[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.]
-