[Senate Hearing 110-728]
[From the U.S. Government Publishing Office]
S. Hrg. 110-728
THE FUTURE OF ALZHEIMER'S BREAKTHROUGHS AND CHALLENGES
=======================================================================
HEARING
before the
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
WASHINGTON, DC
__________
May 14, 2008
__________
Serial No. 110-28
Printed for the use of the Special Committee on Aging
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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SPECIAL COMMITTEE ON AGING
HERB KOHL, Wisconsin, Chairman
RON WYDEN, Oregon GORDON H. SMITH, Oregon
BLANCHE L. LINCOLN, Arkansas RICHARD SHELBY, Alabama
EVAN BAYH, Indiana SUSAN COLLINS, Maine
THOMAS R. CARPER, Delaware MEL MARTINEZ, Florida
BILL NELSON, Florida LARRY E. CRAIG, Idaho
HILLARY RODHAM CLINTON, New York ELIZABETH DOLE, North Carolina
KEN SALAZAR, Colorado NORM COLEMAN, Minnesota
ROBERT P. CASEY, Jr., Pennsylvania DAVID VITTER, Louisiana
CLAIRE McCASKILL, Missouri BOB CORKER, Tennessee
SHELDON WHITEHOUSE, Rhode Island ARLEN SPECTER, Pennsylvania
Debra Whitman, Majority Staff Director
Catherine Finley, Ranking Member Staff Director
(ii)
C O N T E N T S
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Page
Opening Statement of Senator Herb Kohl........................... 1
Opening Statement of Senator Gordon Smith........................ 2
Statement of Senator Ron Wyden................................... 4
Statement of Senator Susan Collins............................... 4
Statement of Senator Ken Salazar................................. 6
Statement of Senator Elizabeth Dole.............................. 7
Statement of Senator Thomas Carper............................... 7
Statement of Senator Bob Corker.................................. 8
Statement of Senator Sheldon Whitehouse.......................... 9
Statement of Senator Norm Coleman................................ 9
Statement of Senator Blanche Lincoln............................. 9
Panel I
Statement of Honorable Sandra Day O'Connor, former Supreme Court
Justice, Member of the Alzheimer's Study Group, Washington, DC. 11
Statement of Honorable Newt Gingrich, former Speaker of the House
of Representatives,............................................ 17
Panel II
Statement of Charles Jackson, Alzheimer's patient, Albany, OR.... 43
Statement of Suzanne Carbone, Alzheimer's patient caregiver,
Silver Spring, MD.............................................. 49
Statement of Rudy Tanzi, Ph.D., director of Generics and Aging
Research Unit, Massachusetts General Institute for
Neurodegenerative Diseases, professor of Neurology, Harvard
University, Hull, MA........................................... 54
APPENDIX
Prepared Statement of Senator Robert P. Casey.................... 65
Justice Day O'Connor's Responses to Senator Hillary Clinton's
Questions...................................................... 65
Dr. Tanzi Responses to Senator Hillary Clinton's Questions....... 66
Additional information from Dr. Tanzi, a piece he wrote for the
Cure Alzheimer's Fund Quarterly Report......................... 69
Statement submitted by Richard E. Powers, MD, Medical Advisory
Board Chair Alzheimer's Foundation of America.................. 74
Statement of Richard Grimes, CEO & president of the Assisted
Living Federation of America................................... 81
Statement submitted by David W. Wright, M.D., F.A.C.E.P.,
assistant professor of Emergency Medicine and co-director of
Research at Emory University................................... 84
(iii)
THE FUTURE OF ALZHEIMER'S: BREAKTHROUGHS AND CHALLENGES
---------- --
Wednesday, May 14, 2008
U.S. Senate
Special Committee on Aging
Washington, D.C.
The committee met, pursuant to notice, at 10:44 a.m. in
room SD-106, Dirksen Senate Office Building, Hon. Herb Kohl
(chairman of the committee) presiding.
Present: Senators Kohl, Wyden, Lincoln, Carper, Salazar,
Whitehouse, Smith, Collins, Dole, Coleman, and Corker.
OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN
The Chairman. Good morning to you all, and we thank you for
being with us here today.
We would particularly like to express appreciation to our
esteemed panel of witnesses for their willingness to
participate in this hearing. Today, we will be discussing
Alzheimer's, a disease that currently affects over 5 million
Americans and their families and is anticipated to affect
millions more as our population ages.
Without a cure or at least some treatment to delay the
progression of Alzheimer's, there will be almost a half million
new cases each year by 2010. So, clearly, Alzheimer's disease
is a growing national crisis, and we must commit to addressing
it in the most comprehensive way possible. There are enormous
costs, both personal and financial. That is why we need to
prepare for this mounting epidemic and to determine in what
capacity we are able to curb it.
Right off the bat, we know that there are three things
Congress can do and has done this year. The first is to
increase funding for research to find cures or treatments that
will slow the onset of this disease. The second is to provide
support to individuals and their families that are living with
the disease. Finally, we can protect those with genetic
predisposition to this and other diseases from discrimination
by their workplace or insurer.
Legislation exists or will shortly be introduced to address
all three of these action issues. For instance, the Alzheimer's
Breakthrough Act aims to increase research funding. The bill,
introduced by my colleagues Senator Mikulski, Senator Bond,
Senator Clinton, and Senator Collins, would double funding for
Alzheimer's research at the National Institutes for Health to
$1.3 billion. This bill passed through the HELP Committee in
July of last year and is currently awaiting a vote.
Recently, I announced a plan to introduce legislation that
would offer training and support services to family caregivers.
Almost 10 million Americans are caring for a person with
Alzheimer's disease or other dementias. These caregivers
frequently do the same work as a professional caregiver, but
they do so voluntarily and with little or no training or access
to broader support services.
Finally, I am happy to say that the Genetic Information
Nondiscrimination Act recently passed both the House with only
one no vote and the Senate with unanimous support. The bill is
currently awaiting the President's signature. Due to recent
gains in the areas of gene mapping and genetic testing, this
legislation is of particular importance to the Alzheimer's
community.
As we will hear today, genetic information plays an
invaluable role in the early detection and treatment of
Alzheimer's disease. The legislation we are talking about will
protect the right of Americans to seek out genetic testing
without fear that the results will be used against them either
by an employer or an insurance provider. Our hope is that this
protection will encourage broader utilization of testing
methods and a greater chance of early intervention where
possible.
Again, we would like to thank our witnesses for their
participation in this hearing. To my knowledge, a congressional
hearing has never cured a disease. But surely, with such a
distinguished panel of witnesses, we can garner valuable ideas
to raise awareness, anticipate challenges, encourage research,
and support Alzheimer's patients as well as their families in
the very best way that we can.
We now turn to the Ranking Member of this Committee,
Senator Gordon Smith, for his comments.
OPENING STATEMENT OF SENATOR GORDON H. SMITH, RANKING MEMBER
Senator Smith. Thank you, Mr. Chairman.
Ladies and gentlemen, good morning. This vast audience that
has come here, I think, is a testament to just the kind of
impact that Alzheimer's is having on America's families, and we
thank you for your presence.
I particularly want to thank Justice O'Connor and Speaker
Gingrich. It goes without saying that these are two historic
Americans who are lending their great prestige to this issue
that is so vital to healthcare in America and to our ongoing
efforts to find a cure.
I want to particularly thank Charles ``Chuck'' Jackson, who
is here in the front row. He will be testifying in the second
panel. He has flown across the country from Albany, OR, to
share his personal story of living with Alzheimer's disease.
Whether it was through watching his family members suffer or in
his personal battle, Alzheimer's disease has had a presence
throughout most of his adult life.
In fact, Chuck, was diagnosed at age 50 with early onset
Alzheimer's. He has lost 17 members of his family to the
disease. I understand that Chuck's aunt, his Aunt Esther
testified at one of the first hearings before Congress about
the need to increase research funding. Chuck, we are pleased to
have you here today, but it is unfortunate that we are
continuing to have to hold hearings on this as the disease
continues to proliferate, yet funding remains insufficient.
The instances of Alzheimer's disease in the United States
are staggering. Every 71 seconds, someone in America develops
Alzheimer's disease. An estimated 5.2 million Americans of all
ages and 1 in 8 persons age 65 and older have the disease.
Additionally, 10 million baby boomers can expect to develop
Alzheimer's disease in the remaining parts of their lives.
In my State of Oregon, a total of 76,000 Oregonians have
Alzheimer's disease or a related disorder. This represents a
nearly 33 percent increase in the number of people age 65 and
older with Alzheimer's disease over the last 8 years. Sadly, to
date, there is no treatment to delay or stop the deterioration
of brain cells in Alzheimer's disease.
To stem this tide, we must increase medical research
funding for the NIH. Just 2 months ago, I sponsored an
amendment to the budget to increase NIH funding by over $2
billion. Although this is a good start, we need to make sure
that the funding actually gets appropriated. Across the Nation,
many advances in research are being realized at NIH-funded
facilities.
For example, in Oregon, the Layton Center for Aging and
Alzheimer's Disease focuses on research aimed at detecting and
preventing cognitive decline even before developing symptoms.
The center integrates its activities with the Oregon
Alzheimer's Disease Core Research Center, 1 of 30 national
centers funded by the NIH.
In addition to supporting ongoing research, I am hopeful
that Congress or the new administration, will lift the ban on
Federal funding for embryonic research. This will allow our
greatest minds in medicine to fully explore, in an ethical
manner, the potential of these cells in creating Alzheimer's
disease, as well as some of life's other devastating diseases,
such as Parkinson's.
I also will continue to lead the effort here in the Senate
to increase funding to the National Family Caregiver Support
Program. This program is a component of the Older Americans
Act, which funds an array of local programs to ensure that our
seniors can remain in their homes as they age.
The caregiver program and the Older Americans Act is vital
to ensuring that families can receive information and
assistance about available services, individual counseling,
respite care, and access to adult daycare or home care
services. Funding for this program also works to organize
support groups and establish caregiver training programs.
Unfortunately, all Older Americans Act programs are
woefully underfunded, and the need for caregiver support far
outweighs the support that local agencies are able to provide.
I will continue to work with my partner on the Finance
Committee in this effort, Senator Lincoln, to ensure that
funding for these programs better reflects the needs of our
country, and I ask that all of you help us in this effort with
the Older Americans Act.
Fortunately, with the good work of the panel before us, as
well as many others, families around the country are receiving
help coping with the disease as well as finding treatment. I
look forward to hearing from each of you about how Congress can
better help support those individuals who are affected by
Alzheimer's disease.
So, with that, Mr. Chairman, I turn it back to you.
The Chairman. Thank you, Senator Smith.
Senator Wyden.
STATEMENT OF SENATOR RON WYDEN
Senator Wyden. Mr. Chairman, thank you.
We have two very thoughtful guests, and I am going to be
very brief this morning.
My mother got a master's degree from Yale back in the day
when that was pretty much unheard of. Now she is on the second
floor of Channing House in Palo Alto, a really wonderful
facility, with a very advanced case of Alzheimer's and
dementia. Justice O'Connor just mentioned to me a situation
much like the O'Connor family is facing.
If my mother could speak today, she would probably say
something like, ``Well, Ronald, what are you going to do to
help the others?'' Today, I hope, will be the beginning of a
national drive, literally a nationwide mobilization to forge a
new strategy against Alzheimer's. The new strategy should be
primarily about prevention. If there is one word that ought to
capture our future strategy, that is it.
Because when you listen to Chuck Jackson--and we are so
thrilled that you are here, Chuck--it is an inspiring story he
tells about his effort to really ring the bell and generate
national awareness about how important prevention is for those
who are under 65.
So I am very much looking forward to our guests. I have had
a chance to work with Speaker Gingrich often on healthcare
issues. There is certainly nothing partisan about this one.
Today, if we can do nothing else but drive home the importance
of a new strategy that zeroes in on prevention, I think that is
something that the whole country will rally to.
I thank you, Chairman Kohl and Senator Smith, for your
leadership and bipartisan focus once again.
The Chairman. Thank you, Senator Wyden.
Senator Collins.
STATEMENT OF SENATOR SUSAN COLLINS
Senator Collins. Thank you. Thank you, Mr. Chairman.
I co-chair with Senator Hillary Clinton the Congressional
Task Force on Alzheimer's Disease. So I am particularly pleased
that you have called this hearing this morning so that we can
get an update on where we stand in the battle against
Alzheimer's.
I am, of course, delighted that we have Justice O'Connor
and Speaker Gingrich with us. Both of them are members of the
Alzheimer's Study Group, which is bringing together the most
creative people that I can imagine to help us chart a new
course in dealing with Alzheimer's.
As someone whose family has experienced the pain of
Alzheimer's over and over again, I know there is no more
helpless feeling than to watch the progression of this terrible
disease. It is an agonizing experience to look into the eyes of
a loved one only to receive a confused look in return. Of
course, my family is by no means alone. An estimated 5.2
million Americans have Alzheimer's disease, including more than
25,000 people in Maine. That is more than double the number in
1980.
Moreover, Alzheimer's costs the United States about $150
billion a year. This figure is going to increase exponentially
as the baby boom generation ages. Our investments in
Alzheimer's research have begun to pay dividends. Effective
treatments are tantalizingly within our grasp. Moreover, if
scientists can find a way to delay the onset of this
devastating disease for even 5 years, our Nation would save
more than $60 billion every year in Medicare and Medicaid costs
and an incalculable amount in human suffering.
So that is why it is so important that we make these
investments, that we pursue every opportunity possible. This
hearing helps set us in that direction.
So, thank you, Mr. Chairman. I am going to submit the rest
of my statement for the record, and I appreciate your holding
this hearing.
[The prepared statement of Senator Collins follows:]
Prepared Statement of Senator Susan Collins
Mr. Chairman, as the Senate Co-Chair of the Congressional
Task Force on Alzheimer's Disease, I am pleased that you have
called this hearing to provide the Committee with an update on
where we stand in the battle against Alzheimer's, and I want to
thank Justice O'Connor and Speaker Gingrich for their advocacy.
Both are members of the Alzheimer's Study Group.
As someone whose family has experienced the pain of
Alzheimer's many times, I know that there is no more helpless
feeling than to watch the progression of this dreadful disease.
It is an agonizing experience to look into the eyes of a loved
one only to receive a confused look in return.
My family is not along. An estimated 5.2 million Americans
have Alzheimer's disease--including more than 25,000 people in
Maine--more than double the number in 1980. Moreover,
Alzheimer's costs the United States just under $150 billion a
year, primarily in nursing home and other long term care costs.
This figure will increase exponentially as the baby boom
generation ages. As baby boomers move into the years of highest
risk for Alzheimer's disease, a strong and sustained research
effort is our best tool to slow the progression and prevent the
onset of this heart-breaking disease.
Our investments in Alzheimer's research have begun to pay
dividends. Effective treatments are tantalizing within our
grasp. Moreover, if scientists can find a way to delay the
onset of this devastating disease for even five years, our
nation will save more than $60 billion every year in Medicare
and Medicaid costs, and an incalculable amount in human
suffering.
If we are to keep up the momentum we have established,
however, we must increase our investment in Alzheimer's disease
research. We have made tremendous progress, but this is no time
to take our foot off the accelerator. That is why I am pleased
to be an original cosponsor of the bipartisan ``Alzheimer's
Breakthrough Act'' to double the authorization levels for
Alzheimer's research at the National Institutes of Health.
In addition to increasing funding for research, we must
also do more to support Alzheimer's patients and their
families. I am therefore also pleased to be an original
cosponsor of the ``Alzheimer's Family Assistance Act'' which
will provide a tax credit of up to $3,000 to help families meet
the costs of caring for a loved one with a long-term, chronic
disease like Alzheimer's. The legislation will also encourage
more Americans to plan for their future long-term care needs by
providing a tax deduction to help them purchase long-term care
insurance.
Alzheimer's disease is tragic at any age. But the tragedy
is particularly poignant when it strikes early, disabling
otherwise healthy individuals in the prime of their lives.
Moreover, when Alzheimer's strikes before 65, it can create
additional problems simply because it is so unexpected and
because most of the potentially helpful programs and services
are targeted to older people. I am therefore particularly
pleased that this morning's hearing will also focus on the
unique challenges faced by the growing population of ``early
onset'' Alzheimer's patients who are diagnosed before the age
65.
Again, I want to thank the Chairman and the Ranking Member
for organizing this important hearing which I hope will help us
to identify new strategies that will move us forward in our
battle against this terrible disease.
The Chairman. Thank you, Senator Collins.
Senator Salazar.
STATEMENT OF SENATOR KEN SALAZAR
Senator Salazar. Thank you very much, Chairman Kohl and
Ranking Member Smith.
Let me just say to both Sandra Day O'Connor, a great
justice, thank you so much for your service to our country for
so many years and thank you for being here, and speaking out on
such an important issue.
To Speaker Gingrich, thank you for your life beyond the
speakership and for continuing to contribute to our country and
dealing with major issues that face our time.
When I look at this audience that is here today putting a
spotlight on the issue of Alzheimer's, I would imagine that
almost everyone out there, including many members of this panel
who are my colleagues in the Senate, have personal stories
about Alzheimer's. Maybe it is those personal stories that make
us all advocates for trying to deal with this issue.
Just like Senator Wyden's story with his mother, I, too,
had a father, a World War II veteran who was strong as nails.
There was nothing that could ever put him down. During the last
few years of his life when he had Alzheimer's, keep his body
was still strong and with the right kind of assistance he could
still be out there feeding cows in his 80's, his mind was not
there.
It is a very difficult and painful thing, I know, for all
families to understand what happens with Alzheimer's, and it is
important that we are doing what we are doing here today.
Hopefully, it is just a mark in a journey that is going to be a
long journey to get us to the point where we can actually
prevent the disease.
Like Senator Wyden, I often wonder what my father would
tell me today. He no longer is with us here today. But I think
he would say, one, we need to get a much better understanding
of the disease than we currently have.
I think when he first was coming down with Alzheimer's, we
didn't know what was going on with him. There was a time period
where he would act in ways that were just so strange, and no
one had any understanding of why it is that sometimes he would
want to choke someone within his own family on issues that had
nothing at all to do with what the dialog was all about.
Then, second of all, moving forward in his life, watching
his body still very strong, but his mind was no longer there
was a very painful thing for all of us to go through. So I
think enhancing the understanding of the disease among all
Americans is something that is very important, and I also think
that moving forward with the kinds of investments in research
that we all support are very important for us to get a credible
and effective prevention program.
Thank you very much, Senator Kohl and Senator Smith.
The Chairman. Thank you, Senator Salazar.
Senator Dole.
STATEMENT OF SENATOR ELIZABETH DOLE
Senator Dole. Thank you, Mr. Chairman, and I certainly want
to thank Ranking Member Smith for holding this hearing today.
What a privilege it is to have Justice O'Connor and Speaker
Gingrich with us today and other members of the panel that will
follow.
As I look out across this hearing room and see the number
of people here, I don't believe I have ever witnessed as many
people at a hearing in the 5, 6 years that I have been in the
U.S. Senate, which certainly speaks--yes. [Applause.]
I will be very brief because we want to hear from our
witnesses. But as we are all aware, more than 5 million
Americans are currently suffering from Alzheimer's disease,
including more than 130,000 in my home State of North Carolina.
There are about 300,000 caregivers in North Carolina, and if
these caregivers were paid minimum wage for their time, it is
estimated that the hours of care would be valued around $2.9
billion per year in North Carolina alone. It is incredible.
I am so pleased to have the opportunity to learn more
today, to be a part of trying to find answers to these very
serious problems. No question the need for more research is
necessary to help prevent, diagnose, and treat Alzheimer's. It
is tremendous the need here.
So just know that I am going to be a strong supporter. I am
very pleased to be a part of the group that has a chance to
learn this morning from our witnesses.
Thank you very much.
The Chairman. Thank you, Senator Dole.
Senator Carper.
STATEMENT OF SENATOR THOMAS CARPER
Senator Carper. Thanks, Mr. Chairman.
To our first witnesses, Justice O'Connor, my former
colleague Speaker Gingrich, welcome. We are delighted that you
are here today, and thank you.
Thank you all for coming. Whether you are from Delaware or
the other 49 States, we are glad you are all here.
My colleague Ken Salazar talked about his dad. My mom, who
passed away about 3 years ago almost to the month from
Alzheimer's disease, was--that was a picture I will telegraph,
that her mom had had Alzheimer's disease. Her grandmother had
had Alzheimer's disease as well. So we knew this was coming.
Even at the end, though, when I would visit her, among the
things that we would do together, we would go to the chapel.
There is a wonderful place that she stayed in Kentucky close to
my sister and close to her younger sister, and we would read
the Bible. It was really interesting. My mother was a deeply
religious woman, and I would start off a Bible verse, and then
she would finish it. She was really good at this.
I would sing, like start off singing a hymn, and she would
finish it. Even near the end of her life, she was able to still
do those things and provide the kind of connection that I
hungered for and maybe she did as well.
Got a lot of people in Washington today. I think most of
them are in this room, as Senator Dole said. But already today,
I have met with families from Delaware. I have met with
students, groups of students from our State. I have met with a
bunch of educators that are here from our State, doctors that
are in town, and several lobbyists drifted by, and then all of
you, all of you.
I just want to say that the most effective lobbyists that I
have met here as a Senator, and as a Governor before that and
Congressman before that, the most effective lobbyists I have
ever met are the people from my State, from my own
constituents, people that I know, people who know me.
I would just say to all of you, there is huge competition
for these Federal research dollars. We doubled the NIH funding,
I think, between 1998 and 2002. President Clinton said we are
going to do it. President Bush in the first year or so of his
administration helped to complete that pledge. It has been flat
ever since. So much competition for Federal dollars.
I would just say you know the old saying, ``The squeaky
wheels get the grease?'' Well, sometimes they do. A lot of
times they do. I would just say that those of you that are here
leaning on us, the rest of us to--when there is some extra
money around, and we are facing a $400 billion budget deficit
this year. But when there is some extra money around and we can
wind down, for example, the cost of the wars that we are
fighting these days and as we come out of the recession, that
we make sure that some of those dollars are going to be
allocated for the research that we need.
The last thing I will say, and someone else mentioned this,
it is worth restating. For every hundred dollars or so that we
spend in helping to keep our parents, our grandparents, our
aunts and uncles in a nursing home and to take care of them the
last months, years of their life, we spend one dollar, one
dollar on research in trying to figure out how do we prevent
this disease and how do we cure that. The sooner we can wake up
to spend $2, $3, $4, $5 for the prevention and cure, we can
spend a lot less of those $100 bills.
We need your help. Not just Federal dollars. Pharmaceutical
companies spending money on this. The money that you and I
raise on these Alzheimer's walks, the memory walks, all of it
together will help us to get where we need to be.
Thank you very much.
The Chairman. Thank you, Senator Carper.
Senator Corker.
STATEMENT OF SENATOR BOB CORKER
Senator Corker. Mr. Chairman, thank you for holding this
hearing.
Out of respect for our distinguished witnesses, I will be
very brief, but I do want to thank all those who are here.
Like everybody in this room, we have all been touched. On
weekends in Tennessee, I visit my dad, who is strapped into a
wheelchair to keep from hurting himself, and I just appreciate
all of you bringing attention to this issue.
Thank you.
The Chairman. Thank you very much, Senator Corker.
We now turn to Senator Whitehouse.
STATEMENT OF SENATOR WHITEHOUSE
Senator Whitehouse. Thank you, Chairman Kohl and Ranking
Member Smith, for holding this hearing.
As we get closer and closer to the witnesses, the pressure
on the panel to be brief grows and grows. So I will simply
express my very great appreciation to Justice O'Connor for
coming forward to bring the enormous reservoir of respect and
affection that America holds for her to bear on this issue.
Speaker Gingrich, you have really distinguished yourself in
your post Speaker years as somebody who has kept very, very
much involved with these issues. Your co-chairmanship of the
Alzheimer's Study Group with our former colleague Bob Kerrey,
who I would like to recognize also, has really been a very
important contribution, and it is inspiring to see this
wonderful crowd.
So, thank you.
The Chairman. Thank you, Senator Whitehouse.
Senator Coleman.
STATEMENT OF SENATOR NORM COLEMAN
Senator Coleman. Thank you, Mr. Chairman.
I, too, shall be brief. Like my colleague Senator Corker, I
have been touched personally.
I am just going to quote Machiavelli. A lot of philosophy
is flawed, but he said this. ``From knowing afar off the evils
that are brewing are easily cured. But when for want of such
knowledge they are allowed to grow until everyone can recognize
them, then there is no longer any remedy to be found.''
Let us take his advice and let this be the beginning of a
national strategy to confront and cure this disease.
[Applause.]
The Chairman. Thank you, Senator Coleman.
The Senator from Arkansas.
STATEMENT OF SENATOR BLANCHE LINCOLN
Senator Lincoln. Thank you, Mr. Chairman.
It has all been said, but not everyone has said it. I, too,
will try to be brief.
I want to say a special thanks to our Chairman, who always
puts together incredibly thoughtful hearings. In the Aging
Committee, it is an issue that is critically important to me
and to my constituents in Arkansas, and I just want to thank
him as well as our Ranking Member, Senator Smith, who I have
worked with on the Older Americans Act and many of the things
that we have been able to accomplish together.
But these two gentlemen do a tremendous job on this Aging
Committee, where we bring forth so many different issues that
are affecting the aging community in this country. Of course,
all of us at some point will be aging. Without a doubt, those
of us who grew up in communities and families where taking care
of our aging family members was an honor and a privilege, it
was something that taught us more about love and family than
perhaps anything else that we may have learned in our lifetime.
I, too, like others, my dad was diagnosed with Alzheimer's
at an early age. My siblings, my mother, we cared for him with
a long journey of almost 10 years of suffering from
Alzheimer's. Early on, when it was something that was
undiagnosable, we had him in the trials, different types of
trials. But it was amazing not only to see him, but to see the
caregivers, the people surrounding him all of his life.
He and my mother were high school sweethearts, and she
never once gave up hope nor has she given up hope. She is still
hosting house parties in our small community where visiting
medical professionals come and talk to the community about the
need for research and the need for the dollars and the new and
exciting things that are coming out in research.
It has motivated me in many ways. The Chairman allowed us
to have a hearing last year on the coordination of care and how
important coordinating care for elderly, the elderly members of
our family is and how incredibly economical it is to our
medical dollars. But more importantly, how it is critically
important to those who suffer from dementia and Alzheimer's.
So there are so many different things that we are all
motivated by, but we are so grateful to be able to have this
opportunity. There is no doubt for us here at the dais, for us
to look out and see this crowd that is here, to understand the
passion, the love, the interest that is in this room of how we
find the kind of cures, the research that we need, how we need
to even further our investigation of caregiving and what it
does, what the needs are and what it does to our families, we
are very grateful.
We are enormously grateful to our distinguished panel here.
Justice O'Connor, thank you again for being here and all the
many things that you have done in your service to this great
country. Speaker Gingrich, thank you for your tremendous
service as well. We appreciate both of you.
So, thank you, Mr. Chairman, for once again bringing us
together in a remarkable way, as you always do in this
Committee. Thank you.
The Chairman. Thank you, Senator Lincoln.
So we turn now to our first panel. Our first witness on
this first panel will be Sandra Day O'Connor, our Nation's
first female Supreme Court Justice. Justice O'Connor served 24
years on the Court. In 2007, she was nominated to serve on the
Alzheimer's Study Group, a task force of national leaders
charged with creating a strategic plan to address the growing
Alzheimer's crisis.
She is currently the chancellor of the College of William
and Mary. She also serves on the Board of Trustees of the
National Constitution Center in Philadelphia.
Following her testimony, we will hear from Newt Gingrich.
During his 20 years in Congress, Speaker Gingrich demonstrated
his commitment to improving the American healthcare system, co-
chairing the Republican Task Force on Health for 4 years prior
to becoming Speaker of the House of Representatives.
Since retiring from Congress in 1999, Mr. Gingrich has
continued to focus on healthcare issues. He co-chairs the
National Commission for Quality Long-Term Care, and he is also
a member of the Alzheimer's Study Group.
Justice O'Connor.
STATEMENT OF HONORABLE SANDRA DAY O'CONNOR, FORMER SUPREME
COURT JUSTICE, MEMBER OF THE ALZHEIMER'S STUDY GROUP,
WASHINGTON, DC
Justice O'Connor. Mr. Chairman, thank you for--and all the
members of the Committee, thank you so much for having the
hearing and for inviting us to share a few minutes with you
this morning.
I think the members of this Committee are probably more
knowledgeable than any of us about this disease. You have
exhibited from your statements already a depth of knowledge and
understanding about the problem that tells me you are not going
to learn anything new from us today.
But Speaker Gingrich and I are both serving on this study
group, which we hope within the span of a year to be able to
come back with some recommendations. I am sure that as members
of the Committee interested in it, you will have heard many of
the recommendations already, but perhaps we can shed some
further light on it.
But I am here in the position of being a caregiver. My
beloved husband, John, suffers from Alzheimer's. He has had it
for a long time now. He is not in very good shape at present.
So, I have some appreciation for the depth of feeling that
you have that has generated the interest and the people who are
in this room today. Do magnify that by people in every State of
this country, and you will understand the depth of concern that
is out there.
This is a really difficult disease because it has no cure
as yet. You have done work by funding research in this area and
by considering some laws, I congratulate you on the one you
just passed to enable people to get an early diagnosis and not
thereby forfeit the right to get long-term care insurance. That
is really important. I congratulate you on addressing that
problem and doing something about it. That should help.
My own sons have not wanted to go be tested, even though,
obviously, with their father in the condition he is, they
should know. But out of the fear that they would then be
ineligible for insurance they have not done so. So you have
done a wonderful thing in getting that legislation passed.
Researchers really haven't clearly determined yet why some
of us get Alzheimer's and others do not. We don't totally
understand the biological processes that cause these
devastating effects, but researchers are closer today than ever
before in developing some proposed drug treatments that might
dissolve the amyloid plaque in the brain. But that is going to
require serious clinical testing. If you are going to dissolve
something in the brain, you want to be sure it isn't the brain
itself.
So that is why the studies are lengthy, to make it
something that we can trust to use. But if you can just shave
off by 5 years the onset of Alzheimer's, broadly speaking,
think of the money you would save nationally on healthcare. I
mean, it is just incredible. So everything you are doing is
worth the effort. It does take a staggering toll on the
families and the caregivers. I can certainly attest to that.
Now I don't know what the official thinking is on the
expansion of Alzheimer's in the future, but the doctors who
take care of my husband tell me that one in two people over 80
are going to have Alzheimer's. Now I am getting pretty close to
80. So that gets my attention. I think a lot of people will be
concerned when they look at it from that standpoint.
What we have to ask is whether this rapid growth is
inevitable. I think it is not if we can fund the research and
encourage it and enable testing to be done and get clinical
trials coordinated and broadly based so that maybe they don't
have to go on forever. We might even encourage drug companies
to do more if they thought that they could somehow extend the
life of the patent.
I mean, it could take 15 years to do the testing. If the
patent life is 17 years, you are not going to have a lot of
encouragement there for this kind of thing. So I think the
Committee has a need for considering coordinated approaches to
what we need to do because this is a problem that cries out for
help, and we do need additional research.
We need to continue to teach people how to care for
Alzheimer's patients. It is better if they can stay home, but
they reach a point where often they can't. Daycare is helpful
at earlier stages of the Alzheimer's patient, very helpful. So,
how can we do that?
I think that our Nation is certainly ready to get deadly
serious about this deadly disease, and I think that your
approach here in the Committee and in Congress encourages me to
think that you are quite well informed and quite interested in
doing something about it.
I think we have to expand the research efforts, and we have
to encourage the sharing of research data across the country
with those who can help further this process. I hope that we
can encourage the private investment that it is going to take
to make drugs, treatment drugs in this area widely available to
the public. We certainly need to encourage the support systems
that we have for the families and the patients themselves.
I just thank you for focusing on this and for sharing with
each other and with everyone in this room your own personal
experiences with it. They are heart-rending, as everybody in
this room can tell you.
Thanks.
[The prepared statement of Justice O'Connor follows:]
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The Chairman. Thank you very much, Justice O'Connor.
[Applause.]
Speaker Gingrich.
STATEMENT OF HONORABLE NEWT GINGRICH, FORMER SPEAKER OF THE
HOUSE OF REPRESENTATIVES, MEMBER OF THE ALZHEIMER'S STUDY
GROUP, WASHINGTON, DC
Mr. Gingrich. I am going to say, first of all, it is a
little intimidating to follow Justice O'Connor, who I think
communicated powerfully the emotional and moral case.
I do want to thank Senator Kohl and Senator Smith for
hosting this and allowing us to come here.
I have submitted testimony for the record and ask that it
be accepted as such. I would like to summarize.
I also want to thank Senator Collins, who, along with
Senator Mikulski, Burr, and Clinton, helped us launch the
Alzheimer's Study Group, when Senator Kerrey and I were up here
about 8 months ago.
I feel very honored--Senator Kerrey and I had co-chaired a
Quality of Long-Term Care Commission for about 3 years, and it
became obvious that if you are really going to deal with long-
term care in America, you had to focus intensely on
Alzheimer's. It meant a great deal to us to have Justice
O'Connor join us in the Alzheimer's Study Group.
Just briefly let me list Dr. Christine Cassel, the
geriatrician and president of the American Board of Internal
Medicine. Meryl Comer, who is president of the Geoffrey Beene
Foundation Alzheimer's Initiative and who herself is a
remarkably powerful witness to being a family member coping
with Alzheimer's, and she is here today.
Dr. Steve Hyman, the provost at Harvard. Henry McCance, who
is chairman of Greylock Partners. Dr. Mark McClellan, who is
the director of the Engelberg Center for Healthcare Reform at
the Brookings Institution, was the head of the FDA and the head
of the Center for Medicare and Medicaid Services.
James Runde, who is special advisor to Morgan Stanley. Dr.
David Satcher at Morehouse Medical School, who was the head of
the Centers for Disease Control and the former Surgeon General
of the U.S., and Dr. Harold Varmus of Sloan-Kettering, who is
the former head of NIH, form the Alzheimer's Study Group.
So we have tried to assemble a team that really brings a
unique level of expertise, and I am going to try to broadly
represent their thinking and add a few points in my summary.
I also want to thank the Alzheimer's Association
leadership. Their 2008 Alzheimer's Disease Facts and Figures is
as useful an introduction to this and as authoritative as there
is in the country, and they do an extraordinary job of pulling
together people who have a deep concern about Alzheimer's.
I want to thank George Vradenburg, who has been
particularly helpful in coaching Rob Egge, who is the staff
director of the Alzheimer's Study Group, and myself in working
on this.
You have already mentioned the impact of Alzheimer's again
and again, and I recommend to all of you, if you have a chance,
to see Meryl Comer's video, which is very powerful. My sister-
in-law's mother currently has Alzheimer's. I think a number of
you, as well as Justice O'Connor, have outlined the personal
human challenge and the pain for the family.
Many years ago, I called Nancy Reagan one evening, and she
said it is such a cruel disease because you are dealing with a
person who in every way looks like the person you used to know
and yet in so many ways they have changed. I think that
captured the sense of cruelty and difficulty.
Yet there is enormous hope for a better future, and the
Alzheimer's Study Group has established five areas--it is in
the testimony--encouraging collaboration among researchers,
improving Alzheimer's clinical trials, rapid learning from
large electronic health datasets, integrating a community-based
care model, and providing better information to policymakers.
I think if we look at the possibilities, I want to start
with a broad generalization. I would really encourage the
entire Congress and the executive branch to take this much more
seriously than we do. We are going to have four to seven times
as much new science in the next quarter century as we had in
the last quarter century. Sixty-five percent of it will come
from outside the United States.
No one on the planet understands how you cope with this
flood of new information. Research on the brain will be one of
the most extraordinary areas of explosive new knowledge because
it is the most complex area of science, and we have only had
really decent technologies for the last 15 years. Almost all of
them, by the way, came out of the National Science Foundation
investment, not the National Institutes of Health.
It is physics and math, which is the underlying base of the
tools, which allow researchers into the brain to acquire real-
time data about living brains. So, it is very important to
understand that a truly basic research strategy has to involve
the National Science Foundation as well as the National
Institutes of Health.
If you take seriously what I just said, and I would be glad
to answer the question of how we got to the four to seven
number, it is inconceivable that we know today as policymakers
what is possible. If we get four times as much new science,
then trying to think out to 2033, which is not very far away if
you are thinking about something like Alzheimer's--I mean, you
look around this room and look at the number of people who are
likely to be alive in 2033 and look at the number who are
likely to be entering precisely the age that Justice O'Connor
talked about. All of a sudden, this gets to be very personal
for most of the people in this room.
But if you are looking out to 2033 and we get four times as
much new science, you are the equivalent of a Senate committee
in 1880 trying to understand today. 1880 is pre-automobile,
pre-airplane, pre-radio, pre-motion picture, pre-long distance
telephone, pre-electric light. I mean, how would you explain to
a Senate committee of 1880 how you got to work this week or how
you go back home to your State or how you stay in touch or the
BlackBerry in your pocket or the cell phone with a camera?
Yet no one tries to say if we could have breakthroughs on
that scale, what is our investment strategy? If I had one
really powerful thing I would like to get you to focus on it is
to take head on the Office of Management and Budget,
Congressional Budget Office design.
I was startled. About 4 years ago, I was trying to
understand what we were doing wrong in the global war on terror
and on Iraq. I met with Fred Smith of FedEx to talk about our
lack of metrics and our lack of ability to manage large
systems.
At one point in our breakfast, he said Government cannot
distinguish between investment and cost. Therefore, Government
could never tolerate in building FedEx or UPS because you could
never explain why the wireless and the laptop are so central.
Now I will say to you as an aside, as an illustration, if I
might? The recent decisions by the Census Bureau are so out of
touch with modern reality they verge on insanity, and yet
nobody is standing up and saying, ``Let me get this straight.
In the age of eBay, YouTube, Facebook, MySpace, Google, we are
going to hire 600,000 temporary workers to do a paper and
pencil census in 2010? '' Which would be grounds, I would
argue, for replacing the entire department and just saying
anybody dumb enough to believe in this is so out of touch.
But let me suggest to you, when you look at Alzheimer's, we
have current projections of a $1.2 trillion in Federal spending
for the baby boom generation, matched by a $1.2 trillion in
personal spending. Now if you instructed the Congressional
Budget Office to design a generational investment strategy
because you know what is going to happen, we are going to run
out of money. We are going to nickel and dime truly stupid
things to try to save money in Medicare and Medicaid. When if
you started right now and had an investment strategy, you might
postpone Alzheimer's by 5 years. If you postpone Alzheimer's by
5 years, you save half that money, $600 billion.
Now if you go to say what is the time value of money, and
could we set up a brand new--an amendment to the Budget Act for
an investment strategy that is fundamentally off budget, but
manageable and defined and that counts against future savings?
This applies to many diseases, but in particular, since we are
here today talking about Alzheimer's, it applies massively to
Alzheimer's.
Now let me carry it a stage further. We have to look at,
first of all, how do you accelerate basic research in the world
I am describing? I think that means--and I say this having
helped double the NIH budget while we were balancing the
budget. So when people tell me we don't have enough money, we
have about $3 trillion. It is a question of priorities. I would
argue passionately NIH should grow at 7 percent a year in
constant dollars. That is about the amount you need annually in
order to sustain the momentum of research.
Second, I would triple the NSF as rapidly as possible. The
biggest single mistake I made as Speaker was not tripling the
National Science Foundation, which was a much smaller
institution, while doubling the NIH. As a result, we are not
getting the investment in math, physics, and chemistry we need
and in basic nonhuman biology, all of which are central to our
future.
I would also insist that Government research have a
substantial information technology investment, and I would
insist on fundamental set-asides for young researchers. We are
moving into a cycle right now where we are over investing in
old senior researchers who have great prestige, but no new
ideas. This will get me in a lot of trouble with NIH.
[Laughter.]
But the truth is--the truth is in an age of radical
scientific change, you want to consciously allocate a fair
amount of money to people under 40. You don't want anyone to
have to spend half their lifetime working as an apprentice to
somebody who is wrong. Again, just read Kuhn's ``The Structure
of Scientific Revolutions,'' and you will get some sense of the
scale of change that I am describing.
We also want to focus on translating basic research into
applied research. I think that means make the R&D tax credit
permanent. I think this will be fairly controversial. I think
you should review the ethics rules to make sure we have not
created such solid firewalls at NIH that we, in fact, inhibit
the flow of knowledge back and forth.
The great engines of translating research into productive
use are the private sector engines. If we build walls that are
too strong, we, in fact, inhibit the transfer of knowledge in a
way that is very, very dangerous in the long run.
How do we accelerate translating applied research into
usable medications? I think that requires FDA reform. I think
that--and particularly in the area of brain science because a
lot of the rules that make perfect sense if you are looking at
a normal physical behavior, cancer or whatever, don't make
sense when you are dealing with the brain. I think that you
need a fundamental rethinking of how the FDA deals with
research and breakthrough in the brain.
How do we get the new breakthroughs used on a daily basis?
Remember that, excuse me, the National Institute of Medicine
points out that it takes up to 17 years to adopt a new best
practice. I would encourage the National Library of Medicine to
help create an electronic Internet-based, real-time 24/7
learning system for doctors and recognize that the continuing
medical education has to be permanent. It has to permeate the
system, and it has to be real time.
I would look at very fundamental investment at the National
Library of Medicine to develop that kind of capability because
you want to get the newest breakthrough to your mother's doctor
this week, not in 17 years.
I think you have to encourage the pharmaceutical investment
in brain science and in the whole range of brain diseases. I
would strongly encourage you to amend the Orphan Drug Act to
include all brain research as an orphan drug activity. That
would begin--because this is a zone that is very complicated
and very hard, and as a result, pharmaceutical companies aren't
going to invest in it.
If you want to maximize the private sector investment, you
want to maximize the possibility of real return. If all of the
work done on Alzheimer's and on Parkinson's and other brain
conditions was treated as an orphan drug for patent purposes,
you would dramatically explode the amount of money being spent.
Now I understand the countervailing argument, which is that
means you have the drug on patent longer. But let me just
suggest to you having the drug is precedent to being able to
get it to be generic. If nobody is going to do the research to
ever develop the drug, you are never going to get to the
generic.
I would rather spend a few extra years on patent and
actually have the drug to save lives than have it explained to
me why we blocked them from having it on patent because that
taught them, but, by the way, the drug doesn't exist. It is a
very fundamental policy question about how we accelerate
private sector investment in this kind of an area.
I would also suggest to you three final very large changes.
The first I have already mentioned. If you can move to an
investment strategy on a generational basis, you can justify a
dramatic increase in investment in these areas, and you will,
over a decade to 15 years, get an amazing level of payout that
will save the budget an extraordinary amount of money.
Second, you should create a public/private partnership for
developing the use of electronic health data. We have over 40
million electronic health records today. They can be used on a
depersonalized, anonymous basis with all HIPAA protections that
are necessary. But do not bury this at NIH.
This is the kind of thing where you all ought to have a
hearing, and you ought to bring in the head of eBay and the
head of Google and the head of YouTube and the head of Facebook
and people of that caliber and say to them, what would a
public/private partnership look like that allowed us to use the
best of IT to create an electronic epidemiology that allowed us
to track millions of data points in real time in a way that we
have--?
Remember, the Framingham study is a very small number of
people, and yet it is the most famous single cardiology study
ever done. We have literally at the Veterans Administration, at
Kaiser Permanente, and at a dozen other facilities, we now have
enough medical records over enough years that if we had a
serious investment in electronic epidemiology, we would have an
extraordinary amount of new knowledge about what works, what
doesn't work, what are the various patterns. Nobody has
seriously explored this yet.
None of the research systems are using the potential we
have, but I would consciously not allow that to be purely an
NIH function.
Last, with as much money as Alzheimer's is going to cost in
as many different places, I would really urge you to create a
White House coordinator who has reach across the entire Federal
Government. It is an absurdity to have all the different
pockets of funding--well, the same thing would apply to
diabetes and one or two other large disease centers.
We have these huge, very expensive--these are things that
cost more than any department in the Federal Government, except
HHS and Defense. Yet they are totally uncoordinated, and there
is no capacity to bring people together and force them to talk
to each other and try to get these things done in a way that
makes sense.
I would really look at a matrix management model for this
kind of thing and try to have a coordinator who had reach into
every aspect of Federal spending on this kind of area. So you
could begin to think about what are the five problems I most
wish I could solve this year, and where can I make the
investment to solve them? That is today not done anywhere in
the Federal Government in an effective way.
Anyway, I appreciate you giving us this kind of
opportunity. I hope that between us, with the power and the
prestige that Justice O'Connor can bring and with the work that
the Alzheimer's Study Group is doing, I hope that we can work
with you over the next few years and truly make dramatic
breakthroughs in enabling America to have a dramatically better
future in the area of Alzheimer's.
[The prepared statement of Mr. Gingrich follows:]
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The Chairman. Thank you very much. [Applause.]
Thank you very much, Speaker Gingrich.
We will turn to the panel now for questions. Senator Smith?
Senator Smith. Justice O'Connor, many of us have watched
the dignity with which you have dealt with your great husband,
and obviously, now he is receiving care in an institution. I am
wondering if during that process if you found any help, Federal
programs, or support system there to lighten your burden or----
Justice O'Connor. Yes, a little bit. Senator Smith, we have
switched John over to something called Evercare for the medical
advice in the care center where he is, and it works quite well.
I don't know how many of you have had any exposure to that.
But I have been pleasantly surprised, frankly, with the
coordination of the advice and care that he is given and right
in the center. He doesn't have to be hauled out to a specialist
hither and yon. They have a coordinated medical program that
comes to him, and it is helpful.
Senator Smith. Is Evercare generally available?
Justice O'Connor. Yes, it is, and your staff can provide
you information about it. I have been pleasantly surprised.
Senator Smith. That is great news.
Speaker Gingrich, you gave us just a wealth of great ideas,
and you asked us to prioritize the long list that you gave us.
What would be one, two, and three that we ought to do?
Mr. Gingrich. Let me say, first of all, I think that
Evercare is a United Health product and is actually--has a
remarkable record of improving lives, improving satisfaction,
and lowering costs and is an example of the kind of
breakthrough that the Center for Medicare and Medicaid Services
should be routinely using to modernize the system across the
whole system.
If I were prioritizing, the number-one thing I would do is
change the way we get--the budgets work. The current budget
process is insane. I use that word deliberately. I mean, I have
had a long--as you know, a long experience up here. I am tired
of being told we have to do things that are really stupid
because we have always been stupid, and therefore, you
literally don't sound appropriate if you are not stupid.
Senator Smith. I have to admit, at 2 a.m., when we are
voting on the budget, it really does seem stupid. But--
[Laughter.]
Mr. Gingrich. Well, you are forced in with the rules that
are set up in black boxes that nobody holds accountable, and
the Congressional Budget Office and the Office of Management
and Budget force you into decisions that are irrational. So, if
I were tackling one thing, I would tackle that first.
If I were tackling a second thing, it would be developing
the ability to use the electronic databases because the amount
we are going to learn when you start tracking 30, 40, 50
million people over 5 and 10 years and you begin to see various
and sundry cross indicators we have never seen.
The third thing I would look at, I think, is this idea of a
coordinator at the Federal level. The morning there is a
coordinator who makes an annual report on Alzheimer's and who
can actually list all the different Federal activities, you
will be startled how much you have on the table and how much
you have at risk in not dealing effectively with this disease.
Senator Smith. Thank you, Mr. Speaker.
The Chairman. Thank you, Senator Smith.
Senator Wyden.
Senator Wyden. Thank you, Mr. Chairman.
Thank you, thank you both for an inspiring morning. Justice
O'Connor, you speak for so many Americans who are trying to
assist a relative, and we are just very grateful for your
leadership.
Speaker Gingrich, let us go to the financing question,
something you and I have talked about in the past because this,
of course, has been the biggest challenge with respect to long-
term care. The bills are crushing for the families. We haven't
had sufficient private long-term care insurance. People fall
between the cracks in terms of public services.
I want to ask this question this way. In the Healthy
Americans Act, which is a bipartisan bill, the first bipartisan
universal coverage bill we have had in the Senate, Senator
Bennett and I make a special focus on the tax code, where we
have between $200 billion and $300 billion go out the door in a
way that disproportionately favors the most affluent and also
rewards inefficiency. So we used that money to start making a
transition to a more sensible, market-oriented approach in
healthcare.
Are there any similar sources of funds that you could
identify that we would zero in on and say this is a place where
we can get more for our money and start moving it into the
kinds of things that you and Justice O'Connor have spoken so
eloquently about, particularly prevention and treatment?
That is what we did in terms of jump-starting the debate
about universal coverage. How do we jump-start this question of
funding the new investment strategy that I think you are spot
on in calling for?
Mr. Gingrich. In the Quality of Long-Term Care Commission
that Senator Kerrey and I had chaired prior to the Alzheimer's
Study Group, we looked at a number of long-term financing
concerns because we have never seen, ever in history, a
population that is going to live as long as people are going to
start living.
A girl born in Japan last year on average will live to be
88. That means half of them will live to be over 88. I mean, no
society in history has tried to deal with this.
As a totally different topic, I would be glad to come up
and talk about it some day because it has all sorts of
implications for Social Security, for retirement, for pension
plans. I mean, we have to become a society with massively
greater savings during our working years and probably with
longer working years if we are going to be able--if we are
going to have people who live to be 100, 110, and 120 who have
a comfortable lifestyle.
My personal bias strongly favors a tax credit for quality
long-term care, and I would even contemplate a tax credit that
was, in effect, a part of what everybody did, almost like FICA,
starting when you first went to work because I think we have
got to find a way to quantify, buildup resources over a
generation. So the generation starts taking care of itself.
I don't think you can have an intergenerational transfer
system when you have a slowdown in population growth and people
living 30, 40 years longer than they expected to. In 1900, the
average age was 46. The average person lived to be 46 years
old. So 100 years later, we have now added some 32 years to
that lifespan. Nobody has ever tried to cope with this scale of
change, and we are going to have to.
I will make a little bit of trouble and just say I have
been astounded that the Congress has not taken seriously
honesty in healthcare. The example I will cite for you is the
New York Times did a four-part series 2 years ago on Medicaid
in New York, where their estimate was that Medicaid in New York
had 10 percent pure fraud. Not waste and abuse, not bad
judgment--pure fraud. Crooks. People who were deliberately
stealing. That is $4.4 billion a year in New York State alone.
HIV-AIDS transfusion in south Florida in three counties is
clearly a stunning racket. There was one raid where the State
and Federal Government collaborated. They closed down 17
infusion centers, five of which were pizza parlors. There is--
my guess is that you have something like 10 percent of all
Medicaid spending in the U.S. is fraud.
If I were looking for cash that would not cost the
taxpayer, I would take seriously the New York Times study and
just ask the question under what circumstance could you get
that down to being, say, a 1 percent fraud rate. But that is a
lot of money. I mean, 10 percent of all Medicaid begins to be a
transferable amount of cash.
Senator Wyden. Thank you.
The Chairman. Thank you very much, Senator Wyden.
Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Thank you both for your excellent testimony.
Speaker Gingrich, when you were talking about the scoring
that is done by CBO, I just could not help but think what a
penny wise, pound foolish approach that we have. We know that
in the long term these investments will save billions and
billions of dollars. Yet when CBO does its scoring, it does its
estimates as if nothing changes, as if human behavior does not
change, as if the investment produces no results. I do think
that that is something we need to change.
You brought up an issue today that most of us don't think
about when we are thinking about Alzheimer's, and that is the
National Science Foundation budget. Our approach, our focus has
been on NIH. Could you talk a little bit more about why we
should triple, as you recommended, the NSF's budget if we are
serious about breakthroughs in Alzheimer's? Because I think
that is not where we have traditionally focused our efforts.
Mr. Gingrich. Brain science is particularly dependent on
nonbiological knowledge. If you are going to--the ability to
scan the brain while it is actually functioning is a direct
function of physics and mathematics. The more breakthroughs you
can make in getting very sophisticated models, the better off
you are.
The human brain has about as many neurons as there are
stars in the universe. That implies a level of complexity that
is unimaginable. Thinking through and dealing with that
complexity involves an extraordinary amount of mathematics,
which is an area you don't think of this as being part of the
National Institutes of Health. Yet if you looked at the
technology we use today, and you went back and said when was it
developed and when did we understand the physics of that, most
of that is done at the National Science Foundation.
The other area of breakthrough that I recommend highly is
looking at nanoscale science and technology. Which is basically
just very small, but the essence of it is down at the level of
one atom or smaller than an atom. We don't fully understand--in
fact, we don't understand much of anything about how it works,
but we are very good at measuring what works.
Almost all the nanoscale breakthroughs originally were
funded by either the Defense Advanced Research Projects Agency
or by the National Institute for Standards, NIST, or by the
National Science Foundation. Yet if we can get down to a point
where we understand how one molecule works and how that relates
to the development of plaque, if we can understand how one
synapse is occurring and we can measure it in real time, we
suddenly can start laying out an understanding, which I think
affects, by the way, not just Alzheimer's, but it affects
Parkinson's. It affects mental health.
It affects our learning--my guess is learning strategies 20
years from now will be totally different than the way we
currently teach people, and it will all come out of this zone
of brain science, which I think will be the most rapidly
evolving area in science. I think that it will drive--much of
its tools and many of its most powerful concepts will come out
of National Science Foundation funding.
I am not anti-NIH, but I am saying I think we have really
underestimated the importance of math, physics, and chemistry
as the underpinnings of what we do at NIH.
Senator Collins. Thank you.
The Chairman. Thank you, Senator Collins.
Senator Whitehouse.
Senator Whitehouse. I am interested, Speaker Gingrich, in
your testimony about the results to be gained from coordination
and electronic assembly, if you will, of the information that
we already have on hand and the conclusions one can draw from
it a la the famous Framingham study. Could you speak a little
bit further about that? If you could, put Americans' concerns
about the privacy of that data into context because that is an
immediate concern of people who discuss this.
Mr. Gingrich. Well, if you are going to look at the
discovery of certain drugs recently which had unexpected side
effects. Kaiser Permanente has had a significant role in
discovering those because it has an electronic database, and so
it can pick up pretty rapidly that there have been eight or
nine bad outcomes scattered across the whole country. When you
correlate them, they all turn out to be a person of a certain
age using a certain drug. So, Vioxx, for example, was surfaced,
in part, by correlating electronic data.
Now, as long as you depersonalize the data so I don't know
who it is, and I am looking at a dataset of in the case of
Kaiser 13 million and the case of the Veterans Administration
about 21 million, in the case of Mayo it would be a couple of
million plus, I am looking at aggregated data that I can't
track down who you are, but you have become part of set of
information. I suspect most Americans would actually be glad to
know that that kind of analysis was underway, and it has
clearly saved lives in the recent past.
But nobody has--we don't invest today. We don't have a
discipline of electronic epidemiology, where people are going
out and developing large-scale studies and saying if I massage
all this data, what do I discover about the interaction between
diet, medicine, exercise, age, geography?
The other example which we will be developing this year, by
the way, is that Gallup, working with Healthways, is now
building the largest dataset in history on attitude about
health. They are actually measuring 1,000 samples a day, 365
days a year. So, by the end of this year, they will have about
365,000 samples in which they are going out and asking people a
whole range of health questions in order to begin to define
which communities in America are healthiest and why and which
communities in America have substantial health problems and
why.
My guess is that 3 years from now, if you would take the
electronic health records datasets and the Gallup Healthways
dataset and match them, you would be startled at how many new
public policy indicators we would have that literally do not
exist today.
Senator Whitehouse. I thank you.
Mr. Chairman, we had a wonderful meeting--hearing, I guess
you would call it--a few years ago in Rhode Island on the
general subject of electronic health records when Speaker
Gingrich came, twinned with our wonderful Rhode Island State
representative Patrick Kennedy in one of the more unlikely
political strange bedfellows pairings that I have ever been
privileged to witness.
But it demonstrates that this question of electronic health
records and the information and savings that can be gleaned
from them truly is a bipartisan issue. It is not right versus
left. It is right versus wrong, or I think, as Speaker Gingrich
has indicted, smart versus stupid. We have been on the wrong
side of that for too long, and I appreciate his testimony.
The Chairman. Thank you, Senator Whitehouse.
Senator Dole.
Senator Dole. Thank you, Mr. Chairman.
Speaker Gingrich, you submitted for the record long-term
care financing. Would you elaborate on how the Alzheimer's
Study Group plans to include suggestions for policymakers to
address long-term care? Could you just give us a summary of
what you think will be forthcoming?
Mr. Gingrich. Yes, I think actually the Alzheimer's Study
Group probably will not get too involved directly with that,
except on the area of the community-based care model, where we
do think we have to have innovative approaches to support
patients and families. Because it--as you can tell from the
list I read earlier, this is a very prestigious group of
people.
Senator Dole. Yes.
Mr. Gingrich. I am not going to get in trouble by
prejudging what they are going to submit. But I can promise
this Committee that as soon as we have developed these ideas,
we will submit them directly to the Committee for your
knowledge. But as you know, I am very seldom timid. In this
case, I am unwilling to get very far ahead of the group because
these are all powerful people, and they will get real mad at
me.
Senator Dole. Well, I think that might apply to my next
question, which was in my State there is a respite group called
Project C.A.R.E. That is Caregiver Alternatives to Running on
Empty. They receive Federal funding, and I was interested in
what the study group might be finding to be most valuable to
the caregivers on a daily basis?
Mr. Gingrich. Let me just say as you are trying to develop
this, and I am speaking now for myself and not for the group.
If you start with the idea, as Justice O'Connor said--and she
may want to add to this--to the degree that we can make it
easier and more affordable for families to care for people as
long as possible, it is more humane. It is more desirable, and
it is less expensive.
So if you were to erase the current system and say what
would a system look like that maximized your ability? I think
two of the things you would do is you would shift the financing
to find ways to subsidize families who are prepared and willing
to do this and to take on this great challenge.
The second thing is you would have a significant part of
either NIH or the Center for Medicare and Medicaid Services
actually trying to work in a collaborative way with the private
sector to develop the technologies. One of the points that
Meryl Comer makes is if it is your husband and they are larger
than you, then just the single act of getting them back into
bed is an enormous challenge.
Well, there are technologies that should be designable to
modify homes to enable you to take care of that kind of a
challenge, and all of that modification ought to be a tax
credit because enabling them to stay for an extra year or 2
years will more than pay in avoidance of long-term care
facility costs to help them.
So I think if your staff were trying--and we would be glad
at the Center for Alzheimer's Information to work with you on
this. But if you were to start from what is the ideal care that
should be happening, and how could we finance and structure and
how could we help invent the technology for that? Then,
frankly, you want that technology to become commercializable--
--
Senator Dole. Right.
Mr. Gingrich [continuing]. In a form where it is sold in
retail stores at the lowest possible cost in a competitive
environment. So I think that is how you want to design it. Then
look at the current system, which is a fundamentally different
system, and I also think, frankly, that a family based model
has much less fraud and much less inappropriate use of
resources than the institutionalized model.
Senator Dole. Thank you very much, Mr. Chairman.
The Chairman. Thank you, Senator Dole.
Senator Salazar.
Senator Salazar. Thank you very much, Chairman Kohl.
Let me ask a question to both Justice O'Connor and Speaker
Gingrich, and that is if we look at the interim time period
between now and the long-term finding of the cure. Some of the
things we have talked about, that you have talked about in your
testimony will require the kind of investment strategy that
Speaker Gingrich spoke about, the kind of development and use
of electronic records and the like to understand the disease.
But in the interim, say, the next 10 years, are there
things that you think we ought to be focused on in terms of
diagnosis, in terms of caregiving to those who are afflicted by
the disease now? What are those steps, those things that we
ought to be doing at the national level here that deal with the
immediacy of those affected by the problem in the next 10 years
or so?
Justice O'Connor and then Speaker Gingrich?
Justice O'Connor. As far as I am concerned, I think we can
hope for rather immediate response to the need to make the
research more effective and to make it more likely that we can
complete clinical trials on promising new approaches and do it
quickly. Because as we pointed out, the returns are enormous if
you can cut back by even 5 years the time that you are going to
have to be totally incompetent as a person with Alzheimer's.
If you can reduce that by 5 years, you have made enormous
gains, and we are on the threshold of that now. But we have to
make the clinical trials broad based and more rapidly
accomplished, and we have to provide the funding that will
enable--I guess I learned something today. The National Science
Foundation and NIH in a position to provide help right now for
these things, not 20 years from now--now. Because we can save a
great deal of Federal money if we just reduce the time that
somebody has to be----
Senator Salazar. Let me sharpen my question, if I may, just
a little bit. I understand the importance of doing that and
those kind of investments. But there are, I think, among many
Americans who have family afflicted by these diseases even the
lack of understanding when they see a family member who is
showing the symptoms of this kind of disease or for family
members knowing what all their options are out there.
Today's effort, I think, is putting a big spotlight on this
issue, and it is very important that we do that. But there are
some interim steps, it seems to me, before we ultimately get to
the results of our clinical trials, before we do whatever we
can do with pharmaceuticals, before we look at major reforms in
how we deliver healthcare to--in a long-term care setting.
Those things are going to take time.
Are there things we could do immediately to help those
afflicted by Alzheimer's and families today that would be
something we could do for next year and the following year?
Justice O'Connor. Probably in the area of tax credits. For
certain things, you could act very quickly.
Senator Salazar. So things like tax credits for family
caregivers and the concept that Speaker Gingrich was speaking
about previously.
Speaker.
Mr. Gingrich. If I can add to that, and I think it is a
very good question, and I hope I can be clear enough. First of
all, to pick up on what Justice O'Connor just said, I think
this idea of changing the resource flow.
If you were to bring in, and I think your staff could
actually help structure this, and it is not necessarily
something you do at a hearing. But if you were to work with,
say, the Alzheimer's Association and develop a series of where
you looked family by family. What happens from the time--and
again, some of you have had this experience in your own family.
But what happens from the time you first learn about this
diagnosis? What is the progression?
We need to build an anticipatory medical model where when
it is something that we know is happening, we can get ahead of
it. So, we can say, gosh, this means if you want to stay in
your home, you probably need to think right now about refitting
your home. OK? That should be a deductible expense or a tax
credit, and you all ought to decide.
But my guess is, again, if you could win the scoring
argument and you could say to the Congressional Budget Office,
OK, if I can get people to be for every month they don't go to
a long-term care facility, what could I afford to help their
family with financially? You could almost immediately craft a
tax policy that would be budget neutral or actually would be
better for the budget.
Second, to the best of my knowledge, there is no place
today where people can turn--and again, I think the Alzheimer's
Association probably comes close to this. But there is no real
place--we need a multilingual audio/video online capability to
learn this stuff. As you know, it has got to be multilingual
because it is not just about our language, but it is also about
our cultural subsets because different groups learn different
things in different ways, and they ask different questions.
People have got, we have got to find ways to get
information out much faster and much more pervasively than we
get it out today, and that means that it has to be Internet-
based and iPod-based and cell phone-based. For the very poor,
the cell phones actually are a very powerful medium of
communication.
Third, you really want to have someplace working to
popularize and commercialize technology. My guess is that the
best technology for helping people care for people with
Alzheimer's is stunningly better than the average technology,
and the average technology is a lot better than what people who
don't know anything are currently doing.
So, if you could accelerate--and places like the MIT aging
lab are perfect examples of this. If you could accelerate the
development--I, frankly, got this idea from the head of the MIT
aging lab, who said to me one day, when these things are
products and they are on the shelf at Wal-Mart and Costco and
other facilities, then you have changed the world. As long as
these things remain out here as professional things that you
get only through a specialized company, you will never bring
the price down, and you will never have this scale access.
Well, you have a marketplace of 6 million people and their
families today. It is going to be a much bigger marketplace in
10 years. How do we get that marketplace to have access to the
best technologies at the lowest cost so it becomes commonplace
to have best care?
Last point I guess I would make because I do want to push
back a little bit on one of your assumptions, and here I think
that Justice O'Connor and I are absolutely in agreement. Even
just making the breakthroughs on the next quality of medicine,
making the breakthrough on marginal improvements and getting it
to every doctor is, in fact, an enormous blessing to the person
who is in the middle of this.
I wouldn't undervalue that in the next 5 years we could
have very substantial improvement in protocols and in medicines
available in Alzheimer's, and that it is both a long-term
breakthrough to get to the equivalent of a vaccine. It wouldn't
be technically a vaccine, but to get to the equivalent of
something that postpones it dramatically. But in the interim,
there are a lot of steps that are more than palliative that
make life dramatically better.
I think at a human level, we should not underestimate how
do we accelerate the FDA, how do we accelerate the drug
companies, and how do we accelerate the doctor learning about
what is available as rapidly as it becomes available? All of
these things will improve the quality of life now for people
rather than 10 years from now.
Senator Salazar. Thank you.
The Chairman. Thank you, Senator Salazar.
Senator Coleman.
Senator Coleman. Thank you, Mr. Chairman.
First, Justice O'Connor, thank you. One of my favorite
quotes is Maimonides, who once said, ``Each of us should view
ourselves if the world were held in balance and any single act
of goodness on our part could tip the scales.'' I think you
have led a life of tipping the scales. You tip them today, too,
by shining a light on the caregiver, and I hope that folks are
watching and read about this understand there are places to go
and things to do and that we care.
Mr. Speaker, you talk about a community-based model. That
is your thought about the benefit of folks being treated at
home. A lot of your discussion on the funding side has been
OMB/CBO. But CMS is a big player here. We have got--I represent
a State that medical technology is a very big deal, and we are
creating remote monitoring, a whole range of things.
Can you--I have been here almost 6 years. You were here for
more than three times that. Can you talk to me a little bit
about CMS, about how do we--I mean, for the things that are
already out there or that are in the stages of being early
development, how do we get them to be funded so folks
understand what Senator Collins talked about, get away from the
penny wise, pound foolish approach?
Mr. Gingrich. Actually, my reflection, when you pointed out
I have been here more than three times longer than you, was I
felt much older, and I am now much more worried about things
than I was when this hearing started. [Laughter.]
Well, let me go back to a piece that I said a while ago and
give you a specific example. Don't underestimate how much the
Office of Management and Budget is the enemy of fundamental
change at the Center for Medicare and Medicaid Services. A
letter was sent last year giving $100 million to a clinic in
New Orleans with the specific provision that none of the money
could be spent on information technology.
Now, given every speech the President has made on this
topic, every speech Secretary Leavitt has made on this topic,
that letter should be a scandal. That letter was directly
caused by OMB. Nobody at HHS thought that was rational. So the
power of relatively obscure bureaucrats who have hidden for 25
years and learned nothing to say no is enormous.
Second, I would suggest to you that part of what you want
to do at CMS, and this would go contrary to some models of
public bureaucracy, you need a lot more fellowship programs
both to get CMS career civil servants out into the private
sector and to get the private sector into CMS. I would try to
look for a model, and I know that Andy von Eschenbach has been
working this at the Food and Drug Administration, and he is
exactly right.
We live in an era when you cannot have policy made by
people who are 5, 10, and 15 years behind the curve. So, part
of what I would look at is how can you dramatically open up the
Center for Medicare and Medicaid Services both so if staff gets
to go out and work at any one of a wide range of private sector
things, but how many people from CMS have ever worked for
Evercare? How many people from CMS have ever worked at a modern
public hospital facility?
As opposed to they have been sitting in Baltimore--and
these are decent people. This is not an attack on them as human
beings. But if you spend your entire life in a risk-averse
environment filling out paper, it is really easy to say no and
not understand the human cost of the decision you just made. So
I would look for literally reshaping CMS.
In my book ``Real Change'' and in a YouTube video called
``FedEx vs. Federal Bureaucracy,'' I tried to outline the scale
of change we need. If you look at the speed and accuracy of UPS
and FedEx, which track 23 million packages a day while they are
moving and enable you to go online and track them yourself at
no cost, and compare that with the inability of CMS to do that
and ask yourself why couldn't all Medicare funding be
electronic? Every charge filed every night and have the same
data flow that you get at McDonald's?
McDonald's files 37,000 stores worldwide every night. You
would then be able to track--first of all, you would flush out
fraud almost immediately. Second, you would begin to have all
sorts of knowledge about what is really happening and what
should we really be changing. It is a totally different model.
I would encourage you to look seriously at fundamental
structural reform of CMS, and I would start by creating very
substantial capacity for people to go out for a year of
sabbatical and to bring in people for a year of internship in a
way that would open the place up to a new generation of ideas.
Senator Coleman. Thank you, Mr. Speaker.
Thank you, Mr. Chairman. [Applause.]
The Chairman. Thank you. Thank you, Senator Coleman.
Senator Lincoln.
Senator Lincoln. Thank you, Mr. Chairman, and thanks to
both of you all for bringing your passion and interest here
today and sharing it with all of us.
We also appreciate your work on the Alzheimer's Study
Group. You know, this is a disease, however, those of us that
are close to the disease know it all too well. But it is,
indeed, a silent disease until you become in contact with it,
and then you begin to realize a little bit of what you have
talked about.
I know Senator Grassley and I have worked on tax benefits
for long-term care and the ability to encourage people to learn
more. I guess that is my question is your recommendation on
early education on Alzheimer's, not just on the effects of the
disease. Obviously, that is critically important, and the
Speaker mentioned training and if you could track the disease.
When my dad became so ill that we needed assistance in the
home, my mother needed assistance, we found a woman who was
unbelievable. Dad was her, I think, sixth Alzheimer's patient,
and she stayed with all of her patients until they passed away.
But she could tell us the signs. She could say, you know,
he is not going to be--he is going to be on these ups and down.
We need to get him up. The weather is pretty. We need to get
him outside because pretty soon he is not going to be able to
do that. You can tell by the different things that you notice.
Those are critical to quality of care, quality of life, but
certainly, how you deal with the disease and the education of
it.
So I guess my question is early education not just on the
disease, but also on care expenses. Dad was diagnosed early.
Mother didn't realize the expenses she was going to see, nor
had she prepared for that, the advanced care planning. Some of
the things that I think most people, quite frankly, or often
people don't realize that Medicare has no funding for long-term
care necessarily. They think Medicare is there, and it is going
to be there for them in their golden years. But in terms of
long-term care, it doesn't cover that.
So I guess if it is long-term care, in terms of both the
care--educational component of the caregiving, but also the
financial literacy that needs to be there in an educational
component and how we do a better job of that. I think Speaker
Gingrich, I think the statistic here in our country is for a
baby girl that is born today in this country, she has a 50
percent chance of becoming a centenarian. My husband's
grandmother will turn 111 in the next couple of months, and she
still plays bridge 4 days a week, still lives on her own.
I mean, people are living longer, and we are going to see
greater numbers. So this financial literacy, this education and
care literacy is going to be critical not just when you see the
disease, but before. Any suggestions on how we do a better job
at that?
Mr. Gingrich. Well, let me say, first of all, I think that
is about as good a statement as I have ever heard. I think you
did an extraordinary job just now. [Applause.]
I think you really captured a lot of different pieces. So I
would almost suggest that we could start with you, and part of
what you are saying is how could we have Alzheimer's caregivers
in a way--and this is a serious example. The woman who came and
helped your father, was she in a setting where she, in fact,
could buildup a pension fund over time? Or was she an
independent contractor in such a form that----
I mean, if we wanted to make it relatively easy to be an
Alzheimer's caregiver, how could we build an ability, and this
will go to something that Ron Wyden has worked on, but maybe to
make it possible in every State to create an Alzheimer's
caregiver coop in a way that they could have group insurance.
They could have pension buildup and a defined contribution. But
to think about this group of people who are an integral part of
what you are describing.
Second, your financial planning point is exactly right.
There is a totality of life, and this is one of the great
problems. This is why I suggested, and Rob Egge and I have been
working on the idea of some kind of coordination. Nobody looks
at the totality of this. So, you have different silos in the
Government, each of which cheerfully runs around doing the best
that it can at its piece, but, in fact, life is lived across
the silos. So, the idea of developing, I think, that kind of
approach is very important.
I don't quite know how to say this. When you go back home,
just ask your audiences how many people have a cell phone with
a camera. Then ask them how many of them have a laptop or some
kind of computer. Nicholas Negroponte came by the other day,
and I have a couple of his computers that were originally
designed for the Third World that cost $187. Peru is buying one
for every child in the country.
I sent it to my two grandchildren and got this wonderful
phone call from Maggie, who is 8 years old, who said, ``Oh,
Grandpa, this package came, and I thought it was for mother,
and it was for me.'' She and her brother Robert are now playing
with this computer.
We haven't stopped and worked back from that is the
potential we have to educate the country. We don't have to set
up--if you go down and look at the Centers for Disease Control,
which is a place I admire much and I have helped as much as I
could over the years, you look at the way that people think,
they still think in a paper-based bureaucratic, gradual model.
You know, why do we put posters up somewhere?
You live in an age when what you ought to say is, gee, what
is the Facebook application for Alzheimer's that everybody
could have friends in a Facebook kind of model or a MySpace
model. I am not company specific here. But we are living in a
different world, and we don't know how to design a Government
whose agility and information flow operates like that.
So, in a sense, you would like to be able to say--because
you think about it. You have 100 Senators and 435 House
members. You could literally communicate to every American. You
could say to every American through your various techniques if
you have Alzheimer's occur in your family, go to this site, and
the site will lead you through how you can plan.
We need to think on that scale of creating democratic
smality, democratic information for the entire country, leading
them to commercializable, lowest possible cost tools to enable
them to maximize the control over their lives. This is true, by
the way, about much more than just the Alzheimer's patient.
But I thought what you said was really eloquent and really
powerful, and I don't know that I can do much to add to it.
The Chairman. Thank you very much, Senator Lincoln.
Behalf of all of us on the panel, people here in the room
and people all across America, we want to thank you both for
giving us your time, your thoughts, and your passion here this
morning as we move toward hopefully coming up with a cure for
Alzheimer's disease as well as treatment. Hearing from you
today has made a big difference, and so giving us your time was
very useful for something we know you care deeply about.
Thank you both for coming. [Applause.]
The Chairman. We will now move on to the second panel. The
first witness on the second panel is Mr. Jackson, and I would
like to ask Senator Smith to introduce him.
Senator Smith. Thank you, Mr. Chairman.
As I said in my opening remarks, it is a particular
pleasure I know for me, and I am sure I can speak for Senator
Wyden on this as well, to welcome Chuck Jackson to the Aging
Committee of the Senate. Chuck Jackson is age 50. He was
diagnosed with early onset Alzheimer's disease. Since his
diagnosis 4 years ago, Chuck has made it his goal to inform the
American public about living with early onset Alzheimer's.
As a former member of the National Alzheimer's
Association's Early Stage Advisory Group, Chuck is well known
and respected for his insight and understanding of the issues
that persons with the disease face.
So, Chuck, thank you for being here, and we look forward to
hearing your testimony today.
The Chairman. Thank you, Senator Smith.
The second witness on this panel will be Suzanne Carbone.
Mrs. Carbone is a family caregiver for her husband, Robert, and
she works full time as a librarian in Rockville, MD. Prior to
his diagnosis at age 70, her husband was dean of the College of
Education at the University of Maryland.
Mrs. Carbone credits the support and services she received,
including caregiver education programs, with allowing her to
care for her husband for 10 years at home while also working
full time. She is a native of Wisconsin, and she currently
resides in Silver Spring, MD.
We are also fortunate to have with us today Dr. Rudy Tanzi.
Dr. Tanzi is a professor of neurology at Harvard University and
serves as the director of the Genetics and Aging Research Unit
at Massachusetts General Hospital. He participated in the
pioneering study that led to the location of the Huntington's
disease gene, and he is credited with isolating the first
familial Alzheimer's gene.
Dr. Tanzi is the fifth most cited scientist in the field of
Alzheimer's disease research, and he was a 2007 recipient of
the Ronald and Nancy Reagan Alzheimer's Research Institute
Award.
We thank the three of you for being with us, and we will
now take your testimony, starting with Mr. Jackson.
STATEMENT OF CHARLES JACKSON, ALZHEIMER'S PATIENT, ALBANY, OR
Mr. Jackson. Good morning, Chairman Kohl.
The Chairman. Thank you.
Mr. Jackson. Good morning, Chairman Kohl. Mr. Smith, thank
you for inviting me here, and all the rest of you distinguished
guests that are here to listen to what we have to say today.
I am Chuck Jackson. I am from Albany, OR. I was actually
raised in the panhandle of Oklahoma. That is where this family
picture I have relates. I took the liberty to bring that today
because I am speaking not only for these 14 people, my mother
and her 13 siblings, but I am also speaking for my cousins and
the other people that branch out from our family tree.
I have what is called the PSN2 genetics that came via what
we call the Volga River Germans that had moved from Germany to
Russia and then to the United States. They brought with them
two or three of the genes that cause early onset with them.
More than 20 years ago, my Aunt Esther testified at one of
the first Alzheimer's hearings held in Congress. Unfortunately,
the former President Ronald Reagan later vetoed the
legislation, and we have not done much since that time. My
experience with Alzheimer's started in 1967 on myself. When I
was 13 years old, I became my mother's caregiver. My mother
Rachel had started and exhibited Alzheimer's similar to what my
aunts and uncles had previously that I had been able to look at
and see and be with.
I received a telephone call from my brother Danny in May of
2004. I was working at the time at Community Services
Consortium as an employment specialist. He had gone through an
experience or research with Dr. Rachelle Doody of Baylor
University on a combination set of drugs called a cocktail, and
he had done so well in the study on these drugs that at the end
of it, she suggested that he call everyone in our family who
was over the age of 50 let them know they had the family gene.
So he gave me the call that day, and I started going to my
doctor to get on this set of drugs, this cocktail, to preempt
the onset of the Alzheimer's is what we thought. In August of
that same year, I was given a very bad evaluation by my
employer. It was quite devastating to me, actually, because
nobody had talked to me about it during the year or brought it
up until that day, and after having worked there for 14 years
with 95 and 97 percent evaluations from the past, it was really
hard for me to take.
But that same--after that Friday, the next Monday, I had an
appointment with my doctor to finish getting on the meds that
my brother had called about. My doctor asked to see that
particular papers that my employer had given to me in the
evaluation. After looking at them, he asked me a question,
``Have there been any other strange things happening in your
life that you haven't told me?''
There were a few that I had planned to tell him, but when I
would come in to see him, they just--I couldn't remember them.
I couldn't talk about them. He looked up at me, and he said,
``We might as well consider that you have already started the
disease. We are not preempting it at this point.'' I really
wasn't prepared for that statement from him. I was shocked.
I hadn't really been catching the signals I should, my body
had been giving me. My family had not caught those signals, but
my co-workers and my employer had. Now they thought I was doing
things on purpose.
In the one--at one time that year, I had walked into the
job site with a black shoe and a brown shoe on. Having gotten
dressed in the dark, I thought I hadn't noticed the shoes. But
my co-workers were laughing, and one of them finally walked up
to me and asked, ``Why are you wearing a brown shoe and a black
shoe?'' I glanced down, and I said, ``I didn't know I was.''
So my supervisor sent me home to change my shoes, which I
did when I got home. When I got home, I put on the other pair
of shoes that also happened to be one brown and one black and
returned to the job. Of course, she was really angry at me.
There are things that I have learned during this time that
I have gotten this diagnosis. I have learned how to live with
the disease. I have learned how to adapt to it. I would like to
say that the research that is available needs to be directed
directly at the effectiveness of keeping a person in the home
as long as possible after they have been evaluated by a doctor
and having given a diagnosis of Alzheimer's because we are
better off in the home than we will ever be in a care center,
and we will last longer.
I once worked for the Burlington Northern Railroad in
Montana. I am sorry. I know I have deviated somewhat from my
written statement. I apologize for that, but I guess that is
just kind of how it happened for me. I am now at age 54. I was
actually 50 when I got my diagnosis. I am on Medicare at this
time. It was a 2-year battle for us. My Representative Hooley's
office helped me a great deal with that.
I am receiving Medicare, and I have a supplemental plan
that I have bought from the PERS program there in Oregon so
that my medications are taken care of as much as I can take
care of them and my doctor's bills. I receive about $2,000 a
month from two different disability programs. One is from
Regency, which is a private program, and the other part is from
my PERS retirement system. By the time I get done paying with
my home and where my food costs and the medical costs, I don't
have any money left at the end of the month. I think you should
know that it is very costly to have this disease.
I have worked for the last 3 years to deal with this
disease in such a way that we have quit thinking about it being
an age disease. This is not--though there are more people over
the age of 65 that have the disease, this disease is not an
ageism disease.
Most people could get through life without having this
disease and live to a long, long old age without any problems.
But our society has come to a point where we believe that when
a person gets to a certain age and they have Alzheimer's, that
is normal aging. I want to tell you it is a disease. It is not
normal aging. Otherwise, I would be 85 right now.
I know there is numbers of people with early onset in this
country that have not been counted, and I often wondered why no
one has ever counted how many people are actually involved in
the disease in this country. But we have a fear of our
Government and our friends and family knowing the disease that
we carry in these families, and we try--well, our predecessors,
my mother and my father's group of generation didn't want to
talk about such things.
If we would have talked about this in the 1960's, we would
have had more done today. But no one would talk about it. We
have the ability in this country to put together a way for us
to defeat this disease or at least make it available a good
drug that will keep a person in the home at the same level as I
may be functional today.
I mean, the small goal of going to the moon and back is--
this is more or just as important as finding the moon and
coming back to it. So it is imperative that the Congress keeps
the Federal commitment to Alzheimer's research now because I
want to be an Alzheimer's survivor. I don't want to die with
this disease. I would rather have a heart attack.
Much like the breast cancer survivors who are all alive
today because of advance in cancer research and treatment, I
would like to be a survivor of Alzheimer's. I would prefer or I
want my daughter Rachel Jackson, that is with me today, not to
have to live through this disease and not have to worry about
it. I have taken this road mostly for her and then also for the
untold thousands of us that are uncounted, that have not found
a voice to tell people they have early onset Alzheimer's in
their family.
My plea to you is that you support the Alzheimer's
Association initiatives to get the research back on track so
that we can stop this disease in its tracks and then find a
cure for it.
I thank you for your indulgence in listening to me and your
patience and the understanding that you are giving me.
Thank you. [Applause.]
[The prepared statement of Mr. Jackson follows:]
[GRAPHIC] [TIFF OMITTED] 46898.013
[GRAPHIC] [TIFF OMITTED] 46898.014
The Chairman. Thank you, Mr. Jackson.
Mrs. Carbone.
STATEMENT OF SUZANNE CARBONE, ALZHEIMER'S PATIENT CAREGIVER,
SILVER SPRING, MD
Ms. Carbone. Good morning. Thank you for the opportunity to
talk with you about our family's experience with Alzheimer's
today.
My husband, Bob Carbone, was diagnosed with Alzheimer's
about 8 years ago. Interestingly enough, he has an identical
twin brother who has no symptoms of the disease. Bob was born
in Plentywood, MT, where his immigrant father was a section
foreman for the Great Northern Railroad, and his mother was a
homemaker.
Bob earned a master's degree from Emory University and a
Ph.D. from the University of Chicago. He was a special
assistant to President Fred Harrington at the University of
Wisconsin, and later he became the dean of the College of
Education at the University of Maryland.
He was always very interested in the political process, and
so he actually ran for the Maryland State legislature in 1982
and garnered a very good percentage of the votes. In January
2007, Bob moved into assisted living when caring for him at
home was no longer an option. Today, he can no longer speak a
coherent sentence. He cannot dress himself. He cannot take care
of his personal needs. My family and I are not sure if he
recognizes us, and my family is with me today.
I am just one of millions of caregivers who are faced with
difficult and heartbreaking decisions of care. Every day, I
meet yet another caregiver who needs help and does not know
where to turn. In fact, in the taxi this morning, we met
another person who knew another person who has Alzheimer's.
Everywhere I turn, people with whom I speak know people with
Alzheimer's.
Upon a diagnosis, families are swept into a sea swell as
they are confronted with the changing levels of ability and
changing patterns of behavior of their loved one. My husband
and I were no different. We left the neurologist's office with
a few prescriptions and minimal advice. We should have been
able to leave that office with something that said these are
the areas in your life that are going to change, and you need
to address these issues during Phase 1, 2, and 3 of this
disease. Here are the best contacts. These are the top
resources in your area to whom you can turn.
I am, therefore, convinced that we need to transform the
way that we support patients and families caught in the tangles
of this disease. I struggled to patch together a system of
support, drawing on public and personal networks to cope with
issues of physical and emotional care, financial and legal
planning, transportation, driving, in-home care, daycare, and
finally, assisted living.
It felt as though we were on shifting sand because as soon
as I had a care plan in place, my husband's needs would change,
and then we had to seek out additional solutions to our
situation. On top of that, we would have to convince him to
accept the new solution.
One of the most useful resources that I found was a 6-week
caregiver training program funded in part by a grant from
Montgomery County, MD, the Department of Health and Human
Services, Aging and Disability Services. From it, I learned
about the process of dementia, its stages and treatments.
I learned about communication needs. I learned about
techniques to use during various stages of the disease. We had
someone talk about environmental modifications to one's home.
Finally, I learned about hiring and working with in-home care,
daycare, respite care, and assisted living.
These workshops were invaluable, and they provided me with
insight, information, skills, support, and contacts. Actually,
the people who attended these workshops became a support group
for one another. I urge that this type of program serve as a
model and be replicated widely in local communities.
I am still working full time as a manager at the Rockville
library in Montgomery County, MD. I must work in order to pay
for the care that my husband receives. He receives excellent
care, but the costs are huge--$73,000 last year.
If I become ill, how will we manage? Given the fact that my
husband's father lived to be 100, it is entirely possible that
he will outlive me. Then the cost of his care will be passed on
to our two children. We must find ways to help families with
this tremendous financial burden.
In conclusion, I look forward to the day when there are
stronger, more cohesive community-based networks of resources
to support patients and families with Alzheimer's. I am
encouraged by the idea of memory centers, which I am just
beginning to learn about, as seen at several universities
throughout the country.
These could provide access to evaluation, diagnosis, and
treatment, as well as a whole system of referrals to caregiver
services and support groups. I wish that we had had such a
resource for Bob.
I urge Congress to immediately increase the investment in
research to find better ways to diagnose and treat Alzheimer's.
I call on policymakers to pass legislation to support
individuals with Alzheimer's and their families, especially
legislation that would develop and improve patient-based
customized care plans, provide families financial assistance in
caring for loved ones with Alzheimer's disease, and that
expands paid leave for caregivers.
Thank you very much for the opportunity to share a portion
of our family's experience with Alzheimer's. I commend you for
holding this hearing on this very critical issue.
Thank you. [Applause.]
[The prepared statement of Ms. Carbone follows:]
[GRAPHIC] [TIFF OMITTED] 46898.015
[GRAPHIC] [TIFF OMITTED] 46898.016
[GRAPHIC] [TIFF OMITTED] 46898.017
The Chairman. Thank you, Mrs. Carbone.
Dr. Tanzi.
STATEMENT OF RUDOLPH TANZI, Ph.D., DIRECTOR OF GENERICS AND
AGING RESEARCH UNIT, MASSACHUSETTS GENERAL INSTITUTE FOR
NEURODEGENERATIVE DISEASES, PROFESSOR OF NEUROLOGY, HARVARD
MEDICAL SCHOOL, BOSTON, MA
Dr. Tanzi. Thank you, Chairman Kohl and Ranking Member
Smith, for giving me this opportunity today to provide an
update on Alzheimer's research and particularly our focus on
how studies of the early onset genes of the type that affect
Mr. Jackson have more than any other piece of knowledge in
Alzheimer's taught us about the causes of this disease and have
guided current clinical trials, some of which I think are very
promising.
Twenty-five years ago at Harvard Medical School, when I was
a student, I had focused my attention--this is during the early
days of the human genome mapping--on trying to identify the
genes for early onset and familial Alzheimer's. In 1987, we
discovered the first Alzheimer's gene called the amyloid
precursor protein. In 1995, we discovered the exact gene
mutation that runs in Mr. Jackson's family by studying the DNA
from the Volga German families of which your ancestry comes.
That gene and the other genes that we have looked at have
taught us so much about this disease.
But before getting into the science, first I wanted to
mention that none of the discoveries or drug trials I will
mention this morning would have been possible without the
courageous involvement of patients like Mr. Jackson and their
families. We could do nothing without them.
This is also why the Genetic Privacy Act and GINA is so
important because it allows families to participate without
fear of discrimination. I do think that GINA could go farther
toward long-term care insurance. It covers employment and
health insurance, but long-term care is what many folks with
Alzheimer's need, and so it would be nice to see that expanded
even farther into long-term care insurance.
Second, I think is very important to emphasize that even
though Alzheimer's drugs today are in trials after being
developed by pharmaceutical companies, the original seeds of
creativity and of basic biological and genetic discoveries
almost all came from academic research. So, it is important to
remember that while the big pharma and biotech take the drugs
to clinical trails and bring them to the market, which is
immensely important, if we dry up funding or don't have
sufficient funding for the academic institutions, the basic
research funded by NIH and nonprofit foundations, you basically
dry up the pipeline. The seeds of creativity almost inevitably
come from academia with nonprofit and Federal funding.
Third, I want to just mention that history has taught us
that it takes about 20 years for basic research to evolve on
and reach a stage of clinical trials, new drugs, and patients.
This is exactly the case right now in Alzheimer's. The first
Alzheimer's gene was found in 1987, more in the early 1990s,
and now here we are in 2008 and some of the first clinical
trials testing drugs that would treat the disease itself, not
just the symptoms, are underway.
So what did we learn? Well, if we look at the three early
onset genes that we know about, they all lead to the same
culprit. That culprit is a small protein called A-beta, also
called the amyloid beta protein. This small protein A-beta
ultimately, in the end, gets deposited in the senile plaques.
But we are learning most recently is it is doing most of its
damage before it gets into the plaque.
So we used to concentrate more on the plaques as the
battleground, but now we are seeing that small assemblies of
this A-beta protein as they stick together--2 of them, 3 of
them, up to 12 of them stuck together--go into synapses. In
these synapses, nerve cells are trying to communicate, and they
create short circuits. So they actually short circuit the
neural circuitry, and this leads to cognitive dysfunction.
So what we have seen over the last few years is that the
battleground has been moving away from the plaques and more
toward the actual nerve connections or synapses, where this A-
beta protein gets in the way of normal neurotransmission.
Now, current Alzheimer's drugs are in the category of
better than nothing. They treat the symptoms. There is usually
minimal benefit and is usually temporary, as most families can
attest to, and caregivers. But, now, there are several
Alzheimer's therapies that are in trial that are aimed at
hitting these toxic A-beta proteins in the brain.
So if you think about it, OK, if the problem in Alzheimer's
is you have an excessive accumulation of the A-beta protein in
the brain, how do you fix that? Well, there are three different
ways. You can limit the production of the A-beta in the brain,
and that is being done with protease inhibitors. There are
trials going on there.
You can try to clear the A-beta out of the brain as a
second approach. The immunization approach is trying to attempt
that, plus some other strategies.
Third, you can try to neutralize the toxicity of the A-
beta. You can try to stop the most toxic form of it from
actually ever taking root in the brain, and there are trials,
testing, trying to hit that part of the pathway as well.
So I think the good news is on all three of these fronts,
where we are trying to hit what looks like the major culprit as
we learned from the early onset gene studies, that there are
exciting trials in the works. I provided details about these
trials, the companies that are doing them, their prospects, all
in the supplemental information that was submitted to the
Committee.
Now, again, I want to emphasize before closing that the
most promising drugs we have in the pipeline that are in the
clinic came from studies of these early onset Alzheimer's
genes. Even though these mutations are rare, they have taught
us more than anything about the cause of this disease.
All told, we know about four Alzheimer's genes, those three
early onsets, plus one late onset one called ApoE. But these
four genes account for only 30 percent of the inheritability of
Alzheimer's. So imagine what we could do with the other 70
percent. I mean, if just these genes have taught us so much and
most Alzheimer's research is focusing on these genes and their
proteins, let us get the other 70 percent.
So my lab and other labs around the world are trying to
find those other genes. We are specifically heading up what we
call the Alzheimer's Genome Project, which is funded by the
Cure Alzheimer's Fund and the NIMH. We have gotten longstanding
funding for this from NIA as well. We have a paper coming out
this summer that will describe our first results of some of the
new Alzheimer's genes.
There are also other groups around the world who are all
pecking away at this, working together, consortium--as a
consortium to do this as well. So I am glad to say that
geneticists are working together to solve this problem and get
the rest of these genes.
The reason why, is that history has shown us every new
Alzheimer's gene provides a new avenue for potential treatment.
The gene teaches us about biological pathways that are going
wrong in the brain. Now we don't want to go in there with drugs
and change the gene. We are not talking about gene therapy.
When we find a new gene, it teaches us what is going wrong,
and then we know how to fix exactly what is broken. Those are
the trials that are going on now based on the early onset genes
we have studied for the last two decades. Ultimately, the idea
will be that these genes will also allow us to predict the
disease early. So, thank God, GINA passed, and we hope it goes
further.
We are converging now toward a personalized medicine
approach. The vision would be to do genetic prediction and then
to personalize treatment with a cocktail of drugs that hit
different parts of the pathway to best treat an individual
based on their genetics, their own genome. So the mantra would
become ``early prediction, early intervention.''
Right now we are in the pioneering days of that vision.
While there is good reason to be optimistic, there is also more
work to do before we reach this goal, and scientists will need
to work more closely than ever with clinicians, patients, the
Government, nonprofits, and pharma to make this happen. We all
have our role. We are well on our way, but the time to really
push hard is now.
So thank you once again for giving me the opportunity to
present.
[The prepared statement of Dr. Tanzi follows:]
Prepared Statement of Dr. Rudolph E. Tanzi
Thank you Chairman Kohl and Ranking Member Smith. I am very
pleased and honored to be here this morning to address the
Special Committee on Aging.
I am a Professor of Neurology at Harvard Medical School and
a geneticist at Massachusetts General Hospital.
Twenty five years ago, as a student at Harvard Medical
School, I participated in the very first human genome mapping
effort to locate a disease-causing gene. That gene was
responsible for Huntington's disease, a horrible
neurodegenerative movement disorder. Shortly thereafter, I
focused my attention on mapping the genes for early-onset
familial Alzheimer's disease, the type affecting Mr. Jackson.
In 1987, my lab discovered the first AD gene and we
identified two more in 1995, all three causing early-onset AD.
This morning, I will summarize the tremendous amount we have
learned about the causes of AD and the ongoing trials of new
Alzheimer's drugs made possible by studies of these early-onset
AD genes.
Before getting into the science, I would like to make three
important points:
First, none of the discoveries or drug trials I will
mention this morning would have been possible without the
courageous involvement of patients, like Mr. Jackson.
Second, few, if any, novel Alzheimer drugs being developed
by the pharmaceutical industry today would have been possible
without the original seeds of creativity and basic biological
and genetic discoveries that have come from academic research,
primarily supported by federal and other non-profit funding for
Alzheimer's research.
Third, it generally takes about 20 years for basic research
findings to reach the stage of clinical trials in patients.
This is the case for the discovery of the first Alzheimer's
genes in 1987, biological studies of those genes, and current
clinical trials in 2008.
By studying the genetic defects in the three early-onset AD
genes over the past two decades, we have learned that the
culprit in Alzheimer's is a tiny protein we call A-beta. As it
accumulates to excessive levels in the brain, it short-circuits
communication between nerve cells, ultimately killing them. The
result is major cognitive dysfunction and memory loss.
While current Alzheimer's drugs only treat the symptoms
offering minimal and only temporary benefit to patients,
several new Alzheimer's therapies currently in clinical trials
are aimed at actually stopping the progression of the disease
by curbing accumulation of toxic A-beta molecules in the brain.
This can be achieved in three ways: 1. Limiting the
production of A-beta; 2. Clearing A-beta out of the brain; and
3. Neutralizing A-beta's toxic properties. Novel drugs of all
three classes are currently in clinical trials, including a
promising one that my lab helped develop over the last ten
years. And, I would be happy to provide more details about
these therapies.
While I am optimistic about the success of these trials,
history dictates that the first drugs out the gate are not
always the best ones. We will clearly need to take many shots
on goal to cure this disease; and, will most likely, someday,
be prescribing a cocktail of different drugs to effectively
treat Alzheimer's.
The most promising new drugs have been made possible from
the knowledge gained from the studies of the gene defects
causing early-onset Alzheimer's. However, these three genes
together with one other (for late onset) account for only 30%
of the inheritance of Alzheimer's disease. Imagine what we
could do with the other 70% identified.
To find these, my lab at MGH is currently heading up the
``Alzheimer's Genome Project'', (primarily funded by a non-
profit foundation and the NIMH). A paper describing the first
set of genes is currently under review at a major scientific
journal, and we expect to announce several novel Alzheimer's
genes this summer. I would be happy to provide you with more
details here, as well.
As history has shown, every new Alzheimer's gene provides a
novel avenue for potential treatment while also improving our
ability to predict risk for Alzheimer's early in life.
Ultimately, the convergence of genetic knowledge and effective
Alzheimer's drugs will allow for a ``personalized medicine''
approach to this devastating disease: ``early prediction, early
intervention.'' These are the pioneering days of that vision.
So, while there is good reason to be optimistic, there is
also a lot more work to do before we reach our goal. Scientists
will need to work more closely then ever with clinicians,
patients, the government, non-profits, and pharma to make this
happen.
Thank you.
The Chairman. Thank you. [Applause.]
Dr. Tanzi, is there a reasonable hope that we could one day
find a cure for Alzheimer's? In the short term, how close are
we to finding a way to delay the disease's progression?
Dr. Tanzi. Well, I think most of the drugs that are in
trials now that are trying to hit the A-beta protein have a
chance to both treat the disease and our best hopes to reverse
the disease. But they could also be used in folks whom we know
are at risk before symptoms to prevent the disease.
I think that of the drugs in trials now, some of them have
a chance of working. But it will only be the first wave, and we
also know from history that the first wave is not always the
best wave. But it opens the door to the next wave of drugs that
do the same thing, but in a more potent fashion.
So my guess is that in about 5 years at least a couple of
these clinical trials will bring us some drugs that work, but
not necessarily the best ones. Then, over the next 5 to 10
years, they will open the door to new drugs that keep making
improvements on these same mechanisms of action. I am hopeful
that within 5 to 10 years, we will have a cocktail of drugs
that will at least be stopping disease progression.
Then you have to trust that the brain can regenerate. That
if you just stop the attack, that the brain has a chance to
come back. I am optimistic about that. It is kind of
controversial how well can the brain come back. Well, it really
depends on when you hit in the disease. So, again, early
diagnosis, early prediction becomes the key.
The Chairman. Well, if early diagnosis is so important, you
are not recommending that everybody have a test?
Dr. Tanzi. Well, I think that--I would think that 20 years
from now, it would be routine that you know your genetic risk
factors for the big diseases that threaten healthy aging--
Alzheimer's, cancer, diabetes, cardiovascular disease. Then you
will be already setting up for lifestyle changes, supplements,
or drugs, if necessary, to prevent those diseases.
We don't have the genetic tests yet. These are still the
early days, the foundational days, but everything is in place
to come up with a good test. We don't have the tests yet to
predict Alzheimer's, except in these rare early onset cases.
But we are moving there, and we are hoping that the ability to
reliably test and predict will dovetail with the drugs that
come out of the knowledge gained from studying those genes so
that we can empower patients with the ability to stop or
prevent the disease once they have their test done.
The Chairman. Ms. Carbone, what advice would you give to
those who are just starting to care for a loved one in this
Alzheimer's?
Ms. Carbone. Well, there were several things that happened
when we received the diagnosis. The first thing that I did was
to decide that we needed to make something positive out of this
devastating news. Because my husband is a twin, we immediately
tried to get into a twin study. So, I think you have to think
about all the people who have this disease and see what it is
that you personally can do.
My husband and I also renewed our vows. I knew that I would
have to strengthen the commitment that we had to one another,
and so that is a second thing that we did.
A third thing that I did was to immerse myself in
everything Alzheimer's, and I read extensively. I attended
every lecture I could find. I joined support groups, and I must
say that I think that having the knowledge from other
caregivers and sharing that with one another was really one of
the strongest supports throughout this experience, and it
continues to be.
But I would not be afraid of letting people know that you
are a point person for Alzheimer's. We all need to be. So, if
we can spread that idea throughout our society, I really would
encourage everyone to do that.
There is an addendum that I would like to add, and I
suppose it is because of my career as a librarian. But remember
that libraries are very trusted institutions in this country.
Remember that they provide the electronic access to information
that Speaker Gingrich was also talking about.
In Montgomery County, we have a place, we have a Web site
called Senior Site. Now if you think a little bit about how
that kind of site could assist all of us with information in
terms of distributing information about Alzheimer's, that is a
way to distribute information throughout the country through
the public library system.
Maybe there are other ideas like this. So those are some
suggestions.
The Chairman. Thank you.
Senator Smith.
Senator Smith. Dr. Tanzi, you, I think, rightly noted the
importance of Federal funding as sort of the seed of research,
and I am aware that it goes to many universities and,
obviously, NIH. I wonder with those dollars, as discoveries are
made, how well is that information shared, or is there some
proprietary quality that takes hold when these things are
discovered?
Dr. Tanzi. When discoveries are made in academic
institutions, our lifeline really is more funding, and that
means publication. So we have to publish our findings for the
good of science. Also there is the ``publish or perish'' rule.
If you don't publish, when you try to renew your grant, it is
unlikely that you are going to get a favorable review even for
the best ideas because you have to show that you can finish the
job.
So I don't think there is a problem in academia with
sharing of information or publishing information. Particularly
in Alzheimer's disease, I see that there is an increasing
vector toward collaboration. All of the geneticists who used to
compete in the old days to find the early onset genes, which
were kind of the low-hanging fruit, are now working together to
solve the more complex question of what are the various risk
factors, genetic risk factors that work with the environment to
cause the more common late onset form.
So I don't see holding proprietary information as an issue.
Senator Smith. You see sharing as expanding?
Dr. Tanzi. I think I see this, at least in my own world of
Alzheimer's research and particularly in genetics and molecular
studies, I think there is just a great trend right now toward
it.
Senator Smith. There are no impediments out there that we
should be aware of?
Dr. Tanzi. No.
Senator Smith. The marketplace of academia is working then?
Dr. Tanzi. Yes, I think that it is great because if you
look at all of the major drugs to come out of pharma, you will
find a relatively low budget versus pharma budgets that lead to
biological breakthroughs, the original seeds of discovery in
academic institution using Federal and nonprofit funding----
Senator Smith. How about research taking place abroad? How
much collaboration and information sharing is there between the
United States and other countries?
Dr. Tanzi. Quite a bit. I don't want to sound too U.S.-
centric, but I think that the research here is amongst the
best, if not the best in the world. We do collaborate with, of
course, folks in particularly in Europe and in Japan. But
mainly for sharing in this case, for example, Alzheimer's
family DNAs and reagents and things we need to do our studies,
we have international meetings all the time. The international
Alzheimer's meeting this year will be in Chicago.
So it does go internationally. But I really consider this
country the clear leaders in research.
Senator Smith. Suzanne and Chuck, I really am touched by
your personal stories, and thank you for having the courage to
share them, one as a caregiver and the other as someone
suffering from early onset Alzheimers.
Chuck, as I inferred from your comments, that your
brother--I don't know whether he has early onset as well--but
he encouraged you to participate in these trials. You did that.
I didn't sense that you felt that was a very positive thing,
and I wonder if it was or if I misheard you, if it was a
positive thing? Do you recommend others with early onset
participate in these trials?
Mr. Jackson. Well, I am sorry if I misled you. It was very
positive. My brother----
Senator Smith. It was positive.
Mr. Jackson. He was further along when they started the
study than I am right now.
Senator Smith. Does he have early onset as well?
Mr. Jackson. Yes, he is 60, 61 right now. He is in Texas,
in assisted living in San Antonio, TX. His wife lately had to
leave him alone and go to Amarillo because her father, who is
elderly, had some brain surgery. I wasn't able to tell her that
I was going to be here until last night when I finally got a
hold of her by phone to let her know where I was at.
Senator Smith. It sounded to me also from your testimony
that your experience with your employer was not necessarily
positive as your diagnosis was being made. I wonder if there
are some suggestions you could give to employers as early onset
affects employees, some things that they might do to enable
those who suffer from early onset to continue working longer
and productively?
Mr. Jackson. I think that is going to happen as more people
get used to the idea that early onset is actually in the
workforce. I know some people who have the diagnosis and
diagnosed in their 40's that have been allowed to stay--their
employers have kept them there, and the physician is the same
physician that they had until they couldn't perform.
The problem with perceptions about Alzheimer's is some of
our early onset problem in that most people don't think a
person that looks as young as 45 or 50 or 55 can possibly have
Alzheimer's. There is education that needs to be done in the
local areas.
There is that little bit of reversed ageism on both sides
of the fence with research. Most researchers limit the age of a
person to be in a trial either at 60 or 55. Am I still correct
on that? That leaves a lot of people that are in their 30's and
40's and 50's. I am not available to get into several different
trials right now because I am 54 that are ongoing.
The researchers have looked at it as if there are two
separate diseases out there. One is late onset and one early
onset. I know that the companies that are doing the work are
expecting a return for the research dollars and that the larger
amount of people is in the older ages past 65 and that they are
actually trying to develop drugs that affect that group. But if
you read some of the research numbers, you will find that
more--more early onset people have been used in research that
is then used for people over 65.
The problem has been for two things. A lot of people in
their 80's--70's and 80's don't want to go into research. Also,
that age group that came out of World War II, which is my
mother's generation, born in the '30's and lived through the
Dust Bowl and then World War II, they don't like to talk about
their medical problems and history. They were silent about it
in our farms because it was stoic and it was shameful to talk
about having a disease like this.
My generation, as a baby boomer, I think I have been quoted
in the New York Times as, ``We are mouthy. We are not going to
take this silently.'' That has kind of been where I have been
at for the last 3 years. I am not going to go down silently. I
would like the disease stopped before it affects my next
generation, that we owe them something.
Senator Smith. Well, you are showing great courage, and I
am glad you are mouthy. That will benefit many in the future,
Chuck, and we are grateful to you and to all of you who have
been our witnesses today.
The Chairman. Thank you, Senator Smith.
Senator Wyden.
Senator Wyden. Thank you, Mr. Chairman.
This has been a terrific panel. You all are really the face
of the challenge--patients and caregivers and researchers and
wonderful advocates. I just have a couple of questions.
First, Ms. Carbone, three cheers for librarians. My mother
was a librarian. I think you all are really one of the
country's great underappreciated treasures, and I so appreciate
the thoughtful way that you have laid out what has affected
your family. I am just interested in following up on one point.
Did you or your husband ever have a period where you tried
to buy private long-term care insurance? The reason I ask
because I was kind of looking over the chronology of events,
and of course, these bills for long-term care are just
crushing. I mean, it is easy for people to go through $60,000,
$70,000 in a year.
What I wanted to ask because I saw that your husband ran
for the legislature in 1982, and in 2007, then he moved into
assisted living. At any point, say, after 1982, did you all
investigate private long-term care insurance and look at how
perhaps something like that would be useful for you?
Ms. Carbone. I am so sorry that we did not take advantage
of long-term care when we could, and I suppose that is the
message. People need to plan ahead for this kind of impact on
their lives. The answer is, no, we did not really seriously
consider that we would need this kind of support.
Senator Wyden. I am grateful that you are speaking out this
way in a public forum like that, and I hope that message will
go out far across the land because, clearly, this is something
that can be of great value to families.
Now, there are a lot of challenges we know with private
long-term care insurance as well. For example, in our
bipartisan legislation, the Healthy Americans Act, we try to
make sure, for example, there is going to be some inflation
protection for families because what happens is they can buy a
policy, and then all of a sudden in a few years, it isn't worth
a whole lot more than the paper it is written on because of
inflation.
But I think that there needs to be a lot more awareness of
this, and I think the fact that you are willing to come and
publicly say that that was something that might have been of
great help to you and your family is so important.
I think the other thing that I want the country to see is
that if we don't have some private long-term care insurance in
the future, what is going to happen is we are going to have two
people who are going to need some assistance. Because I saw
also in your testimony that you put in this grueling schedule.
You are there working. Then on top of it, you are trying to
assist your husband.
As sure as the night follows the day, when people are
putting in essentially two full-time grueling, emotionally
draining kinds of efforts like that, it is hard to do it
physically. So----
Ms. Carbone. There is a spiraling effect on the caregiver.
Senator Wyden. Well, you have said it very well, and I just
appreciate your being here.
Chuck, a question for you, and you put up that picture of
your family, and I can tell there are a lot of Jacksons and the
lineage goes back a long ways. But you are not just speaking
for the Jackson delegation----
Mr. Jackson. No.
Senator Wyden. You are speaking for millions and millions
of people, and it is a great service. We think you are an
Oregon treasure, but you are really a national treasure. I just
have a couple of questions for you.
What do you want to say to all those people in this country
who right now are kind of fearful? They are a little bit
reluctant to come forward. I notice now even with these new
testing products that are available, and there are scores of
new products out where you can test yourself, and I am sure
some of them are a lot better than others, people are saying
they are frightened about coming forward.
It is easy to see why they are frightened about coming
forward because until we have a new policy that really zeros in
on better prevention and treatment, they are worried about what
is ahead when there is a diagnosis. So what would you like to
say today to all of those who are fearful and reluctant to come
forward?
Mr. Jackson. OK. Let me think just a second. One thing that
happens is our early onset group were not caught by our--people
we were living with or married to. We were discovered by our
employers. A lot of people before they even have the knowledge
that they possibly can have Alzheimer's will be sent by their
employer or go by themselves to get a diagnosis, and the doctor
will tell them that they have a number of different things,
including depression or a whole list of things before a doctor
will finally say maybe we should find out if you have
Alzheimer's.
I have friends of mine that I have met since 2004 coming to
the forums and coming to the Alzheimer's Association who were
diagnosed after 7 long years of searching from doctor to doctor
and trying to skip from job to job that they had been laid off
from because of failures in the job site, who finally gave them
a diagnosis of Alzheimer's because they didn't know that they
had it in their family history.
We had in our first meeting that my family attended here in
Washington, DC, 3 years ago with Alzheimer's Association, we
had--the first night we had a young woman, two young women and
their father come in and sit down at our table. The next thing
I know, one of them jumped around the table, grabbed me and
hugged me, and said, ``We are related.'' Her mother had
Alzheimer's for 5 years, and they had come to that conference
to find out if they could find the families that they were
connected to that also were in the research study with Dr.
Tanzi.
They found us that day just by chance, and ever since then,
I have really thought there is ways--there is reasons for my
being here today. The possibilities of finding a better test
for a dementia test needs to be examined and researched for the
people who are in their younger years because a lot of doctors
don't want to turn around to someone that is 34, 35, 54, 45,
``I think you might have Alzheimer's,'' until they have done
all the other tests for any other thing that can happen to
their body.
Does that make sense?
Senator Wyden. It does. It seems to me, just as Ms. Carbone
made people more aware of the need to look at private long-term
care insurance and opportunities to plan for the future, what
you have done, Chuck, is made it a lot more likely that people
are willing to come forward, work with employers and family and
be part of this new ethic of prevention and treatment.
I will close with one comment for you three, but I think it
also goes to the whole discussion. It is not exactly a secret
that in this Congress there has been a lot of brawling between
Democrats and Republicans and pretty fair amount of
partisanship.
What you all have done and Alzheimer's advocates, and
particularly the Alzheimer's Association today, is you have
really brought the Congress together. You brought the Congress
together regardless of party, regardless of philosophy, that
this isn't a partisan challenge. This is an American challenge.
This has been a terrific panel. Our thanks go to our
Chairman, who consistently speaks up for older people and their
families. Senator smith, my colleague from Oregon, as well, and
I just want to thank you three. It has been a long morning. The
room is not as full as it was 3 hours ago. But your views and
your comments we are going to get out across the country
because the American people need to hear them, and we thank you
all for your service. [Applause.]
The Chairman. Thank you very much, Senator Wyden.
I would like to echo his comments of gratitude to you for
the wisdom, the experience and knowledge that you have brought
to the table here this morning, which will be transmitted--it
has been out across our country.
Alzheimer's--disease it has been--a disease that, as we can
tell from this hearing this morning, is of the greatest
interest to everybody in our country for all the reasons that
we have described this morning. Hearing you talk about it from
your various vantage points makes a big difference and helps
the process to move along considerably to get to that day that
we are all looking forward to.
So we thank you for giving us your time, your energy. We
appreciate all that you are going through and your
contributions.
With that, the hearing is closed.
[Whereupon, at 1:11 p.m., the hearing was adjourned.]
A P P E N D I X
----------
Prepared Statement of Senator Robert P. Casey, Jr.
Mr. Chairman, thank you for scheduling this important
hearing on Alzheimer's disease, a disease that afflicts
millions of our older citizens and has a profound impact on
their families and our nation. I also want to thank our
witnesses for coming here today to share their stories, their
experiences and their recommendations about how the federal
government can better assist those living with Alzheimer's
disease, as well as their families and caregivers.
The Alzheimer's Association estimates that 5.2 million
people in the United States live with Alzheimer's disease and
over 8 million individuals over the age of 65 will have it by
2030. Pennsylvania has the second oldest population in the
country after Florida and it is estimated that 250,000
individuals are living with Alzheimer's disease in Pennsylvania
today.
This is a significant number of people and as we all know,
and as I'm sure Justice O'Connor and our other witnesses will
discuss today, Alzheimer's disease does not just affect the
individual living with it, but family members, friends and many
others including caregivers who selflessly devote their lives
and careers to caring for individuals with Alzheimer's disease.
There are almost ten million Americans caring for people
with Alzheimer's disease and other forms of dementia. An
additional 250,000 caregivers are children between the ages of
eight and eighteen. This illustrates that burden placed on
young family members when there is no one else to provide
assistance.
With the aging of the baby boom generation, we can expect
to see even more individuals diagnosed with Alzheimer's
disease. It is estimated that one in eight baby boomers will
develop Alzheimer's disease and this will put increased
hardship and pressure on families, communities and our health
care system.
While anyone connected to this disease feels the biggest
cost in human terms, the economic cost is significant as well.
It was estimated in 2007 that unpaid caregivers of people with
Alzheimer's disease and other dementias provided care valued at
$89 billion. Medicare spends more than three times on
beneficiaries with Alzheimer's disease than any other disease
and it is estimated that by 2010, Medicare spending on
Alzheimer's disease will reach $160 billion per year.
There is no one single protocol that suits all patients
with Alzheimer's. Every person diagnosed with this disease
progresses differently and every person responds differently to
treatment. This is why continued research is so critical.
Until we find a cure for this ravaging disease, we must
work to ensure individuals with Alzheimer's disease and those
who love and care for them receive the help they need. Hubert
Humphrey always said societies are judged by how they treat the
children, the elderly and the sick. We much continue to hold
ourselves to his high standards and help those who cannot help
themselves.
------
Justice Sandra Day O'Connor Responses to Senator Hillary Rodham
Clinton's Questions
Question. In your written testimony, you stated that
caregivers of Alzheimer's patients are more likely to develop
depression and suffer compromised immune systems. In your
experience caring for your husband, John, what assistance has
been most helpful in supporting your physical and mental
health? What can the federal government do for caregivers like
yourself across the country?
Answer. I have not sought help for my own physical and
mental health thus far. I assume some medicare coverage will
help if I do decide to consult a doctor. We must rely on our
regular health care resources.
------
Dr. Rudolph Tanzi's Responses to Senator Hillary Rodham Clinton's
Questions
Question. You testified that the most fruitful research has
originated from the study of early onset Alzheimer's genes,
which enables you to delay the onset of people at risk. You
also noted that it would be 20 years before genetic testing
became routine. In the short-term, how do you recommend best
identifying those at risk for Alzheimer's disease?
Could you provide us with more detail regarding new drugs
that attack the toxic A-beta molecules in the brain? How soon
will these drugs be available? Are they well-tolerated by
individuals?
In your view, how critical is understanding the genetic
causes of Alzheimer's in developing treatment and an eventual
cure? Can you elaborate on the ``Alzheimer's Genome Project''?
What is the relationship between the ``Alzheimer's Genome
Project'' and the NIH-funded Human Genome Project?
In your research, what have you discovered on the link
between Traumatic Brain Injury (TBI) and Alzheimer's disease?
Answer. 1. With regard to how we can ``best identify those
at risk for Alzheimer's disease'', currently, we can only
predict risk with 100% accuracy in patients with early-onset
(<60 years), familial Alzheimer's disease that carry a mutation
in one of the three familial genes that we and other's
discovered between 1987-1995. These three genes are the amyloid
precursor protein (APP) and presenilin 1 and 2 (PSEN1 and
PSEN2) genes. We presently know of >200 different mutations in
these three genes, which when inherited, cause early-onset
Alzheimer's with virtual certainty. These mutations are rare,
accounting for only 1-2% of all Alzheimer's and half of the
early-onset, familial cases, e.g. the type that afflicts the
family of Chuck Jackson who also testified at the hearing on
May 14, 2008.
The majority of Alzheimer's is the sporadic, late-onset
(>60 years) form. We know from studies of identical twins, that
at least 80% of the common "sporadic" late-onset form of
Alzheimer's also involves inherited genetic risk factors. The
only confirmed genetic risk factor in this category is the APOE
gene. A risk variant of this gene, called ``epsilon-4''occurs
in 25% of the general population and in 50% of Alzheimer's
population. Unlike the early-onset, familial gene mutations,
inheritance of the APOE risk variant only confers increased
risk for the disease, and does not guarantee onset. Thus, it is
a ``susceptibility'' gene that requires other genetic and
environmental factors to trigger, the disease. As such APOE is
neither necessary nor sufficient to cause Alzheimer's, and is
not intended for use as a diagnostic or predictor of the
disease. It is only approved for use as a ``differential
diagnostic'', i.e. for use in a patient presenting with
dementia to help determine whether it is due to Alzheimer's
disease. Neither APOE, nor any of several dozen ``putative''
and unconfirmed Alzheimer's genetic risk factors are approved
for use as sole diagnostics or predictors of the common, late-
onset, sporadic form of Alzheimer's disease. To someday
reliably and accurately predict late-onset Alzheimer's disease,
we must first ``identify and confirm'' the full set (likely
dozens) of genetic risk factors that work together with each
other (and environmental factors) to trigger this disease.
As an aside, it should be noted that companies like
23andMe, Navigenics, Knome, and DeCode are already charging
considerable sums of money for anyone who wishes to pay to be
tested for the ``unconfirmed'' genetic risk factors for
Alzheimer's and other common diseases, e.g. cardiovascular
disease, cancer, and stroke. In my view, it is highly premature
and both medically and commercially irresponsible to be
conducting these tests. To reliably predict disease risk, we
will first need to establish the full set of ``confirmed'' risk
factors and then determine how they work together to influence
risk in a ``multigenic'' manner. As these companies become more
popular, the public will need to be increasingly informed and
educated about the fact these tests are not yet accurate,
reliable, or scientifically sound. I am concerned that these
tests may increasingly lead to unwarranted anxiety or a false
sense of security about one's genetic destiny as these
companies services become more ``trendy''.
In specific response to your question about how we can best
identify the full set of genetic risk factors for Alzheimer's
disease, we must first ``identify'' novel Alzheimer's gene
candidates in genetic association studies and then attempt to
``confirm'' them by testing them for replication in independent
Alzheimer's samples. We are approaching this in two ways.
First, we have established a very successful and highly
accessed website called AlzGene (http://alzgene.org), which is
supported by the Cure Alzheimer's Fund. This site compiles and
systematically displays all of the data generated in all
available publications (>1600) that have addressed Alzheimer's
genetics. Most importantly, for novel genetic risk factors that
have not yet been confirmed but are gradually being tested for
replication in multiple independent Alzheimer's populations, we
compile all of the published data for the candidate risk factor
and perform genetic analyses on the sum data to determine which
novel genetic risk factors for Alzheimer's have the highest
likelihood of being confirmed as bona fide risk factors for
Alzheimer's disease. To date, over 1500 gene variants have been
tested as genetic risk factors for Alzheimer's, of which we
(AlzGene) have found that only 29 have yielded statistically
significant results toward confirmation. Every week, we update
these analyses with the ultimate goal of establishing the
complete set of confirmed Alzheimer's genetic risk factors,
which determine one's predisposition for the common, late-onset
form of Alzheimer's. With the overwhelming success of AlzGene,
we have established similar sites for Parkinson's disease
(http://pdgene.org) and schizophrenia (http://szgene.org). The
CDC has recently indicated interest in eventually doing the
same for all common human disorders with complex genetics. For
the success of all these efforts, Alzheimer geneticists will
have to work closely with each other and patients and their
families to test candidate risk factors in as many independent
Alzheimer's populations as possible. GINA should go a long way
in providing protection to patients and their family members
who participate in these studies. However, GINA covers
employment and health insurance, but not life insurance or
long-term care insurance. Thus, I believe that there is still
more work to do on a comprehensive genetic privacy act as we
move into the age of personalized medicine. A second strategy
for finding the remaining Alzheimer's genes is our Alzheimer's
Genome Project, which is described in more detail below in
answer #3.
With regard to when we will be able to do routine genetic
testing for life-long risk of Alzheimer's disease and other
common age-related disorders, e.g. stroke, diabetes, cancer,
currently, we can already reliably predict many of the rare,
early-onset, familial forms of these diseases, which generally
represent 1-2% of these diseases. But, for the vast majority of
cases, which are late-onset, we will first need to identify and
confirm dozens of genetic risk factors that work in concert to
determine one's life-long risk for disease. For Alzheimer's and
other common, complex genetic diseases, we have established
four ``confirmed'' genetic risk factors and are still
investigating dozens of ``putative'' risk factors that have yet
to be confirmed. To reliably and accurately predict disease
risk, we will ultimately need the complete set of ``confirmed''
risk factors and we will need to understand how they work
together in a ``multigenic'' manner. While great progress is
being made, these are still the early and ``pioneering'' days
of this effort. Great progress is being made via AlzGene, the
Alzheimer's Genome Project and other Alzheimer's genetics
efforts. However, given the scientific challenges of
identifying and confirming novel genetic risk factors, I
believe that it will take 5-10 more years to assemble the first
reliable multigenic tests for late-onset Alzheimer's disease
and other common, age-related, complex genetic diseases.
Routine testing should be possible in 15-20 years. And once
again, the genetic testing currently being sold by companies
such as 23andMe, Navigenics, Knome, and DeCode is, in my
opinion, entirely premature and scientifically unsound, and it
would be prudent to educate the public about this. I and other
geneticists are currently doing so through the media, e.g. in
an upcoming episode of Nova on PBS.
2. The second question regards the new drugs that target
toxic A-beta molecules in the brain. These drugs are aimed at
retarding disease progression by curbing the accumulation of
the neurotoxic protein, A-beta, in the brain. The four
established AD genes (APP, presenilins 1 and 2, and APOE) have
taught us that the common pathological feature in the AD brains
of patients carrying defects in any of these four genes is the
excessive of accumulation of neurotoxic A-beta. There are two
basic ways to lower A-beta levels in the brain: Promote the
clearance of A-beta from brain, or curb the production of A-
beta in the brain. Details on the anti-A-beta drugs currently
in development and their prospects for success are provided in
a separate word file (Abeta--AD--drugs.doc).
With regard to the predicted timeline, I believe the first
anti-A-beta therapies should hit the market in 2-3 years, but
as is often the case with the first wave of therapies, these
will not necessarily be the best ones. They will, however, open
the door for more effective versions of anti-A-beta therapies,
which should come on line in 5-7 years.
With regard to the question of safety, generally, I believe
this class of drugs will be well tolerated with one exception.
We will need to carefully watch for adverse events, e.g. micro-
hemorrhages and encephalitis, from immunotherapy approaches
involving active vaccination or passive immunization.
3. Regarding the third question of how critical is
``understanding the genetic causes of Alzheimer's in developing
a treatment and eventual cure'', the vast majority of
researchers and clinicians in the Alzheimer's field would agree
that the contribution of genetics to solving the mystery of
Alzheimer's disease has been unmatched and unprecedented. The
genetic component of Alzheimer's disease is very strong with at
least 80% of cases involving inheritance, according to large
twin studies. Most of what we now know about the etiology and
pathogenesis of Alzheimer's disease has come from the discovery
and characterization of the four known Alzheimer's genes (APP,
PSEN1, PSEN2, and APOE). Moreover, most Alzheimer's therapies
currently in development, e.g. anti-A-beta therapies have been
made possible from studies of the four known Alzheimer's genes,
particularly, three early-onset genes.
In 1987, we, and others, reported the isolation of the
first AD gene (APP) then went on to co-discover two more early-
onset genes (presenilin 1 and 2) in 1995. I wrote about these
discoveries and their impact on Alzheimer's research in my book
``Decoding Darkness: The Search for the Genetic Causes of
Alzheimer's Disease'' and would be more than happy to send the
Senator and her staff a copy. In addition to these early onset
genes, a late-onset genetic risk factor gene, APOE, was
discovered in 1992. These four genes account for only 30% of
the inheritance of AD with 70% still remaining a mystery. If
one considers what the field has accomplished with the known
genes, imagine what we can achieve with the remaining 70%.
Every new gene we identify and confirm as a bona fide genetic
risk factor in AD provides a new biological target for drug
discovery while also enhancing our ability to predict and
diagnose the disease. While, I am generally optimistic about
the ongoing clinical trials of anti-A-beta therapies, we must
ready ourselves for the possibility that they may not be
sufficient to fully treat or prevent the disease, or may even
fail. This is why we must identify the genes underlying the
remaining 70% of the inheritance of Alzheimer's. As history has
shown us, every new gene we can identify will provide another
shot on goal to effectively treat, prevent, or even cure this
disease.
To elucidate the complete set of Alzheimer's genes, labs
all around the world are trying to identify the remaining AD
genes. Toward this end, we are carrying out the AlzGene project
(described above in answer 1 above) and the Alzheimer's Genome
Project (AGP). The AGP, which is based in my laboratory at
Massachusetts General Hospital, is a three-year, approximately
$3 million effort mainly being funded by the Cure Alzheimer's
Fund with additional support from the NIMH and NIA. We are
scheduled to publish the first set of results by the summer of
2008. The AGP is the first family-based whole genome
association study for Alzheimer's disease, being carried out in
over 1300 AD families. This study requires the newest
technology, e.g. microarray genotyping ``chips'', sophisticated
statistical analyses, large family samples for DNA, and
especially, the many databases made possible by the NIH-funded
human genome project. The databases have been absolutely
essential, if not indispensable, to the success of the AGP and
other efforts like it. They provide details about individual
genes as well as the structure and organization of the human
genome. We need this information to interpret or genetic
findings from studies of patients and their family members.
4. The fourth question regards the relationship between
Alzheimer's and traumatic brain injury (TBI). After age, family
history, and gender, the greatest risk factors for Alzheimer's
disease are head injury and stroke. Over the past several
years, we and others have discovered both stroke and TBI
significantly increase production of the neurotoxic A-beta
protein in the brain. This, in turn, leads to increased risk
for Alzheimer's disease over the ensuing years following
injury. In 2007, we published the molecular mechanism by which
stroke leads to increased generation of A-beta in the brain.
Over the past year, we have found that TBI increases cerebral
A-beta levels in the same manner. Consequently, we believe that
those who suffer from a stroke or undergo head trauma, e.g.
soldiers in Iraq and Afghanistan, also incur increased risk for
Alzheimer's disease. We are currently studying the molecular
mechanism underlying the stroke/TBI-induced increase in A-beta
in order to develop strategies to reduce A-beta generation
immediately following brain injury. Such therapies could
include the anti-Abeta drugs currently in clinical trials for
the treatment of Alzheimer's. If successful, one could envisage
a medical protocol in which patients entering the emergency
room or soldiers undergoing TBI in the battlefield would
immediately be given such drugs to help ward off downstream
risk for Alzheimer's disease later in life.
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