will facilitate research into AD and other 

neurological disorders is the NIH Blueprint for Neuroscience Research. The Neuroscience Blueprint brings the 16 NIH Institutes, Centers, and Offices that support 

neuroscience research into a collaborative framework to coordinate their ongoing efforts and to plan new cross-cutting initiatives. By pooling resources and expertise, 

the Blueprint aims to accelerate neuroscience research and to reduce the burden of 

nervous system disorders. Working together, representatives from the partner Institutes, Centers, and Offices identify pervasive challenges in neuroscience and any 

technological barriers to solving them. This enables the Blueprint to support the development of new tools, training opportunities, and other resources to assist 

neuroscientists in both basic and clinical research. Each year from fiscal year 2007 

to fiscal year 2009, the Blueprint will focus on one of three themes: 

Neurodegeneration, neurodevelopment, and neuroplasticity. Four funding announcements related to the neurodegeneration theme were released in fiscal year 2007. 

These initiatives support the identification of biomarkers for neurodegeneration, the 

development of new ways to deliver therapeutics to the nervous system, and two 

interdisciplinary training programs in neurodegeneration research. 

8 

Finally, NIH conducts a number of research studies that support caregivers of AD 

patients. AD caregiving is highly stressful, emotionally and physically, and Dr. 

Hodes will tell you about some of the ways NIH works to develop and disseminate 

interventions to help the millions of Americans who care for a loved one with AD. 

To further explore the economic, social, and psychological costs of AD, the NIH supports studies such as the Health and Retirement Survey, the leading source of combined data on health and financial circumstances of Americans over age 50. Now 

in its 14th year, the HRS follows more than 20,000 people at 2-year intervals, and 

gathers important data that informs health care policy regarding AD and a number 

of other health conditions. 

It is important to note that the NIH cannot and does not conduct its important 

work in a vacuum. We work closely with partners in academia, in the private sector, 

and elsewhere in the government to develop new diagnostic tools and methodologies, 

to conduct clinical trials, to disseminate the results of our research, and to implement new interventions and policies resulting from our research at the community 

level. For example, the AD Neuroimaging Initiative is a joint venture between NIH 

and a number of academic and industry partners. Another is the AD Cooperative 

Study, which I described earlier, is conducted in close collaboration with our partners at the University of California–San Diego and scores of clinical sites across the 

Nation. Compared to even a decade ago, the field of neuroscience is moving at an 

extraordinary pace. We know, however, breakthroughs cannot come quickly enough 

for the millions of Americans touched by Alzheimer’s disease. I can report to you 

today that real progress is being made, and that we at NIH are committed to seeing 

that progress continues toward treatment, and ultimately prevention, of Alzheimer’s 

disease. 

This concludes my statement, and I will be happy to discuss these matters further 

with the subcommittee. 

Senator MIKULSKI. Thank you, Dr. Zerhouni. We would now like 

to hear from Dr. Hodes, who heads up the National Institute of 

Aging and has been a long time advocate of what we need to do 

on the concept of both basic research and breakthrough and I think 

what we’re looking for is, of course, stay the course but what are 

your ideas and recommendations here? 

STATEMENT OF RICHARD HODES, M.D., DIRECTOR, NATIONAL 

INSTITUTE OF AGING, NATIONAL INSTITUTES OF HEALTH, 

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, 

BETHESDA, MD 

Dr. HODES. Well, thank you, Senator Mikulski. 

Senator MIKULSKI. We kind of have this sense of urgency and to 

move the kind of breakthrough thinking along. 

Dr. HODES. Yes, you in your opening comments and Dr. Zerhouni 

as well, have stressed the burden at present of Alzheimer’s disease—emotional, and financial to the public health system as well 

as the urgency imposed by the demography and the increased number of individuals who will age, hopefully successfully, and be at 

risk. 

As Dr. Zerhouni has stressed, the new paradigm of trying to understand diseases from their earliest beginnings so one can intervene at an early stage rather than treat at a later stage, perhaps 

have their most impressive prototype where it’s been showed that 

years and indeed, decades before the disease can be identified clinically, there are changes in the brain that can be detected. 

For this reason, the research supported by NIH and I should in 

collaboration with the other agencies here, have focused broadly to 

find risk factors for disease, which can be translated into opportunities for intervention. These clues have come from a number of directions. They come from basic science, where genetics has been 

most informative, identifying the genes which can pre-dispose or 

9 

cause Alzheimer’s and providing, therefore, targets that have been 

translated, in fact, in clinical trials, to a point to which we could 

intervene in that process. 

As recently as a few months ago, yet a new Alzheimer’s risk factor gene, SORL1, was described and this impetus has continued in 

now a formalized genetics initiative, which is typical of the directions researchers are taking now in that. This initiative, for example, is collecting 1,000 families with multiple members with Alzheimer’s disease. 

This goes far beyond the work that any single investigator or 

academic institution can do. It’s a coalition of investigators that are 

generating these data, who can be made available to the whole 

international and national community of investigators and this, I 

think, in terms of breakthroughs and trends, is one of the advances 

we’re making to move from privatized research to research that becomes maximally leveraged in populations of scientists. In addition, 

we’re learning about risk factors that accompany epidemiologic 

studies. As Dr. Zerhouni alluded to, the risk factors for cardiovascular disease such as hypertension earlier in life, diabetes, increased homocysteine levels are all associated as risk factors and 

these, too have led to translation to clinical trials, intervening in 

each of these variables in an attempt to determine whether the 

causal link can be made and indeed, intervention to these variables 

will have an impact on preventing or slowing progression of Alzheimer’s disease. 

It’s stressed, appropriately, the importance in all of these studies 

for identifying the disease early so that one can make early diagnosis and can track progression. Most importantly perhaps, is that 

one can identify more accurately and more rapidly the effect, positive or negative of any of the interventions and trial and among the 

markers being used to do this, as Dr. Zerhouni alluded to, are 

markers that come from nerve imaging techniques. Quite striking 

in the last years, we’ve seen the development, previously unimaginable, of dyes that can actually identify both plaques and tangles, 

the lesions in the brain of Alzheimer’s patients in the living patient 

and the hope is that by tracking the progress of this and the ability 

of drugs, vaccines, other interventions to arrest this progression, 

we can have far more cost efficient and more rapid answers to clinical trials that are underway. 

An initiative called the Alzheimer’s Disease Neuro Imaging Initiative is really a landmark of its kind. I think it stresses the kind 

of innovation in terms of collaboration that is required. This is an 

initiative that is looking at a number of older American men and 

women who either have no disease, have mild cognitive impairment 

or have Alzheimer’s disease and it’s over time, following them for 

their clinical state, their psychological testing results, their new 

imaging results as well as the results of tests of cerebral spinal 

fluid and serum and other evidence of biological markers, including 

genetics. 

What’s noteworthy about this initiative is that it will create a 

panel of materials that will be used, once again, by all qualified scientists and equally remarkable, is the nature of the partnership involved. This initiative was carried out by NIA in collaboration with 

other institutes at NIH with very close association with the FDA, 

10 

recognizing that the progress in this initiative has to feed into the 

ability of the FDA to access the efficacy of drugs. It involves as 

well, partnership with more than 20 pharmaceutical companies 

and the bio-technology companies who are contributing not only 

their expertise but funding, recognizing that the outcomes of studies such as this will serve all of the public and private sectors with 

a common goal of identifying ways to intervene successfully in Alzheimer’s disease. 

So long as we are progressing in this direction, so long as we are 

faced with Alzheimer’s disease to be cared for, we also need to be 

cognizant of the burden on caregivers. As Dr. Zerhouni noted and 

was noted in the introductory comments as well, the burden on 

those taking care of loved ones, family members, people with Alzheimer’s disease is itself, huge. It has an impact not only financially but on the health and mental State of those taking care of 

individuals with Alzheimer’s disease. We’re happy to identify the 

results of the clinical trial, which was targeted, in this case, at 

Caregivers, an intervention that can improve the State of caregivers. The study was successful, in fact, identifying the kind of 

intervention that can reduce stress and improve quality of life, both 

for those afflicted with the disease and those who care for them. 

So long as we are progressing in the direction of preventing disease and treating those already afflicted, as well as easing the burden of those providing important care for them. We will continue 

in our collaboration across agencies, across sectors to this end. 

Finally, in all of this, we maintain the sense of responsibility 

that was enacted in the congressional establishment of a facility 

through NIA in leadership to provide information to the public, not 

only a clearing house for publications but a multimedia effort to 

keep the public informed of progress of the state of medical knowledge, of needs to recruit people and their interests into clinical 

studies in support of our overall enterprise. 

I thank you again for this opportunity to speak with you and to 

continue our long and I hope, soon to be, successful partnership in 

attacking Alzheimer’s disease. 

[The prepared statement of Dr. Hodes follows:] 

PREPARED STATEMENT OF RICHARD J. HODES, M.D. 

Senator Mikulski and members of the committee, thank you for inviting me to appear before you today to discuss Alzheimer’s disease (AD), an issue of interest and 

concern to us all. I am Dr. Richard Hodes, Director of the National Institute on 

Aging (NIA), the lead Federal agency for Alzheimer’s disease research. NIA is one 

of the 27 Institutes and Centers that comprise the National Institutes of Health 

(NIH), an agency of the U.S. Department of Health and Human Services (HHS). I 

am delighted to be here today to tell you about the progress we are making toward 

understanding, treating, and preventing AD. 

Dr. Zerhouni’s statement cites the number of Americans whose lives are deeply 

affected by AD. The numbers are indeed stark and are growing with the aging population. But there is another part of the Alzheimer’s story that we can tell; although 

AD remains a major public health issue for the United States, we have made, and 

are continuing to make, dramatic gains in our ability to understand, diagnose, and 

treat the disease. This progress offers us hope of reversing the current trends so 

that the risk of AD can be reduced for millions of older adults and their families. 

As the lead Federal agency supporting AD-related research, the National Institute 

on Aging conducts and supports a portfolio of research that encompasses topics 

across the spectrum of AD-related inquiry. Active areas of research include basic 

brain biology, pre-clinical and clinical research on potential interventions, and population-based assessment of the epidemiology, economic, social and psychological 

11 

costs of dementia to the family and society. Our research agenda is broad, and we 

pursue that agenda in partnership with scientists across the Nation. In October 

2006, NIA convened a major scientific planning meeting to discuss future directions 

for Alzheimer’s disease research at NIH, with particular attention to research issues 

that need to be addressed in order to improve diagnosis and treatment of AD. This 

meeting brought together internationally-recognized experts in the field, and the results will influence the direction of the research we support over the next few years. 

RISK FACTORS AND EARLY DIAGNOSIS

Identification of risk factors for AD may enable us to develop interventions to 

delay or even prevent its onset, and NIA-supported researchers are making important advances in several key areas. 

Genetics. Discovery of risk factor genes will help illuminate the underlying disease 

processes of AD, open up novel areas of research, and identify new targets for drug 

therapy. Researchers recently determined that variations in a gene known as 

SORL1 may be a risk factor for the development of late-onset AD. While this discovery provides a new genetic clue about the late-onset forms of AD, further research is needed to determine the role of SORL1 in AD pathogenesis. 

Research is continuing in this important area through the AD Genetics Initiative, 

which to date has recruited nearly 1,000 families to establish a resource for studies 

of the genetics of late-onset AD. In addition, NIA has established a national genetics 

data repository to facilitate access by qualified investigators to genotypic data for 

the study of the genetics of late-onset AD. Investigators have already begun submitting data to this repository and requesting additional data for genetic studies. We 

also expect genome-wide association studies, mentioned by Dr. Zerhouni, to provide 

important information about AD’s genetic underpinnings. 

Health Conditions Affecting Risk. Population studies suggest that conditions affecting cardiovascular and cerebrovascular systems may be associated with higher 

risk for dementia or that the presence of vascular disease may influence the progression of AD. One recent report indicated that AD dementia may be exacerbated 

by other cerebrovascular problems such as small strokes, while another linked untreated high blood pressure in mid-life with increased risk of dementia in later life. 

The possible association of diabetes, insulin resistance, and AD is garnering increased attention as well. Recent findings from at least four long-term studies link 

diabetes with decline in cognitive function. The NIA is currently supporting three 

clinical trials to examine directly whether diabetes-related interventions might be 

effective in preventing or delaying cognitive decline or development of AD or AD 

progression. 

Early Diagnosis: Advances in Neuroimaging. Research suggests that the earliest 

AD pathology begins to develop in the brain long before clinical symptoms yield a 

diagnosis. Therefore, it is critical that we find a way to detect signs of the disease 

at the earliest point possible so that we can test interventions and, ultimately, treat 

the disease as early as we can. Toward that end, the NIA has embarked on ambitious efforts to find new ways to measure AD changes in the brain or in other systems including blood and cerebrospinal fluid. These programs are already yielding 

results. Improvements in brain imaging, coupled with the development of more sensitive cognitive tests, are enabling us to diagnose AD in the research setting with 

greater precision than ever before. The discovery of compounds such as Pittsburgh 

Compound B and, more recently, FDDNP that enable the visualization of AD’s characteristic amyloid plaques and neurofibrillary tangles in the living brain—an impossibility only a few years ago—will not only enable scientists to diagnose AD earlier, 

but may also help researchers and clinicians develop new treatments and monitor 

their effectiveness, as well as reduce the time and cost of clinical trials. 

Research in this area has been intense and productive. The Alzheimer’s Disease 

Neuroimaging Initiative (ADNI) is currently the major venue for facilitating 

neuroimaging research relevant to AD. Early results from ADNI show that, in addition to aiding early diagnosis, researchers may be able to reduce the time and expense associated with clinical trials by improving methods and developing uniform 

standards for imaging and biomarker analysis. For example, one ADNI study found 

that a standard physical model can be used successfully to monitor performance of 

MRI scanners at many different clinical sites; this will help ensure accuracy of the 

MRI images produced from ADNI volunteers. Investigators on another ADNI study 

compared changes over time in PET scans of brain glucose metabolism in people 

with normal cognition, mild cognitive impairment, and AD, and they found that 

scans correlated with symptoms of each condition and that images from different 

clinical sites were consistent across sites, suggesting the validity of PET scans for 

12 

monitoring the effectiveness of therapies in future clinical trials. This study will 

continue to provide a foundation for future efforts to identify biomarkers. 

An important achievement of ADNI is the creation of a publicly accessible database available to qualified researchers worldwide. The database contains thousands 

of MRI and PET scan brain images and clinical data and will include biomarker 

data obtained through blood and cerebrospinal fluid analyses. ADNI includes samples and brain scans from 200 people with Alzheimer’s, 400 people with mild cognitive impairment and 200 cognitively healthy people. All volunteers are between 

ages 55 and 90. Confidentiality of the participants is rigorously protected. To date, 

over 200 researchers have signed up for database access. 

TRANSLATIONAL RESEARCH: MOVING BASIC FINDINGS INTO CLINICAL PRACTICE

New findings about AD’s characteristic pathology are leading to insights that may 

eventually inform treatment strategies. Amyloid and amyloid-producing enzymes, 

tau, oxidative damage to the brain, and mediators of inflammation are all under 

consideration as treatment targets, and investigators are also looking at new ways 

to protect brain cells as they age and to validate ways to enhance memory and improve cognition with age. For example, recent discoveries have provided support for 

the validity of beta-secretase (BACE1) as a therapeutic target. BACE1 comes from 

a family of enzymes known as secretases that cut, or cleave, the amyloid precursor 

protein (APP) in the brain; working in concert with a partner enzyme, gamma 

secretase, BACE1 is responsible for the formation of amyloid in AD. In a recent 

study, NIA-supported investigators were able to silence the production of BACE1 in 

mice that were genetically engineered to develop AD-like pathology. They found that 

reducing BACE1 levels slowed the production of amyloid plaques and diminished 

the damage to neurons and synapses in the brains of the mice receiving the treatment. Notably, the mice in which BACE1 production was halted had less difficulty 

learning a new task than control mice. NIA’s Translational Research Initiative aims 

to speed research across the continuum of intervention development, from drug discovery to full-scale clinical trials. Components of the effort include grant solicitations to stimulate the discovery, development, and preclinical testing in cellular, tissue, and animal models of novel compounds for the prevention and treatment of the 

cognitive impairment and behavioral symptoms associated with AD. The ultimate 

goal of this initiative is to facilitate submission of investigational new drug applications to the Food and Drug Administration so that more clinical trials testing promising therapies can be started. NIA also supports toxicology services for investigators or small companies that have a potentially viable candidate drug for AD treatment but lack the resources to begin the formal drug testing process. 

In addition, NIA is currently supporting approximately 25 AD-related clinical 

trials. These include studies of: 

• Physical exercise, which epidemiological studies suggest may have a specific influence on aspects of cognitive decline. Small clinical trials are currently testing the 

effects of exercise on cognitive decline and brain function, both in older adults with 

normal cognition and in persons with mild cognitive impairment with memory decline. 

• Statins, which lower cholesterol levels, to determine whether these drugs can 

modify disease progression in people with mild AD. 

• Valproate, which is used to treat epilepsy and some psychiatric disorders, to determine whether this drug can slow decline or help delay the agitation and psychosis that often accompany AD. 

Dr. Zerhouni mentioned in his statement that the Alzheimer’s Disease Cooperative Study will implement several new clinical trials over the next 6 years. One, a 

study to determine whether docosahexaenoic acid (DHA), an omega–3 fatty acid, 

will slow cognitive decline in AD, has begun recruitment. Other trials planned by 

the ADCS include: 

• Intravenous Immunoglobulin (IVIg). IVIg, a form of passive immunization, contains naturally-occurring antibodies against beta-amyloid, and preliminary studies 

have shown that IVIg promoted clearance of beta-amyloid from cerebrospinal fluid, 

as well as improved cognition in AD. The new ADCS trial will demonstrate whether 

IVIg is useful clinically for treating AD. 

• Lithium. Lithium, commonly used to treat bipolar disorder, has been shown in 

animal studies to block abnormal changes in tau and to regulate beta-amyloid. 

ADCS investigators will undertake a pilot biomarker study to see whether the drug 

can lower tau and beta-amyloid levels in cerebrospinal fluid and be safely tolerated 

in older AD patients. 

13 

We have also been encouraged by several recent studies related to AD prevention 

and the maintenance of cognitive health in old age. In 2006, results from the Active 

Cognitive Training for Independent and Vital Elderly (ACTIVE) study demonstrated 

for the first time in a randomized, controlled trial that certain mental exercises can 

offset some of the expected decline in older adults’ thinking skills and show promise 

for maintaining cognitive abilities needed to do everyday tasks such as shopping, 

making meals, and handling finances. Some of the benefits of the short-term training tested in this study lasted for as long as 5 years. Investigators also recently announced the discovery of the first agent shown to delay the clinical diagnosis of Alzheimer’s in people with amnestic mild cognitive impairment (MCI), an MCI subtype 

strongly correlated with the later development of AD. The investigators found that 

individuals who took the drug donepezil (Aricept®) were at reduced risk of progressing to a diagnosis of Alzheimer’s disease during the first year of the trial. In 

addition, there was benefit over a longer 2-year period that was limited to those individuals positive for the APOE–4 gene allele, which confers a strong predisposition 

to the development of late-onset AD. Although donepezil’s effects were limited, the 

results are nonetheless encouraging. And although too little is known about 

donepezil’s long-term effects to support a recommendation for its routine use to forestall the diagnosis of AD in people with mild cognitive impairment, these findings 

do suggest that chemoprevention of AD is possible and support our hope that future 

clinical studies will lead to more significant progress. 

CAREGIVER SUPPORT

Most Americans with AD today are cared for outside institutional settings by an 

adult child or in-law, a spouse, another relative, or a friend. Research has shown 

that the stress of caring for a loved one with AD can have a profoundly negative 

impact on health and well-being. NIA-supported investigators have found that a 

personalized intervention consisting of home visits, structured telephone support 

sessions, and telephone ‘‘check-ins’’ can significantly improve the quality of life for 

AD caregivers. The study, Resources for Enhancing Alzheimer’s Caregiver Health II 

(REACH II), was funded by NIA and NIH’s National Institute of Nursing Research 

and is the first randomized, controlled trial to look at the effectiveness of an AD 

caregiver support intervention for ethnically diverse populations. Follow up studies 

are needed to examine how the intervention might be used through existing community networks of health and aging services. 

OUTREACH TO THE PUBLIC

Since its inception, NIA has provided the public and health professionals with information about Alzheimer’s disease and age-related cognitive change. Twenty-one 

years ago, Congress established NIA’s Alzheimer’s Disease Education and Referral 

(ADEAR) Center to ‘‘compile, archive, and disseminate information concerning research, demonstration, evaluation, and training programs and projects concerning 

AD and related dementias.’’ Today, that mission is being accomplished through a 

wide variety of materials, resources, and activities for the general public, health professionals, and people with Alzheimer’s disease and their families. 

ADEAR’s programs are active and comprehensive. For example, the number of 

print materials distributed went from about 377,000 in 2005 to more than 645,000 

in 2006. As more and more Americans turn to the Internet for health information, 

the Center has experienced a striking increase in the number of web visits, up from 

1.9 million in 2005 to 2.9 million in 2006. Further, the NIA and ADEAR Center 

staff, based in Silver Spring, MD, proactively invite the public to use its resources. 

In 2006, the ADEAR Center distributed 43 e-mail alerts to various subscriber lists, 

letting subscribers know about research news, new publications, and other updates. 

The effectiveness in developing information products and strategies is based in 

part on the NIA’s collaborations with agencies, academic institutions, and other organizations. The success of new easy-to-read publications involved collaboration between the ADEAR Center and the NIA’s network of Alzheimer’s Disease Centers. 

A new project aims to respond to a lack of materials for the newly emerging audience of people with early-stage AD and their families. In this effort, ADEAR is 

working with the Northwestern University School of Medicine’s Alzheimer’s Research Center to produce a publication What Happens Next: A Booklet About Being 

Diagnosed with AD and Related Disorders. The booklet is actually written by earlystage patients to provide those newly diagnosed with resources and with comfort 

and support from others who have walked the same path. 

14 

CONCLUSION

It is difficult to predict the pace of science or to know with certainty what the 

future will bring. However, the progress we have already made will help us speed 

the pace of discovery, unravel the mysteries of AD’s pathology, and develop safe, effective preventions and treatments, to the benefit of older people and their families. 

Thank you for giving me this opportunity to share with you our progress on Alzheimer’s disease. I would be happy to answer any questions you may have. 

Senator MIKULSKI. Well, we’ll come back to you but now we want 

to hear from Dr. Joy Gerberding, our Director of the Centers for 

Disease Control and Prevention. I want to acknowledge the fact 

that our colleague from Georgia, Senator Isakson, has joined us. He 

has a long time, both personal and professional interest in this 

issue and his advocacy is really most welcome, his prudent advocacy on this committee. 

Dr. Gerberding, we’re anxious to hear from you. You’ve been at 

CDC now for 10 years and you were there as the Deputy Director 

for Infectious Disease, dealing with things like Anthrax, but now 

tell us how you’re going to deal with another A word. But we really 

count on CDC for this kind of news that you can use. 

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

GA 

Dr. GERBERDING. Thank you very much and CDC is very privileged to be here and to have a chance to speak to our Senators and 

we thank Senator Isakson for coming. We really appreciate the 

support the Georgia delegation brings us as well. 

You know, when you think about Americans, all of us are aging 

and when you think about what people really want when they age, 

they want to be able to work productively and then retire and enjoy 

some leisure time, do the things that they missed doing when they 

were working. They want to enjoy their loved ones and their 

friends. They want to be able to contribute to their communities 

and I think most of all, they want to be independent. 

But what do Americans fear? Well, about 30 percent of them fear 

loss of physical functioning but about two-thirds of them are afraid 

that they are going to lose their mental capacity and sadly, for 

about 4.5 million people today, the worst has happened. They have 

developed Alzheimer’s disease and they really truly are suffering 

the most severe form of cognitive impairment. 

What we need to focus on is not just the 4.5 million people who 

are robbed of their independence. I like to think of this as the great 

brain robbery because it truly does take away people’s ability to do 

the things that they value most in life. But we also need to think 

about their caregivers who are profoundly impacted, about 7 out of 

every 10 people with Alzheimer’s disease live at home and we need 

to remember that there are things that we can do today to help 

ameliorate this burden on individuals, their caregivers and our society. 

I want to thank Congress for supporting CDC to bring together 

the collaboration that helped create this roadmap, the Healthy 

Brain Initiative. This represents the input of many people at this 

table but I would also like to acknowledge a quartet of people who 

are not here today and that would be Josefina Carbonell from the 

15 

Aging Group at HHS, Betty Duke from HRSA, Carolyn Clancy 

from AARC and Leslie Norwalk from CMS, in four other agencies 

and those women would have big signs, too, if they were here at 

the table because they’ve made some tremendous contributions to 

this issue and I think across HHS, we recognize that Federal leadership really is important but we also need to work with the Alzheimer’s Association and others to create and enact this kind of 

roadmap. 

There are two tragedies. One is the tragedy of not knowing what 

to do and you’ve heard, I think, some of the exciting research that 

our collaborators at NIH are working on. You’ll hear from Dr. von 

Eschenbach about what the FDA can do. So there is the tragedy 

of not knowing and I think we are investing in learning more and 

being able to do more. 

But there is also the current and ongoing tragedy of not doing 

what we know and I think that’s what this roadmap is all about, 

that there are things that we can and should be doing now. We 

need to make a commitment. We need to inspire people to share 

that commitment. We need to build the partnerships and I think 

most importantly, we need to get the word out that prevention is 

possible. 

We already know that vascular disease is a major risk factor for 

the development of cognitive dysfunction. There are some hints 

that physical activity may be important, some early hints that 

maybe diabetes, exposure to passive tobacco and in fact, if you look 

at the health promotion agenda for health aging, many of the 

things that we should already be recommending to our seniors are 

the same constellation of things that may end up having a very important role in protecting cognitive health as well. 

So we need to reach out and help seniors achieve the best possible health span and I think importantly, that includes a much 

greater emphasis on cognitive health. 

I’d just like to end with one little vignette of hope. There is a 

wonderful program that was supported in Seattle, in part through 

one of CDC’s Prevention Research Centers, whom were using some 

volunteer physical trainers in the community facility for seniors. 

They initiated an exercise program and what they were able to 

show with a very small investment that the participating seniors 

had better balance. They were overall better fit. They were 

happier. They reported better mental health and most importantly, 

their program was associated with a 23 percent reduction in group 

health expenses. So a very small investment, a very significant improvement in health, even for some very senior people and I think 

it means that we have to never give up. There is always room for 

health promotion and always room for prevention at every age. 

Thank you. 

[The prepared statement of Dr. Gerberding follows:] 

PREPARE STATEMENT OF JULIE L. GERBERDING, M.D., M.P.H. 

Good afternoon, Madam Chair, Senator Burr, and distinguished members of the 

subcommittee. I am Dr. Julie Louise Gerberding, Director of the Centers for Disease 

Control and Prevention (CDC) within the Department of Health and Human Services (HHS). Thank you for the opportunity to be here today to talk with you about 

the importance of safeguarding the cognitive health of our Nation’s aging population. We, at CDC, share your commitment to doing all we can to address the imVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00019 Fmt 6633 Sfmt 6621 S:\DOCS\36838.TXT DENISE
16 

1 American perceptions of aging in the 21st century. Washington, DC.: The National Council 

on Aging, Inc., 2002. 2 Research!America. America speaks. Poll data summary, volume 7. Alexandria, VA: Research!America; 2006. http://www.researchamerica.org/polldata/2006/mentalhealth9–06.pdf 

(slide 6). 

pact of cognitive impairment, which includes Alzheimer’s disease and other forms 

of dementia. We recognize the impact it has on individuals, families and society. As 

you know, the numbers of people with Alzheimer’s disease and other dementias are 

expected to increase substantially over the coming decades unless these conditions 

can be prevented. 

Thanks to funding provided by Congress, CDC has established an Alzheimer’s disease segment within the Healthy Aging Program, which we refer to as the Healthy 

Brain Initiative. We have reached out to collaborate with the National Institutes of 

Health and the Administration on Aging, and we have formed a strong partnership 

with the Alzheimer’s Association. A critical outcome from this partnership is the release last month of The Healthy Brain Initiative: A National Public Health Road 

Map to Maintaining Cognitive Health. I will tell you more about this Road Map 

shortly. 

With the increase in life expectancy over the past century, most older adults look 

forward to having a long life. However, one of the greatest worries about living to 

age 75 and beyond revolves around memory loss.1 The public’s concerns about losing 

their mental capacities as they age are also reflected in a recent national poll conducted by Research!America.2 When asked to think about aging and losing either 

physical or mental capacity, 62 percent of respondents indicated they feared losing 

their mental capacity as compared to 29 percent who feared losing their physical 

ability. These fears of declining mental capacity and Alzheimer’s disease have led 

to increased attention by the public, the media and public health professionals. Despite all the attention, the public and even many health care providers still know 

very little about the specific factors that increase a person’s risk of experiencing cognitive decline. 

CDC recognizes the importance of considering the entire person and not focusing 

on physical health alone. One of our four key Health Protection Goals is to ensure 

that all people, and especially those at greater risk of health disparities, will achieve 

their optimal lifespan with the best possible quality of health in every stage of life. 

This holistic approach takes into account mental and cognitive health as well as 

physical health. 

I would like to briefly define cognitive decline and talk about how the aging of 

our population is expected to affect the national burden posed by cognitive impairment. I will then talk about the role of public health, including a brief highlight of 

our achievements to date and where we expect to take these activities in the future. 

DEFINITION OF COGNITIVE DECLINE

Much like physical health, cognition can be viewed along a continuum—from optimal functioning to mild cognitive impairment to severe dementia. While there are 

certain cognitive changes that occur with age—what we call normal age-related 

changes—such as a slower pace of learning and the need for new information to be 

repeated, cognitive decline is not a normal part of aging. It is more serious. Cognitive decline can range from mild cognitive impairment to severe dementia, but 

these two conditions are not necessarily manifestations of the same condition. Many 

people never develop any serious decline in their cognitive performance and those 

who develop mild cognitive problems do not necessarily develop dementia or Alzheimer’s disease. 

IMPLICATIONS OF A RAPIDLY AGING POPULATION

The aging of the U.S. population is expected to place demands on our public 

health system, medical services and social services. The growth in the number and 

proportion of older adults is unprecedented in the history of the United States. A 

hundred years ago, only 3 million people in this country were aged 65 or older. 

Today, more than 36 million Americans are in this group, and that number is expected to grow during the next 25 years to more than 70 million as the baby 

boomers age. Public health’s prevention efforts and improved medical care have contributed to a significant increase in life expectancy in the United States during the 

past century. However, this success has been accompanied by a major shift in the 

leading causes of death for all age groups, including older adults, from infectious 

diseases to chronic and degenerative illnesses. Alzheimer’s disease is one of the top 

10 leading causes of death. We know Alzheimer’s disease and cognitive impairment 

17 

have economic costs and impacts on individuals and their families. Recent scientific 

advances have highlighted potential risks associated with cognitive decline and may 

ultimately pave the way for preventing cognitive decline. 

Alzheimer’s disease and cognitive impairment can cause years of disability, and 

loss of function and independence. We must focus on preventing or delaying disability and the loss of function. Although the risk for disease and disability clearly 

increases with advancing age, poor health is not an inevitable consequence of aging. 

It is a priority for all of us that we work to find ways to prevent or postpone functional loss including losses to physical, mental and cognitive health. 

BURDEN OF COGNITIVE DECLINE

In the United States, the burden of cognitive impairment has been expressed 

mainly in terms of prevalence, incidence, and mortality for dementia generally or 

for Alzheimer’s disease in particular. An estimated 4.5 million people currently have 

Alzheimer’s disease, and census population projections indicate that by 2050, as 

many as 16 million individuals will have the disease. More recently, prevalence statistics for mild cognitive impairment have become available. Mild cognitive impairment refers to a level of impairment that is more serious than normal age-related 

changes, but it is not as severe as Alzheimer’s disease or other forms of dementia. 

Studies from the United States and Canada have suggested that mild cognitive impairment may be a problem for 16–25 percent of older adults aged 65 years and 

older. 

SOCIETAL AND ECONOMIC IMPACT

Alzheimer’s disease and other dementias place a costly burden on the Nation’s 

health care system. Individuals with Alzheimer’s disease make up less than 13 percent of the Medicare population, yet they account for 34 percent of Medicare spending (approximately $91 billion in 2005). In 2000, Medicare spending for persons with 

Alzheimer’s disease and other dementias was nearly three times as much, on average, as spending for individuals without these conditions (Urban Institute, unpublished tabulations from the 2000 Medicare Current Beneficiary Survey and Medicare Claims, 2005; published by the Alzheimer’s Association, Alzheimer’s Disease 

Facts and Figures, 2007). 

Cognitive decline can have profound implications for a person’s health and quality 

of life. It affects a person’s ability to use words, identify objects, make decisions, and 

communicate with loved ones. Gradually, people experiencing severe cognitive decline may be unable to care for themselves or to engage in necessary activities of 

daily living or instrumental activities of daily living, such as preparing meals or 

managing their finances. Cognitive decline may also limit one’s ability to effectively 

manage medications and existing medical conditions. Adverse changes in cognitive 

abilities can make an individual more vulnerable to malnutrition, improper use of 

medications, injuries, and even abuse and other crimes. 

The adverse effects of cognitive decline go well beyond those suffering from it. 

Seven out of every ten people with Alzheimer’s disease live at home. Caregivers 

often find the task of caring for a person with Alzheimer’s disease to be physically 

exhausting and emotionally challenging. The demands on caregivers adversely affect 

their lives and eventually impact our economy when caregivers must take time off 

from work, work part-time instead of full-time, take less demanding jobs, opt for 

early retirement, or stop working altogether. Because of these adjustments, Alzheimer’s disease costs American businesses billions of dollars each year—more than 

$36 billion in lost productivity (absenteeism, productivity losses, and worker replacement costs) plus nearly $25 billion for the businesses’ share of coverage for health 

and long-term care expenses (Koppel R. Alzheimer’s disease: the costs to U.S. businesses in 2002. Chicago, IL: Alzheimer’s Association; 2002.). 

THE ROLE OF PUBLIC HEALTH

Public health’s role in physical health is well defined. Thanks to decades of multidisciplinary research, prevention efforts are now applied to a variety of chronic conditions and their associated risk factors. In the area of cognitive health, however, 

we have only recently begun to delineate public health’s roles and responsibilities. 

Alzheimer’s disease and other dementias are costly and debilitating, and we anticipate the incidence of Alzheimer’s disease and other dementias will increase 

markedly as our population ages. Recent scientific findings by the National Institutes of Health focus on factors such as high blood pressure, diabetes and physical 

inactivity associated with cognitive decline. According to the Cognitive and Emotional Health Project report, a large number of lifestyle and health behaviors may 

18 

3 Hendrie HC, Albert MS, Butters MS, Gao S, Knopman DS, Launer LJ, et al. The NIH cognitive and emotional health project: report of the critical evaluation study committee. Alzheimer’s & Dementia 2006;2:12–32. 

alter the risk for maintenance of cognitive and emotional health.3 However, the report cautions that it is not yet possible to develop individual prescriptions. 

Public health has an opportunity to build upon existing knowledge, anticipated future breakthroughs, and the public’s desire for information. By embracing cognitive 

health as a priority issue, the public health community with CDC’s leadership can 

be mobilized to study, identify, implement, and monitor effective interventions that 

preserve this key component of health and well-being, and help to maintain independence and quality of life. 

COGNITIVE HEALTH: AN EMERGING PRIORITY AT CDC

CDC recognizes the vital role that physical, mental and cognitive health play in 

shaping our overall well-being. We are committed to ensuring that all people, especially those at risk for health disparities, enjoy good health and the best possible 

quality of life at every stage of life. For older adults, a primary goal is to ensure 

that the years gained through increased life expectancy are healthy years and to 

prevent or delay illness and functional decline. It might be said that our goal is to 

help ensure Americans live a vibrant and productive life throughout their aging 

years. 

CDC takes a multi-faceted approach to improving cognitive health. Some of the 

outcomes CDC has either achieved or is working to advance include the following: 

• Last month we released The Healthy Brain Initiative: A National Public Health 

Road Map to Maintaining Cognitive Health (www.cdc.gov/aging/roadmap). This 

call to action proposes priority actions to move cognitive health into the national 

public health arena. The Road Map is a major accomplishment. Under shared leadership of the CDC and the Alzheimer’s Association, and in close collaboration with 

the National Institutes of Health, the Administration on Aging and others, we embarked on an intensive process to develop the Road Map. Several cross-cutting areas 

of focus are recommended drawing on the proven expertise and capacities of the 

public health community. These include communicating the current state of science 

about cognitive health to Americans; developing tracking measures to better understand the public health burden of cognitive impairment; and delineating the potential value of public health strategies known to be effective for other health issues, 

such as physical activity, in maintaining cognitive health and preventing cognitive 

decline. • CDC is bringing public health practice and research communities together to 

move them forward on getting out current scientific information about cognitive 

health. CDC is funding the Healthy Aging Research Network, within its larger Prevention Research Centers Program (PRC–HAN), to increase our understanding of 

the public’s, including caregivers and health care providers, needs and perceptions 

about cognitive health. Assessing the public’s needs and how they think and talk 

about this issue is an important part in addressing cognitive health. 

CDC is excited to be at the forefront of national efforts, working in collaboration 

with Federal and private sector partners, to advance cognitive health. Cognitive 

health is a cross-cutting issue that touches upon areas such as vascular risk factors, 

physical activity, social engagement, and caregiving. It fits within CDC’s healthy 

aging agenda and older adult health goal to promote health at every stage of life. 

It is aligned with CDC’s commitment to increase the number of older adults who 

live longer, high-quality, productive, and independent lives. Our involvement with 

the Healthy Brain Initiative also is aligned with CDC’s strategy to create and disseminate the knowledge and innovations people need to protect their health now 

and in the future. 

CDC is known for monitoring changes in health status, translating research into 

practice and providing high-quality health information. Maintaining cognitive health 

and preventing cognitive decline is a cross-cutting issue. CDC’s activities to prevent 

cognitive decline already touch on several promising areas, such as physical activity, 

and managing diabetes and cardiovascular risk factors. However, our work also extends to new areas, such as the benefits of social engagement and caregiving concerns. Working within the framework set out by the Road Map, CDC has identified 

several national public health efforts we can best advance and support to safeguard 

Americans’ cognitive health. We hope to build upon our existing activities with the 

Alzheimer’s Association and other partners to put critical public health elements in 

place to promote cognitive health and prevent cognitive decline. As the science 

evolves, we hope to develop community-based public health interventions designed 

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to help Americans maintain their cognitive health. And, as we proceed on this journey together, we look forward to collaborating with our colleagues across the Department of Health and Human Services to inform the Nation’s public health infrastructure about the science undergirding our knowledge about cognitive health and 

promising interventions. 

CLOSING SUMMARY

Thank you for the opportunity to speak on the issue of cognitive health and the 

benefits of addressing cognitive health within the public health arena. No less than 

cardiovascular disease, cancer or diabetes, addressing cognitive impairment should 

be a critical public health priority and deserves committed national public health 

action. Promising research findings coupled with public health action in the areas 

of epidemiology, surveillance and evidence-based interventions can translate to a 

difference in our understanding of cognitive decline, and our ability to address this 

issue in a positive way for the benefit of all Americans. We at CDC appreciate your 

continued commitment to efforts related to Alzheimer’s disease and other dementias, and we look forward to working with you and our national partners in ensuring 

that cognitive health is addressed in an aggressive manner commensurate with the 

fundamental role that it plays in our overall health and quality of life. I would be 

happy to answer any questions you might have. 

Senator MIKULSKI. Dr. von Eschenbach, you’ve come to us from 

FDA that has the job of standing sentry over our food supply and 

our drugs to go into clinical practice and our medical and biomedical products and devices. You come with an incredible background and you were at NIH yourself, heading the National Cancer 

Institute. And now, of course, you come with a background in oncology. We’d like to hear, then, from you, how you see FDA’s role 

in dealing with the epidemic, at the same time having the mandate. We ask you to do two things. We ask you to move things as 

quickly as possible into clinical practice but at the same time, including this committee, has been very demanding in terms of the 

safety issues as well as efficacy. 

So tell us how you see we can deal with the epidemic, the new 

thinking, how you work with the private sector. 

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

Dr. VON ESCHENBACH. Thank you very much, Senator and thank 

you for framing it so well, but let me first thank you and Senator 

Burr and Senator Isakson and other members of the committee for 

convening this really extremely important discussion. I’m joined 

today from the FDA by Dr. Bob Temple and Susan Winkler, Rph, 

Esq., but it’s a particular honor for me to appear on the same panel 

with my colleagues from CDC and from NIH. 

Dr. Zerhouni, Dr. Gerberding and I have been working hard to 

make our relationships productive and integrated so this is not 

simply a ceremonial gathering. This is evidence of a commitment 

on our part for close collaboration to be able to accomplish progress 

in the diseases like Alzheimer’s. 

Every promising new drug, every diagnostic test, every imaging 

technology that’s designed to help Alzheimer’s patients must come 

through the FDA before it reaches those people. So our responsibility is to help make sure that those products are available and 

to determine that they are safe and effective. We are doing this imVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00023 Fmt 6633 Sfmt 6601 S:\DOCS\36838.TXT DENISE
20 

mersed in the 21st century revolution in science and technology 

that I personally describe as the molecular metamorphoses. 

It’s particularly important because it now provides us, as you 

heard from Dr. Hodes, unique opportunities to understand diseases 

like Alzheimer’s at the genetic, molecular and cellular level and 

therefore be able to make possible extraordinary new opportunities, 

new interventions, new solutions to prevent, treat and slow the 

progression of this disease. 

In that context, FDA—the FDA of the 21st century must be a 

bridge and not a barrier to that new future. From the very discovery of promising new therapies through their development and 

ultimately to its delivery to Alzheimer’s patients, FDA is committed 

to be immersed in promoting and fulfilling our promise to the 

American people. 

We must be actively engaged at every step along that continuum 

and we want to do that in a way to be an efficient and effective 

pathway so that we’re free of speed bumps and potholes in our regulatory process. But as you pointed out, also be sure that we have 

strong guard rails on that pathway with guidances, regulations and 

standards that will also protect the American people. 

Central to our efforts in this regard to modernize the FDA is the 

Critical Path Initiative, which is bringing the tools of modern 

science and technology to the regulatory journey that these medical 

products, these solutions must make from the earliest stages of development to their use in patients. We, among the Critical Path 

Initiatives, have many activities that are being carried out in partnership with NIH and others, particularly, for example, around the 

area of developing biomarkers that can be used to determine the 

impact of a drug on the amyloid plaque that is associated with Alzheimer’s disease or to use new clinical trial designs that will not 

require 20 years for us to determine whether a new product can 

help prevent this dreaded disease. 

We are, in a sense, attempting to try to open the floodgates of 

the development of products for Alzheimer’s disease and we will 

continue to move this process forward in concert with and in collaboration not only with our partners but with the community. 

Over the past year, I’ve personally met with two prominent Alzheimer’s disease patient advocacy organizations, the Alzheimer’s 

Association and the organization, Accelerate New Treatments for 

Alzheimer’s disease. I share their concerns around the urgency of 

FDA’s ability to bring these new products to patients. 

We are continuously, throughout FDA, remaining in contact with 

these organizations and particularly to be able to understand the 

opportunities that we must be addressing. We also are engaged 

with the academic industry and particularly seeing this as a problem in which we are all in this together: industry, government, 

caregivers and the scientific community. 

I just want to highlight a few of the important initiatives that 

I think are tangible contributions to this overarching strategic perspective. During fiscal year 2006, our Division of Neurological 

Products and our Center for Drug Evaluation and Research held 18 

formal meetings with industry and this doesn’t include internal 

FDA meetings to discuss sponsors’ investigational new drug applications. To this date, the Division has met with industry six times 

21 

in an effort to help facilitate their ability to develop and bring to 

the regulatory process, successful drugs for Alzheimer’s disease. 

We need to also be able to leverage progress that’s being made 

in other neurologic diseases. For example, we are conducting a 

planning meeting to help determine the best designs for clinical 

trials for Parkinson’s disease but we are doing that in a way in 

which we expect to extrapolate those results for our formal guidance that would be directed and applicable to trials, clinical trials, 

in Alzheimer’s. 

We’re working to improve our internal processes, our standards, 

our processes for expediting review and we’ve established within 

the FDA, an inter-agency neurological working group so that we’re 

focused across the agency on the critically emerging problems that 

we’re discussing today. This group meets monthly, includes members from our Center for Biologics Evaluation and Research, our 

Center for Drug Evaluation and Research, our Center for Devices 

and Radiologic Health, along with the Office of the Commissioner, 

Office of Critical Path Programs, Office of Special Health Issues 

and Office of Science and Health Coordination. This is an effort to 

bring the full force of the FDA to bear on this critically important 

problem. 

We’re also attempting to contribute to the underlying understanding of this disease and the tools that we must apply so that 

within the FDA’s National Center for Toxicological Research in Arkansas, we have two very specific Alzheimer’s-related projects underway. One is to develop a non-invasive automated technology for 

assessing patients with Alzheimer’s disease so that we may be able 

to provide reliable and objective measures to monitor the progression of the severity of the disease and the impact of these innovations on that progression. We see this as an invaluable tool that 

will spur academic research in the pharmaceutical and biotechnology industry in the development of these medical products. 

We’re also looking at a new histochemical test battery that will 

enable us, as regulators, to assess the efficacy and toxicity of potential drugs for Alzheimer’s and this could help us be able to streamline and improve the development of these drugs to be able to bring 

them more reliably, more safely and sooner to patients that are 

threatened by this degenerative disease. 

These are just a few examples of how we at the FDA want to be 

a bridge and not a barrier to providing hope and expectation for 

those with and those threatened by Alzheimer’s disease for a new 

future, a future in which they will not fear the consequences of this 

terrible degenerative process. 

[The prepared statement of Dr. von Eschenbach follows:] 

PREPARED STATEMENT OF ANDREW C. VON ESCHENBACH, M.D. 

INTRODUCTION

Madam Chairman and members of the subcommittee, I am Dr. Andrew C. von 

Eschenbach, Commissioner of Food and Drugs at the Food and Drug Administration 

(FDA or the Agency). I would like to applaud the subcommittee for holding this 

roundtable discussion to discuss Federal initiatives to address the cruelly debilitating condition known as Alzheimer’s disease. FDA shares your commitment to vigorously addressing Alzheimer’s disease, and shares your hope that safe and effective 

treatments for this condition will be approved in coming years. It is a pleasure to 

22 

be here today with my colleagues from the Department of Health and Human Services, Dr. Julie Gerberding, Dr. Elias Zerhouni, and Dr. Richard Hodes. 

I very much appreciate the opportunity to join this discussion to explain FDA’s 

role as it applies to new products being developed for treatment of Alzheimer’s disease. Further, I will describe several initiatives FDA is undertaking to transform 

the Agency in an effort to meet the regulatory challenges arising from rapid advancements occurring in all areas of medical research including Alzheimer’s disease, 

and several special initiatives underway at FDA that are directed toward Alzheimer’s disease. 

In the two recent hearings on Alzheimer’s disease before this subcommittee you 

heard current statistics recently released by the Alzheimer’s Association including 

that this disease now afflicts one in eight Americans over the age of 65 and some 

47 percent of Americans over the age of 85. At the present rate, the estimated 4.5 

million cases of Alzheimer’s disease today can be expected to rise to around 16 million by 2050. With the aging of the baby boom generation over the next several decades, without safe and effective treatments and preventatives, a huge population of 

seniors stands to be robbed by this disease of the enjoyment of their later years. 

In addition to the burdens placed on patients and their families, insurance programs 

surely will face overwhelming demands on their services and resources. 

There is cause for some cautious optimism. You also heard of exciting advancements in research on Alzheimer’s disease such as identification of amyloid peptide 

as a possible molecular cause of Alzheimer’s disease. Some researchers believe it is 

realistic to expect that the progress of Alzheimer’s disease can be slowed or halted 

by products developed to affect the amyloid peptide. However, researchers also have 

emphasized that this is a very complex disease that will need to be approached from 

several different directions. A number of promising new treatments in many areas 

are in the works; a few were mentioned in your previous hearings as approaching 

the stage of clinical trials. 

As you may know, FDA is legally restricted from discussing any individual products that already may be under review by the Agency. This precludes me from being 

able to discuss specific unapproved products in today’s public forum. I can tell you, 

however, that Alzheimer’s and other neurological diseases are very active areas of 

research and of work within the Agency. FDA reviewers interact constantly with 

manufacturers and sponsors of prospective new products (drugs, biologics, medical 

devices or combination products) to help develop, and then to review, suitable clinical trials to test whether their products are safe and effective. This is a very intricate and time-consuming process. Our reviewers work with industry in all phases 

of the development of a new product, both before and during clinical trials, as requested by the sponsors. As always, FDA stands ready to expeditiously review applications for any breakthrough products that are presented to us. 

FDA recognizes its dual role as evaluator of the safety and effectiveness of new 

therapies and as the encourager and facilitator of efforts to apply new scientific discoveries to patients who are in need. FDA serves as a bridge to the future of successful new medical product development. The Agency has a proud record over the 

past hundred years of being the world’s gold standard in medical product regulation, 

but FDA cannot rest on its past and must come to grips with the new realities of 

our regulatory responsibilities. Therefore, we have embarked on a process of looking 

internally at transformations that must occur within the Agency, and to identify opportunities to collaborate with drug developers and other scientists on the discovery, 

development, assessment and delivery of new treatments. I would like to share some 

of these efforts with you. 

THE CRITICAL PATH INITIATIVE

In today’s world of health care and medicine, we are on the brink of unprecedented advances in our ability to predict, diagnose, and treat disease. Approximately 

100 years ago, our ability to understand disease moved from the macro level, where 

we were limited to what was visible to the naked eye, to the micro level—when we 

gained a microscopic view of disease at the cellular level. In the last decade or two, 

we have been able to approach disease at the molecular level, where we now can 

observe and understand disease as a process. As our knowledge of genetic molecular 

mechanisms evolves and our understanding improves, we will be uniquely positioned to develop interventions against disease processes at the molecular level. 

Yet a problem emerges. Despite an unprecedented increase in funding for biomedical research, both in the private sector and through Federal funding, this increased research has not translated into many new medical products being available 

in the medical marketplace. There are exceptions, of course, notably in the development of new treatments for cancer and AIDS, and some inflammatory diseases. 

23 

Close to 9 in 10 pharmaceutical products in phase 1 clinical testing are never approved for marketing, and half of all drugs that enter phase 3 clinical trials are 

never approved. In an effort to help expedite and simplify the medical product development process, in 2004, FDA advanced the notion of focusing on the critical path 

which medical products must travel from the earliest stages of development to their 

use in patients. The Critical Path Initiative is FDA’s effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. 

FDA is working with the academic community, the public, the pharmaceutical industry, and other Federal health agencies (e.g., the National Institutes of Health 

(NIH), the Centers for Medicare & Medicaid Services, and the Department of Veterans Affairs) to modernize and transform the development and use of medicines. 

After intensive consultation with many stakeholders, last year the Agency published 

our Critical Path Opportunities Report, which details 76 specific scientific projects 

with great promise for smoothing the path from lab to bedside. Last December, we 

followed up by announcing more than 40 very promising scientific projects that we 

have helped launch. These projects support the development and approval of new 

treatments for conditions such as Alzheimer’s, diabetes, cancer, and chronic pain. 

For example, improved predictive and evaluative tools that help identify candidate 

products that are likely to fail early in the development process will enable the investment of resources in those products most likely to succeed. Streamlining clinical 

trials—making them more efficient and safer—will help move new therapies to patients sooner while protecting clinical trial participants. Among many other activities, the Initiative also supports the implementation of information technologies that 

will enable us to tap into existing data repositories to expand research into disease 

areas and improve efficiencies. The Critical Path Initiative is a long-term, national 

effort that is helping to ensure that promising new therapies in the development 

pipeline today will reach the patients who need them sooner and at less cost. The 

projects under way today as part of the Critical Path Initiative will improve treatment, improve safety, and improve patient access. 

Another example of the Critical Path Initiative is The Biomarkers Consortium 

launched in October 2006. This is a public-private biomedical partnership established by FDA and many colleagues in the scientific community that is supported 

by the Foundation for the National Institutes of Health. The Biomarkers Consortium strives to accelerate the delivery of successful new diagnostic approaches and 

therapies to prevent, detect early, diagnose, and treat a wide variety of diseases. 

Among other efforts, the Consortium seeks to identify biomarkers and develop tests 

to determine whether a drug is appropriate for an individual patient. It also is 

working to find ‘‘markers’’ that will show whether a drug is having the right effect 

in the patient. For example, researchers have found that patients whose tumors 

have specific genetic mutations or surface properties respond to particular treatments. This mutation then serves as a ‘‘marker’’ to identify the patients who are 

best treated with these medications. 

Over time, similar discoveries related to other tumors, other diseases and conditions, and other drugs will yield a major public health impact—and that is the point 

of the Critical Path Initiative. Working with all stakeholders, the Critical Path goal 

is to get the right medicine to the right patient, in the right dose, and at the right 

time. It will make innovative medical products available sooner, increase our ability 

to monitor their safe use once they have reached the medical market, provide for 

personalized diagnosis and treatment, and introduce great efficiencies while reducing risk. 

TWO EXAMPLES OF ALZHEIMER’S RESEARCH WITHIN THE AGENCY

Now, I would like to talk about two Alzheimer’s-specific projects that FDA has undertaken. First, FDA scientists from our National Center for Toxicological Research 

(NCTR) collaborated recently with scientists at the University of Arkansas for Medical Sciences, the University of Arkansas at Little Rock, and the Central Arkansas 

Veteran’s Health Care System to conduct an automated cognitive assessment of persons with and without Alzheimer’s disease. The study investigated performance on 

metrics for a variety of behavioral test tasks that measure timing perception ability, 

short-term memory, and learning ability using an automated system called the 

NCTR Operant Test Battery (OTB). The study outcome indicated that the persons 

with Alzheimer’s disease were significantly less accurate in the time perception and 

short-term memory tasks and were rarely responsive in the learning task. The OTB 

is a non-invasive, automated, non-threatening assessment technology that can differentiate between normal controls and persons with Alzheimer’s disease. This automated assessment instrument has the potential to provide reliable, objective measVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00027 Fmt 6633 Sfmt 6621 S:\DOCS\36838.TXT DENISE
24 

ures that can be used to monitor the progression and severity of the disease process 

and assess effectiveness of interventions over time. A report on this study is in preparation. 

Currently, FDA/NCTR scientists are initiating a study to develop a histochemical 

test battery for assessing the efficacy and toxicity of putative anti-Alzheimer’s disease drugs, the safety of which will need to be evaluated in the FDA regulatory review process. There are two broad categories of anti-Alzheimer’s drugs: those that 

provide symptomatic relief and those designed to prevent or slow the degenerative 

process. So far, those in the first category have been developed and shown effective, 

and are approved for use by FDA. Those designed to cure or reverse the disease 

process are in early development or, in some cases, in clinical trials. The development of a therapeutic histochemical test battery has the potential to help identify 

earlier and more reliably drugs that might slow the degenerative process. This 

study is scheduled to begin later this fiscal year. 

THE PATIENT REPRESENTATIVE AND CONSULTANT PROGRAMS

FDA also has engaged with the Alzheimer’s disease patient advocacy community 

regarding that community’s involvement in FDA decisionmaking during development of new medical products. Through FDA’s Patient Representative Program, 

they will be able to participate in FDA advisory committee meetings, advising the 

Agency on marketing approval decisions and in response to issues arising with marketed products, as well as help advise the Agency about the development of investigational drugs. Their involvement is important to FDA’s capacity to make informed regulatory decisions that are sensitive to the needs and preferences of those 

affected by this disease. 

This expansion of FDA’s programs has involved considerable challenge, as FDA 

has negotiated with Alzheimer’s disease advocacy organizations regarding the role 

of Alzheimer’s disease patients themselves. FDA considers patient involvement important, since patients with a given disease are generally best able to speak for others with that disease. Involvement of patients with Alzheimer’s disease is also an 

important priority to the Alzheimer’s disease advocacy community. However, participation of patients with Alzheimer’s disease is problematic because of diminished intellectual function that is a primary manifestation of this disease. This challenge 

is exacerbated by Alzheimer’s disease patients’ deterioration in intellectual function 

over time. 

After extensive negotiation, we have agreed to recruit advocates from the Alzheimer’s community, including couples consisting of a patient with early-stage disease and his or her caregiver, both of whom have a background appropriate for involvement as FDA patient advocates. The caregiver will serve as the primary 

spokesperson for the couple, but both parties will have access to materials for review, will be able to review and discuss those materials prior to their engagement 

with FDA, and will have the opportunity to participate. When the patient is no 

longer able to participate, the caregiver will continue to serve with FDA. FDA and 

the Alzheimer’s community agree that this approach involves challenges, but both 

parties are willing to work to maximize involvement of patients. 

THE FDA INTRA-AGENCY NEUROLOGY WORKING GROUP

Next, I would like to mention FDA’s Intra-Agency Neurology Working Group. 

Neurology products regulated by FDA, comprised of drugs, devices, biologics, and 

combination products, are a diverse group of products aimed at advancing patient 

care in a number of disease areas for which the unmet therapeutic need is great. 

Some diseases affect a large number of patients, such as Alzheimer’s disease and 

Parkinson’s disease, while others affect smaller numbers of patients. In either case, 

the consequences can be devastating for patients and their families. 

FDA’s goal is to improve communication about neurological disease across the 

Agency among the various groups charged with regulating these products. To accomplish this end, FDA has established a Working Group to serve as a forum for 

information exchange on leading-edge developments, enable sharing of technical and 

regulatory expertise, and provide for greater consistency of review standards and 

processes across the Agency. Further, we are expanding patient advocate involvement in FDA neurological disease-related review and decisionmaking to include Parkinson’s disease, Alzheimer’s disease, and other neurological diseases as Agency resources allow. 

Meetings occur monthly and are chaired by Dr. Celia Witten, Director, Office of 

Cellular, Tissue, and Gene Therapy in our Center for Biologics Research and Evaluation (CBER), and Dr. Robert Temple, Director, Office of Drug Evaluation I and 

Director of the Office of Medical Policy in our Center for Drug Evaluation and ReVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00028 Fmt 6633 Sfmt 6621 S:\DOCS\36838.TXT DENISE
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search (CDER). Other members include Dr. Russell Katz, Director of the Division 

of Neurology Products (CDER), and supervisors, reviewers, and project managers 

from CDER, CBER, and our Center for Devices and Radiological Health. Also included are staff from the Office of the Commissioner, including the Office of Critical 

Path Programs, the Office of Special Health Issues (OSHI) and the Office of Science 

Health Coordination. Standing agenda items include policy development (guidance, 

workshops, and advisory committee meetings), opportunities for Critical Path 

projects, significant review projects (major investigational/marketing applications 

under review, marketing approvals, studies of interest, etc.) upcoming neurologyrelated meetings and patient advocate involvement, and OSHI updates. 

ADDITIONAL FDA ALZHEIMER’S-RELATED ACTIVITIES

The Agency is engaged in a number of additional Alzheimer’s-related activities. 

For instance, FDA is helping with a study called the Alzheimer’s Disease 

Neuroimaging Initiative. This is a 5-year public-private initiative involving industry, 

academia and the NIH. The goal of this study is to obtain standardized MRI, biochemical, and clinical data over several years in prospectively followed groups of 

normal elderly patients with mild cognitive impairment, considered the very early 

stages of Alzheimer’s disease, and patients with diagnosed Alzheimer’s disease. We 

anticipate that this study will help in the use of some of these measures in future 

clinical studies to expedite the development and approval of drugs to treat patients 

with Alzheimer’s disease, especially in its very earliest stages. A particularly exciting and important aspect of this study is that the data are available to scientists 

all over the world in real time as the data are acquired and entered into the database. 

Additionally, FDA has a productive and close working relationship with the Alzheimer’s disease advocacy community. For example, FDA has worked closely for 

many years with the Alzheimer’s Association on scientific, technical, and advocacy 

issues. Their counsel and direct assistance to FDA have been invaluable as we have 

worked to improve our regulation of Alzheimer’s disease treatments and to expand 

patient involvement in FDA decisionmaking. 

FDA recently met with, and remains in contact with, the Accelerate Cure/Treatments for Alzheimer’s Disease (ACT–AD) Coalition. They are concerned that the 

Agency retains a strong focus on drug development for Alzheimer’s disease. The 

Agency works and keeps in contact with these organizations through OSHI. I certainly encourage this important exchange of ideas with advocacy groups. 

Development of drugs with an effect on disease progression is the most critical 

need in Alzheimer’s disease, as it is with other progressive neurological diseases. 

FDA is planning a future public meeting to discuss design of clinical trials and how 

to design studies to determine whether or not a drug for Parkinson’s disease has 

an impact on the underlying cause of the disease and not just the symptoms of the 

disease. It is expected that the designs useful in Parkinson’s disease should be 

equally applicable to drugs for Alzheimer’s disease. 

In addition, FDA is organizing an upcoming meeting with neurological disease organizations involved in advocacy and medical research. This meeting will involve 

discussion of scientific, technical, and advocacy issues related to their and FDA’s 

roles in development of important new treatments for serious neurological diseases, 

including Alzheimer’s disease. 

CURRENTLY APPROVED DRUGS FOR ALZHEIMER’S TREATMENT

Finally, I want to make sure that I mention to the committee that there currently 

are five drugs approved for the treatment of Alzheimer’s disease: Cognex (tacrine); 

Exelon (rivastigmine); Razadyne (galantamine); Aricept (donepezil); and Namenda 

(memantine). All except Namenda are approved for the treatment of mild to moderate Alzheimer’s disease. In addition, Aricept also was approved recently for severe 

Alzheimer’s disease. Exelon was approved on July 6, 2007, in the form of a 

transdermal patch, which reduces gastrointestinal side effects compared to the oral 

form of the medication. All of these drugs except Namenda act by increasing brain 

levels of acetylcholine, a neurotransmitter that is abnormally low in patients with 

Alzheimer’s disease. Nerve pathways in the brain that are thought to be involved 

in memory and cognition, that ‘‘use’’ acetylcholine as a neurotransmitter, degenerate 

in patients with Alzheimer’s disease. 

Namenda is approved for the treatment of moderate to severe Alzheimer’s disease 

only. It works differently than the other approved drugs. It interacts with a receptor 

that is thought to be involved in preventing the death of certain cells in the brains 

of patients with Alzheimer’s disease. However, the drug has never been shown to 

prevent or slow the underlying nerve degeneration in these patients, nor have any 

26 

of the other approved drugs been shown to do anything other than treat the symptoms of Alzheimer’s disease. 

CONCLUSION

We await, together with the rest of the world, for new drugs that may some day 

be able to treat the underlying cause of this insidious disease as well as other neurological diseases, not just the symptoms. We are very encouraged by the progress 

being made in the scientific community and pharmaceutical industry on products 

you heard about in testimony in the previous two hearings. As indicated earlier, 

FDA stands ready to facilitate any breakthrough product applications that are submitted to the Agency for review. 

This concludes my formal statement. I will be pleased to respond to any questions 

from the subcommittee. 

Senator MIKULSKI. Well, thank you very much, Dr. von 

Eschenbach. I think already—did you want to ask a couple of questions and I’d be happy—but I just wanted to say first of all, it’s a 

very impressive group but it’s impressive already at the level of coordination and communication that’s going on. So I said, this is not 

to be a roundtable. Our friend, Senator Isakson, has to leave and 

I didn’t know if you had a couple of questions you’d like to pose 

and the way we see it, is we’re just going to kind of jump in and 

even though you might pose it to someone, if somebody else has got 

something to add, we don’t have to be starchy and choreographed 

here. 

OPENING STATEMENT OF SENATOR ISAKSON

Senator ISAKSON. Well, thank you, Madam Chairman. I am going 

to have to leave because I have another Georgia company waiting 

in the office but anytime Dr. Gerberding shows up, I show up because I am her biggest cheerleader. She’s done a marvelous job for 

CDC and I’m very grateful for the many contributions that she 

makes. 

I won’t ask a question. I’ll just make a comment. The reason I 

have a passionate interest in this, I lost my mother to Alzheimer’s. 

But over the years, I’ve had some experiences that illustrate to me 

how important it is for us to get into the surveillance business that 

you talk about in your pathway and look for some answers because 

I’ve had one of my doctor’s wife, at the age of 46, who was diagnosed with Alzheimer’s, Governor Carol Campbell, a great governor 

of South Carolina in his fifties was diagnosed and died in 3 years 

and in my church. I have two members whose wives—both of their 

wives have had Alzheimer’s for a significant period of time and it’s 

apparent in the last decade that some pharmaceutical therapies 

and other treatments are beginning to work to prolong and improve 

the quality of life of those individuals with it but it’s a must—and 

I agree with what Dr. Gerberding said that everybody fears physical impairments but everybody is more fearful of cognitive impairment. 

So I appreciate the Chairperson’s diligence on this effort and her 

real passion in seeing to it that we raise the eligibility and as I told 

her a few months ago, I’m here to be a soldier in that army and 

I’m grateful to you all for what you do. 

Senator MIKULSKI. Thank you very much, Senator. At the end of 

this conversation, we will begin to meet on getting ready for our 

markup on our Alzheimer’s Breakthrough bill, particularly the research component. It would be the goal of Senator Burr and myself 

27 

to have this marked up either by the end of July or certainly in 

September and move it on through to get it done. So we’ve heard 

from the Alzheimer’s Association, research community and we’re 

going to have more conversation with you. 

Let me jump in with my question. Of course, we agree with Dr. 

Zerhouni that intervention, even before physical or mental manifestations of anything from heart disease—you don’t want to wait 

for that out-of-breath shooting pain or for women, fatigue and other 

symptoms. And we’ll be talking about that. But one of the things 

that I’m interested in is how we can now take basic research findings that we already know that might not need a pharmaceutical 

intervention and move it into clinical practice, better diagnosis because we’ve heard that in many instances, it’s misdiagnosed as depression early on or when people start that 36-hour day, the agitated behavior where other medications are prescribed. 

That’s one—use information we already have, say at NIH or the 

private nonprofit community and then how does that get translated 

into clinical practice or what we fund. Let me go to something else, 

which is what seems to be emerging from the research is the lowtech solution that what is needed of good diet, exercise of both the 

body and the mind, is very good. If you have heart disease, diabetes—any propensity that you might have that is starting back here, 

though you might not be able to beat change, you can delay the 

consequences of genes and so on and my question then is, if that’s 

so and that’s thoroughly been validated and I think it has, then 

how does it get out to both clinical practice and then even to entities like the Office on Aging? What does all that mean while we’re 

working on even more sophisticated and more precise breakthroughs? Do any of you want to comment on translating research 

into clinical practice? I just throw out diagnosis and I just put that 

out for discussion, the techniques we now know for the management of any chronic illness seems to have a major role also or significant role in preventing cognitive decline, whether it’s Alzheimer’s or something else. Do any of you want to comment on 

that? 

Dr. HODES. I think you posed a very critical question about our 

translation from scientific findings from what we know into practice and let me try to give two examples because I think it’s important that we recognize our obligation to do the most we can with 

what we know. 

Now let me first take one of the more precise examples of an attempt to translate genetic and biological information at the interventions and this comes from the original observations 100 years 

ago, when the initial patient with Alzheimer’s disease, by the professor of the same name, identified plaques and tangles in the 

brain and we’ve seen over the past years, his remarkable identification of the biochemical nature of these plaques and tangles, the 

genes that encode the products. This has led, in turn, to the ability 

to generate animal models that reproduce much of the lesion, the 

memory defect of Alzheimer’s disease caused by introducing a particular gene product. So there is very strong evidence that it is 

quite possible that a particular molecular lesion is responsible for 

Alzheimer’s disease. 

28 

This is now leading to clinical trials. The only way to completely 

verify the ability to intervene in this pathway and have an effect— 

the trials are not simple as with any drug trials but they are attempts to modify the effect of the enzymes that cause the amyloid 

plaque or as we’ve heard, immunization treatments to try to prevent or reverse the accumulation of amyloid plague. 

So this is an example of translating the most basic molecular 

level through very rigorous levels of evidence to establish whether 

or not an intervention, pharmacological, immunological, have the 

desired impact and this is one important pathway to pursue. It’s 

important that our basic science from institutions like NIH are 

translated to both private sector enterprise and academic enterprise and ultimately to the FDA to deal with final demonstration 

of efficacy. 

There is another pathway and one that you’ve eluded to that 

deals with evidence or associations of certain lifestyle factors and 

risk factors with Alzheimer’s disease. So as you’ve noted, there is 

strong epidemiologic data that indicate that individuals who have 

many of the risk factors for cardiovascular disease, diabetes, high 

levels of homocysteine are more likely to have Alzheimer’s disease. 

Therefore, it is important that we carry out rigorous clinical trials 

to see whether the interventions for those treatments will or will 

not have effect on Alzheimer’s disease. 

Now, do we need to wait until we have that information before 

recommending that people follow lifestyle interventions such as 

diet, control of blood sugar in individuals with diabetes, diets that 

are demonstrated to protect against cardiovascular disease—of 

course not. So this is a case in which we don’t have the highest 

level of evidence to show these interventions will, without doubt, 

from randomized clinical trials, prevent Alzheimer’s disease. We 

know enough to recommend to the public that in terms of general, 

successful aging in health, these are strong measures that should 

be translated while at the same time, I would suggest we pursue 

the rigorous science to see just how they affect variables such as 

cognitive function. 

I think the same is true for—— 

Senator MIKULSKI. It wouldn’t hurt, would it? 

Dr. HODES. We certainly think it wouldn’t help. It’s been demonstrated that these interventions are helpful for many other aspects. 

Senator MIKULSKI. Well, let me tell you when I first heard about 

this and Dr. Zerhouni, you’ll enjoy this. Senator Burr, you might 

want to come with me. The National Institutes of Aging is the one 

campus called Bayview at Johns Hopkins but it’s not in the main 

Broadway campus, which is like the mother ship, contiguous to a 

neighborhood called Greek Town. Now, Greek Town is where a 

large number of Greek immigrants settled and oh gosh, they have 

food that is both the Mediterranean diet, which we’re supposed to 

follow but then they’ve got the fried calamari and they have the 

baklava—you get it? 

Dr. ZERHOUNI. You tell me where to eat and I’ll go. 

Senator MIKULSKI. And I’ll get it for you. So I went to visit then, 

that old creaking building that I know we’re replacing, but one of 

the first things that we heard was the research in animals that 

29 

really, the reduction in calories, the improvement of exercise enables, at least it seemed to have a positive impact. But what we 

also know is diabetes is a factor, maybe. That this is a preventive 

act that does no harm, which as all of you have taken that oath 

that the first thing is, we could do things that do no harm. So Dr. 

Gerberding, what you do think about that? Should we now, as a 

major public policy, take what you’re saying in the Healthy Brain 

Initiative but really, what we already know for heart-smart, we 

could really be troubadouring and promulgating. Do you have a reaction to this and what you already know, knowing that we could 

always validate more? And also then, what is CDC doing about 

this, say in conjunction with the Office on Aging that funds every 

senior center in America. 

Dr. GERBERDING. My reaction is enthusiasm in a short word. I 

think we’ve got to set a stage to get this ball rolling and one of the 

remarkable things that I observed on the times that I was participating in some of the Medicare sign-up events or some of the Welcome to Medicare, get your prevention screening activities going on 

at the grass roots level, is how extensive the network of support for 

seniors really is in our communities because of the Agency on 

Aging and HERS and others and many, many not private and 

other organizations. We have an extensive network of community 

support in many communities and even reaching into those populations that are hard to reach and have the worst health disparities. But that network is not aware that this is a critical strategy 

for protecting brain health and I think the concept of social marketing, getting out to the grass roots level and really informing 

people that it’s not only good to do these health promotion activities because they are heart healthy. Some aspects of them are highly likely to preserve mental functioning and as the database for 

that grows, it will be able to give us stronger scientific basis for 

that. 

So the first thing is to get the word out into the community to 

the affected people but also that incredible hidden network of support that already exists and mobilize it to start really adding this 

to the perspective. 

Senator MIKULSKI. Is that what CDC does and are you meeting 

with the Office on Aging to do that? 

Dr. GERBERDING. Absolutely. And I think we did not have these 

strong ties, admittedly in our Department but we have come together in many different ways to support some of the modernization of Medicare activities and we’ve discovered how much leverage 

we actually have within HHS. I mean, Medicare pays $91 billion 

a year for Alzheimer’s disease. That’s a tremendous investment and 

we ought to be able to work with that kind of resource and do more 

to help people prevent this in the first place. But the other piece 

of this that we can’t forget is that clinicians also play a very important role and I do think we need to be more aggressive about clinician education. 

You’ve described in your written testimony, some centralization 

of testing for Alzheimer’s and cognitive dysfunction so that we 

make a more accurate and early diagnosis in those patients that 

can benefit from drug treatments, get access to them but also it 

helps us understand the relationship between cognition and capacVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00033 Fmt 6633 Sfmt 6601 S:\DOCS\36838.TXT DENISE
30 

ity to engage in physical exercise and the other Heart Healthy activities. 

The tragedy here is as your cognitive function declines, your ability to take your medications and to maintain your mobility and 

control your blood sugar declines concomitantly so you get into a 

vicious cycle of deterioration. 

Senator MIKULSKI. Exactly. 

Dr. GERBERDING. I think we can do a lot more at the clinical 

interface to prevent that deterioration. 

Senator MIKULSKI. Well, I know Dr. von Eschenbach wants to 

talk. I’ll turn to Senator Burr but as we now get ready for our 

markup, would you have your team meet with us to see how, as 

part of our Alzheimer’s Breakthrough, where we move to increase 

funding for research, we look at how we can also more effectively 

involve the role of CDC exactly in this coordination in kind of moving out what we do know. 

That if nothing else, how it’s managed, the chronic illness that 

Dr. Zerhouni said, you said, 75 percent of those people over 55 consulting a clinician is for the consequence of a chronic condition, not 

an acute episode or a fall or an orthopedic injury or anything like 

that. So we want to come back to you. Dr. von Eschenbach, did you 

want to say something? 

Dr. VON ESCHENBACH. With your permission, I’d just like to amplify on two points I made in my statement, which go along with 

the comments that have already been made. I indicated this fact 

that today, we’re in the midst of this molecular metamorphosis. I 

also indicated that we’re all in this together and I think that bodes 

very well for tomorrow. 

First of all, one of the implications of this tremendous progress 

in biomedical research is the fact that as Dr. Zerhouni alluded to, 

health care will be personalized, much more predictive, pre-emptive 

and more participatory. And the implications of those four P’s for 

tomorrow is that first of all, one of the things that’s going to go a 

long way for us having these public health interventions is to be 

able to define populations at risk and to do that in a way that we 

can really hone in on where these targeted interventions have to 

occur that are going to be much more preventative and we’ll know 

that they’ll be predictive because we know the evidence of their 

outcomes. 

At the same time, when we look at what’s happening today with 

information technologies and communications, we’re seeing health 

care become much more participatory. Faces no longer are just passive recipients but actively participating in their care and we now 

have the tools of communication and interaction that enable us to 

help continuously guide patients in terms of interventions that 

they should be carrying out day by day and that’s where agencies 

and organizations like the Alzheimer’s Associations have alluded to 

and others, like AARP, have a real role in continuing the impact 

of these interventions at the public health or community level and 

to do that in a way that mobilizes and moves us to a better level 

of health. 

I think it’s comprehensive, it’s integrated but I don’t—and I 

think the tools are going to enable us to do it far more effectively 

tomorrow than we could do it yesterday. 

31 

Senator BURR. Thank you, Madam Chairman. I was struck, as I 

listened to Dr. von Eschenbach, that we have a tendency to focus 

on specific diseases and it just struck me with some of the things 

you were saying, Andy, that we have a health care delivery system 

designed in America not to fully engage us in prevention and 

wellness and not really in disease management unless someone is 

triggered from a quality of life standard to do it. 

And I would say to my good Chairman, maybe it’s an area that 

we can explore. I’m sure the answer to this is in the challenge of 

how do you continue to see a population of a country increase at 

the rate we are, while we devote 161⁄2 percent of the GDP to health 

care and not be influenced by other models around the country 

where they say, ‘‘well, we do it so much cheaper’’ and the reality 

is that we can look here today and as Dr. Zerhouni said, in X number of years that 5 million individuals with Alzheimer’s are going 

to be 16 million with Alzheimer’s and there’s full agreement at the 

research table that the answer here is, we have to get ahead of the 

curve. We have to be preventive. We have to be predictive. 

We have to be willing to personalize and that’s a tremendous 

goal that NIH is under and it puts tremendous strains on you from 

a standpoint of the agency at the end that’s going to be trying to 

approve therapeutics and vaccines that are trying to keep somebody from getting the disease. What a tremendous step we’ve 

made. 

Dr. Hodes, today, how is the typical patient with Alzheimer’s diagnosed? What is it that triggers that person to go in and say, 

‘‘boy, I think I got it.’’ Or that family member—who is it that initiates that and what process do they go through? 

Dr. HODES. I think the simple answer is that it’s very heterogeneous and very variable. With a spectrum from individuals who 

are very sophisticated, families are very perspective and connected 

to a medical care system so that at the early appearance of changes 

in behavior, including changes in memory, they turn to physicians 

who are informed and capable. 

All too sadly, though, a large percentage of our population is unfamiliar with the concept of these changes or anything more than 

a part of aging and they are accepted as such and diagnosis is, 

therefore, delayed. It isn’t so many years ago that everyone accepted dementia as an accompaniment of aging and so we’re at a point 

of transition where I think the best informed and we need to make 

all of Americans better informed, are tuned to seeking medical attention. 

Once having come to medical attention, to a physician or care 

provider, in the best of settings, estimates are that approximately 

90 percent accuracy in diagnosing Alzheimer’s disease is the theme. 

This is what we see in the best of hands and far less accurate in 

others. So here, our commitment is to try to identify the psychological test and our imaging tests that can continue to refine a 

standard strategy for diagnosis that will allow all of the care providers around this country to be more astute in making diagnoses. 

The impetus for making diagnosis is, of course, an important 

issue. What is the motivation? Right now, a great deal of the motivation is to rule out other causes of dementia that are clearly treatable and reversible and one of the greatest tragedies would be to 

32 

be missing one of those. If Alzheimer’s disease is diagnosed and diagnosed early, of course, there are real advantages to the individual and the family in terms of planning and understanding 

prognosis and finding those treatments, which are able to modify 

the course of the disease. 

But we have to concede that those treatments, those interventions are currently of limited effectiveness and effective for a limited period of time so that the motivation to identify disease early, 

to come to diagnosis and to treat, is going to become more critically 

important as we identify and communicate interventions that make 

a difference. 

Senator BURR. Well, we probably all agree that the first interventions are probably going to be therapies that potentially either slow 

or stop the progression of disease, therefore the earlier we can detect, the better off the quality of life and the outcome is. 

Dr. HODES. I should maybe just comment that while we have 

great hopes and need for much more improved interventions, it was 

just in the past months that there was a statistical significance 

from a clinical study showing that one agent, Donepezil, was in fact 

able to reduce the risk of moving from mild cognitive impairment 

to a diagnosis of Alzheimer’s disease. It was a limited effect. It occurred only over the first year of the study in most individuals but 

I think it provides the first prototype, if you will, of an intervention 

that can actually prevent the onset of disease. 

I should also reinforce what’s been said by my colleagues about 

the importance in the area of public education, of organizations 

that are in the grass roots. The organizations prominently including the Alzheimer’s Association, with whom we have great interactions, not only in the planning of research agendas but in the 

grass roots contact with individuals who are affected in their families, important to providing and communicating information, to recruiting individuals interested in participating in clinical studies, 

which I need to stress, is very important to progress so that all of 

the Federal agencies, private sector organizations need to work together to inform the public so they can both understand early 

signs, seek diagnosis and then participate with us in the research 

that is necessary to come to better means of intervention. 

Senator MIKULSKI. I just want to come back to Senator Burr’s 

point about diagnosis. My father died of the consequences of this, 

but these early signs—no one was quite sure what it meant and 

this is when we had access at Johns Hopkins, to a geriatric evaluation program, where a geriatrician, someone skilled in the diseases 

or effects of aging, could evaluate, what is the medications Dad was 

taking for some other things, where the synergistic effect affected 

his cognitive ability? Was it that he needed that shot of Vitamin 

B–12, which we all hoped he needed, et cetera. 

Well, unfortunately, it wasn’t that but it could have been that. 

And isn’t this where, really, there needs to be some type of really 

overall assessment? But do you feel that also, there needs to be 

more of the specialized centers where a primary care physician to 

validate what they suspect would occur? Or do you feel that you 

can develop these—I don’t want to say check, but prototypes for at 

least the primary care people to make some type of diagnosis? 

33 

That’s not a catch–22 but it all goes to what should be supporting here, one of which is accurate diagnosis even though we 

might not have some magic bullet now. There are tools available. 

Dr. ZERHOUNI. I’d like to, if I may, really stress the point you 

just made and that is, if you look on the forecast basis, on how 

many geriatricians are going to be available to really take care of 

an age population, what you find, in fact, is that the number of 

geriatricians is not growing. It’s actually flat or decreasing in terms 

of the number of people who graduate to study the diseases of old 

age. 

So I think if you were from the 50,000-foot view before we go to 

Alzheimer’s, we have a fundamental issue in orientation of resources toward creating the human capitol needed to take care of 

this population as we go forward. There will be a deficit in 

healthcare providers at all levels. It will be care providers at home, 

care providers at the intermediate levels of care. 

So it’s clear that when you really look at the total system, we 

have an issue and we need to really work together on finding ways 

of preventing the loss of the talent. 

The other is that Alzheimer’s disease today is a diagnosis of 

elimination. You try to eliminate every possible potential causes of 

cognitive deficit before you can make this diagnosis because it is 

only diagnosable at this point through a biopsy and we’re not going 

to perform biopsies on live individuals, biopsies of the brain. 

So one of the things that need to be done is more standardization 

of the diagnostic tests, an educational program for centers to diffuse around them because we’re not going to be able to do it just 

with geriatricians. So we’re going to have to educate, at a very fast 

pace, not only in terms of the prevention activities that Dr. 

Gerberding was talking about but just pure clinical medicine for 

family doctors, internal medicine doctors, a little bit of what we did 

for heart attacks. 

I mean, it was clear they didn’t have enough cardiologists to take 

care of heart attacks so you had to really diffuse the knowledge 

way beyond the specialists. I think if you really think about it, Senator, what you have to have—you have to have a systems approach 

to the disease, from the first point of contact, the loss of cognitive 

function, mood disorders, wandering, losing your keys, losing the 

address of your house, knowing how to go back, all these signs are 

overlapping with many other conditions. So you have to eliminate 

it but at the end, we as scientists, have to agree on a standard set 

of parameters and tests to develop sets that are more objective. 

There is no blood test today like there is for diabetes, for Alzheimer’s and we need to really come up with something, some answers. 

We’ve funded very innovative research at the NIH. We funded 

nano-medicine, to pioneer, to in fact tell us whether he could detect 

the very first signs of Alzheimer’s disease in the fluid that is within 

the brain, what we call the CSF, the cerebral spinal fluid. And for 

the first time, we had a positive result so there is hope to be able 

to do that on an objective basis. 

My message here is this: if you look at any one point and try to 

improve that, you’re not going to get to your goal. In other words, 

fighting Alzheimer’s disease is only as strong as the weakest link 

34 

in the chain of research, intervention, prevention, payment systems—how do you cover that? The workforce planning, how many 

healthcare providers do you need? This is truly, I think, the challenge that we have. 

We have tried to educate, from our standpoint, we’re just releasing today the progress report on the research, on the Discovery 

Pathways for Alzheimer’s Disease and I want to commend the National Institute of Aging and all our sister agencies participating in 

this but this, in fact, is the message that you will not solve this 

problem with a one magic bullet approach. 

Senator BURR. I’m sure Senator Mikulski agrees with me that we 

really need each of you to pledge to work with us on this legislation. There’s only one way to get a perfect bill and that’s to make 

sure that all the stakeholders are on board at the beginning of the 

process rather than to shoot at a bill that we think is a pretty good 

product and I hope you’ll do that. 

I remember years ago, Dr. Zerhouni, among the—almost the 

completion of the mapping of the human genome. I was at SAS 

Corporation in North Carolina, the largest privately owned software company in the world and they envisioned at the time that 

when they got the final genome mapping that they would be able 

to go in and write a computer program that could then take all of 

the known drugs and things that we had and could potentially test 

them on what they had learned. How far are we from that? 

Dr. ZERHOUNI. We’ve made tremendous progress. I have to tell 

you that over the past 3 years—when I became NIH Director, I can 

recount the story about the fact that the human genome had been 

completed. We, in diabetes, we knew one gene, suspected gene. 

This was the effect of 30 years of work and it was p-parg gamma 

as an enzyme and that’s what we knew. Since then, just this year, 

we found 10 very, very strong candidates to understand at the genetic level, what makes a person diabetic and why is it that they 

become diabetic, very, very early in their natural history. 

If you look at all of the progress that has been made because of 

the biotech advances and the technologies today, we have a project 

and it’s called pharmacogenetics. It started about 4 years ago and 

we have over 400 discoveries that show why you or I would respond differently to a drug. The next step is what we call the Gene 

Environment Initiative, which we launched this year, where we’re 

going to find the common genetic traits of the 10 most common diseases, including Alzheimer’s, actually, which is also being researched. 

We’re very close to this. We have to accelerate our research 

there. The opportunities are enormous. This is the basis, actually, 

of this personalized medicine idea that you and I, even though our 

DNA is only different by .1 percent, we can react to the same treatment in completely different ways. To know that ahead of time is 

very important. 

Let me give you a very specific example. Today, we use cholesterol lowering drugs, statins—Lipitor and Zocor on millions of people but we know from the epidemiology that only 10 maybe, 10 percent of these people would ever develop a heart attack or cardiovascular disease. Yet we give it to a hundred percent of the people. 

35 

Wouldn’t it be great if I had a signature that told me I am part 

of the 10 percent that’s going to get it and I need that drug and 

you’re part of the 90 percent that do not need to have that drug. 

So you can see the impact on the cost of health care, the precision 

with which we will treat people—all of this is related to the advances of the past 2 years. 

Senator BURR. Let me ask, I’m sure somebody has put together 

information that’s more global in scope for Alzheimer’s. The percentage of the American people that are affected by Alzheimer’s, is 

the percentage consistent with the percentage of other countries in 

the world? 

Senator MIKULSKI. Good point. Interesting. 

Dr. ZERHOUNI. That’s a good question. I actually will defer to my 

colleague here. 

Dr. HODES. Well, there’s incomplete information but enough to be 

responsive. That is, I don’t think that we have comparable information on the prevalence of Alzheimer’s by similar standards in so 

many countries that we can answer that with precision. But we do 

have information from very specific studies that have, for example, 

compared the risk of Alzheimer’s disease in particular populations, 

one versus the other. For example, in the population of individuals 

still residing in Nigeria versus population in Indianapolis, in fact, 

a very direct Nigerian descent and one can find in that sort of comparison, a very significant increase in the proportion of Alzheimer’s 

disease in those individuals who now reside in the United States. 

Similarly, there have been comparisons of Japanese, Japanese 

Americans in Hawaii, Asian Americans, which have indicated the 

change and prevalence of Alzheimer’s, it appears, over a generation 

with a change of environment. These are important because it is 

unlikely although not yet definitely established that these changes 

result from selective genetic differences but more likely, do reflect 

the impact of environmental risk factors. 

So we know that populations, when studied in some of these discreet areas, do differ. We don’t have a global national/international 

comparison. 

Senator MIKULSKI. You could also go to diet. Dr. von Eschenbach, 

you seem eager to say something here. 

Dr. VON ESCHENBACH. Dr. Gerberding is right. I just wanted to 

emphasize one other element of this equation. I think it has been 

pointed out, we really do need to continue our investment into the 

discovery end of the continuum, to learn more about this disease 

so we’re not just recognizing it when we’re looking at the end 

stages of the degenerative process and people have already lost 

function. And at the same time, we have to have attention to the 

deliver end of the continuum so we get the kind of prevention and 

intervention that Senator Mikulski was talking about. 

But there’s that middle piece between discovery and delivery of 

development and I think we need a strategic approach to that from 

the perspective that we are going to need platforms, be they genetic 

or genomic platforms or whatever that helps to find risk. Who is 

likely to succumb to this disease? We need platforms for earlier diagnosis. They may be imaging strategies. They may be nano-technology strategies. We need development of interventions that are 

going to prevent the disease at its very earliest stages before someVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00039 Fmt 6633 Sfmt 6601 S:\DOCS\36838.TXT DENISE
36 

one has obviously lost the ability to remember where their keys 

are. 

So that development piece has to be thought of strategically, as 

where in this disease process, given what we know about its molecular basis, can we target and define and develop interventions that 

are going to help us predict, detect, prevent and when necessary, 

intervene and hopefully even reverse. I don’t think we should lose 

sight of that in this overall approach that you are fostering, to say 

we, as a nation, have to do something about this disease from the 

very beginning through its entire course. 

Senator MIKULSKI. Thank you. I think that’s an excellent point. 

I just want to ask one other question and then maybe we can go 

to wrap-up. I know Dr. Gerberding has got to leave and we already 

delayed the hearing and I’m sure you all have, we know you have 

ongoing responsibilities. 

Dr. Zerhouni, you talked in your testimony about the Alzheimer’s 

disease cooperative study and in it, you talk about something called 

the ADCS drugs. You say they are not typically studied by the 

large pharmaceutical companies that are off patent or were patented and are marketed for another use. Here goes my question— 

is this an area when we look at our overall framework for our legislation, we should be sure that we specifically mention and also in 

Appropriations that this is an area where you do things that the 

private sector—that’s not where the private sector is going to go. 

They might add value to what you’re doing but you’re spending $52 

million on this over 6 years, which is what? Seven million dollars 

a year or five, six and a half million? 

Dr. ZERHOUNI. Eight, eight and a half. 

Senator MIKULSKI. Yes. Is this an area that we should—— 

Dr. ZERHOUNI. Right. There is definitely a need for that because 

obviously as you know, what we do at NIH—think of it as a pyramid for our budget and our efforts. Sixty percent of what we do 

is really the basic discovery, understanding the disease. Twentyfive percent is what we call translational. When we have an idea 

and we want to have a proof of concept at a very early stage so 

that eventually, this will become an incentive, if you will, for the 

private sector to take it and develop it further and 15 percent, we 

spent on really doing, for example, things in orphan diseases where 

at one point there was no incentive, really, to develop these treatments for rare conditions. 

So in the ADCS, what the institutes—the National Institute of 

Aging, National Institute of Neurological Diseases have come together in a collaboration to say, when we have gaps like this, how 

do you tackle them and it’s not so easy. Because you’re talking 

about doing, for example, trials on things that may be very useful 

but they are not patentable and therefore, no one is going to do 

them. So you have cracks in the system from either the need for 

us to do a trial on drugs that exist that are not patented, that the 

FDA has already approved, but that may be useful—in fact, one of 

the treatments for Alzheimer’s disease actually was out of patent 

and became quite useful in the treatment of Alzheimer’s disease 

early, and delayed the onset of the disease. 

So we do need to have a framework to understand the gaps in 

the system. Like the Institute for example, will fund young sciVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00040 Fmt 6633 Sfmt 6601 S:\DOCS\36838.TXT DENISE
37 

entists with good ideas who have no access to what a drug company would have access to. They can’t figure out if the idea they 

have is going to be positive and then be followed. So that’s something that NIH has to do but it’s very, very expensive and very difficult. 

One of the things that we did through the Roadmap for Molecular Research is we built what we call a molecular library system 

for all academic sector investigators who can have access to it for 

all diseases so that we can at least allow our scientists to fill those 

gaps. 

Senator MIKULSKI. Well, first of all, I find that very instructive. 

I want to thank all of you for coming. I think it’s been a very enlightening and instructive conversation. I’m going to reiterate what 

Senator Burr said, which is an invitation now to take a look at our 

legislation. Our legislation really has two parts. What we call the 

Alzheimer’s Breakthrough doubles the funding for NIH research 

and some of the others and then there is a second component that 

will really go to the Finance Committee on some tax breaks for 

caregiving and we’ll be looking at caregiving later on. But we’re not 

going to slow that down for what we want for our Alzheimer’s 

Breakthrough. So we ask you now to think about what we could 

be emphasizing in the bill or authorize that would really enhance 

prevention and be willing, as an approach, for prevention of all 

chronic challenges that our population is facing because there 

seems to be so many similarities that there will be consensus within the public health community. 

Second, how you think in our legislation, we can make sure that 

we help with the Healthy Brain Initiative, which everyone worked 

on and is so promising because I think the way we both see it, is 

one, we don’t want to be disease d’jour. This is a very important 

issue. A national epidemic is on its way but we want to do this in 

a way that’s really a groundwork to help you be you that would 

have a multiplier effect with so many other things you’re working 

on. 

But to just conclude about Alzheimer’s, I do see an analogy with 

diabetes again and that’s a situation where my own mother died 

because of the consequences of it. She started on oral insulin at age 

40 and died at about 82. But look at where we are now. When 

Mother was first diagnosed, it was diabetes, yes or no. And you had 

either the injected insulin or this enormous breakthrough called 

Diabinese, which was of great help. Then she had to go for her test 

but then came something called Home Testing, which looked like 

a 13-inch TV set. Now you can test at home with reasonably 75 

percent accuracy, Senator Burr, with something that looks like a 

stopwatch. And when you look at the array now, one would say this 

is a genetic propensity. 

We start back here. You have to say goodbye to the baklava, you 

have to say goodbye to the pirogue. You have to say hello to broccoli and so what. It sure beats some of the other things and then 

moving along to dealing with insulin resistance to all these other 

kinds of tools. There are now 300 or more things that her primary 

care physician or endocrinologist could have had of avail. And this 

is, I think, the way we see here. Back here, the prevention we’re 

talking about would be for all chronic illness and really get that 

38 

going because we will do no harm in helping diet and exercise, 

physically and mentally and really getting this out in any way we 

can and particularly in the centers where seniors gather and then 

to look at what are the other continuum of things like we now see 

because it’s no longer diabetes, yes or no. It starts before you see 

it. It’s been insulin resistance and then it progresses. 

But at the end of the day, you don’t want to have that disintegration in mitro-vascular disintegration of your neurons, your kidneys 

and your eyes and with what we now know, look what’s already 

happening. So diabetes now, rather than a cure, is viewed as a 

chronic illness and if controlled and managed with so many tools, 

you’re preventing the consequences of it and so on. 

So this is where we see heading to diet with Alzheimer’s and this 

is the continuum here. But we want to work with you to get this 

going and I mention this because I think this is the way you see 

it, too. From genetic propensity—not genetic determinism—but genetic propensity, all the way through to what we can do for prevention, intervention and in each passing year, to get even more precise about it. 

So Senator Burr, do you want to say something? 

Senator BURR. I’d only end this way, Madam Chairman. I think 

the big question is, what is our role? We need you to share that 

with us, not just limited to Alzheimer’s. What is the role Congress 

can play today in the agencies that you head that best helps you 

to do what we’ve asked you and your many talented employees to 

do? Because at the end of the day, this is about the impact that 

we can make on the quality of life of individuals and what the cost 

of healthcare looks like in the future. 

I thought as the Chairman talked about the advances in diabetes, a month ago, actually being at a Community Health Center, 

seeing a remote monitor where an individual could take it home or 

could run the software on their computer where it could check their 

blood sugar multiple times a day, not just for the purposes of them 

but for the purposes of their doctor electronically receiving it and 

knowing exactly the tolerance that they’ve been able to maintain 

on their blood sugar or for the congestive heart patient who hooks 

up to five times a day, remotely transmits that to a cardiologist. 

The cardiologist can detect whether there is fluid that’s beginning to form, can verbally call and change that individual’s medication, which eliminates that emergency room visit. The 3-day stay, 

as they begin to mobilize again and then a routine back on medication. 

We have the capabilities today to make sure that a physician and 

a patient do exactly the right thing on disease management and it’s 

back to something you said, Dr. Zerhouni. At some point, we have 

to figure out how to pay for it, if in fact we want people to implement it and to use it. I go back to, I think what we started on, this 

hearing, when the Chair talked about HIV/AIDS and the reality is 

that when did people get serious about a cure for HIV/AIDS? It 

was really when we realized that it was cheaper to make sure that 

everybody with HIV got drugs because we knew exactly how many 

hospital visits they were going to have that year. We knew the cost 

of those hospital visits at the time, the original time, was about 

$25,000 a year. A case of pneumonia. A case of retinal eye infecVerDate Nov 24 2008 15:06 Feb 17, 2009 Jkt 035165 PO 00000 Frm 00042 Fmt 6633 Sfmt 6601 S:\DOCS\36838.TXT DENISE
39 

tion. They’d visit twice but for $14,000, we could give them the 

medication and save ourselves a $25,000 inpatient experience twice 

a year. 

That’s a budgetary answer to something that also has a quality 

of life component and that’s that we stop disease in its tracks, but 

the reality is that sometimes it takes understanding what we’re 

saving to understand what we’re willing to invest. Unfortunately, 

we don’t have a scoring mechanism within the Congress that we 

can dynamically score things to show us what we save. It will only 

show us what we spend. That’s where we’re going to have work in 

partnership together to make sure that we implement the right 

types of policies that not only address the quality of life but address the budget savings that is absolutely vital for us to be able 

to pay for it. I thank the Chairman. I thank our witnesses. 

Senator MIKULSKI. Well said and yes, this committee stands in 

adjournment, subject to the call of the Chair and at that time, we 

will begin to proceed to mark up our bill. We want to thank all of 

our witnesses for their outstanding contribution. 

[Additional material follows.] 

40 

ADDITIONAL MATERIAL 

PREPARED STATEMENT OF SENATOR CLINTON

I would like to thank Chairman Mikulski and Ranking Member 

Burr for convening today’s hearing on what we are presently doing 

at the Federal level to combat the growing threat that Alzheimer’s 

poses to the health of our citizens, our healthcare system, and our 

Nation’s financial resources. 

I applaud Senator Mikulski for her tireless work on issues related to Alzheimer’s disease, and I’m proud to work with her and 

Senator Bond on the Alzheimer’s Breakthrough Act. This important 

legislation is critical in our fight against the disease, and I look forward to its markup in the HELP Committee next week. 

Last week I joined Senators Mikulski and Burr, as well as my 

fellow co-chair of the Senate Alzheimer’s Task Force, Senator Collins, in welcoming the creation of a new Alzheimer’s Disease Study 

Group. As envisioned by the Alzheimer’s Association, this Study 

Group would be an independent, non-partisan collection of health 

policy experts who will assess America’s current approach to Alzheimer’s and will develop new strategies for how the private and 

public sectors can better meet the challenges posed by this devastating disease. 

Former Speaker Newt Gingrich and former Senator Bob Kerrey 

have agreed to take the lead as co-chairs of the Alzheimer’s Disease 

Study Group. The combination of balanced, independent viewpoints 

and expert opinion should make a strong contribution to America’s 

current efforts to combat Alzheimer’s disease, and I look forward 

to the release of the Alzheimer’s Disease Study Group’s findings 

and recommendations. 

While outside advice is important in the fight against this terrible disease, it is our responsibility as elected officials to do all we 

can to advance the cause of prevention, diagnosis, and treatment 

of Alzheimer’s, including rigorous examination of whether we are 

doing all we should at the Federal level. 

Are we setting aside enough resources so that current researchers have the tools they need to investigate the etiology of this disease? Are we prioritizing the recruitment and training of the next 

generation of scientists and physicians who will make finding a 

cure for this disease their life’s work? Are we doing all we can to 

support the millions of caregivers who make tremendous personal 

sacrifices—and suffer emotionally, mentally, physically and financially—in order to take care of and advocate for someone who is 

suffering from Alzheimer’s? Are we making every effort to safeguard the mental health and physical well-being of adults with Alzheimer’s and other dementias—who constitute one of our most vulnerable populations? 

Even as we pause to take assessment of our actions and ask ourselves these questions—the toll of the disease continues to grow. 

An estimated 5.1 million Americans now have Alzheimer’s—and 

their loved ones and caretakers wake up every day and not only 

provide support and comfort for a loved one, but confront the difficult toll of the disease. We are approaching a crisis as the Baby 

Boom generation grows older. By the year 2050, up to 16 million 

older Americans are expected to be living with Alzheimer’s. 

41 

This stark increase is more than a statistic. It represents millions of families facing an emotional struggle and tremendous financial pressure; a new strain on our healthcare system; new costs 

for Medicaid and Medicare. 

For the past 3 years, Senator Collins and I have co-chaired the 

Senate Task Force on Alzheimer’s Disease. We have highlighted 

the importance of early detection of Alzheimer’s; helping people 

with Alzheimer’s and providing support services for their families 

and caregivers; highlighting promising research findings that suggest that healthy diet, regular exercise, as well as social and mental activity may help to decrease the risk of Alzheimer’s; and the 

latest innovations for facilitating early detection and intervention. 

Senator Collins and I are also working to improve older Americans’ access to mental health services. Diseases such as Alzheimer’s can contribute to depression and anxiety for both those 

who suffer from the disease as well as their caretakers. In last 

year’s reauthorization of the Older Americans Act, we successfully 

enacted Title I of the Positive Aging Act of 2005 which authorized 

grants for the delivery of mental health screening and treatment 

services for older adults and grants to promote awareness and reduce stigma regarding mental disorders in later life. 

While this took an important step toward improving mental 

health services for older adults, significant efforts are necessary to 

ensure comprehensive geriatric mental health care. That is why 

Senator Collins and I introduced the Positive Aging Act of 2007, which will integrate mental health services into primary care and 

community settings. 

But improving access to mental health services is just one element of responsibly providing the care that Alzheimer’s patients require. The majority of caregivers have outside employment in addition to their caregiving responsibilities at home. Research tells us 

that, because of the lack of support services, most caregivers either 

miss work or quit their jobs in order to meet the health needs of 

their family members. 

Respite care services provide temporary relief for caregivers and 

decrease the likelihood of formal long-term care, thereby resulting 

in significant savings for the healthcare system and taxpayers. 

Further, respite care also provides family caregivers with the relief 

necessary to maintain their physical and mental health, as well as 

bolster family relationships. 

Last December, my Lifespan Respite Care Act was enacted after 

4 years of bipartisan effort. The law will help millions of Americans 

who struggle to provide care for a family member with a chronic 

illness or disability so they may remain at home and out of more 

expensive institutional care. Now we are working to fund the bill 

with $300 million over 5 years. Compare that to nearly $300 billion—the cost of the services family members provide as caretakers 

of a sick or disabled loved one. 

42 

A great deal has been achieved in the last 15 years in the awareness, diagnosis, and treatment of Alzheimer’s disease. But much 

more still needs to be done. We must continue to make Alzheimer’s 

a national priority. The more we learn, the further we travel on the 

path toward a world without Alzheimer’s—and we know that we 

cannot travel on that road quickly enough. 

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

Æ