[Senate Hearing 107-293]
[From the U.S. Government Publishing Office]



.                                                       S. Hrg. 107-293
                 ALZHEIMER'S DISEASE, FISCAL YEAR 2002

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

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                     APRIL 3, 2001--WASHINGTON, DC

                               __________

         Printed for the use of the Committee on Appropriations











 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 senate
                                 ______

                        U.S. GOVERNMENT PRINTING OFFICE
74-574                          WASHINGTON : 2002
____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512-1800  
Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001












                      COMMITTEE ON APPROPRIATIONS

                     TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico         ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri        PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky            TOM HARKIN, Iowa
CONRAD BURNS, Montana                BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama           HARRY REID, Nevada
JUDD GREGG, New Hampshire            HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah              PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado    BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho                   DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas          RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio                    TIM JOHNSON, South Dakota
                                     MARY L. LANDRIEU, Louisiana
                   Steven J. Cortese, Staff Director
                 Lisa Sutherland, Deputy Staff Director
               James H. English, Minority Staff Director
                                 ------                                

 Subcommittee on Departments of Labor, Health and Human Services, and 
                    Education, and Related Agencies

                 ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi            TOM HARKIN, Iowa
JUDD GREGG, New Hampshire            ERNEST F. HOLLINGS, South Carolina
LARRY CRAIG, Idaho                   DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas          HARRY REID, Nevada
TED STEVENS, Alaska                  HERB KOHL, Wisconsin
MIKE DeWINE, Ohio                    PATTY MURRAY, Washington
                                     MARY L. LANDRIEU, Louisiana
                                     ROBERT C. BYRD, West Virginia
                                       (Ex officio)
                           Professional Staff
                            Bettilou Taylor
                             Mary Dietrich
                              Jim Sourwine
                        Ellen Murray (Minority)

                         Administrative Support
                             Correy Diviney
                       Carole Geagley (Minority)












                            C O N T E N T S

                              ----------                              
                                                                   Page
Opening statement of Senator Arlen Specter.......................     1
Opening statement of Senator Tom Harkin..........................     2
    Prepared statement...........................................     4
Statement of Hon. Edward J. Markey, U.S. Represenative from 
  Massachusetts..................................................     5
    Prepared statement...........................................     8
Statement of Hon. Christopher H. Smith, U.S. Representative from 
  New Jersey.....................................................     9
    Prepared statement...........................................    10
Statement of Dr. Richard J. Hodes, Director, National Institute 
  on Aging, National Institutes of Health, Department of Health 
  and Human Services.............................................    14
    Prepred statement............................................    16
Prepared Statement of Senator Harry Reid.........................    27
Statement of Steven T. DeKosky, M.D., professor of neurology, 
  psychiatry, neurobiology and human genetics, and director, 
  Alzheimer's Disease Center, University of Pittsburgh Medical 
  Center.........................................................    28
    Prepared statement...........................................    30
Statement of Christine Frey, advocate, Alzheimer's Association...    33
    Prepared statement...........................................    35
Statement of John Wagenaar, patient, Alzheimer's disease.........    36
    Prepared statement...........................................    38
Statement of David Hyde Pierce, advocate, Alzheimer's disease....    39
    Prepared statement...........................................    41













                 ALZHEIMER'S DISEASE, FISCAL YEAR 2002

                              ----------                              


                         TUESDAY, APRIL 3, 2001

                           U.S. Senate,    
    Subcommittee on Labor, Health and Human
     Services, and Education, and Related Agencies,
                               Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:32 a.m., in room SH-216, Hart 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senators Specter, Craig, Harkin, and Reid.

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Ladies and gentlemen, the appropriations 
subcommittee on Labor, Health and Human Services, and Education 
will now proceed, the hour of 9:30 having arrived.
    The subcommittee has scheduled this hearing to coordinate 
with the 13th Alzheimer's Association Public Policy Forum. This 
hearing will kick off the Association's Capitol Hill Day.
    This is a terrifying illness, as we all know; one where 
Senator Harkin and I, as ranking and chairman of the 
subcommittee, have been very anxious to increase funding as 
substantially as we can.
    During the course of the last four appropriations cycles, 
we have taken the lead on this subcommittee, Senator Harkin and 
I, in moving forward to increase the funding in the National 
Institute of Health by some $8 billion, from $12 billion in 
fiscal year 1995 to now more than $20 billion. And it is our 
hope, this year, to add an additional $3,400,000,000 to 
National Institute of Health funding to move toward the stated 
goal of doubling the NIH budget over the course of 5 years. 
That funding for NIH has had a very marked impact on the 
funding for Alzheimer's disease.
    Since 1996 the budget has risen from $308 million to $520 
million this year. And we hope to reach a figure of almost $583 
million for fiscal year 2002. This increase in funding is in 
response to a tremendous problem in America today. The 
statistics show that there are some 4 million Americans with 
Alzheimer's, and that figure will increase by 50 percent to 
about 6 million by the end of this decade. If projections are 
correct that number will double to 14 million by the middle of 
the next century. One in 10 individuals over 65 is afflicted 
with Alzheimer's, and half of those over 85 have Alzheimer's.
    If we are able to delay the incidence of Alzheimer's, we 
will be able to save a tremendous amount of money. The 
statistics show that delaying the onset of Alzheimer's for 5 
years would save some $50 million in annual health care costs.
    Of course, we all know that President Reagan suffers from 
Alzheimer's, and his condition has brought to the attention of 
the American people the very, very serious problem. President 
Reagan's Alzheimer's disease is something that everyone knows 
about.
    One additional note before turning to my distinguished 
colleague, and that is the issue on stem cell research. At the 
present time, through an opinion of counsel for the Department 
of Health and Human Services, Federal funds may be used on stem 
cell research after the stem cells have been extracted from the 
embryos, but it is not possible to use Federal funding to 
extract the stem cells from the embryos.
    Stem cells hold enormous promise in virtually every line of 
disease. On Saturday the New York Times carried an extensive 
story about how stem cells may be inserted into diseased heart 
tissue to deal with the problems of heart attacks, heart 
disease, and hardening of the arteries.
    The efforts to cure Parkinson's disease has benefitted 
enormously from stem cells with estimates that Parkinson's may 
be curable within 5 years.
    Spinal cord injury is another ailment where stem cell 
research can be very, very helpful. And it may be that 
Alzheimer's, too, could benefit from stem cells.
    During the course of today's hearing, we will hear 
testimony about advances which have been made to combat the 
onset of Alzheimer's.
    Senator Harkin and I have taken the lead in sponsoring 
legislation which would remove the prohibition now preventing 
funds being used for research to extract stem cells from 
embryos. We realize that this is a controversial issue and that 
there are some who contend that the embryos constitute human 
life.
    The fact is that the embryos were created for in-vitro 
fertilization and there are many excessive embryos which will 
be destroyed, if not put to the use of saving lives. These stem 
cells are a veritable fountain of youth. I mention that because 
I think it is important to have as much public awareness on 
this issue as possible, so that the people of America may be 
informed, may express themselves, and have an impact on 
Congressional action.
    Now, I am pleased to turn to my distinguished colleague, 
Senator Tom Harkin.

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. Well, Mr. Chairman, thank you very much. 
You have been a great champion for research on Alzheimer's 
disease over the years. We have worked very closely together. I 
commend you for calling this hearing. And obviously, there is 
more than just a little bit of interest in this hearing, as I 
can see by the audience here today.
    I want to thank you, Mr. Chairman, for giving my remarks 
for me. I think you have said just about everything I wanted to 
say.
    Senator Specter. So, that is what happens when you work 
together with someone for more----
    Senator Harkin. That is right.
    Senator Specter [continuing]. Than a decade and have 
similar aptitudes.
    Senator Harkin. We have been working together, now, for 11 
almost 12 years now. That is right. And it has been a great 
partnership. And I appreciate it, Mr. Chairman.
    We are fortunate to have a distinguished panel of guests 
with us this morning. I especially wanted to extend a welcome 
to John Wagenaar, who is visiting us from George, Iowa.
    Mr. Wagenaar, we have heard great things about the work you 
and your wife, Darlene, have done to raise awareness about 
Alzheimer's. And we thank you for making the trip to Washington 
to tell us about your experiences.
    I am told that there are many who are here today who will 
be on the Hill today and tomorrow who have Alzheimer's. I 
commend you for your courage in being here. Do not fade into 
the shadows. Get out in front and make sure people are aware of 
what is going on in your families and in your lives.
    The most poignant and most telling stories to have the 
impact, I think, on Senators and Congressmen, are your own 
personal stories. And so, I commend each of you who is here in 
Washington, who is battling this disease, this illness. And I 
commend you for being here and being out in front.
    Like everyone here, I am deeply concerned about 
Alzheimer's. Four million Americans currently suffer. Unless we 
take immediate and dramatic action, that number could rise to 
about 14 million in the next 40 years.
    Fortunately, researchers have made some extraordinary 
advances in recent years. A decade ago there were no 
Alzheimer's drugs on the market. Today there are four. More are 
on the way.
    One of the areas I am interested in, and Dr. Hodes, I know, 
will be talking about it after a bit, is that scientists have 
developed a vaccine, that when tested on animals, appeared to 
ward off the brain-clogging deposits that are associated with 
Alzheimer's. Now, plans are underway to test this in humans. 
That is why we need more money for research.
    Researchers have also come a long way in learning how to 
diagnose Alzheimer's. And they are doing some promising studies 
on the links between this disease and vascular disorders, like 
strokes and high blood pressure.
    I also want to commend the chairman for his statements this 
morning and the position he has taken on stem cells. We are in 
lockstep on this issue, I can tell you. This is not a partisan 
issue, but we are in lockstep on this issue.
    There are hundreds of thousands of embryos that are now 
frozen in nitrogen. Quite frankly, they are going to be 
discarded. And to think of the potential that these might have 
for saving human lives, because of the research that can be 
done, is something that we just cannot back away from.
    So, I commend you for that. And we have just got to move 
ahead in letting our researchers do the research that is 
necessary.
    So, again, we hope that we can raise the NIH budget this 
year and reach our goal, but there is one other thing I want to 
mention. I mentioned it to some of my friends who are here from 
Iowa, just before we came up here. Senator Specter and I worked 
together to fully fund the Family Caregivers Support Program. 
Seven in ten people with Alzheimer's live at home where family 
members provide over three-fourths, 75 percent, of their care.
    Those of us who have been touched by Alzheimer's in our 
families and our relatives know what kind of a toll that takes 
on families; the financial toll, the psychological toll. And 
so, hopefully, we can do something with the Family Caregivers 
Support Program to help provide some support for the families, 
for respite, the kind of support they need in their own homes 
to take care of their loved ones.
    This year the Federal Government will spend more than a 
half of a billion dollars on preventing and finding a cure for 
Alzheimer's. Now, a lot of people say that is a lot of money, 
but it is pocket change compared to the $100 billion that 
Alzheimer's costs us every year in this country.
    By 2010 the annual Medicare and Medicaid costs, alone, will 
rise from $50 billion to $82 billion. In Iowa, where we have a 
high share of elderly in our society, those costs will increase 
by 63 percent.
    So, as the chairman said, if we can just forestall the 
onset by 5 years, we really save a lot of money in Medicare. 
That is really the answer to the problems that plague us in 
Medicare.
    So, again, we cannot stop now. We have come too far. I 
thank all of you for being here. We need your help, both in the 
overall funding for NIH, but also in ensuring that we get the 
adequate monies that we need to really zero-in on Alzheimer's. 
We are close. We cannot give up. We cannot step back. We have 
got to take a big step forward.
    And I thank you all for being here today and, well, they 
say sometimes that leadership requires a big foot in the middle 
of the back or maybe lower down.
    So, I thank you. I am not saying you all have big feet.
    But I thank you for being here and putting the foot in the 
back of Senators and Congressmen.
    Thank you.
    [The statement follows:]
                Prepared Statement of Senator Tom Harkin
    According to the Alzheimer's Association the costs of treating the 
disease in Iowa will increase more than $300 million this year, going 
from $480 million to $784 million.
    Thank you, Mr. Chairman. You've been a great champion for research 
on Alzheimer's Disease over the years, and I commend you for calling 
this hearing.
    We're fortunate to have such a distinguished panel of guests with 
us this morning. I'd like to extend a special welcome to John Wagenaar, 
who's visiting us from George, Iowa. Mr. Wagenaar, I've heard great 
things about the work that you and your wife, Darlene, have done to 
raise awareness about Alzheimer's. Thank you for making the trip to 
Washington to tell us about your experiences.
    Like everyone here, I am deeply concerned about Alzheimer's 
Disease. It's a serious health problem now, but it could reach epidemic 
proportions in the near future. Four million Americans currently suffer 
from Alzheimer's. Unless we take immediate and dramatic action, that 
number could rise to 14 million by the year 2050.
    Fortunately, researchers have made some extraordinary advances in 
recent years. A decade ago, there were no Alzheimer's drugs on the 
market--today there are four, and more are on the way. Scientists have 
developed a vaccine that, when tested on mice, appears to ward off the 
brain-clogging deposits that are associated with Alzheimer's. Plans are 
now under way to test this vaccine in humans.
    Researchers have also come a long way in learning how to diagnose 
Alzheimer's. And they're doing some promising studies on the links 
between this disease and vascular disorders like strokes and high blood 
pressure.
    Those advances are a direct result of this nation's growing 
investment in medical research. Chairman Specter and I have worked 
hand-in-hand for many years to provide more resources for NIH. This 
year, we hope to raise the agency's budget by $3.4 billion. And next 
year, we hope to reach our five-year goal of doubling federal spending 
on medical research.
    The chairman and I have also worked together to fully fund the 
Family Caregiver Support Program. Seven in 10 people with Alzheimer's 
live at home, where family members provide 75 percent of their care. We 
all know the financial and psychological toll that Alzheimer's takes on 
these caregivers. They need help, too, and the Family Caregiver Support 
Program is a good start.
    This year, the Federal Government will spend more than half a 
billion dollars on preventing and finding a cure for Alzheimer's. That 
might seem like a lot of money, but it's pocket change compared to the 
$100 billion that Alzheimer's Disease costs this nation every year.
    By 2010, the annual Medicare and Medicaid costs alone will rise 
from $50 billion to $82 billion. In Iowa, the costs will increase by 63 
percent, from $480 million to $784 million. But if we can find a way to 
delay the onset of Alzheimer's by just five years, we'll cut the cost 
of this disease by $50 billion a year.
    So we can't stop now. We're making great progress--but we don't 
have much time. We need to invest more money in Alzheimer's research 
today, before it's too late for millions of Americans who could be 
stricken with this disease in the years ahead.
    Again, I thank Chairman Specter for calling this hearing, and I 
look forward to the testimony.

    Senator Specter. Thank you, Senator Harkin.
    Senator Craig, an opening statement?
    Senator Craig. Mr. Chairman, I do not have. I want to thank 
you for holding this hearing and drawing our attention to this 
horrible disease.
    I now Chair the Aging Committee. And we are going to spend 
a good deal of time on this and other issues, as we examine the 
difficulties and the problems that an aging American population 
has.
    What you offer us with your leadership in the necessary 
monies to do the kind of healthcare research that we are doing 
and doing very effectively now, is extremely important. We 
bring those forces together. And we now know that with our 
technology and our ability we can lick a lot of problems or 
diseases. This is one of them. And I think Senator Harkin has 
put it well; you all are here today with a very loud voice. We 
hear you. And we will respond.
    Thank you.
    Senator Specter. Thank you very much Senator Craig.
    We have invited the co-chairman of the House Alzheimer's 
Task Force, Congressman Markey and Congressman Smith. It is 
always a question as to who goes first. And I note that we have 
two very, very senior Members of the House here today; 
Congressman Smith being elected in 1980, and Congressman Markey 
being elected in 1976.
STATEMENT OF HON. EDWARD J. MARKEY, U.S. REPRESENATIVE 
            FROM MASSACHUSETTS
    Senator Specter. We will lead with Congressman Markey. I 
would read you Congressman Markey's biographical resume, but it 
would take longer than the few minutes which are allotted to 
Congressman Markey. Suffice it to say that he is a leader in 
many fields in the House, including telecommunications issues, 
and just yesterday received the Alzheimer's Association 
Humanitarian Award for 2001.
    Thank you for joining us Congressman Markey, and we look 
forward to your testimony.
    Mr. Markey. Thank you, Mr. Chairman, very much.
    And as amazed as I am that I have been a Congressman for 25 
years, it is even more amazing to everyone I went to high 
school with.
    So, I agree with you. Each of us, I think, kind of still 
wonders how we got here and got to serve in this amazing 
institution that allows us to help so many people.
    Senator Specter. Senator Bumpers said to me shortly after I 
arrived: ``Arlen, you are going to spend the first 6 months 
wondering how you got here, and the next 5\1/2\ years wondering 
how everybody else got here.''
    Mr. Markey. Well, I actually still have the opposite. I 
wonder how I got here. I have great respect for, obviously, 
this committee and honestly, the wonderful work that it has 
done over the years, not only for Alzheimer's, but for every 
other disease.
    Chris Smith and I founded the Alzheimer's caucus 2 years 
ago. We now have 131 Members of the House who are members of 
the Alzheimer's caucus.
    To be honest with you, my mother contracted Alzheimer's 
back in the mid-eighties. Up until the eighties, I had been 
focusing upon Alzheimer's as the disease which I've worked on 
in the House of Representatives, little knowing that my wife--
that my mother had it. And once she had it, and I am sure that 
many people behind me know what I am talking about, it became 
impossible for me, really, to even talk about it.
    My mother was valedictorian of her high school class. She 
was able just--without going to college, of course, because in 
that era women did not go to college. She graduated in 1926 
from high school. Her mother had died the year before. The 
Social Insurance Program for the United States, in 1926, was 
that if the mother died, one of the daughters would have to 
stay home and raise the rest of the family. And that is the way 
it was.
    So, that as we grew older, my brothers and I, we realized 
that the fun that she used to have in solving calculus 
problems, trigonometry problems for us in college was strictly 
a reflection of the strength of this brain that God had given 
to her.
    Now, by the time she was able to get married, because she 
had to raise that other family, she was in her late thirties. 
She married my father, who was a milkman for the Hood Milk 
Company. My father always said to us that he was going to do 
the best he could to make sure that my mother never stepped 
foot in a nursing home, because it was an honor that she had 
married him; that the valedictorian had married a milkman.
    And so, at 81, 82, 83, 84, 85, 88, he stayed--he kept her 
in the home. He got up five, eight times a night, lifted her 
up, put her on the toilet, wiped her off, put her back in the 
bed again; fed her all day long, because it was an honor.
    Now, the interesting thing about this disease is that 
unlike just about any other disease, the people who are 
afflicted by it cannot be their own advocates, with the 
exception of those who are in the early stages. Moreover, those 
who are their principal caregivers at home cannot be their 
advocates.
    So, unlike just about every other disease, those who are 
afflicted by it and their primary caregiver in the home cannot 
go out and lobby. They cannot go out and march. They are 
trapped. They are trapped by this disease.
    Now, there are 4 million people who have it today. And 14 
million by the time all of the baby boomers retire. Fourteen 
million people, plus a principal caregiver at home. That is 28 
million people, at a minimum, whose entire lives will be 
Alzheimer's. That is all they will have in their life, because 
once it hits, it becomes all encompassing, as the people over 
my shoulder know.
    So, what we advocated last year and you were good enough to 
help us to make that come true, was for an $85 million increase 
in Alzheimer's research funding, which brought the number up to 
$525 million. A $2.25 million program for clinical research 
awards, so that we could focus upon the clinical aspects of 
this disease. We hope that it is cured, but we are not 
confident it will occur in the next few years. We just pray 
that it will.
    And we also were able, with your help, to clarify the 
homebound definition, because up until the end of last year, if 
anyone wanted to take this other person in their home to 
church, to mass, to synagogue, to a mosque, or to an adult day 
care center, they would lose the benefits in the home; someone 
coming in for an hour or two a day to help out.
    That was a huge restriction on these people. They almost 
had to be prisoners in their home with this person who they 
might be able to take out for an hour, especially to go to 
church. So, that was a great boon to these families to repeal 
that. And I understand that it was $1.2 billion over the next 
10 years, but, still, I think it is critical, because so much 
of this ultimately is affecting the caregivers, as well. And 
so, not only is it good for the person victimized by it, but 
also by the family caregiver.
    So, this year, what we are asking for is a $200 million 
increase in the research budget. And in addition, that we fully 
fund----
    Senator Specter. Congressman Markey, I am sorry to 
interrupt you, but the time is--you are a bit over, and we have 
a large number of witnesses, and the budget is on the floor. 
Senator Harkin and I are going to have an amendment pending to 
try to raise NIH funding. So, we are going to have to stick 
very close to time.
    Mr. Markey. Could I have 1 minute, then, to complete, 
Senator?
    Senator Specter. Sure.
    Mr. Markey. I thank you. On the Apollo 13 mission, the 
chamber had lost its oxygen. It was about to head for a crash. 
They called back to Control Center in Houston. And Jim Lovell 
was there. And he said, ``We are going to have to find a way to 
adapt; to find a way in which we are going to solve this 
problem,'' because the wires were on fire; the oxygen had been 
lost.
    And those astronauts did not know if they could do it. And 
Jim Lovell sent back the message that they were going to use 
any device they could, find any means they could, to solve this 
problem. And when they questioned it again, Jim Lovell said, 
``Failure is not an option.''
    The same kind of oxygen is being lost. The same kind of 
wires are on fire in the brains of these Alzheimer's victims. 
And for these families and for our country, failure is not an 
option. We must find the cure for this before 14 million 
victims and their spouses or their loved ones are trapped 
forever.
    And so, you have the power to increase this budget by 
$100--by $200 million this year; $2.25 million for the clinical 
program and $25 million to expand the Alzheimer's matching 
grant program by $6 million. And I hope that you can make that 
possible.
    Thank you.
    [The statement follows:]
              Prepared Statement of Rep. Edward J. Markey
    Good morning. I would like to thank Chairman Specter, Ranking 
Member Harkin and the entire Subcommittee for holding this important 
hearing and for your ongoing support for research funding for 
Alzheimer's Disease.
    In addition, I thank you for this opportunity to testify on behalf 
of the 4 million Americans afflicted and the countless others affected 
by this devastating illness.
    In 1999, I approached my good friend Chris Smith with one thing in 
mind . . . to make Alzheimer's a top priority issue for Congress. That 
June, we started the Bipartisan Congressional Task Force on Alzheimer's 
Disease. Our objectives included increasing federal research dollars to 
aid in the discovery of treatments, preventative measures and a cure; 
and addressing the needs of patients and their caregivers burdened with 
the daily duty of dealing with an afflicted loved one.
    Today the Task Force is at a membership of 131 and growing. And 
thanks to the efforts of many, the 106th Congress took three 
significant steps toward meeting the goals of the Task Force. These 
steps included: (1) increasing research funding for Alzheimer's by $85 
million (2) creating a new clinical research and training awards 
program to fund physician-scientists in clinical research and (3) 
clarifying the ``homebound'' definition in the Medicare law so that all 
beneficiaries could attend religious services as well as adult day 
care. For Alzheimer's beneficiaries this was a crucial clarification in 
the law as adult day care is not only a proven therapeutic treatment 
for patients but it provides a much needed break in the day to family 
caregivers.
    This Congress we want to build on our past successes by encouraging 
scientists to build on the progress that we've made in Alzheimer's 
research.
    Research is medicine's field of dreams from which we harvest new 
findings about the causes, treatment, and prevention of disease. Since 
1950, we have learned more about health and disease than in the entire 
history of medicine. In fact, we've eliminated some of the major 
scourges that killed us at the turn of the century like smallpox and 
diptheria.
    That's why we must make sure that research not only survives but 
thrives. We are asking for a $200 million increase in federal funding 
for the National Institutes of Health--with an ultimate goal of $1 
billion by 2003. In addition, we ask that the program which the Task 
Force was instrumental in authorizing--The Alzheimer's Clincal Research 
and Training Awards--be fully funded at $2.25 million. In addition to 
building on successful research, it's also important to build on 
successful programs. Specifically, we are asking that funding for the 
Alzheimer's Matching Grant Program currently available in only 16 
states be increased by $6 million to $25 million. Expanding this 
program which encourages innovation in long-term care, will enable all 
50 states to reach Alzheimer's families in underserved areas, 
particularly minority and rural communities.
    As many of us here today know, Alzheimer's Disease is cruel and 
indiscriminate--it attacks the brain, captures the mind and erodes the 
mental and physical abilities of its victim before ultimately stealing 
his or her life. If you have one parent affected with Alzheimer's you 
are three times more likely to develop the disease yourself and if both 
of your parents are affected, you are at a fivefold increase in risk.
    In fiscal year 2001, the Federal Government spent an estimated $520 
million on Alzheimer's research--this is a modest investment compared 
with the annual $100 billion cost of the disease. We know that the 
disease process begins 10-20 years before symptoms begin. If science 
can find a way to delay the onset of Alzheimer's for even five years, 
our nation will save an estimated $50 billion in annual health and long 
term care costs.
    In 1900, the average life expectancy was 48. In 1999, life 
expectancy at birth reached an all-time high of 77 years. In 1900 about 
1 in 25 Americans were over the age of 65. In 1990, the proportion rose 
to 1 in 8--a 10-fold increase. It is estimated that by the year 2040, 1 
in 5 Americans will be over the age of 65 and there will be almost four 
times as many very old people over the age of 85 as there are today. 
Right now we know that one in ten Americans over age 65 and half of all 
persons over the age of 85 have Alzheimer's. This means that by 2050--
if we fail to find a way to prevent or cure Alzheimer's 14 million 
Americans we fall victim.
    Pasteur once observed that ``Chance favors the prepared mind.'' We 
can choose to prepare, or we can turn a blind eye and leave the fate of 
our future aging population to chance.
    So, as we leave here this morning, let us all continue to work 
together to soon reach that day when children will have to turn to 
their history books to find out what Alzheimer's Disease was.
    I thank you.

    Senator Specter. Thank you very much, Congressman Markey.
    Every witness is going to be allowed 5 minutes. And I 
regret to say that we are going to have to stick very close to 
time. The budget is on the floor. And let us repeat, Senator 
Harkin and I will offer an amendment to the Budget Resolution 
that will raise the figure for NIH, and we may be called upon 
to offer that amendment today. So, we are going to be under 
very considerable time constraints.
STATEMENT OF HON. CHRISTOPHER H. SMITH, U.S. 
            REPRESENTATIVE FROM NEW JERSEY
    Senator Specter. We turn, now, to our Congressman 
Christopher H. Smith, who is the co-chair of the House caucus 
on Alzheimer's. Congressman Smith is in his 11th term, having 
been elected in 1980. He chairs the House Veterans Committee. 
And in that capacity, he and I have worked very closely 
together, since I chair the Senate Veterans Committee.
    Thank you for joining us, Congressman Smith, and we look 
forward to your testimony.
    Mr. Smith. Thank you very much, Mr. Chairman and members of 
this committee. Thank you for this opportunity. And let me just 
say that when Ed Markey was talking about his mother doing his 
homework, it is good to know that somebody else's mother did 
his homework in high school, as well.
    I have just a couple of points, and Ed has asked--and the 
bottom line is we are requesting $200 million in NIH increases 
for Alzheimer's--on the issue of basic research; the $2.25 
million for the Alzheimer's clinical research and training 
program; and the $6 million increase for the matching grant 
program, so that all the States that would like to participate, 
can.
    We have a very short window of opportunity here. We know 
that the onset of this can take between 10 and 20 years. We 
need to get to the bottom of it. And hopefully, more money will 
make a difference.
    And bottom line, 25 percent of all the promising and 
meritorious Alzheimer's applications receive funding; meaning, 
many others that are very, very good and--and viable--never get 
funding. So, the money, I think--we think, would be very well 
utilized.
    Since, Senator, you did raise the issue--a controversial 
issue of--of embryo stem cells, let me just address some of my 
comments to that, because many of us do believe, quite 
passionately, that destroying human embryos for so-called 
medical research purposes is unethical.
    We believe that human life cannot be reduced to the level 
of a guinea pig; that there is no such thing as a ``spare 
embryo.'' There may be those that are in cryogenic tanks, but 
there is no such thing as a spare human being. And thankfully, 
there are alternatives. And I hope that this hearing today 
begins to refocus on the other stem cells, and that is adult 
stem cells.
    You mentioned, over the weekend, the remarkable 
breakthrough reported in The New York Times, and elsewhere, on 
the use of stem cells to treat cardiac patients. The study you 
mentioned was not an embryonic stem cell study, but adult stem 
cells. Robert Bazell made a comment on MSNBC about this study. 
And in his report, he has a Dr. Orlic from the National Human 
Genome Research Institute in Bethesda, making some very 
profound comments that can hopefully keep us in consensus, 
rather than shattering that consensus.
    And this is Dr. Orlic's statement, ``Until now, researchers 
thought that stem cells from embryos offered the best hope for 
rebuilding damaged organs, but this latest research shows that 
embryos, which are politically controversial, may not be 
necessary. We are currently finding,'' he goes on to say, 
``that adult stem cells can function as well, perhaps even 
better than embryonic stem cells.''
    Dr. Douglas Melton of Harvard University recently wrote, 
``Human embryonic stem cells are trickier than even mouse; they 
are more tedious to grow.''
    Molecular biologist Michael Shamblock, a Ph.D., sums up the 
concerns with embryonic stem cell research when he said, and I 
quote, ``We thought, from the first, that problems would arise 
from using HPSCs [human pluripotent stem cells, or embryonic 
stem cells] to make replacement tissues. The early stage stem 
cells are both difficult and slow to grow. More important, 
there are risks of tumors. If you are not very careful when 
coaxing these early cells to differentiate to form nerve cells 
and the like, you risk contaminating the newly differentiated 
cells with stem cells. Injected into the body, stem cells can 
produce tumors.''
    There are a number of other similar suggestions that there 
is another way, there is another path--that I would 
respectfully submit needs to be followed--which does not take 
human life and turn human life into the status of a guinea pig.
    So, having said that, we can have a consensus; we can work 
in a way that everyone can feel good, and we can have very, 
very fine research using adult stem cells, because they offer 
great promise. And the breakthrough over the weekend, which is 
one item in an ongoing series of breakthroughs, suggests that 
there is a path around which we can all rally. Use the money 
and use it for many kinds of research, including adult stem 
cell.
    I thank you for this opportunity and look forward to any 
questions you may have.
    [The statement follows:]
            Prepared Statement of Rep. Christopher H. Smith
              the race for answers to alzheimer's disease
    Mr. Chairman, thank you for providing me with an opportunity to 
urge the committee to set aside sufficient funding for critical 
lifesaving and life affirming medical research.
    Congressman Markey and myself are here to represent the interests 
of the four million Americans afflicted with Alzheimer's Disease and 
the 19 million caregivers who look after loved ones suffering from the 
disease.
    As co-founder of the Bipartisan Congressional Task Force on 
Alzheimer's Disease--which is currently comprised of 133 members--we 
are seeking Committee support in three areas: (1) adequate support for 
Alzheimer's research at the National Institute of Health so as to 
accommodate a $200 million increase in research funding (2) an increase 
of $2.25 million to fully fund the Alzheimer's Clinical Research and 
Training Program--a worthwhile program authorized last year to improve 
diagnosis, treatment and prevention, and (3) a $6 million increase in 
the Alzheimer's Matching Grant Program so we can bring funding to $25 
million and allow all eligible states to participate in the program.
    Mr. Chairman, your committee gets many requests for increased 
funding. So you would be justified in asking why these three requests 
are worthy of your support. The bottom line is that we have a very 
narrow window of opportunity to save millions of Americans from 
developing this disease. The disease process begins 10 to 20 years 
before symptoms appear. This means we must find a way to stop or slow 
the disease process within the next five or ten years. Right now, 50 
percent of every American aged 85 and above suffer from some kind of 
dementia. As life spans increase, the number of Alzheimer's patients 
will rise from 4 million to 14 million over the next 50 years. Thus, if 
we fail to seize this unique moment in history, the implications for 
our society and our economy will be staggering.
    Unlike many diseases, Alzheimer's affects the entire family, as 
caregivers make enormous sacrifices of time, money, and even then own 
health status. There is simply no way we can save Medicare if we let 14 
million baby boomers develop Alzheimer's disease. Medicare patients 
with Alzheimer's cost 70 percent more to treat than those who do not. 
And a lifetime cost of just one case can run between $174,000 and 
$200,000. If every Alzheimer's patient needed a long-term stay in the 
nursing home, state and federal Medicaid budgets would burst at the 
seams, threatening the nation's safety net for all indigent persons.
    So what needs to be done? First, we need to boost NIH funding so 
that it can accommodate a $200 million increase in total Alzheimer's 
research across all agencies. An increased investment will allow for 
researchers to search for simple, practical, widely available, and 
affordable ways to detect the earliest changes in the brain. This is 
the only way physicians will be able to identify who needs the 
treatment that will help alter the course of the disease while there is 
still enough time to make a difference. It will also allow for 
additional large-scale trials aimed at prevention of Alzheimer's 
disease, including studies of persons with mild cognitive impairment 
and new longitudinal studies of persons who are aging successfully. 
Part of the answer to Alzheimer's may lie in discovering why many live 
well into their 90s with their cognitive abilities intact. Furthermore, 
appropriate funding will permit us to establish additional large-scale 
clinical trials of early intervention to slow or prevent decline. 
Scientists have many more sound ideas for effective treatments that 
they can test with increased funding.
    Sadly, only 25 percent of all promising and meritorious Alzheimer's 
disease applications receive funding from the NIH. Thus, it is evident 
that the overwhelming percentage of well-scoring Alzheimer's 
applications do not receive support from the NIH. Many valid scientific 
opportunities that could enhance our knowledge of Alzheimer's have been 
lost. Mr. Chairman, we are headed in the wrong direction--we need to be 
funding most, if not all, promising and viable Alzheimer's studies. We 
certainly should not be rejecting nearly 75 percent of every promising 
new research project presented to the NIH.
    Secondly, and building upon the first request, is $2.25 million for 
the Alzheimer's Clinical Research and Training Program This program was 
authorized last year to improve diagnosis, treatment and prevention of 
Alzheimer's disease. Better training and education will allow 
professionals to improve their diagnosis, management, and prevention of 
Alzheimer's disease. The program is designed to help promising young 
researchers who wish to make Alzheimer's research, their life's work. 
The $2.25 million asked for in this program is a modest amount to train 
a core group of bright and upcoming professionals in managing 
Alzheimer's disease.
    Finally, we believe that states who wish to participate in the 
Alzheimer's Matching Grant Program ought to be allowed to do so and 
receive some level of federal support. This is a focused program to 
promote innovation and experimentation in state long-term care programs 
treating Alzheimer's patients. This 15-state demonstration has operated 
for 8 years with enormous success. A $6 million increase, bringing 
total funding to $25 million, would allow all states who are expected 
to apply for funding the ability to receive support. I believe the 
states have often led the way for new ideas. If we are serious about 
letting states continue to innovate, we need to get behind this 
program.
    Mr. Chairman, we have seen that the Alzheimer's investments 
Congress has made in the past decade are now paying off in rapid 
discoveries regarding the basic mechanisms of the disease, the complex 
interplay of genetic and environmental risk factors, and the treatment 
and interventions that can slow decline. Discoveries in the past year 
alone have generated great excitement in the field of Alzheimer's. For 
instance, scientists have developed a third FDA-approved drug designed 
for the treatment of the disease's cognitive symptoms. In addition, 
scientists have completed Phase 1 of a clinical trial involving humans 
in which they used a vaccine that appears to prevent in the brains of 
mice the amyloid deposition that forms plaques which characterizes 
Alzheimer's disease.
    The United States enters the 21st Century facing an imminent 
epidemic. By 2050, 14 million of today's baby boomers will have 
Alzheimer's disease. For most of them, the process that will destroy 
their memories, their lives, and their savings has already begun, The 
annual cost of Alzheimer's disease will soar to at least $375 billion, 
overwhelming our health care system and bankrupting Medicare and 
Medicaid. The only way to avoid this crisis is to act now.

    Senator Specter. Thank you very much, Congressman Smith. 
You and I have a somewhat different view on the subject. And we 
had a chance to discuss it at some length on a train ride to 
Philadelphia when we visited the Veterans' Hospital there. When 
the Secretary was en route to go to New Jersey with you.
    And there will be an opportunity to go into some detail as 
to the issue of whether adult stem cells are adequate. I have 
seen the body of the literature on it. And I have a different 
conclusion. But I very much respect what you have said.
    When you talk about human life, I quite agree with you; 
that I would not do anything to invade human life and would not 
want to make any form of life or any human life a guinea pig. 
The difficulty that I have is that these embryos are going to 
be destroyed. And I know your view is that action ought to be 
taken to avoid the destruction. And this is a very, very 
sensitive matter and a very important matter.
    I know that there will be time for extended debate, both in 
the House and in the Senate. And I appreciate your point of 
view. We will give you the last word, if you want to make an 
additional comment.
    Mr. Smith. I appreciate that, Senator and Mr. Chairman. You 
know, when you say they are going to be destroyed, that is a 
possibility. It is not an absolute certainty. And with--if the 
concept and if the proverbial Rubicon is crossed, that there 
are certain human beings that could be destroyed, in the 
process of having their stem cells taken away, it does indeed 
turn them into the status of a guinea pig.
    And there will be, after that, once that bridge is crossed, 
other efforts will be made--I mean, if we can take those human 
embryos and use them, it undermines the sanctity of human life 
and puts us on a slippery slope where all of our lives are put 
at risk and devalued.
    You know, there is no such thing as a spare embryo. There 
is no such thing as a spare human being. I would argue, 
passionately and hopefully persuasively, that from the moment 
of fertilization until natural death, we need to have 
protection for innocent human life to the greatest extent 
possible.
    And thankfully--and I cannot stress this enough--there is 
an alternative that offers greater promise and does not have 
the ethical baggage that embryonic stem cells have. It is the 
adult stem cell approach.
    Senator Specter. Thank you very much. Unless there is some 
question, we will move to panel two. Thank you very much.
    Senator Harkin. I must say, Mr. Chairman, you and I have 
both put too much into this whole effort. Listen, Chris knows I 
respect him highly. And he is a very principled person. I hope 
you give us the same benefit; that we are principled, also.
    Both Senator Specter and I have been involved in the stem 
cell thing from the beginning. I believe that we have crossed 
all of the t's and dotted all of the i's, in terms of the 
ethical underpinnings of this. I just say two things; that I 
think there is a lot of misconception about stem cells. I have 
talked to many people who think that you are talking about 
embryos and that equals the fetus.
    I always do this: I hold up a piece of paper. What is on 
that piece of paper? I defy anyone there to see it. You cannot 
see it. I put a little dot. I took my pencil and put a little 
dot on it. That is how big those embryos are. It is not a 
fetus. It is an embryo.
    These are the leftovers from women who, for one reason or 
another, could not have a child. And so, they went through 
embryo placements. They now are happy parents. They have a 
child. But obviously, you know, a lot of embryos are left over 
and they are now in cryogenic tanks. To think that we are going 
to keep those for the next 10,000, 1 million, 2 million years--
no. Yet they hold a lot of promise.
    Now, I do disagree with you, Congressman Smith, about the 
pathways. Yes, there are other paths. This premise is where we 
differ. I think we ought to go down that path of adult stem 
cells. I think it may hold a lot of promise, but basic 
research, I have always said, is like you have 10 doors that 
are closed.
    If you open one door, the odds are 10 to 1 that you are 
going to find a cure. If you open five doors, it is 2 to 1. We 
are trying to open doors. And to shut off one pathway that may 
lead to a cure and which scientists believe that can be done 
ethically, under sound ethical guidelines that have been set 
up, to me, is to cut off the possibility that they may lead to 
the kind of interventions and cures that we need for a host of 
different illnesses, not just Alzheimer's.
    And so, yes, I think we do have a disagreement there, but I 
believe it can be done very ethically. And I believe it can be 
done in a manner that takes these little embryos the size of a 
dot, size of a pinhead, and further enhance human life. And it 
seems to me that is what we all ought to be about.
    Thank you, Mr. Chairman.
    Mr. Markey. Tom. I'm sorry. Tom. Can I say that I agree 
with you and agree with Senator Specter on stem cell research? 
So, I think----
    Senator Specter. Thank you, Congressman. I think we 
better----
    Mr. Markey. I take the position we choose--just so you will 
know that the Congressional Task Force on Alzheimer's does not 
take a position on the subject. Chris and I have different 
points of view.
    Senator Specter. Sure.
    Mr. Markey. I share your view on the subject. We try to 
find agreement on all the issues upon which we do agree.
    Senator Specter. We will have an opportunity at a later 
time to explore it in some detail.
    I spoke, perhaps, too soon, Congressman Smith, in promising 
you the last word. I should have known better, with Senator 
Harkin at my side.
    But I respect----
    Mr. Smith. But do I get another last word?
    Senator Specter. I respect your views, Congressman.
    Senator Craig. Mr. Chairman, I will remain silent.
    Senator Specter. It is too late, now, Senator Craig.
    But I respect your views. And I think you are passionate 
beyond any question. And I think you are persuasive, as well. 
Thank you very much, Congressman Markey and Congressman Smith.
STATEMENT OF DR. RICHARD J. HODES, DIRECTOR, NATIONAL 
            INSTITUTE ON AGING, NATIONAL INSTITUTES OF 
            HEALTH, DEPARTMENT OF HEALTH AND HUMAN 
            SERVICES
    Senator Specter. We will now turn to Dr. Richard Hodes, 
who, since 1993, has been the Director for the National 
Institute on Aging. He has had several other posts at NIH, 
including Clinical Investigator at the National Cancer 
Institute, Program Coordinator for the U.S.-Japan Cooperative 
Cancer Research Program. He is a graduate of Yale University 
and an M.D. from Harvard Medical School.
    President Kennedy would say, Dr. Hodes, you have the best 
of both worlds. Thank you for joining us and we look forward to 
your testimony.
    Dr. Hodes. Thank you, Mr. Chairman and members of the 
committee, for this opportunity to appear before you, again, to 
describe some of the progress over the past year in the 
research to understand and ultimately to treat and prevent 
Alzheimer's disease.
    Alzheimer's disease is a progressive and devastating 
disorder of the brain, which is a result of a long cascade of 
events. It results in the deterioration of intellectual 
functioning and ultimately a loss of independence.
    As noted, some 4 million Americans currently suffer from 
the disease. And due to the unprecedented increase in the 
number of aged among the American population in years to come, 
this number threatens to increase and create a true crisis of 
both personal and public health.
    With this understanding of urgency, the National Institutes 
of Health have been acting, through the Congressionally 
supported Alzheimer's Disease Prevention Initiative, to 
understand the processes which underlie the disease and to 
translate this understanding into means of intervening.
    I would like, briefly, to review for you some of the 
clinical activities that exist today, built upon prior years of 
basic research, and then also to share with you the excitement 
of some of the current research that offers hope for next 
generation of interventions.
    The National Institutes of Health now support a number of 
clinical trials. Among these, some of the most challenging, 
most expensive, but most important, are those which attempt to 
intervene and prevent Alzheimer's disease before its symptoms 
occur.
    Some of the active studies that are ongoing now are listed 
in the first transparency and visual. They represent trials of 
a number of agents, the promise of which was provided by prior 
studies of epidemiology and basic biology.
    They include studies of classes of agents, such as 
antioxidants, anti-inflammatories, estrogen, ginkgo biloba. As 
you note, from the timeline, these studies, because they are 
aimed at preventing the appearance of disease, require many 
years to completion. They are, therefore, a type of study that 
needs to be carried out in parallel, as we explore multiple 
avenues to opportunity, not knowing which is going to be the 
one that offers the greatest promise.
    In addition to these studies of clinical trial, we focus, 
as well, upon the needs of caregivers; those persons, loved 
ones, family members, taking care of individuals with 
Alzheimer's disease. And there are, indeed, clinical trials 
that are underway in attempts to minimize this burden, as well.
    Some of them focus on patients with Alzheimer's, reducing 
symptoms, such as agitation, improving sleep, to the benefit of 
both patients and their caregivers. Others have demonstrated 
the effects of interventions as diverse as exercise or the use 
of computer web-based resources to decrease stress among 
caregivers.
    And there is a large scale clinical trial now, nearing the 
stage of interpretation of reporting of data, the Resources for 
Enhancing Alzheimer's Caregiver Health, or REACH initiative, 
which is attempting, in a large and diverse population of 
American caregivers, to look for techniques and methods to ease 
the burden on caregivers and to improve the quality of life for 
those for whom they provide this care.
    In addition to these ongoing studies, as we, as scientists, 
and as the public awaits their results, we turn to basic 
studies to try to improve our understanding at a molecular and 
genetic level of what is responsible for the devastation of 
Alzheimer's disease, in an effort to then translate these 
findings into a new generation of promising interventions.
    Over the past years, excitement has occurred in a number of 
areas, tracing discoveries that included the identification of 
the chemicals involved in the lesions, plaques, and tangles in 
the brains of Alzheimer's patients, then the genes which encode 
these products. And ultimately, it allowed us, for example, to 
transfer these genes by genetic engineering into mice, 
creating, for the first time, mouse models of Alzheimer's 
disease.
    What you see in this schematic is the demonstration of the 
process by which a normal membrane protein in cells, the 
amyloid precursor protein, is cut by chemicals called 
secretases or enzymes, that, as indicated by the two scissors, 
can, to the misfortune of the individual involved, clip the 
protein into a peptide that can lead to amyloid plaques and on 
to Alzheimer's disease and may thus be responsible for the 
disease.
    Now, armed with the information about what causes formation 
of these plaques, we can intervene to inhibit enzymes, and 
through that route, attempt to arrest or prevent disease.
    In the next transparency, you will see the example that 
Senator Harkin referred to.
    Now, with animal models available of Alzheimer's disease, 
we can generate animals that are bearing human Alzheimer's 
genes. As a result of this expression, they have, as shown in 
the upper left corner, the amyloid plaques stained in brown 
here, which are similar to the lesions seen in the brains of 
Alzheimer's patients.
    And now, over the past year, we have seen interventions 
that have taken the approach of immunizing against this 
peptide, with the results seen in the bottom left, where, 
indeed, these plaques are prevented or in fact disappear.
    The figure to the right shows that it is not only the 
plaques that disappear. The high level of errors made in the 
abnormal mice, because they have poor memory can, in fact, be 
corrected or reversed by immunization with this peptide. These 
are studies now which move on to clinical trials.
    I thank you for the time to discuss with you the advances 
and the promise for future advances, as we translate our 
understanding of Alzheimer's into clinical interventions. And I 
welcome an opportunity to answer any questions you may have.
    Thank you.
    [The statement follows:]
               Prepred Statement of Dr. Richard J. Hodes
    Mr. Chairman and Members of the Committee: Thank you for inviting 
me to appear before you today on an issue of interest and concern to us 
all, Alzheimer's disease. I am Dr. Richard Hodes, Director of the 
National Institute on Aging (NIA), the lead federal agency for 
Alzheimer's disease (AD) research. It is an honor to return to the 
Subcommittee with promising news about the progress that has been made 
in the past year to understand, treat and prevent AD. The fast pace of 
research is providing insight into AD as well as other 
neurodegenerative diseases and normal brain function.
      preventing alzheimer's disease: the ad prevention initiative
    Alzheimer's disease is the most common cause of dementia among 
older persons. It is a progressive, and at present irreversible, brain 
disorder that leads to a devastating decline in intellectual abilities 
and changes in behavior and personality. AD patients eventually become 
dependent on others for every aspect of their care. Scientists believe 
that AD develops as a result of a complex cascade of events, influenced 
by genetic and non-genetic factors, taking place over time inside the 
brain. These events cause the brain to develop lesions, including beta 
amyloid plaques and neurofibrillary tangles, and to lose nerve cells 
and the connections between them in a process that eventually 
interferes with normal brain function.
    As many as four million Americans now suffer from Alzheimer's 
disease.\1\ The prevalence of AD doubles every five years beyond the 
age of 65, which will lead to dramatic increases in the number of new 
cases as the population ages. The last Census Bureau projections 
indicated there will be approximately 20 million people in the United 
States aged 85 or older by 2050, suggesting that there will be many 
more people at very high risk for AD. The National Institutes of Health 
(NIH) recognizes the urgency of this public health threat and is 
committed to supporting critical bench-to-bedside research to develop 
strategies for treating and, more importantly, preventing the onset of 
this devastating disease.
---------------------------------------------------------------------------
    \1\ Evans, D.A., Estimated prevalence of Alzheimer's disease in the 
U.S. Milbank, Q. 1990;68:267-289.
---------------------------------------------------------------------------
    The AD Prevention Initiative is a congressionally-supported 
intensive coordinated effort among several NIH Institutes, including 
the NIA, National Institute of Neurological Disorders and Stroke 
(NINDS), National Institute of Nursing Research (NINR), and National 
Institute of Mental Health (NIMH), to accelerate basic research and the 
movement of basic research findings into clinical practice. Improved 
understanding of the initial stages of AD has allowed researchers to 
focus on the development and testing of new treatments targeted at the 
earliest stages of the disease process. The core goals of the 
initiative are to invigorate discovery and testing of new treatments, 
identify risk and protective factors, enhance methods of early 
detection and diagnosis, and advance basic science to understand AD. 
The initiative also endeavors to improve patient care strategies and to 
alleviate caregiver burden. (Chart #1)
                        ongoing clinical trials
    The NIA is currently supporting 17 AD clinical trials, seven of 
which are large-scale cognitive impairment and AD prevention trials. 
Prevention trials are among the most challenging and costly of research 
projects but, if successful, the payoff for people at risk, their 
relatives and society will be significant. Many of the agents being 
tested in these trials have been suggested as possible interventions 
based on long-term epidemiological and molecular studies. For example, 
epidemiology studies show that persons who have taken anti-inflammatory 
drugs have a lower risk of developing AD; and in basic research, 
inflammation around plaques is a hallmark of the disease. (Chart #2) 
There are similar rationales for estrogen and for anti-oxidant 
therapies. The first large-scale AD prevention clinical trial supported 
by the NIH, the Memory Impairment Study (MIS), is evaluating vitamin E 
and donepezil (Aricept) over a three-year period for their 
effectiveness in slowing or stopping the conversion from mild cognitive 
impairment (MCI) to AD. MCI is a condition characterized by a major 
memory deficit without dementia. The trial is being conducted by the 
NIA-funded Alzheimer's Disease Cooperative Study (ADCS) group at 
medical research institutions in North America, including NIA-supported 
Alzheimer's Disease Centers. The trial is scheduled to end in 2003. 
Other recently-started primary prevention trials will be completed in 
the years from 2003 through 2008. These trials are testing a variety of 
agents, such as aspirin, antioxidants such as vitamin E, combined 
folate/B6/B12 supplementation, estrogen, anti-inflammatory drugs, and 
ginkgo biloba, to determine if they will slow the rate of cognitive 
decline or prevent AD onset. (Chart #3) As scientists await the outcome 
of these ongoing studies, the next generation of drugs is being 
developed, targeting specific pathways in plaque and tangle formation 
and dysfunction and death of brain cells.
    Information about ongoing clinical trials and recruitment 
opportunities is available to the public through the NIA-supported 
Alzheimer's Disease Education and Referral Center web site (http://
www.alzheimers.org) and toll-free number (1-800-438-4380), as well as 
on the NIH clinical trials web site (http://www.clinicaltrials.gov).
                    from basic science to treatment
    Developing effective treatments for AD based on advances in basic 
research is a major focus of NIA-supported studies. Important progress 
has been made in recent years by generating animal models of AD through 
genetic engineering of transgenic mice that express human AD genes and 
that express features of the human disease, such as the formation of 
amyloid plaques. In addition, the ability of researchers to develop 
drugs for effective treatment of AD was greatly enhanced last year by 
the discovery of enzymes called secretases. These enzymes are involved 
in the clipping of a normal cell surface protein to produce the amyloid 
peptide that forms the senile plaques found in the brains of AD 
patients. (Chart #4) The discovery of these enzymes, together with 
availability of animal models of AD, will be critical to the 
development and testing of effective and safe amyloid-preventing drugs. 
Major advances were also reported by researchers in the public and 
private sectors regarding the amyloid immunization approach to blocking 
the formation of amyloid plaques. In another major development, vaccine 
treatment prevented much of the cognitive decline usually seen with age 
in two AD transgenic mouse models. (Chart #5) To accelerate research 
into the vaccine approach to treating AD, NIA and NINDS have announced 
a Request for Applications (RFA) for research to understand and enhance 
vaccine-related therapies for AD prevention.
    Research on tau, the protein that forms the other major AD lesion, 
the neurofibrillary tangle, has also accelerated this year. Mutations 
in the tau gene have been shown to cause some forms of another late-
onset dementia. A transgenic mouse strain was developed in the past 
year that expresses one of the human tau mutations and develops AD-like 
tangles. This animal model will help researchers understand why tangles 
form and what role they play in the pathology of AD and other 
dementias.
    Understanding the subtle physical changes that accompany aging and 
developing treatments to address these changes may also be useful in 
treating early stages of other neurodegenerative diseases such as 
Parkinson's disease. For example, new results from a study on reversing 
the age-related shrinkage and dysfunction of certain brain cells that 
produce the memory-related chemical messenger acetylcholine show that 
nerve growth factor can reverse the age-related reduction in transport 
of acetylcholine from these cells to different parts of the brain 
important to attention and memory. This approach is now being tested in 
a small industry-funded clinical trial. Results from another recent 
breakthrough have shown that, contrary to prior belief, the nervous 
system retains the ability to make new neurons even in old adults. This 
research has uncovered environmental factors such as exercise that can 
increase the numbers of new brain neurons, improving memory function in 
adult mice. Studies are beginning to unravel the molecular steps that 
control the production of new neurons in different areas of the nervous 
system, including the spinal cord. These findings are major steps 
forward not only to enhancing nerve cell development, but also to 
replacing nerve cells lost through age, trauma, or disease.
    Major breakthroughs in our understanding and treatment of AD are 
coming from identifying the mutated genes responsible for early onset 
AD. In the more common late onset form of AD, a combination of risk 
factor genes and non-genetic factors seems to be key. In the early 
1990s, APOE4 was identified as the first major risk factor gene for 
late onset AD. In the past year, three groups simultaneously discovered 
a region containing another risk factor gene on chromosome 10. 
Identifying this gene and other still unknown risk factor genes will 
lead to greater understanding of the molecular processes underlying AD, 
and will result in new treatment strategies, some of which will likely 
be tailored to an individual's unique genetic profile. New risk factor 
genes will also lead to better prediction of a person's individual 
genetic risk profile for AD. Strategies are being developed for large-
scale collection of appropriate families and analysis of genetic data 
for these studies.
                drug discovery, development and testing
    The only currently FDA-approved treatments for AD are tacrine, 
donepezil, rivastigmine and galantamine, each of which boosts levels of 
acetylcholine, the chemical messenger involved in memory. However, 
there are currently many drugs at various stages of testing that have 
shown promise in either treating the symptoms associated with AD or 
slowing the progression of the disease. To screen as many potential 
drugs as possible, the NIA has developed the infrastructure for 
preclinical drug discovery and testing for drug safety in animals. 
Pilot and planning mechanisms have also been developed, along with NIMH 
and NINDS, to facilitate development of full-scale clinical trials, and 
this year, the first pilot clinical trials have been funded through 
this mechanism.
    NIA supports AD clinical trials through a variety of mechanisms. In 
addition to individual investigator-initiated clinical trials, the NIA 
supports the Alzheimer's Disease Cooperative Study (ADCS), established 
to support multi-site clinical trials on compounds that large 
pharmaceutical companies generally would not test. The ADCS is also 
designed to develop and test new instruments for effective clinical 
trials. Several clinical trials now in progress are being supported by 
the NIA through the ADCS. The ADCS has also been key in developing 
standardized procedures and measurements in clinical trials, widely 
accepted in both academia and in industry. The ADCS will continue to be 
an important part of NIA support of large-scale AD prevention trials as 
well as the search for biological markers for monitoring the efficacy 
of drugs in clinical trials.
                           early ad diagnosis
    Much of our understanding of the clinical course of AD and the 
underlying brain pathology comes from longitudinal, interdisciplinary 
studies of persons with AD and normal controls. Many of these studies 
have been coordinated through the NIA-funded Alzheimer's Disease 
Centers. A newly-funded collaborative infrastructure, the National 
Alzheimer's Coordinating Center, is enhancing collaboration among the 
Centers to study important new areas of research. One such area 
involves understanding the preclinical stages of AD, a major new 
frontier in AD research and of the utmost importance in implementing 
future preventative treatments.
    Recent advances in imaging and in clinical and pathological 
assessment are focusing on identifying persons diagnosed with mild 
cognitive impairment (MCI) accompanied by memory impairment. Prevalence 
estimates show that there are as many persons with MCI as there are 
persons with a clinical diagnosis of AD. In one study, 80 percent of 
persons diagnosed with MCI had developed clinically diagnosed AD within 
eight years. Distinguishing between persons with MCI who will and will 
not progress to AD is a critical objective. In a recently published 
study, the degree of impairment found in clinical assessment predicted 
those who would develop AD more rapidly; and in an imaging study of 
persons with MCI, the smaller a particular brain region at the 
beginning of the study, the greater the risk of developing AD later. 
(Chart #6) Abnormally low brain activity, identified by positron 
emission tomography (PET) scanning, may be able to identify abnormal 
patterns of activity predictive of later AD diagnosis earlier than 
other currently available tests.
    Besides their potential utility in early diagnosis, these imaging 
techniques are also being assessed for their ability to determine the 
effectiveness of early treatments or interventions, such as those being 
tested in the AD Prevention Initiative. Investigators believe that they 
may be more rapid and cost-effective indicators of treatment efficacy 
than conventional measurements.
                      risk and protective factors
    Recent epidemiology studies focus attention on cardiovascular risk 
factors such as high blood pressure in middle age and elevated 
cholesterol as risk factors for AD. Further animal and human studies 
and clinical trials will be required to determine if AD and 
cardiovascular disease share common risk factors and possibly 
concurrent intervention strategies. One approach to identifying causal 
factors is to compare populations with very different life styles. One 
recent study showed that the rate of AD diagnosis was approximately 
half in an urban population of older Africans in Nigeria than it was in 
African Americans of Nigerian origin now living in Indianapolis. The 
Africans in the study had much lower prevalence of risk factors for 
cardiovascular disease such as high blood pressure, high cholesterol 
and diabetes than did the U.S. population. Future studies will pinpoint 
exactly which of these or other factors was responsible for the 
difference in AD development between the two groups.
    Early life environment has been implicated as a risk factor for 
several late life chronic diseases. Socioeconomic or environmental 
variables may affect brain growth and development, perhaps affecting 
the risk of developing AD in later life. Other life course variables 
such as exposure to environmental toxins or traumas may increase 
susceptibility to cognitive decline and neurodegenerative diseases in 
later life. One risk factor may be severe head injury, as shown by a 
recent study of World War II Veterans. Recent studies correlate a 
number of other variables including education, occupation, leisure 
mental activities and social support systems with the risk of cognitive 
decline or AD. Evidence that particular environments or lifestyles 
would reduce the risk or delay the onset of AD would have enormous 
implications for lifestyle changes to maximize healthy cognitive aging. 
Older Americans already have better education and health and are less 
disabled than in previous generations. It is possible that one or more 
of the above factors may already be causing a lower prevalence of 
severe cognitive decline in the elderly than would have been predicted 
from earlier studies.
              patient care strategies and caregiver burden
    Perhaps one of the greatest costs of Alzheimer's disease is the 
physical and emotional toll it takes on family, friends, and other 
caregivers. There is clearly a critical need to develop more effective 
behavioral and pharmacological strategies to treat and manage problem 
symptoms in people who have AD and to alleviate caregiver burden. This 
is one of the major goals of the NIH Alzheimer's Prevention Initiative. 
(Chart #7)
    Agitation and sleep disturbance are two of the major behavior 
problems in AD patients that increase caregiver burden. Two clinical 
trials are determining whether drugs can reduce agitation in patients 
with AD. In another small trial, melatonin is being tested for 
reduction of sleep problems in patients with AD. In other studies 
focusing on elderly caregivers of patients with dementia, moderate-
intensity exercise showed marked improvements in caregiver 
physiological reactions to stress and in sleep quality when compared to 
a control group maintained on a nutrition program. In another 
controlled trial, caregivers given web-based support experienced 
significantly reduced strain, while greater use of the support system 
resulted in lower strain among caregivers who lived alone with care 
receivers. To make the web more accessible to older caregivers, the NIA 
and National Library of Medicine are testing a senior-friendly web site 
model that features information about Alzheimer's disease and 
caregiving. The project will be launched later this year.
    As part of the AD Prevention Initiative, the NIA, in collaboration 
with the National Institute of Nursing Research, is supporting the 
Resources for Enhancing Alzheimer's Caregiver Health (REACH) 
initiative. This large, multi-site intervention trial is testing the 
effectiveness of different culturally sensitive home and community-
based interventions for families providing care to loved ones with 
dementia. The interventions that are being tested include psychological 
education support groups, behavioral skills training, family-based 
systems interventions, environmental modifications, and technological 
computer-based information and communication services. Some 1,000 
families are enrolled in the REACH study, including large numbers of 
African-Americans and Hispanics. Results from the REACH study will be 
available in the next year, and I look forward to sharing any 
significant advances with the Congress and the general public.
    In conclusion, the pace of scientific discovery in the area of 
Alzheimer's disease research has further accelerated this year and 
optimism is growing that effective treatment may follow from the 
current generation of clinical trials. Much remains to be understood 
about the underlying causes of AD, and the NIA continues to support a 
spectrum of basic and clinical research aimed at comprehending the 
multifaceted factors interacting throughout the lifespan to cause AD. 
Only by understanding these varied factors will we be able to develop 
the most effective and safe strategies for defeating this much-feared 
scourge of later life. I am happy to answer any questions you may have 
at this time. 




















    Senator Specter. Well, thank you very much, Dr. Hodes.
    What can you tell us in concrete terms what has been done 
with the increase in funding? When the funds rose from $456 
million in fiscal year 2000 to $520 million, what did that 
enable you to do to justify that increased expenditure?
    Dr. Hodes. Well, I think, Senator, some of the concrete 
examples were portrayed in the information that I have shared 
with you. For example, the prevention trials. As noted, these 
trials take many years, many individuals. They are perhaps the 
most expensive form of research that we carry out.
    Individual trials of this sort may involve a cost in the 
range from $20 million to $40 million or $50 million. The 
ability to carry out these trials of the multiple agents, for 
each of which there was promise shown by past research, was 
facilitated, indeed, by the increase in the budget that NIH has 
enjoyed over past years.
    Equally so, the basic research described has been, to a 
large extent, enabled by the increase in budget and allocations 
through appropriations.
    Senator Specter. One of the questions, which understandably 
comes to this subcommittee repeatedly, from our colleagues, is 
are you just throwing money at the problem, or is it 
effectively used? If we are successful in increasing your 
budget from $520 million to $582 million, a $62 million 
increase, what would you project to use that additional funding 
for next year?
    Dr. Hodes. I think we already are able to see in the 
applications we are receiving and in conversations and input 
from the scientific community, that the opportunities, both for 
basic science and for the generation of new clinical trials for 
treatment and prevention, are highly meritorious, have been 
reviewed as such, and will easily allow us to spend the 
magnitude of budget increase that you mentioned, continuing to 
find only the highest quality of outstanding applications.
    Senator Specter. Will easily allow us to spend? I am a 
little concerned with your articulation, Dr. Hodes, of ``easily 
allow us to spend.'' It is not too hard to spend. Are we 
getting the bang for the buck?
    Dr. Hodes. Absolutely. The rest of the sentence was 
``easily allow us to spend supporting still the most 
outstanding caliber of research.'' And so, yes, the direct 
response is that that amount of money would be spent, 
supporting the very highest quality of research. As noted, our 
success rate, that is, the proportion of applications we 
currently fund, is approximately 25 percent now.
    There are many applications we are not able to fund, which 
have high promise, as reviewed by peers, by experts in the 
field. When the question was raised and it is a critical 
question--3 years ago, when the proposal of doubling the NIH 
budget over 5 years, the question was raised whether we could, 
indeed, wisely and appropriately use these resources.
    I think that the experience of the past 3 years has 
indicated that indeed we can; that the research supported with 
this increased funding has been outstanding and highly 
meritorious. And I think every indication, the prospect for the 
years to come, is that we can continue this trend.
    Senator Specter. One of the questions which is customarily 
asked by the subcommittee, although very obviously very 
difficult to answer is: What are the prospects for finding the 
answer to Alzheimer's? On Parkinson's we have--after some 
question, had gotten comments from the experts at NIH that we 
may be within 5 years of conquering Parkinson's.
    Now, it is put in ``may'' terms, not absolute terms. But 
could you give us a projection, if the funding is increased, as 
to the likelihood or some ballpark figure on time span when we 
might conquer Alzheimer's?
    Dr. Hodes. I truly and sincerely do not know, Senator. For 
example, the time that it takes to carry out studies, such as 
those which are now ongoing. If some of these studies were to 
be successful, we would know those answers in the range of the 
next 5 to 10 years.
    From the point of such findings, there would still be a 
need then to look at how they generalize to the larger 
population. So, I can provide you, in that sense, only with the 
minimum, the amount of time it would take if the current 
interventions, the current trials under study, were to prove to 
be successful.
    We, unfortunately, as is the nature of science, 
particularly in biology, do not know if they will be, and for 
that reason, cannot provide even an informed and responsible 
estimate of how long I think it may be to arrive at an ultimate 
cure.
    Senator Specter. Well, I can understand that. You make a 
projection of 5 to 10 years where you will know what results 
the current studies will produce. To what extent is that period 
of 5 to 10 years acceleratable by the increase in funding which 
we want to get for you next year?
    Dr. Hodes. The increase in funding would make it possible 
to study a larger number of candidate agents; and as noted, the 
more doors open, the more paths taken, the greater the 
probability of finding, as rapidly as possible, the correct 
one.
    We do not have the luxury, in terms of these sorts of 
trials, in waiting until we have the outcome of one study 
before beginning the next. If we, in that sense, conducted a 
new study or a new set of studies only every 7 to 10 years, the 
path would undoubtedly be slowed beyond what we can accomplish 
with the resources we have, those we project, by being able to 
bring each promising candidate to clinical trial.
    Senator Specter. My red light just turned on. So, I am 
going to yield at this point, because of time pressures, and 
turn to Senator Harkin.
    Senator Harkin. Thank you very much, Mr. Chairman.
    And Dr. Hodes, thanks for coming back to the committee and 
testifying and for your leadership at the National Institute on 
Aging.
    I have two paths, two questions. One has to do with the 
here and now and the immediate, in the REACH program, and--
because I hear from so many families that are just at wits' end 
in terms of how they are dealing with this.
    And if you could just elaborate a little bit more on what 
your plans are for the REACH initiative. And would that be part 
of the increases, aside from the basic research that we are 
doing, that you would envision?
    Dr. Hodes. I would be happy to answer this important 
question. Clearly, research for the here and now--research 
involving the welfare of those who currently give care is as 
important as our research aimed at the future and prevention.
    The REACH initiative, which is a trial involving multiple 
centers and a diverse population, is exploring different means 
of reducing stress, providing respite for caregivers. The 
actual study has been completed, and it is now in its first 
stage in the state of data analysis.
    We would expect, over the next few months, to have that 
analysis completed and hope that its successes would then be 
translated into a future, next generation of intervention 
trials. The appropriations that will be available in the next 
year, would, in addition to the many other areas of research 
that we intend to pursue, allow us to follow-up on positive 
findings that may have come from this first stage of REACH to 
design further interventions to the benefit of caregivers and 
those for whom they care.
    Senator Harkin. Thank you. Second, on the research side, 
how soon will you be going to human clinical trials on the 
vaccine?
    Dr. Hodes. The clinical trials on the vaccine are currently 
being carried out by Elan Pharmaceuticals. These studies have 
progressed through the state of initial, so-called, phase one 
to determine if there are any toxicities. This intervention is 
now being taken to larger numbers of individuals in the so-
called stage two or preliminary phase of clinical trials.
    We will be meeting and working with Elan in what we hope in 
the best spirit of public/private partnerships, as we attempt 
to facilitate the best and most rigorous quality of research 
from which we will learn the most about the effectiveness of 
this approach.
    Senator Harkin. Okay. I like that. This is Elan?
    Dr. Hodes. Yes.
    Senator Harkin. Elan----
    Dr. Hodes [continuing]. Pharmaceutical.
    Senator Harkin. Pharmaceutical. There are no other 
pharmaceuticals involved in this.
    Dr. Hodes. Currently not.
    Senator Harkin. I see. And this is a vaccine in which NIH 
had been very heavily involved, if I am not mistaken.
    Dr. Hodes. Yes, sir. For example, the discovery of the 
gene----
    Senator Harkin. Yes.
    Dr. Hodes [continuing]. The making of the animal models in 
which this was carried out, were NIH-supported. Some of these 
results that I have shown you about the vaccine in animal 
studies were supported by NIH, as well.
    Senator Harkin. Yes. Now, again, I just want to be very 
clear about this. I believe in the public/private partnerships. 
They have brought us great drugs in the markets.
    I am not a scientist. Do I know how much promise this has? 
I do not know, but I have been reading about the initial stages 
of this and it looks like it holds a lot of promise. I do not 
know when the phase two trials will be done. Do you have any 
idea about that?
    Dr. Hodes. My understanding is that patients are currently 
being accrued onto the phase two trial presently.
    Senator Harkin. Do you know the length of time? Is it 2 
years, 3 years? What is it? Do you know?
    Dr. Hodes. I do not know the specifics of the trial, but we 
can certainly find more information and come back to you for 
the record.
    Senator Harkin. Well, I just want to state for the record 
that we have to move as rapidly as possible on these trials. 
And I want NIH to be involved to the maximum extent possible, 
but I just hope and trust that if these prove out and there is 
that kind of vaccine, that it is not so expensive that families 
cannot afford it once we develop it. And I intend, as long as I 
am here, and I am sure Senator Specter and others, we are going 
to keep a watchdog eye on this.
    Now, I believe that pharmaceuticals have got to make a good 
return. They are putting a lot of their money up. But 
nonetheless, we have put a lot of public involvement and a lot 
of the public's money into this. And these drugs have got to be 
affordable when they come on the market.
    Thank you very much, Dr. Hodes.
    Senator Specter. Thank you very much, Senator Harkin.
    Senator Reid.
    Senator Reid. Mr. Chairman, I would ask your permission and 
that of Senator Harkin to have my statement made part of the 
record as if read.
    Senator Specter. Without objection, your full statement 
will be made a part of the record.
    Senator Reid. I apologize to you and the rest of the 
committee and the witnesses. I have a meeting I was supposed to 
be to at 10 o'clock. But I wanted to come here to indicate how 
important this hearing is and to congratulate you and Senator 
Harkin for your continued efforts in trying to find some relief 
to this terrible disease.
    [The statement follows:]
                Prepared Statement of Senator Harry Reid
    Good morning Mr. Chairman, members of the Committee, and 
distinguished guests.
    I want to thank the Alzheimer's Association and the families who 
are here today for their willingness to share their personal stories 
and insights. You bring an important voice and focus to our discussion 
today.
    My home state of Nevada has the fastest growing population in the 
country. In southern Nevada alone, one-half of the population is over 
the age of 65. Statistics predict that 10 percent of this group will 
develop Alzheimer's Disease.
    I strongly support increasing the federal investment in basic and 
clinical research as the best avenue we have for solving the complex 
puzzle that is Alzheimer's Disease. This investment will lead us toward 
better treatment and management of those affected by this progressive 
condition.
    However, until our research achievements provide a cure for 
Alzheimer's Disease, I do not want us to forget the vital role played 
by family and professional caregivers who make it possible for 
Alzheimer's Disease patients to remain in their homes as long as 
possible.
    When I am home in Nevada talking with young families, it is clear 
that the phrase ``sandwich generation'' is an apt term. These parents 
are squeezed emotionally and economically by the need to provide care 
both to their young children and to their aging parents.
    While it is clear that the longer Alzheimer's patients can remain 
in their homes, the better they and their families cope with the 
condition, it is also clear that we must support programs such as the 
Administration of Aging grant program, which provides funding that 
allows states to make available needed respite care to families.
    The future demand for home health workers, respite care services, 
and family member support are going to be staggering. As we progress in 
our understanding about the cause and treatment of Alzheimer's Disease, 
we need to also actively and responsibly support the family and 
professional caregivers who serve these patients.

    Senator Specter. Thank you very much, Senator Reid.
    Thank you very much, Dr. Hodes. We very much appreciate 
your work at NIH. And we intend to do our very best to continue 
to give you financial assistance to move toward delaying, if 
not solving, Alzheimer's disease. Thank you.
    I would like to call, now, Dr. DeKosky, Ms. Frey, Mr. 
Wagenaar, and Mr. Pierce.
STATEMENT OF STEVEN T. DE KOSKY, M.D., PROFESSOR OF 
            NEUROLOGY, PSYCHIATRY, NEUROBIOLOGY AND 
            HUMAN GENETICS, AND DIRECTOR, ALZHEIMER'S 
            DISEASE CENTER, UNIVERSITY OF PITTSBURGH 
            MEDICAL CENTER
    Senator Specter. Our next witness is Dr. Steven DeKosky, 
director, Alzheimer's Disease Research Center and director, 
Division of Geriatrics and Neuropsychiatry at the University of 
Pittsburgh's School of Medicine.
    Dr. DeKosky chairs the National Medical and Scientific 
Advisory Board--Advisory Council for the Board of Directors of 
the Alzheimer's Association; he also chairs the Professional 
Advisory Board of the Greater Pittsburgh Chapter of the 
Alzheimer's Association; and his, perhaps, greatest 
accomplishment is the father of Ally DeKosky, who is one of my 
key staffers.
    Ally, are you here today? Would you mind standing, please?
    She is an extraordinary young woman, and the apple has not 
fallen far from the tree, Dr. DeKosky. We look forward to your 
testimony.
    Dr. DeKosky. Thank you, Senator. I would like to compliment 
you, by the way, not only on your perspicacity in picking 
personnel, but also on the quality of your staff.
    Senator Specter. How do you spell perspicacity, Dr. 
Dekosky?
    Dr. DeKosky. I will put it in the record, Senator.
    Senator Specter, Senator Harkin, and members of the 
subcommittee, I am very glad to be back before this committee 
to report on some truly amazing progress that has been made in 
AD over the past year, and to express our thanks for your 
steadfast efforts to double funding at the NIH, and make what 
we believe is a compelling case for an immediate and major 
additional investment to prevent the epidemic in Alzheimer's 
disease.
    As you know, I head the Alzheimer's Center at the 
University of Pittsburgh, one of 29 such centers in the United 
States, created by the NIA for--as an infrastructure for 
studying Alzheimer's disease. And I am here today as Chair of 
the Medical and Scientific Advisory Council of the Alzheimer's 
Association.
    The Association is calling upon Congress to double its 
investment in Alzheimer's research to reach an annual funding 
level of $1 billion over the next 3 years. This will require an 
increase of $200 million in fiscal year 2002.
    And we realize that if Congress agrees to the very tight 
spending caps that have been proposed in the pending budget 
resolutions, the subcommittee will have to make some very 
difficult choices about where to put the money. Why should that 
choice be Alzheimer's research?
    The answer is simple and has two parts. First, demographics 
alone demand that we find a way to stop the progress of 
Alzheimer's disease before it bankrupts us all. If we want to 
protect the surplus, assure the future of Medicare and Social 
Security, and leave money in the Federal budget for other 
urgent national priorities, we have to find a way to prevent 14 
million baby boomers from getting this disease.
    Second, we can now say with confidence that the answers are 
within reach. We are at an unprecedented place in Alzheimer's 
research, facing possibilities that did not exist when I first 
came before this committee in 1998. That is because of the 
investment you have already made, not just in AD research but 
in the human genome project, and imaging techniques, and in 
basic science.
    We will lose that investment, however, unless we escalate 
efforts in three broad areas of research: Large-scale clinical 
trials aimed at prevention; basic research to complete our 
understanding of the disease, risk factors, early detection, 
and potential treatments; and social and behavioral research to 
improve management of the disease and reduce its burden.
    The NIA continues to lead the war against AD. You have 
heard Dr. Hodes, who has been the able leader of this effort, 
but as our knowledge has expanded, the effort has attracted 
attention in resources from across the National Institutes of 
Health. The progress we have made in the last 12 months has 
truly been astounding, and investigators have identified 
multiple targets, multiple doors, as Senator Harkin put it, for 
further research, and new ones are emerging in laboratories 
across the country almost on a daily basis.
    In 1998, at this subcommittee's direction, the NIH stepped 
into a whole new area of Alzheimer's research, the Prevention 
Initiative. Based on a simple premise that scientists knew that 
changes in the brain begin 10 to 20 years before symptoms first 
appear.
    We began to change strategies, some of which you see on the 
board with the studies on prevention, which is now being 
organized, to look for ways to interfere with the process 
early, before symptoms occur, and slow it down or stop it. And 
if successful, we can keep people who are at risk from ever 
being disabled by the disease.
    The first of these prevention trials started in 1998. Eight 
are now in progress. Some are testing with early mild cognitive 
impairment, a memory disorder that appears to put people at 
increased risk of developing the disease. Most of these studies 
are testing relatively inexpensive and readily available 
compounds, including vitamins and over-the-counter drugs. We 
are looking for cheap and simple ways to stop this disease from 
draining billions from families, from State and Federal 
treasuries, and from our economy.
    But it takes time, as you can see, and money to do this 
kind of research. Because AD develops slowly, large numbers of 
people must be enrolled in these trials and they must be 
followed over time.
    For example, I am the principal investigator for a multi-
site trial of ginkgo biloba funded by the National Center for 
Complementary Alternative Medicine, NHLBI, and the NIA. We are 
enrolling 3,000 people over the age of 75 and will follow them 
for 5 years. This one study will cost at a range of $18 million 
to $20 million.
    All told, NIH is already investing over $80 million in 
these prevention trials, but we will need the money to start 
new trials soon, both to replicate those that are underway and 
test new compounds. We have a narrow window of time to make 
this work.
    We found lots of pieces to the puzzle, which is why the 
Prevention Initiative could get started, but we need to 
continue the basic research to complete that puzzle. Without 
these additional resources, we will have to rob Peter to pay 
Paul.
    In fact, one of the points that I think is very important 
is that since there have never been clinical trials to try and 
prevent Alzheimer's disease, the monies to do all of these 
clinical trials simply come out of de novo budgets.
    The vaccine, we have already discussed. Imaging techniques 
in plaques of animals and duplicative experimental studies in 
imaging let us, we hope, be able to derive images of amyloid 
load in humans, while----
    Senator Specter. Dr. DeKosky, your full statement will be 
made a part of the record. So, if you could summarize at this 
point, we would appreciate it.
    Dr. DeKosky. I think if you showed the pictures that Dr. 
Hodes showed you of the mouse to a researcher 5 years ago, they 
all would have broken their jaws when they hit the table.
    The knowledge of the basic science of what happens with 
amyloid in this disorder and the progress that we have made, 
both with mice and with men, is absolutely astounding. We have 
this disease, we think, on the ropes. And this is not a time to 
let up.
    Thank you.
    [The statement follows:]
              Prepared Statement of Dr. Steven T. DeKosky
    Senator Specter, Senator Harkin, and Members of the Subcommittee. I 
am delighted to be back before the Subcommittee to report on the truly 
amazing progress in Alzheimer research over the past year, to express 
our thanks for your steadfast efforts to double funding at the National 
Institutes of Health, and to make what we believe is a compelling case 
for an immediate and major additional investment to prevent an epidemic 
of Alzheimer's disease.
    As you know, I head the Alzheimer's Disease Research Center at the 
University of Pittsburgh, one of 29 such centers funded by the National 
Institute on Aging to create an infrastructure for this critically 
important research. I am here today as the Chair of the Medical and 
Scientific Advisory Council for the Alzheimer's Association.
    The Alzheimer's Association is calling upon Congress to double its 
investment in Alzheimer research, to reach an annual funding level of 
$1 billion over the next three years. That will require an increase of 
$200 million in fiscal year 2002. We realize that if Congress agrees to 
the very tight spending caps that have been proposed in the pending 
budget resolutions, this Subcommittee will have to make very difficult 
choices about where to put the available funds. Why should that choice 
be Alzheimer research?
    The answer is simple and has two parts. First, demographics alone 
demand that we find a way to stop the progress of Alzheimer's disease 
before it bankrupts us all. If we want to protect the surplus, assure 
the future of Medicare and Social Security, and leave room in the 
federal budget for other urgent national priorities, we must find a way 
to prevent 14 million babyboomers from getting Alzheimer's disease.
    Second, we can now say with confidence that answers are within 
reach. We are at an unprecedented place in Alzheimer research--facing 
possibilities that just didn't exist when I first came before this 
Subcommittee in 1998. That is because of the investment you have 
already made, not just in Alzheimer research but in the human genome 
project, in imaging techniques, and in basic science.
    We will lose that investment, however, unless we escalate our 
efforts in three broad areas of research:
  --large scale clinical trials aimed at prevention,
  --basic research to complete our understanding of the disease, risk 
        factors, early detection, and potential treatments, and
  --social and behavioral research to improve management of the disease 
        and to reduce the staggering health and long term care costs 
        that are associated with it.
    The National Institute on Aging continues to lead the war against 
Alzheimer's disease, under the very able leadership of Dr. Richard 
Hodes. But as our knowledge has expanded, this effort has attracted 
attention and resources from across the National Institutes of Health. 
The progress we have made in the past twelve months has been truly 
astounding. Investigators have identified multiple targets for further 
research and new ones are emerging in laboratories across the country, 
on an almost daily basis.
                       the prevention initiative
    In 1998, at this Subcommittee's direction, the National Institutes 
of Health stepped into a whole new area of Alzheimer research--the 
Prevention Initiative. That initiative was based on a simple premise. 
Scientists could now say with some certainty that the changes in the 
brain that lead to Alzheimer's begin 10 to 20 years before symptoms 
first appear. We began to change our strategies, to look for a ways to 
interfere with that process early, to slow it down and perhaps to stop 
it. If we succeed, we can keep most people who are at risk from ever 
being disabled by the disease.
    We were beginning to identify compounds that might do that, but 
they needed to be tested in large numbers of people to prove if they 
would really work. The first of those prevention trials got started in 
1998; eight are now in progress. Some are testing compounds in people 
with mild cognitive impairment; others are enrolling older people who 
are cognitively normal.
    Most of these studies are testing relatively inexpensive and 
readily available compounds--including vitamins and over-the-counter 
drugs. We may be able to find cheap and simple ways to stop this 
disease from draining billions from families, from state and federal 
treasuries, and from our economy every year.
     But it takes time and money to do this kind of research. Because 
Alzheimer's disease develops slowly, large numbers of people must be 
enrolled in these trials and they must be followed over time. For 
example, I am the principal investigator for a multi-site trial of 
gingko biloba funded by the National Center for Alternative Medicine. 
We are enrolling 3,000 people over the age of 75 who are not demented 
and will follow them for 5 years. This one study will cost $18 million.
    All told, NIH is already investing over $80 million in these 
prevention trials. But we will need the money to start more trials 
soon--both to replicate the findings of those already underway and to 
test new compounds that look equally promising.
    We have a very narrow window of time to make this prevention 
strategy work. In 10 years, the babyboomers will reach the age where 
the symptoms of Alzheimer's disease begin to appear. If we haven't 
found an answer by then, the numbers of people with the disease--and 
the costs of their care--will explode. We are in a Race against Time.
                         completing the puzzle
    We have found a lot of the pieces of the puzzle of Alzheimer's 
disease, which is why we could begin the Prevention Initiative. But we 
must continue the investment in basic research to complete that puzzle. 
Without additional resources, however, we will have to rob Peter to pay 
Paul. We are already seeing this in the declining ``success rate'' at 
the National Institute on Aging. Because the prevention trials are 
expensive, NIA is able to fund a lower percentage of the high quality 
research grants it receives. In 1997, NIA was funding almost 40 percent 
of the grants it received. In 2000, that success rate was down to about 
26 percent. This means we are missing important opportunities to 
advance our knowledge of Alzheimer's disease and to discover new 
targets for treatment.
    There are few areas of scientific research where the progress has 
been as rapid and far-reaching. The excitement that surrounds the 
science of Alzheimer's disease was dramatized last summer at the World 
Alzheimer Congress here in Washington. That meeting drew over 3000 
Alzheimer scientists from around the world--from Nobel Prize winners to 
new postdoctoral students.
    Consider just a few of the far-reaching discoveries that have been 
reported since the Subcommittee met about Alzheimer's disease last 
year:
  --A ``vaccine'' has been developed that appears to prevent in the 
        brains of mice the accumulation of the plaques that are the 
        hallmarks of Alzheimer's disease. Phase I clinical trials in 
        humans have shown the vaccine to be safe. Phase II trials to 
        test effectiveness will begin this year.
  --A new imaging technique has identified plaques in the brains of 
        living mice--something that until now could only be identified 
        at autopsy. If that technique works in humans, we may have an 
        important new tool for early and even presymptomatic 
        identification of people for whom treatments will be effective.
      These mouse studies underscore the importance of animal models in 
        Alzheimer research. They allow us to explore theories and 
        potential treatments without putting human subjects at risk. 
        But it is very expensive to develop and maintain these animal 
        models.
  --We now understand the role of certain enzymes, called secretases, 
        in the production of amyloid, a protein implicated in 
        Alzheimer's disease. That is the first step toward developing a 
        compound that could block the production of the protein and the 
        development of disease.
  --Discoveries about the role of nerve growth factor may open the way 
        to protecting brain cells from damage and possibly rebuilding 
        them. Work is already underway on a drug that may mimic the 
        activity of nerve growth factor in the brain; another is 
        exploring a therapy that would prompt brain cells to produce 
        the protein.
  --Another essential area of Alzheimer research is the investigation 
        of how genetic and environmental risk factors combine to 
        produce disease. Even in identical twins, some get the disease 
        and others do not. A new study of World War II veterans has 
        produced importance evidence that establishes a clear link 
        between serious head injury in early adulthood with Alzheimer's 
        disease in later life.
    One of the most important scientific questions involves the 
connection between vascular disease and Alzheimer's. These vascular 
disorders include stroke, high blood pressure, aetherosclerosis, and 
diabetes. They disproportionately affect Hispanic and African-
Americans--the largest growing segment of our elderly population.
    We now have evidence to suggest that risk factors associated with 
these disorders, including high cholesterol and high fat diets, may 
also be associated with increased risk for dementia. If that is true, 
we can do something about these risk factors and could have a major 
impact on future prevalence of the disease.
  --Two separate studies have shown that cholesterol-lowering drugs 
        called statins may reduce the risk of Alzheimer's disease.
  --Other research has suggested that a high-fat diet in early and 
        middle adulthood may be associated with an increased risk of 
        Alzheimer's.
  --A new report, just in, on an 8-year cross-national study found the 
        rate of dementia among African Americans to be twice that of 
        residents of Nigeria. It suggests that environmental risk 
        factors such as diet and exercise may combine with genetic risk 
        factors to cause disease.
    There is an immediate need for investment in additional research to 
follow up on these leads, to determine the exact relationship between 
vascular disorders and Alzheimer's. This will require additional basic 
research on molecular and cellular changes as well as large-scale 
population studies to test potential drug treatments and life style 
changes that can reduce the risk of both vascular disease and dementia. 
This is a particularly promising area for collaboration between the 
National Institute on Aging, the National Heart, Lung and Blood 
Institute, and the Center for Minority Health Research.
                the changing face of alzheimer's disease
    However quickly we get to the finish line in the Race against 
Alzheimer's disease, it will not be soon enough for millions of people 
for whom the disease process has already progressed too far. Some of 
those people are in this hearing room today--including John Wagenaar 
who will testify in a moment. Frank Carlino, who testified before you 
last year, is also here and has brought with him a number of members of 
his support group. They have been raising money all year to come to 
Washington to ask Congress to do something about Alzheimer's disease.
    These courageous people represent the new Face of Alzheimer's 
Disease. We are identifying and diagnosing people at early stages of 
the disease--when available treatments are likely to be most effective 
and when they can have time to make decisions about how they and their 
families will live through the course of the disease. We need to 
continue the search for more effective treatments to stave off the most 
devastating impact of the disease, even if we can't prevent it for 
them. And we need to educate both the public and clinicians, especially 
primary care physicians, about the importance of early diagnosis.
    We also need to make sure that our health and long term care 
systems will adapt to accommodate changing care needs. People will be 
living with the disease longer, and differently than they have in the 
past. Congress must invest in the social, behavioral, and health 
services research--not just at NIH but also at the Agency for 
Healthcare Research & Quality, the Health Care Financing 
Administration, and the Centers for Disease Control--to develop the 
outcomes measures, quality indicators, and other evidence that will 
support high quality and cost-effective care throughout the course of 
the disease.
    The Alzheimer's Association will continue to its own investment in 
research. We have already budgeted over $20 million for research in 
fiscal year 2002. We will continue to provide the early money to 
encourage new researchers to the field, and to collaborate with the 
National Institute on Aging and other institutes at NIH in this all-
important Race against Time. But we must turn to Congress for the $1 
billion that we need to get to the finish line, before it is too late.
    Thank you for inviting me here again today.

    Senator Specter. Thank you very much, Dr. DeKosky.
STATEMENT OF CHRISTINE FREY, ADVOCATE, ALZHEIMER'S 
            ASSOCIATION
    Senator Specter. We turn, now, to Ms. Christine Frey, a 
probation officer from Peoria, IL. Her family suffers from 
Early-Onset Alzheimer's, a form of the disease that prematurely 
strikes patients in the fourth or fifth decade of their lives. 
To date, 32 members of Ms. Frey's extended family, including 
her father, grandfather, aunt and uncle, have died as the 
result of Alzheimer's disease.
    Ms. Frey is active in the Central Illinois chapter of the 
Alzheimer's Association and organizes an annual fundraiser in 
Peoria for Alzheimer's research.
    You certainly have had tremendous impact in your family, 
Ms. Frey. We welcome you here and look forward to your 
testimony.
    Ms. Frey. Thank you. Thank you very much, Senator Specter 
and Senator Harkin, for inviting me to testify at this hearing. 
I want to thank you, in advance, for your continued commitment 
and support to Alzheimer's research and for your leadership in 
securing funding for the National Institutes of Health. I am 
very grateful for this opportunity to speak to you about an 
issue that has so deeply affected my family.
    My name is Christine Frey and my commitment and dedication 
to this cause is very personal, because this disease has 
claimed over 32 members of my family in just the last five 
generations.
    My family suffers from Early-Onset Alzheimer's disease, 
meaning, we get it at a much earlier age. My great grandmother 
was 35 years old and pregnant with the last of her seven 
children when she started to become easily confused. At 37, she 
was hospitalized. And by 39, she could no longer walk and could 
barely speak. She died at the age of 40.
    Both her mother and grandmother also had the disease, but 
at the time, they were declared insane and both died in mental 
institutions in their forties. Because of their ages, no one 
thought to consider Alzheimer's as the cause of their 
illnesses. Of my great grandmother's six siblings, three died 
of this disease, again, all in their forties.
    My grandfather, Joseph Esposito, a major in the Army, began 
showing symptoms of Alzheimer's at the age of 37 and eventually 
took a medical retirement. At the age of 42, he was placed in a 
VA Hospital, where he remained until his death at the age of 
55. Of his six siblings, four would eventually die from this 
disease.
    My dad, Robert Esposito, was the oldest of six children 
born to my grandfather, Joseph, and my grandmother, Adeline. 
All of his life, my dad was haunted by the knowledge that he, 
too, might carry the deadly gene that had plagued his family 
before him. Misplacing his car keys would send him into a 
month-long depression. And although every doctor he went to 
told him he just suffered from stress, he was convinced that he 
would get Alzheimer's. Unfortunately, he was right.
    When I was in college----
    Senator Specter. Take your time, Ms. Frey. Take a glass a 
water.
    Ms. Frey. When I was in college, he started showing signs 
of memory loss and confusion. He would get into his car, drive 
away, only to sit at a stop sign for 10 minutes, forget where 
he was going, give up, and return home. By 46, he was 
diagnosed----
    Senator Specter. Ms. Frey, we understand the difficulty of 
the things you are talking about, so just take your time.
    Ms. Frey [continuing]. And at 51, he was dead.
    Three months later, his brother, Joey, passed away at the 
age of 48. Four years earlier, his sister, Barb, died at the 
age of 47. His brother, Richard, although never formally 
diagnosed with the disease, was showing signs of Alzheimer's 
when he committed suicide the day after Christmas in 1999. We 
believe he simply could not bear the thought of living the 
nightmare he had seen so many times before.
    The news of Richard's death was delivered to me, along with 
the news that my Uncle Michael, my godfather, age 40, and my 
Aunt Jennifer, age 38, had just been diagnosed with the 
disease. Both are in the early to moderate stages of the 
disease today.
    My family has long been involved in the research to find a 
cure for this disease. My family is one of the case studies for 
the National Institutes of Health. And the research done on my 
family has helped to find the gene that causes Alzheimer's. My 
family has donated blood, skin. And several members of my 
family, including my dad, donated their brains for research.
    Researchers have studied my family since the 1960s and have 
traced my family back as far as the 1700s. My sisters and I are 
on the list as possible research subjects and are committed to 
finding a cure.
    Every year I organize and hold a fundraiser to raise money 
for research. This year I hope to raise $3,000, which may seem 
inconsequential to some, but $3,000 might pay for that last 
test that would lead to a cure. And if I thought that raising 
money for research did not matter, then somebody else might 
think it does not matter, and then maybe you would not think it 
does not matter. But every dollar committed to Alzheimer's 
research is worthwhile. Every dollar matters. And I will 
continue to do my part in raising money for research.
    By profession, I am an adult probation officer in Peoria, 
IL. I currently supervise 170 clients, which would tax any 
normal person's memory. I try not to follow in my father's 
footsteps, but with a history like mine, it sometimes makes me 
wonder, when I cannot put a face to a name or when I cannot 
remember certain information about my clients. I truly believe 
that my occasional forgetfulness is brought on by doing too 
many things at once, but there is always that little voice in 
the back of my mind telling me otherwise.
    The average age of diagnosis in my family in 39, and I am 
31. My thoughts are of nursing home and long-term care 
policies, and whether or not my husband should divorce me if I 
get sick, so that he does not go bankrupt trying to take care 
of me.
    My thoughts are of trying to start a family right away, so 
that I have more time to spend with my kids in case I get sick. 
My thoughts are with my 33-year-old sister, who has two kids 
and one on the way, and whether she will see them graduate from 
high school or college or get married. My thoughts are with my 
24-year-old sister, who is starting her adult life and has so 
much to look forward to. My thoughts are with my mom, who might 
be the only one left to tell our children who we really were.
    Strangely, I imagine the only thing worse than actually 
having this disease would be the guilt of the family members 
who were spared and the sorrow of people like my grandmother, 
Adeline, who had to watch helplessly as generation after 
generation after generation after generation died one by one.
    We need this funding now, to find the cure in time, so that 
she will be spared the pain of watching my generation die, too.
    Thank you.
    [The statement follows:]
                  Prepared Statement of Christine Frey
    Thank you very much Senator Specter and Senator Harkin for inviting 
me to testify at this hearing. I am grateful for this opportunity to 
speak to you about an issue that is very dear to me.
    My name is Christine Frey and I live in Peoria, Illinois. In my 
professional life, I am a probation officer for the State of Illinois. 
I have been a probation officer for the last six and a half years. My 
work is very rewarding and challenging. Right now, I have a caseload of 
170 clients.
    In my other life, I advocate for increased funding for Alzheimer 
research. My dedication to this cause is deeply personal. My family 
suffers from what is known as Early-Onset Alzheimer's disease. Nearly 
six years ago, my dad, Robert Esposito, passed away from Alzheimer's 
disease at the age of 51. He was diagnosed with Alzheimer's at age 46 
and my stepmother, who had Multiple Sclerosis, took care of him at home 
for 2 years. He spent the last 3 years of his life in a nursing home. I 
was in college when my dad was diagnosed but he had the signs of 
Alzheimer's for some time before he actually received his diagnosis. I 
would call home from school and talk to my dad and I knew something was 
wrong with him. He underwent a lot of testing but the doctors told him 
that he was just suffering from stress. My dad however, was convinced 
that he had Alzheimer's. He had a good reason to be.
    You see, my dad's younger brother, Joey, had also been diagnosed 
with Alzheimer's. He died three months after my dad. He was 49 years 
old. My dad's sister, Barb, died of Alzheimer's in 1987 at age 43. My 
dad's other brother, Richard, died the day after Christmas in 1999 at 
the age of 44. Although he was never positively diagnosed with 
Alzheimer's, he committed suicide due to the stress of watching his 
brothers and sisters succumb to this terrible disease. My father's 
remaining siblings, Michael and Jennifer were both diagnosed with 
Alzheimer's in 1999. Michael was 40 when he received his diagnosis and 
Jennifer was only 38 when she got hers. My dad's father, Major Joseph 
Esposito, died in his early 50's after suffering from Alzheimer's for 
12 years, the last ten of which were spent in a nursing home. Of my 
grandfather's six siblings, four died from Alzheimer's. My great-
grandmother also had Alzheimer's but because of her young age when she 
was diagnosed, the doctors thought she was insane and she was put in an 
asylum.
    My family is one of the American case studies at the National 
Institutes of Health (NIH). My mom and dad participated in NIH 
research, as did all of my aunts and uncles. When my dad died, we 
donated his brain to NIH for further research. My two sisters and I are 
currently on the list for future research subjects. In fact, one of the 
genes that is associated with Alzheimer's was found in part by the 
research done on my family. The NIH has traced my family tree back 
through America, Italy and France and has found at least 32 members who 
died of Alzheimer's disease over the last five generations. The average 
age of diagnosis of Alzheimer's in my family is 39. I am 31 years old.
    In 1996, I got married and I cried all the way down the aisle 
because my dad was not there to give me away. My husband Mike and I 
really want to have children but we feel like we are in a race against 
time because of Alzheimer's disease. It scares me that if we do not 
have kids soon, I might not be around to see my children enter high 
school, let alone get married. I do not want my husband to have to 
explain to our nine-year old that mommy can't come to his or her soccer 
game because she is in a nursing home. At age 31, I should be excited 
about my future. Instead I am thinking about long term care insurance 
policies and nursing homes. I've already told my husband that he should 
divorce me if I get Alzheimer's because I don't want him to go broke 
taking care of me. Three years ago, when I was 28, I looked into buying 
a long term care insurance policy. The agents I talked to told me I was 
too young to buy a policy and said to call back when I turned 30. 
Because of my family history, it is not clear that anyone would even 
sell me a policy.
    My husband and I both have good jobs and we work hard. We are 
trying to plan for our future but there are things we want to do today 
while we are still young. Most other couples our age are going on 
exotic vacations or saving for their first house. It's hard to look at 
our budget each month and know that we should be putting money aside in 
case I get Alzheimer's. A few months ago I really wanted to buy a new 
chair for our living room but we decided that we should hold off on the 
expense for now.
    Over the last few years, I have spent a lot of time talking to 
doctors in Chicago and Springfield. I have also talked to researchers 
at NIH. Everyone I have talked to is excited about the pace of 
Alzheimer research right now. I have read news articles that talk of 
preventing Alzheimer's and I pray that science will find the answers. I 
pray not only for myself and my family, but also for the millions of 
baby-boomers who will soon be entering the age of increased risk for 
Alzheimer's. We need to make a huge investment in Alzheimer research 
because if we do not, we will be paying for this disease a hundred 
times over.
    Every year for the last few years I have organized a fundraiser in 
my dad's name to raise money for Alzheimer research. The first year I 
did the fundraiser it was a lot of work and we only raised $1,700. I 
almost didn't do it again the next year because I figured that doing 
all of that work to raise so little money didn't make any sense. But 
then I started thinking about my family, particularly my two and a 
half-year-old niece. Will her mother, my 33-year-old sister, be around 
to watch her daughter grow up? What about my 24-year-old sister? Will 
she get Alzheimer's too? Alzheimer's disease terrifies me but the one 
thing I am most scared about is what if my two sisters get it and I do 
not? I could not deal with that.
    So Senators, I will continue to hold the fundraiser in honor of my 
dad because I cannot afford not to contribute to the fight against 
Alzheimer's disease. There is too much at stake not only for me 
personally, but also for millions of other Alzheimer families. I am 
here today to thank you for your commitment to Alzheimer research and 
for your leadership in securing funding for the National Institutes of 
Health. I will continue to do my part to raise money for research and I 
ask you to remember my family as you make future decisions about 
funding for the NIH.
    Thank you for taking the time to listen to my story. And thank you 
for holding this hearing to educate your colleagues and the rest of the 
country about the importance of investing in Alzheimer research.

    Senator Specter. Ms. Frey, we really very, very much 
appreciate your coming in. Obviously, it is very difficult for 
you to talk about what has happened to your family. It has been 
extraordinarily debilitating and devastating to your family. I 
can see why you worry. I can see why, understandably, you are 
very emotional about it.
    And that, as the expression goes, puts a face on 
Alzheimer's in a way which the statistics and generalizations 
cannot do. So, we thank you for coming here today and sharing 
that experience with us.
    Ms. Frey. Thank you for having me.
STATEMENT OF JOHN WAGENAAR, PATIENT, ALZHEIMER'S 
            DISEASE
    Senator Specter. Our next witness is Mr. John Wagenaar, 
diagnosed with Alzheimer's in 1998. With substantial help from 
his wife, Darlene--40 years married--his children, 
grandchildren, employer, and co-workers, Mr. Wagenaar continues 
to lead an active life in George, IA.
    He is an advocate for Alzheimer's disease research and is 
active in the Sioux City chapter of the Alzheimer's 
Association.
    Thank you for coming in, Mr. Wagenaar, and telling us your 
own personal experience to help us better understand this 
terrible ailment.
    Mr. Wagenaar. Thank you very much. It is a pleasure being 
here. I am John Wagenaar. And 3 years ago I worked at a factory 
that was just right across the highway from us. We lived right 
along the highway. I went to work that morning and there was 
one certain part of the plant that was brand new.
    I had to check the plant in the mornings, first, when I got 
there for--if there was any trash laying around or if the 
dumpsters were out of place or--I tidied the place up was my 
job, first.
    So, then, I got that done. I walked into this new part of 
the building and it was just like the lights went out. I just--
I didn't remember a thing. I walked and I walked and couldn't 
get my way out of that building.
    Then toward noon, we decided--had to go to--we would walk 
home and have dinner, me and my wife. They had noticed, in the 
plant, then, that there was something wrong with me. They 
thought that I had a stroke. So, we walked home; walked across 
the highway, a busy highway, to get the mail. I do not remember 
it. Had my dinner. I do not remember it.
    But as soon as--we have our medical doctor--I mean, nurse 
at the plant, and when I took off just walking across the 
highway, then Darlene had called the nurse in the plant. They 
checked me over right away and took me with the ambulance to 
the nearest hospital. They put me on oxygen, which the further 
we got down the road, the better I started to recognize a 
little bit. But at that time, when we got there, there was--
they did a lot of tests and stuff, and then they--the next day 
they sent me on to Sioux City to check things out.
    While we were in Orange City, they checked everything and 
it was all done. They--my son and my daughter and their spouses 
and my wife was along. They took her in a separate room and 
with the--with the kids. They said that I had--they told the 
family, first, that I had Alzheimer's.
    Then he come to my room, and he says, ``You have 
Alzheimer's. Expect 1 to 3 years.'' That did not--did not hit 
good, but we--oh, to drop this on you, he said 1 to 3. Well, 
about 3 weeks ago, I hit number 3, plus 3. So, I am ahead of 
it, if I can just keep going.
    But when something like that happens and you get--you get 
your stuff in order, because the time could be short, it could 
be long. So, we--I had a toy collection that--half the basement 
was not walkable. It was full. We had over 600 tractors in 
there. The two boys--I also have a son that lives in Anchorage, 
AL. So, when he--we called him and he says, ``Go ahead and sell 
it.'' That's the most honest way, because you hand a couple of 
pieces to this child and you hand some to that child. So, 
anyway, we got all the stuff out of the basement. We went to a 
community building. And we had a sale on Friday night. And then 
we had a sale all day Saturday.
    So since that--after that was over with, I thought, now is 
the time to--to buy a house. I owned houses before, but we was 
renting at the time. So, we found a house and we got that.
    My son, up in Alaska, has a new motor home. And when we--we 
flew up there. And then he gave us a ride back to George, IA. 
It was a little over 8 hours--or 8 days, continuous. We had 
three grandsons with us. So, we would stop early at night, so 
they could go swimming. And later in the morning we would leave 
again.
    So, to make the long story short, the lights have not gone 
out yet on me. I am going to stay one ahead of that switch. But 
while I am still able, I want to do whatever I can to speak out 
for Alzheimer's disease. I have traveled to Washington to meet 
my Senators and Representative. I am testifying today to urge 
you to continue to investigate Alzheimer's research, so that we 
can spare my children and grandchildren and others from the 
disease. We are in a race against time. And if we do not find 
the answer soon, Alzheimer's will be an epidemic.
    Thank you so much for giving me the opportunity to speak to 
you today.
    [The statement follows:]
                  Prepared Statement of John Wagenaar
    Thank you very much Senator Specter and particularly Senator Harkin 
for giving me the opportunity to speak to you this morning. I am truly 
honored to be here.
    My name is John Wagenaar and I am a proud resident of George, Iowa. 
For those not familiar with Iowa geography, George is a small community 
of a few thousand people in the northwest corner of the state. With me 
today is my beautiful wife, Darlene. We will celebrate our 41st wedding 
anniversary this May. We have three grown children--a son and daughter 
who live in Iowa and a son who is in Alaska. We also are blessed with 
eight wonderful grandsons and one adorable granddaughter.
    Despite these blessings, our family is facing some challenges. 
Three years ago, in March of 1998, I was diagnosed with Alzheimer's 
disease. I was 60 years old. My problems actually started about five 
months before I received my diagnosis. I was on vacation with Darlene. 
We had taken our trailer on a camping trip to South Dakota. I had 
trouble backing into our camping spot which was very unusual because I 
was an expert at parking the trailer. The whole time we were camping 
Darlene kept asking me if I felt sick because I was very quiet and was 
not my usual bubbly self. Even before we went on vacation, I remember 
feeling more tired than usual around that time. I would come home from 
work at night, have supper and then fall asleep right away. Sometimes I 
would sit in my favorite chair and stare off with a blank look on my 
face. I was losing weight as well and our friends were asking Darlene 
if something was wrong with me because I didn't look good. I went to 
the doctor and had a complete physical but the exam didn't find 
anything wrong with me.
    Several weeks after my physical, I got up one morning and went to 
my job at the DEMCO manufacturing plant in Boyden, Iowa as I had done 
everyday for the past 11 years. Sometime that morning, I got lost in 
the plant's new addition. I knew something was wrong with me. Darlene 
thought maybe I had had a stroke so she called the nurse at the plant. 
I spent that night under observation in the local hospital but the 
doctors concluded that I had not had a stroke. The next day I went to a 
larger hospital in Sioux City. I saw a neurologist, had a CAT scan and 
underwent many tests. A few days later the neurologist called me, my 
wife and family in to her office and told us that I had Alzheimer's 
disease. We looked at the CAT scan which showed that my brain was 
shrinking away from my skull. I left the hospital devastated at the 
news. I took some time off work and went to see my son who lives in 
Alaska because I figured that it might be my last chance to make the 
trip.
    Today, my life is a little more calm than it was in the days 
immediately following my diagnosis. I am still working at the DEMCO 
plant. My employer has been incredibly sympathetic, supportive and 
understanding over the last three years. I was able to adjust my 
schedule so that I can work a later shift. Darlene works at the plant 
with me and switched from a part time job to a full time position so 
she can watch out for me at work. The plant manufactures car caddies, 
like the kind you pull behind motor homes, farm machinery, grain carts, 
tow bars and some chemical sprayers. It's a busy place but my coworkers 
look out for me and I can ask them questions anytime I'm not sure about 
what I am doing or how to use a machine. That's what Alzheimer's does 
to you--it makes you unsure of yourself and sometimes you can get in 
dangerous situations and get hurt. A few months ago we got a new 
computer system to replace the time clock that we used to record when 
we started a job and when we finished one. My coworkers help me push 
the right buttons so that I record my work properly.
    I am on the Alzheimer's drug Aricept and it has made a huge 
difference. I felt better and more like my old immediately after I 
started taking it. Once I forgot to take my pill and I could tell the 
next day because I wasn't as talkative as usual. Darlene noticed too 
and now she reminds me to take my pill every night. Even though the 
Aricept is helping me now, the doctors have told me that it is not a 
cure and that it will not stop Alzheimer's disease.
    I still drive but only when someone else, like Darlene, is in the 
car with me. Mostly I drive the 12 miles from our house to work and 
back. Darlene and I are both active with the Alzheimer's Association 
chapter in Sioux City. Last year we participated in their Memory Walk 
with a group of members from our church. I was so pleased that members 
of the church did the walk with us. The Alzheimer's Association in 
Sioux City has been wonderful to us as well. One of the people who 
works there came to DEMCO to talk to everyone about Alzheimer's disease 
because most of my coworkers didn't know what it was or what was 
happening to me. Some of them wouldn't even talk to me when I told them 
I had it. The presentation that the Association person made to my 
coworkers was very helpful and helped them understand more about the 
disease. They learned how they could help me at work and keep me safe.
    While I am still able, I want to do whatever I can to speak out 
about Alzheimer's disease. I have traveled to Washington to meet with 
my Senators and Representatives and I am testifying here today to urge 
you to continue the investment in Alzheimer research so that we can 
spare my children and grandchildren and others from this devastating 
disease. We are in a race against time and if we don't find the answers 
soon, Alzheimer's will be an epidemic. Darlene is truly my angel and I 
am grateful that she is in my life. Perhaps the best thing to come of 
this terrible experience is that our love for each other has grown 
deeper. But we know what the future holds and I would do anything to 
spare her from the years of caregiving she is facing. If the research 
can proceed fast enough, there may be something that will make a 
difference for me, but I pray that the discoveries will come in time 
for the next generation.
    Thank you so much for giving me the opportunity to speak to you 
today.

    Senator Specter. Thank you very much, Mr. Wagenaar. We 
appreciate your coming in and telling us of your own personal 
experience. And we agree with you that if we do not act, it 
will be an epidemic. But we are going to do our very best to 
respond to the needs of the research community.
STATEMENT OF DAVID HYDE PIERCE, ADVOCATE, ALZHEIMER'S 
            DISEASE
    Senator Specter. Our final witness is Mr. Hyde Pierce, best 
known for his role as Niles Crane in the hit NBC series 
``Frazier,'' for which he has won an Emmy and Screen Actors' 
Guild Awards.
    Mr. Hyde Pierce has been actively involved with the 
Alzheimer's Association for years, serving on the National 
Board of Directors. His personal fight stems from his father 
and grandfather's struggles with the disease. He helped raise 
some $15 million for the 1999 Alzheimer's Association's Memory 
Wall. In March 1999, he was awarded the first ever Elsa Rose 
Fabares Award given by the Los Angeles chapter of Alzheimer's 
Association.
    Thank you for joining us, and we look forward to your 
testimony.
    Mr. Hyde Pierce. Thank you, Mr. Chairman. Thank you, 
members of the subcommittee.
    I am very proud to be testifying today, but I am especially 
proud to be able to be here to hear the testimony of these 
extraordinary people who are sitting next to me.
    I am here today on behalf of millions of families, like 
mine, across America, who have confronted the challenge of 
Alzheimer's disease. I am also here on behalf of the 14 million 
people of my generation, the baby boom generation, and their 
families, who, right now, have a death sentence of Alzheimer's 
looming in their future.
    I want to thank you both for your extraordinary work in 
helping to double the funding for the NIH. And please know that 
the Alzheimer's Association is here on Capitol Hill en masse 
today to help make sure that your colleagues are following your 
lead.
    Two of our friends who are not here today wanted to express 
their thanks and send their wishes; Shelley Fabares, who is, as 
you know, recovering from liver transplant surgery at home, and 
Maureen Reagan, who is fighting her own personal battle now 
with malignant melanoma.
    And Senator, you mentioned before the idea of throwing 
money at a problem. Well, Maureen said to me before I came out, 
she said, ``You know how you cannot throw money at a problem? 
Well, you can with Alzheimer's. And you have to.''
    And there are three compelling reasons why I believe that 
is true. The first reason is just basic human decency. We have 
to stop what is happening to people like Chris and John, here.
    The second is the promising research that Dr. DeKosky and 
Dr. Hodes have referred to, and all the breakthroughs that we 
have had so recently.
    The third is basic economics. If Alzheimer's is not stopped 
in its track, it will bankrupt the nation, just as it is now 
bankrupting families across the nation.
    This morning, the Alzheimer's Association is releasing a 
report on the cost of Alzheimer's disease to Medicare and 
Medicaid. And I would like to offer a copy of that report for 
the record.
    Last year, Medicare spent $31.9 billion to care for 
beneficiaries who had Alzheimer's. That cost will rise to $49.3 
billion by the year 2010, an increase of 54.5 percent.
    And as for Medicaid, last year, the States spent $18.2 
billion just on nursing home care for people with Alzheimer's 
disease. And by 2010, the cost will be $33 billion, an 81.3 
percent increase.
    The shocking part of these projections is that all of these 
huge costs, all of these huge increases occur before the baby 
boomers hit the age of maximum risk and the number of people 
with this disease explodes.
    We cannot go on like this. We cannot sustain these 
skyrocketing human and financial costs to families and Federal 
and State budgets. And fortunately, we do not have to. But we 
have a very narrow window of time in which to act. Half of us 
in this room today already have the time bomb of Alzheimer's 
disease ticking in our brain.
    Congress has to find a way to diffuse that time bomb, or it 
will destroy us.
    I do not know if you all remember polio, but I do not. 
Fifty years ago polio was the dread disease that threatened 
every American family; that struck down presidents and factory 
workers alike. And today most of us only know about polio from 
the history books.
    Two of the scientists who helped develop the polio vaccine, 
Dr. Joseph Melnick and Dr. Dorothy Horseman, died last year of 
Alzheimer's disease. If only we can do for Alzheimer's what 
they were able to do for polio.
    I believe, with your leadership and our advocacy, that we 
can. I believe that we will reach the day when young people, 
like Christine, no longer have to live in fear of the terror of 
Alzheimer's disease. And I hope, for all of our sakes, that 
that day comes soon.
    Thank you.
    [The statement follows:]
                Prepared Statement of David Hyde Pierce
    Mr. Chairman and Members of the Subcommittee, thank you for 
inviting me. I am here today on behalf of millions of families like 
mine from across the United States who have confronted the challenge of 
Alzheimer's disease. Even more, I am here for the 14 million 
babyboomers and their families who, right now, have a death sentence of 
Alzheimer's disease looming in their future.
    For all of them, I say thank you, Senator Specter and Senator 
Harkin, for your steadfastness in leading the fight to double funding 
for the National Institutes of Health. And for holding your colleagues 
feet to the fire. The Alzheimer's Association is here on Capitol Hill 
today, en masse, to meet with our own Senators and Representatives to 
make sure they are following your lead.
    As Dr. DeKosky already told you, the Association is asking Congress 
to escalate the war on Alzheimer's disease, by increasing funding to $1 
billion within three years. That will require an increased investment 
of $200 million this year. I am here to add my voice to the eloquent 
testimony you have already heard about the urgency of this request.
    My grandfather and my father died of Alzheimer's disease. That is 
why I got involved in the Alzheimer's Association. I stay involved 
because of the incredible people who have dedicated their lives to 
fighting this disease. Some are well known--people like Shelley Fabares 
and Maureen Reagan who have testified before you in the past.
    (As an aside, I recently visited Maureen Reagan, who as you know is 
fighting her own personal battle with malignant melanoma. I am happy to 
report she is doing well and her prognosis is good. She asked me to 
tell you she is disappointed that she couldn't be here today--but to 
warn you that she will be back, to work with you until we conquer the 
disease that has stolen her father from us all.)
    The real heroes, however, are not the celebrities. They are all the 
people from the Alzheimer's Association sitting behind me, and the two 
courageous people sitting here at the witness table with me. Each of us 
has a personal story to tell about the devastation of Alzheimer's. 
Undoubtedly, members of this Subcommittee could add their own accounts 
of family or friends whose lives were fundamentally altered by this 
awful killer.
    There are three compelling reasons why Congress must accelerate its 
investment in Alzheimer research now.
    The first reason is just basic human decency. We need to put a stop 
to the kinds of stories you heard from Christine Frey and John 
Wagenaar.
    The second reason is the scientific opportunity that Dr. Hodes and 
Dr. DeKosky discussed.
    The third reason, which I want to talk about, is basic economics.
    This Congress is engaged right now in a far-ranging debate about 
how we will use the projected budget surplus. That is a discussion 
about our future--how to pay down the national debt, how to preserve 
Medicare and Social Security, how to protect sufficient discretionary 
spending to meet our urgent national priorities.
    But unless we stop Alzheimer's disease in its tracks, we will not 
be able to answer any of those questions adequately. Because 
Alzheimer's disease will bankrupt the nation, just as it is already 
bankrupting individual families.
    This morning, the Alzheimer's Association is releasing a startling 
report on the cost of Alzheimer's disease to Medicare and Medicaid. It 
is a wakeup call to us all. (I would like to offer a copy of that 
report for the record.)
    When you look at the numbers, it is hard to see how you can protect 
the Medicare trust fund if we don't find a way to stop Alzheimer's 
disease. Last year, Medicare spent $31.9 billion to care for 
beneficiaries who had Alzheimer's. That cost will be $49.3 billion by 
2010, an increase of 54.5 percent.
    The numbers are just as frightening when we look at Medicaid. 
Because Medicare does not pay for prescription drugs or long term care, 
nearly half of beneficiaries with Alzheimer's disease use up their 
personal resources and become eligible for Medicaid as well. Last year, 
the states spent $18.2 billion, just on nursing home care for people 
with Alzheimer's disease. By 2010, the cost will be $33 billion--an 
81.3 percent increase.
    The most alarming part of these projections is that these very 
large cost increases come even before the baby boomers reach the age of 
risk, and the number of people with Alzheimer's disease explodes. 
Neither Medicare nor Medicaid will be able to survive the onslaught of 
14 million babyboomers with Alzheimer's disease.
    The only reason that Alzheimer's has not already bankrupted 
Medicare and Medicaid is that those programs don't pay for much of the 
care a person with Alzheimer's needs. We rely heavily on families, to 
provide most of that day to day care.
    But we are incurring a lot of collateral damage. One in eight 
Alzheimer caregivers becomes ill or injured as a direct result of 
caregiving. Older caregivers are three times more likely to become 
clinically depressed than others in their age group. And elderly 
spouses strained by caregiving are 63 percent more likely to die than 
others their age.
    We simply cannot go on like this. We cannot sustain these 
skyrocketing costs--to families or to federal and state budgets. The 
good news is that we don't have to do so.
    But our window of time is very short. Half of us in the room 
already have a time bomb ticking away in our brains, each and every 
day. Congress must find a way to defuse this bomb, before it destroys 
us.
    The possibilities have never been greater. Think about what we did 
with polio. Fifty years ago, polio was the dread disease that terrified 
every American family. It struck down Presidents and factory workers 
alike. Today, most of us know about polio only from the history books.
    Two of the scientists who helped develop the polio vaccine died 
this year--they both had Alzheimer's disease. If only we can do for 
Alzheimer's what they did for polio. I know, with your leadership and 
our advocacy, we can. I believe that we will reach the day when young 
people like Christine Frey and her sisters won't live with the terror 
of Alzheimer's disease. They will only read about it in the history 
books. I hope that day comes soon.
    Mr. Chairman, the Association has made a strong case for research 
in its National Public Policy Program to Conquer Alzheimer's Disease. I 
request that the text of the program be inserted in the hearing record.
    I would also like to take a moment to thank the Subcommittee and 
urge its continued support for two programs that are providing 
immediate help to people who are living with Alzheimer's disease. We 
urge you to fund further expansion of the Alzheimer matching grant 
program, to support model programs to reach underserved communities, 
particularly minority populations and rural areas. And we support 
continued full funding of the $125 million Family Caregiver Support 
Program.
    Let me close by reiterating my personal thanks and that of the 
entire Alzheimer's Association for your continued leadership in the 
fight to conquer Alzheimer's disease. Each of us pledges to intensify 
our own advocacy in support of your efforts. Thank you for the 
privilege of testifying today.

    Senator Specter. Thank you very much, Mr. Hyde Pierce. You 
characterize it very well when you refer to polio. That is a 
disease, at least in the United States, which has been 
conquered. It is worth mention that it has not been conquered 
worldwide.
    Mr. Hyde Pierce. No, that is true.
    Senator Specter. I had occasion to be in India recently, 
and was asked to administer some polio vaccine to babies in 
India. Quite an experience to do that. It really brings it home 
how a few drops placed in an infant's mouth can immunize the 
child from the onset of polio.
    I recall the problem growing up in Wichita, KS. We could 
not go swimming in the summer, because it was thought that that 
would subject someone to the problem of polio.
    Thank you for your testimony. We very much appreciate Ms. 
Frey sharing with us her family's experience; and Mr. Wagenaar, 
his own personal experience and obviously the difficulties in 
coming here; and you, too, Mr. Hyde Pierce, who have had the 
family problem.
    I want to ask Dr. DeKosky just one line of questioning. 
Alzheimer's is interested in having an increase of $200 million 
in fiscal year 2002. I believe that health is number one. There 
is nothing more important than health. As we have seen in this 
subcommittee, with the variety of illness which we have 
hearings on, it is really, really heartbreaking. When you ask 
for $200 million, I would like to see you get $200 million, but 
I do not know quite how to square that with what we are seeking 
to do on other ailments.
    If we are successful in getting a budget increase of 
$3,400,000,000, right now--the administration budget is at 
$2,750,000,000, that projects to an administration increase of 
$62 million for Alzheimer's disease--we would have to do more 
than triple the overall award, which would be in excess of $10 
billion for this year. And candidly, my colleagues are not very 
happy about what Senator Harkin and I are doing by putting in 
the money we have.
    We tried for $1 billion a few years ago and were turned 
down. So, the next year we tried for $2 billion and were turned 
down. And the next year we tried for $2.3 billion and were 
turned down. Finally, we went for $2.7 billion and we won. I 
will not give you all of the statistics, but I think, this 
year, when we ask for $3.4 billion, we will win. But I think 
even our winning streak or our abilities to get the funding 
would balk at $10 billion.
    Now, I know, Dr. DeKosky, you do not suggest that we rob 
Peter to pay Paul, as you stated earlier in your testimony, or 
take it from somewhere else. And the allocation is really the 
job of NIH. They make the determination on a non-political 
basis as to how the money ought to be allocated.
    If you were sitting in my chair, Dr. DeKosky, and with that 
background in mind, how would you respond to--Senator DeKosky, 
how would you respond to Dr. Specter's request for $200 
million? I just demoted you and promoted me.
    Dr. DeKosky. My first thought would be Aunt Rose would give 
me the money. My second thought has to do with the issue of the 
future and having the investment to put back into the Federal 
budget, instead of having to spend money taking care of people 
as the programs that are on the rise, even before the boomers 
hit their age of high risk, causes us to lose. This, I see, 
rather than an open-ended issue, being more of an investment.
    We have the ability, we believe, to head off the disorder. 
We would like to be able to turn the graphic which shows the 
effect of a decline in the number of cases, which represents 
real dollar savings, into reality.
    So, my belief is, in terms of the timing of when these 
cases will begin to increase, that the money spent now makes 
much more sense.
    My only other comment is that the research that is done 
directed towards Alzheimer's disease has a whole variety of 
spin-outs into disorders of stroke, cerebrovascular disease. It 
will probably have effects on diabetes and a variety of other 
illnesses. So, although this is focused on Alzheimer's, the 
people who have come to it and the advances in different areas 
and for different diseases have been surprising; sometimes 
unpredictable.
    Senator Specter. Well, that is a good answer, Dr. DeKosky. 
And we will do our very best to get the maximum funding we can.
    On a parochial matter, may I ask all those from 
Pennsylvania who are here today, I understand we have a very 
large contingency, to stand up?
    [Pennsylvania group stands.]

                         CONCLUSION OF HEARING

    Senator Specter. Thank you all very much for being here, 
that concludes our hearing.
    [Whereupon, at 10:45 a.m., Tuesday, April 3, the hearing 
was concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]

                                   - 
