[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
ALZHEIMER'S DISEASE: THE ONGOING CHALLENGES
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
DECEMBER 9, 2010
__________
Serial No. 111-162
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah JOHN SULLIVAN, Oklahoma
JANE HARMAN, California TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
C O N T E N T S
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Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 3
Hon. Lois Capps, a Representative in Congress from the State of
California, opening statement.................................. 4
Hon. John Barrow, a Representative in Congress from the State of
Georgia, opening statement..................................... 5
Hon. Donna M. Christensen, a Representative in Congress from the
Virgin Islands, opening statement.............................. 6
Hon. Zachary T. Space, a Representative in Congress from the
State of Ohio, opening statement............................... 7
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, prepared statement.............................. 57
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 59
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, prepared statement............... 63
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, prepared statement......................... 65
Witnesses
Marcelle Morrison-Bogorad, Director, Division of Neuroscience,
National Institute on Aging, National Institutes of Health..... 9
Prepared statement........................................... 12
Harry Johns, President and Chief Executive Officer, Alzheimer's
Association.................................................... 22
Prepared statement........................................... 25
Eric J. Hall, President and Chief Executive Officer, Alzheimer's
Foundation of America.......................................... 31
Prepared statement........................................... 33
Marc Cantillon, M.D., Executive Director, Coalition Against Major
Disease, Critical Path Institute............................... 39
Prepared statement........................................... 41
Submitted Material
Article entitled, ``Evidence for Neurocognitive Plasticity in At-
Risk Older Adults: The Experience Corps Program,'' in Journal
of Gerontology: Medical Sciences, 2009, submitted by Mr.
Shimkus........................................................ 68
ALZHEIMER'S DISEASE: THE ONGOING CHALLENGES
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THURSDAY, DECEMBER 9, 2010
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 1:47 p.m., in
Room 2322, Rayburn House Office Building, Hon. Frank Pallone,
Jr., [chairman of the subcommittee] presiding.
Present: Representatives Pallone, Engel, Capps, Barrow,
Christensen, Space, Gingrey, and Markey.
Staff Present: Ruth Katz, Chief Public Health Counsel;
Sarah Despres, Counsel; Steve Cha, Professional Staff Member;
Allison Corr, Special Assistant; Alvin Banks, Special
Assistant; Elizabeth Letter, Special Assistant; Ronald Allen,
Staff Assistant; Clay Alspach, Minority Counsel, Health; Sean
Hayes, Minority Counsel, Oversight and Investigations; and Ryan
Long, Minority Chief Counsel, Health.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. The meeting of the House subcommittee is
called to order. And today we have a hearing on Alzheimer's
disease and its ongoing challenges, and I will recognize myself
for an opening statement.
As many of us know, Alzheimer's disease is an irreversible
progressive brain disease that slowly destroys memory and
thinking skills and, eventually, even the ability to carry out
the simplest task. Damage first strikes the areas of the brain
that control memory, and problems in memory are the first
symptoms to be noticed in early stages of Alzheimer's disease.
As deterioration progresses to other areas of the brain,
problems with other brain functions develop as well, as severe
Alzheimer's disease can affect every part of the brain and rob
its victims of their very lives and dignity.
Alzheimer's disease is fatal. It is estimated to be the
sixth leading cause of death in our country. NIH estimates that
as many as 5.1 million Americans may have Alzheimer's today,
and this figure is expected to grow to 13.5 million Americans
by 2050.
The truth of the matter, though, is that these figures give
an incomplete snapshot of Alzheimer's disease and related
dementias. Alzheimer's disease is, at the heart, a family
disease, as the intense caretaking that those afflicted with
the disease requires places a heavy financial and emotional
burden on the family. The serious medical complications related
to Alzheimer's disease mean that caregivers often struggle to
maintain work outside their home to earn a living, while
balancing a never-ending schedule of monitoring and treatment
for family members living with the disease.
For many adults, known as the sandwich generation, they are
duly responsible for caring for their aging parents while they
are also caring for their children. And Alzheimer's has a
devastating impact not just on families but on our national
economy. It is projected that the national cost associated with
caring for those with Alzheimer's exceeds $172 billion each
year, with the figure expected to rise to $1 trillion by 2005.
And these costs represent the burden on Medicare, Medicaid,
private insurance caregiving and out-of-pocket costs for
families. Of this figure, $123 billion can be attributed to
Medicare and Medicaid alone.
Until we cure Alzheimer's, it is imperative that our health
care system provides stronger support for families caring for
loved ones with the disease. The Affordable Care Act, which we
passed earlier this year, establishes the Community Living
Assistance Services and Support, or CLASS programs, a new
national long-term care insurance option. This legislation also
provides Medicare beneficiaries with free annual wellness
visits, which may increase the detection of early cognitive
impairment, enabling patients and families to better plan for
care needs. And, finally, the Affordable Care Act will ensure
that Americans living with Alzheimer's disease and other
preexisting conditions will not have to worry about having
their insurance coverage discontinued or denied.
In the future, whether families are subject to the triumph
or tragedy of Alzheimer's will be dependent on the innovation
and new drugs and therapies being investigated in laboratories
across our Nation. And today we are going to hear from the
National Institute on Aging at the NIH about the great work
their scientists are doing to better understand, diagnose, and
treat Alzheimer's disease. NIA's translation objectives have
focused on supporting early drug discovery and preclinical drug
development of novel compounds for Alzheimer's therapy.
We are also going to hear from the Coalition Against Major
Diseases within the Critical Path Institute on its efforts to
improve applied regulatory science and how this will strengthen
our ability to treat diseases like Alzheimer's.
And, finally, we will hear from the Alzheimer's Association
and Alzheimer's Foundation of America about the key research
they are supporting, as well as their initiatives and resources
that help support day-to-day caretaking of individuals with
Alzheimer's.
Now, many of the members of this committee have been
touched by Alzheimer's and expressed interest in examining the
complex issues related to the disease. I do want to highlight
the exemplary leadership and advocacy for Alzheimer's disease
by a member of our full committee, Mr. Markey. I think he is
going to be able to come today, but he basically has been
touched, of course, by his late mother's own struggle with the
disease, and because of that and for a lot of reasons he has
been an energetic leader in Congress and also chairs the
Congressional Caucus on Alzheimer's disease. So he may be
joining us later, but I did want to mention him today.
And I will now recognize for an opening statement our
ranking member, Mr. Gingrey.
OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Gingrey. Mr. Chairman, thank you. And I certainly want
to thank our witnesses for their patience with us today. The
witnesses will testify, as we hear from them, Alzheimer's
disease presents a looming threat to the health of our Nation,
and today I think the number is as many as 5 million Americans
in the United States have this dreaded disease. And the
scientific community is in agreement that these numbers will
only increase significantly in the coming years as our society
ages.
According to the United States Census Bureau, the number of
seniors age 65 and older will actually double to about 72
million in the next 20 years as these baby boomers all reach
retirement age. However, as Dr. Morrison-Bogorad will testify,
the generation behind them, I think this is what is referred to
as Generation X, and these are the folks born between 1965 and
1980, it is a significantly smaller generation than the baby
boomers.
So why is this comparison significant for the purposes of
the hearing today? As Alzheimer's is a degenerative and, as of
yet, incurable disease that requires constant monitoring, the
role of the main caregiver often falls to our family members,
as we all know. According to a study conducted by the
Alzheimer's Association, an estimated 11 million Americans
provide 12.5 billion hours of unpaid care annually for people,
usually their loved ones, with Alzheimer's and other dementias.
The disease also does require large amounts of medical care
in addition to in-home and community-based services. This high
use of medical services results in substantial cost to the
Federal Government, States, employers, and indeed families.
If the number of Alzheimer's patients does indeed double
over the next 20 years as many predict it will, we could be
facing a health care crisis if the number of family caregivers
declines, and of course the costly care for these patients
ultimately shifts to paid health care professionals.
Alzheimer's disease is also a personal issue for me. My
wife's mother, Laura Neill Ayers, was a very healthy and
vibrant 88-year-old woman. She didn't hear very well. I think
she loved that. But she was active. She loved to watch sports,
and she spent time in her room every day watching baseball. Her
husband, Bill Ayers, actually played baseball for the New York
Giants in the 1940s, and Laura picked up her love of the game
from her husband. Watching baseball became one of her favorite
pastimes and thoughts of spring training I think kept her warm
all winter long.
Seemingly overnight, all of that changed. She was diagnosed
with dementia and, we suspect, Alzheimer's halfway through her
89th year, and the woman that we know and love was changed
forever. Gone was the active woman, 88. In her place was a
woman that seemingly was trapped inside her own body, unable to
enjoy the comforts of these golden years.
I cannot begin to describe how emotionally destructive this
disease was, as many of you I am sure know, not only for my
mother-in-law but for my entire family.
There are many stories like this one that help underscore
the importance of finding a cure. Today there are no known
treatments to prevent, cure, or even delay the onset of
Alzheimer's. The five drugs currently approved by the FDA have
been shown to be successful in reducing the symptoms of the
disease, but much more needs to be done to ultimately find a
cure.
And so with that thought in mind, I would like to welcome
all of our witnesses here today. Specifically, I am interested
in hearing from Dr. Marc Cantillon, the executive director of
the Coalition Against Major Diseases for the Critical Path
Institute. As Dr. Cantillon will touch on in his testimony, the
goal of his organization is to promote a forum for scientists
from the FDA, academia, and industry to evaluate innovative
testing methods for the use in drug development.
As members of this subcommittee have heard during past
hearings, pharmaceutical drug development in the United States
can benefit from greater collaboration between industry and the
FDA. To the FDA's credit, they have recognized this fact in
many areas, including antibiotic drug development, something
for which I and a bipartisan group of members on this
subcommittee will be advancing pieces of legislation in the
112th Congress.
As a representative of the citizens of the 111th of
Georgia, I believe the government works best when its processes
are constantly scrutinized and reformed, when necessary, to
ensure they work as efficiently as possible. That theory
applies not only to Congress and the White House, but
government agencies as well. Therefore, I hope to learn more
about this phrase, ``applied regulatory science,'' during the
question-and-answer portion of the hearing and how it might
improve patient access to quality care.
Mr. Chairman, thank you for scheduling this hearing today.
And with that, I see my time has expired and I yield back.
Mr. Pallone. Thank you, Mr. Gingrey.
Mr. Gingrey. Mr. Chairman, I did want to ask for unanimous
consent to submit for the record our actual subcommittee
ranking member, Mr. Shimkus, a study that comes out of John
Hopkins, ``Evidence for Neurocognitive Plasticity in At-Risk
Older Adults,'' and the experience of that study.
Mr. Pallone. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pallone. Next for an opening statement, the gentlewoman
from California, our vice chair, Mrs. Capps.
OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mrs. Capps. Thank you, Chairman Pallone, for holding this,
the final Health Subcommittee of the 111th Congress. And I want
to thank you for your wonderful service as chairman over the
last 4 years.
Alzheimer's disease is a very topical subject for this
hearing, because the challenges faced by patients and their
loved ones are so reflective of the challenges we face
throughout our health care system. Long term, these are some of
the challenges which fit with Alzheimer's so well: long-term
care availability and its costs; respite care; an adequate
workforce; and research for better treatments and a cure.
Now, that is just touching the surface of the many
challenges that we face with this and so many other chronic
conditions. And thankfully, the new health care law provides
much-needed relief for many of these concerns. One of these is
the new long-term care insurance option. There is also Medicare
prescription cost relief. And there is opportunities for
training the next generation of health professionals; in
addition, the Cures Acceleration Network, along with what our
chairman mentioned as the CLASS Act. And, of course, we have a
lot more that we should undertake now within this framework of
the new legislation.
Some of these other steps we can take, such as passage of
legislation that I am very proud to cosponsor in the National
Alzheimer's Act I know you are going to be addressing today in
your testimony, including the National Alzheimer's project,
with the goal being that we can provide and develop a
comprehensive strategy for how to address Alzheimer's disease,
how to continue, as many of you have been doing over these past
many years.
So I do look forward to hearing from our witnesses today
about the latest in Alzheimer's research. I understand there
are some very critical breakthroughs that have been working
their way through the clinical trials and so forth, and also
what you see for us in guidance in the next Congress as
pressing needs that patients and so many of them, increasing
numbers of their family members and caregivers, are going to
experience.
As has also been mentioned, there is probably not one
person in this room who hasn't been touched personally by this
devastating disease. And we need to know it is a crisis
proportion, really, in our society now, how to best equip
ourselves and our communities to cope with it.
So I yield back and look forward to today's hearing.
Mr. Pallone. Thank you. And I also wanted to thank you also
as the vice chair. You have been really tremendously helpful,
and so often giving us insight on issues because of your
practical experience also as a nurse and your background. So
thank you.
Our next member for an opening statement, the gentleman
from Georgia, Mr. Barrow.
OPENING STATEMENT OF HON. JOHN BARROW, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Barrow. Thank you, Mr. Chairman. I want to thank you
also for your leadership throughout the 111th Congress on this
committee.
The poet said that comparisons are odious, and at the
personal level no one wants their personal trauma or tragedy
compared to someone else's. But at the level of public health
and social impact, I think some comparisons are useful. The
scourge of cancer has many faces. The scourge of Alzheimer's
has a very definite profile, many different impacts on folks,
but a very different impact in terms of the family.
I think it is useful to point out that we didn't really
begin to marshal the Nation's resources in the war on cancer
until folks could say, everybody knows somebody who has been
touched by cancer. I think it is fair to say that everybody now
knows somebody who has been touched by Alzheimer's. Nobody
knows the particular impact it has on family and on the
communities of interest around families that is the hallmark of
this dreaded disease. So I think we can take inspiration from
the fact that so many folks are impacted by this.
I think it is important to point out also in ways that
supplement what others have said, the cost of this disease. The
uncompensated care and the out-of-pocket expense to our system
is staggering and growing exponentially in ways that I think
compare very unfavorably to some of the other diseases that we
deal with at a social level. Right now, we are spending
something like $170-plus billion a year in compensated and
uncompensated care, taking into account the fair market value
of the services that folks are being forced to render and not
getting any kind of compensation for at all. That is coming out
of our gross social product. It is projected to cost our
society something on the order of $1 trillion a year at current
growth levels by the time we reach 2050. So it is staggering in
its potential for exponential growth and impact on folks.
The point is, this is not only the right thing to do in
terms of the quality of the life of folks affected by this. It
has never been truer to say that this is not only the right
thing to do, but it is the smart thing for us to do, to marshal
our resources in more effectively and economically managing and
treating and preventing this dreaded disease.
So, with that, I look forward to hearing the testimony of
our witnesses and thank them for coming today. And I thank you,
Mr. Chairman, for making this, the last hearing of this
committee and this Congress, a very large issue that we are
going to be dealing with for a very long time.
With that, I yield back.
Mr. Pallone. Thank you, Mr. Barrow.
Next, the gentlewoman from the Virgin Islands, Mrs.
Christensen.
OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A
REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS
Mrs. Christensen. Here thank you, Mr. Chairman. And thank
you for holding this hearing. And thank you, welcome to the
folks who are here to testify. And thank you not only for
taking the time to be here but for the work that you all are
doing. I really appreciate the approach that is being taken to
this devastating disease, a disease that is devastating to not
only individuals but families and communities, and potentially
to our country, because it is a wholistic approach, looking at
prevention, treatment, and research, but also looking at the
caregivers who are often forgotten.
I wanted to call attention to several areas.
First, the cost of care. Due to the cost of care, this
disease has the potential to bankrupt our health care system
unless we invest in all of these aspects today. In fact, by
2050, it is estimated that 13.5 million Americans will be
suffering from Alzheimer's, and the cost might be as much as $1
trillion a year.
Second, there is a grave discrepancy between the funding
for research for this sixth leading cause of death compared to
other leading causes of death, where billions are being spent
compared to just over $400 million on Alzheimer's.
Third, I want to call attention to the fact that racial and
ethnic minorities are disproportionately impacted with
Alzheimer's, with African Americans being twice more likely and
Hispanic Americans 1.5 more likely to suffer from Alzheimer's
and other dementias, despite the fact that they are
underdiagnosed compared to their white counterparts.
And I wanted to mention, too, other pieces of legislation
just to show that the Congressional Black Caucus has been aware
and engaged in this issue for several years. One is H.R. 4123,
the Alzheimer's Treatment and Caregivers Support Act,
introduced by Representative Maxine Waters, and H.R. 1192, the
Alzheimer's Family Assistance Act, introduced by Eddie Bernice
Johnson. Both of these bills, like the others that are being
mentioned in the testimonies, will help to take the fight
against Alzheimer's several steps forward and be a part of this
solution to this devastating problem.
So, again, thank you, Mr. Chairman. And thanks, all of you,
for being here.
Mr. Pallone. I thank the gentlewoman.
And next is the gentleman from Ohio, Mr. Space.
OPENING STATEMENT OF HON. ZACHARY T. SPACE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO
Mr. Space. Thank you, Mr. Chairman. Today is my final
hearing in committee, and I wanted to first express my
gratitude to Mr. Chairman and to Chairman Waxman, as well as
members on both sides of the aisle, for their work in some of
the most profound issues of the day and even a generation:
issues like energy and health care and the transformational
effect that the whole broadband era has brought to this country
and to our culture. And while we didn't accomplish everything
that I think we had set out to accomplish, we got a lot done.
And there is a lot to be done.
My district back in Ohio is a very rural district. It is
Appalachian Ohio, where the people are good and they work hard,
a lot of good things going for us back there. But there are a
lot of challenges that we have, and we share those challenges
with the rest of rural America. And one of the things that is
unique about this committee, I think, is the effect that it can
have on bridging the divide that exists between urban and
suburban America and rural America. And certainly the divide
does exist when it comes to accessing education, certainly with
regards to accessing health care. And I encourage the committee
to be every bit as ambitious in tackling some of those
challenges in the upcoming session of Congress.
With respect to the issue of today, Alzheimer's, I
sympathize with the remarks of my colleague and friend from
Georgia, Mr. Barrow; $172 billion a year, those are war-like
numbers. In other words, those are the kind of numbers you
spend when you go to war. If you couple the amount of money
that we are spending as a society on a disease like Alzheimer's
with what we are spending on diseases like diabetes, cancer,
and the list goes on and on, it soon reaches the trillion-
dollar level. In fact, Alzheimer's alone, by the year 2050,
will reach that level. And we cannot sustain that as an
economy.
When John Barrow says it is not only the humane thing to
do, it is the right thing to do, what he is saying is if it is
not important enough to deal with these issues simply because
of the mitigation of human suffering that occurs as a result of
these diseases, then certainly we should be able to justify it
because of the cost. And like Alzheimer's and diabetes and
cancer, the answer, at least from the congressional
perspective, is in medical research. We cannot simply rely upon
the private sector to tackle these diseases, not simply because
it is not the right thing to do but we can't afford it.
For every dime we invest today in research, we will receive
a return of dollars in the future. Many dollars. So I urge this
committee in future efforts, including its efforts with regards
to Alzheimer's, to bear in mind the obligation that we have as
an institution, as a government, and the duty we have to our
people to conquer these diseases through early diagnosis,
advanced diagnosis, advanced treatment, and above all, cure.
Let's not forget cure.
With that, Mr. Chairman, again thank you for your
leadership, and it has been a pleasure serving on your
committee.
Mr. Gingrey. Mr. Chairman, could I have a brief point of
personal privilege, a friendly point of personal privilege?
Mr. Pallone. Absolutely.
Mr. Gingrey. And let me first of all, to my friend from
Ohio, Mr. Space--and he truly is my friend and he and I know
that--indeed we will miss him. He is a great member with a
great heart, and I think the words that he just expressed to
this committee indicate the type of person that he is. And,
Zack, we will miss you and I really enjoyed serving with you.
And I hope we will keep in touch, my friend.
Also, I wanted to say to you, Mr. Chairman, and I say this
on behalf of my colleagues who I guess are on airplanes about
now, trying to get home to their families, and not the least of
which, of course, would be ranking member John Shimkus. We have
really enjoyed serving with you, under you, on this Health
Subcommittee of Energy and Commerce, not always agreeing on
every vote, in fact disagreeing a lot of times. But no one
could be more agreeable when he disagrees. Mr. Chairman, We
respect you and hold you in high regard and look forward to
serving with you in the 112th.
Mr. Pallone. Well, thank you. I really appreciate that. And
I want to say the same about you. Your input not only as a
physician, but just in general, has been fantastic. And I kind
of wish that Mr. Shimkus was here today, too, because I wanted
to say how easy it was to work with him in the last--I guess
not 2 years, a little over a year or so. And it is true, I
think, that even though we often disagree on a lot of issues,
that we have been able to work together on many issues. And it
kind of bothers me sometimes when the media, I guess, pays
attention to the differences and doesn't highlight how many
bills we have actually passed out and worked on together and
got signed into law that were very important for the American
people. So thank you.
And let me say about Mr. Space. Again, I know that I am
really going to miss him. He has really contributed a lot and
he has been a friend on so many issues. So thank you. Thank you
very much.
So we will get to our panel. Let me welcome you, first of
all. We only have one panel today, so I will introduce the
members.
Starting on my left is Dr. Marcelle Morrison-Bogorad, who
is director of the Division of Neuroscience at the National
Institute on Aging, with the National Institutes of Health.
And next is Mr. Harry Johns, who is president and chief
executive officer of the Alzheimer's Association.
And then we have Mr. Eric J. Hall, who is president and
chief executive officer of the Alzheimer's Foundation of
America.
And, finally, Dr. Marc Cantillon, who is executive director
of the Coalition Against Major Disease, from the Critical Path
Institute, and also happens to be a constituent, so I should
know how to pronounce his name, from one of my towns,
Kingsbury. So thank you in particular for being here today.
We have 5-minute opening statements that become part of the
record, and each of you can also submit additional statements
in writing for inclusion if you would like.
STATEMENTS OF MARCELLE MORRISON-BOGORAD, DIRECTOR, DIVISION OF
NEUROSCIENCE, NATIONAL INSTITUTE ON AGING, NATIONAL INSTITUTES
OF HEALTH; HARRY JOHNS, PRESIDENT AND CHIEF EXECUTIVE OFFICER,
ALZHEIMER'S ASSOCIATION; ERIC J. HALL, PRESIDENT AND CHIEF
EXECUTIVE OFFICER, ALZHEIMER'S FOUNDATION OF AMERICA; AND MARC
CANTILLON, M.D., EXECUTIVE DIRECTOR, COALITION AGAINST MAJOR
DISEASE, CRITICAL PATH INSTITUTE
Mr. Pallone. And I will now recognize Dr. Morrison-Bogorad.
STATEMENT OF MARCELLE MORRISON-BOGORAD
Ms. Morrison-Bogorad. Thank you very much, Chairman. And I
really thank you for inviting me to appear before you today to
discuss the pressing issue of Alzheimer's disease.
The National Institute on Aging is the lead institute for
Alzheimer's disease of the NIH. So in this regard I want to
tell you that you can now download copies of our 2009
congressionally mandated ``NIH Progress Report on Alzheimer's
Research'' from the NIH Web site.
I am retiring at the end of this year and am truly sad that
a cure for Alzheimer's has not been found on my watch. But the
momentum is there, and I believe that my successor will have
this joy.
Federal researchers, other scientific agencies, the private
sector, and not-for-profit are collaborating as never before to
try to solve the mysteries of this disease. For example, we
have regular meetings with each of the entities that will
testify at this hearing. We have partnered with the Alzheimer's
Association on many occasions, and ongoing is a joint venture
on updating the definition of AD.
The Alzheimer's Foundation of America and other
organizations held House and Senate briefings a couple of weeks
ago where Richard Hodes, director of NIA, was asked to testify.
And we work with the Coalition Against Major Diseases for the
Critical Path Institute on matters related to innovations and
marker use on clinical trials.
The NIA plans and manages an extensive program to better
treat and ultimately to prevent Alzheimer's. How do we do this?
Well, from our Alzheimer's Summit in 2006, the 2010 State of
the Science Conference, from numerous specialized workshops,
from program review by our NIA Council every 4 years, we get
input from all these sources, and from these decide on the best
ways to advance Alzheimer's research commensurate with our
funding.
For example, at the 2006 Summit, it was recommended that we
develop a project focusing on early onset AD families. We have
since funded the International Dominantly Inherited Alzheimer's
Network to study preclinical disease in these families. Earlier
this year, an NIH State of the Science Conference reported that
there was, so far, insufficient evidence that any behavioral
interventions for AD or age-related cognitive decline were
effective, and that we ought to devote more resources to these
questions.
Even before the report was finalized, we had stepped up our
funding of clinical trials to get definitive evidence whether
or not various exercise and cognitive interventions might
impact age-related cognitive decline, mild cognitive
impairment, and AD. Now we are funding around 20 such trials.
The Alzheimer's Disease Neuroimaging Initiative is another
example of our leadership. ADNI is a very successful public-
private partnership to identify biological and imaging markers
for better ways of monitoring AD clinical trials and also
identifying persons at risk for the disease preclinically. Here
we initiated the process through a series of meetings where we
brought together all interested parties to discuss what
initiative would be most useful for them for development in a
precompetitive setting, and these discussions led to funding of
ADNI in 2004, with substantial financial support from industry
and from not-for-profits such as the Alzheimer's Association,
coordinated by the Foundation for NIH.
Another aspect of our planning process is to ask our
director for funds to specifically target new areas that need
to be developed. An example is our Translational Initiative.
Partly through these targeted funds, this important and
innovative portfolio has grown to over 60 projects, each aimed
squarely at bringing a new drug to the stage where it can get
FDA approval for performing clinical trials. This is a
particularly important area for us to develop, as
pharmaceutical companies are often unwilling to put monies into
the beginnings of the drug discovery process and translational
research.
One reason that drug trials have not worked so far may be
that the drugs are given too late in the disease to have any
effect, but prevention trials to test those possibilities take
a lot of money and time under current protocols. We are
developing new methodologies, and in the meantime we have been
able to fund a number of prevention trials by the simple way of
adding cognitive measures on to trials started for other
clinical conditions often by other institutes. So it is a cheap
way of funding these trials.
But other possible drug therapies for Alzheimer's are
directed against unique aspects of the disease, and so for
these more specialized interventions NNIA must continue to
develop AD-specific trials.
We make difficult decisions all the time about where to put
our resources. We do not have a crystal ball to tell us what
approach will eventually pay off in relieving suffering from
this frightening disease. We are committed to trying every
promising avenue, and we will succeed. Thank you.
Mr. Pallone. Thank you very much.
[The prepared statement of Ms. Morrison-Bogorad follows:]
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Mr. Pallone. Next is Mr. Harry Johns.
STATEMENT OF HARRY JOHNS
Mr. Johns. Thank you very much, Chairman Pallone,
distinguished members of the committee. I want to also thank
Ranking Member Shimkus and all of you for holding this hearing
this afternoon.
My name is Harry Johns. I am the president and CEO of the
Alzheimer's Association. The Alzheimer's Association was
created in 1980 and is the leading voluntary health
organization in both the provision of Alzheimer's care and
support, and in the funding of Alzheimer's research, as the
largest nonprofit funder of Alzheimer's research in the world.
To do our job well, we spend a lot of time listening,
listening to people with Alzheimer's, their caregivers, their
families, to researchers, our many collaborators, and to
hundreds of thousands of our advocates. We hear their stories
and experiences, and they inspire us to go further, faster, to
provide better care, and ultimately the cure that we all seek.
We listen to those families in your districts and we listen to
our own families.
My mother had Alzheimer's disease herself. Any of us who
have seen the disease up close don't want to see it again, for
anyone to have the disease or to be a caregiver. Regrettably,
we know it is going to happen much more ahead of us.
You know, the effects of Alzheimer's, as it has been stated
previously, are truly devastating at the human level. In this
country alone, as previously referenced, we estimate actually
there are about 5.3 people who have the disease, about 200,000
of them younger onset, younger than 65. And by the middle of
the century it could be as high as 13.5, or even as high as 16
million individuals in the United States alone. Today, there
are 35 million people worldwide who have the disease.
Today, if you do develop Alzheimer's, we can say with
certainty, absolute certainty, that you will either die with
the disease or of it. And of the 10 leading causes of death, as
previously mentioned, Alzheimer's is now sixth, Alzheimer's is
growing by far the most rapidly, a 50 percent increase between
2000 and 2007, the last year that statistics are available. And
it is the only one of the top 10 causes of death that has
nothing to do to prevent, stop, or even slow it. For
perspective, even though Alzheimer's is likely seriously
underreported, already today it is killing more people than
diabetes and more people than breast cancer and prostate cancer
combined.
The 11 million caregivers in the United States, Alzheimer's
can literally take everything they have to give: their time,
their money, their jobs, and their own good health. And it
happens every day, oftentimes never to be recovered. One study
at least indicates that people who are caring for a spouse with
Alzheimer's can actually predecease the individual with the
disease.
The economic impact of Alzheimer's is also devastating,
truly staggering numbers. You have already mentioned the $172
billion in costs today for Alzheimer's going as high as $1
trillion by the middle of the century, which was reported in
the Alzheimer's Association's trajectory report earlier this
year. And those are in today's dollars. Those are not inflated
dollars. Those are dollars rated in today's terms. A total of
$20 trillion over the next 40 years just to pay for the care
costs, not an additional cent for the research we so badly
need. And our country is simply not ready for this onslaught of
Alzheimer's that is already upon us.
Let's take the case of research funding. You know, we have
made significant progress in other diseases, in fact, in no
small part because of the significant investments we have made
in those diseases. Research spending at the Federal level for
cancer is about $6 billion today; for a cardiovascular disease
about $4 billion; for HIV/AIDS it is about $3 billion. Now, all
of those are good investments. They have paid off in lives
saved, and they are going to continue to pay in that way for
our country. But in Alzheimer's, we are only spending $469
million a year, despite those other huge impacts we have
already discussed.
We know that more money invested in research save lives,
but we also know that too little money invested in research
actually costs lives and ultimately will drive those very huge
care costs into the trillions. Today, right now, we spend $250
in America on care cost for Alzheimer's and dementia compared
to $1 invested in research; 250 to 1.
So to address the underinvestment in Alzheimer's research,
the Alzheimer's Association strongly supports the Breakthrough
Act. It is a bill that authorizes $2 billion in Alzheimer's
research.
But the Alzheimer's Association will not ask others to do
what we won't do ourselves. We play an unparalleled role in the
research community in Alzheimer's, globally as well as in the
United States, and that certainly includes direct investment in
Alzheimer's and effectively investing in science.
Our peer-reviewed research program since its inception has
funded $279 million worth of research to 1,900 investigators,
making us the largest funder in the nonprofit world. And
through partnerships and our own funding, we have played some
kind of a part in every major advance over the past 30 years as
a result.
But as I discuss these necessary investments in Alzheimer's
research, and more broadly, I certainly recognize that our
country is currently engaged in a very appropriate and very
necessary conversation about our fiscal situation, our fiscal
situation as a country, and we have to address that. But
Alzheimer's, unaddressed, is one of our most devastating
issues, both human and financial, as we have all discussed. So
we must aim at what is the highest return potential we have for
investments, Alzheimer's one of them.
So if we can't fix Alzheimer's, I don't think we can fix
Medicare. Medicare costs three times more for each individual
in the system who has Alzheimer's than it does for a normal
individual.
Mr. Pallone. Mr. Johns, I have been trying not to cut
anybody off because we only have the one panel.
Mr. Johns. Let me wrap really quickly then, Mr. Chairman.
Certainly I want to mention the National Alzheimer's
Project Act, and I want to thank this committee for its
leadership. I certainly again want to recognize Congressman
Markey who you mentioned for his leadership as the author;
certainly recognize Dr. Burgess who has also provided
leadership on this. And we know, of course, the Senate passed
the bill yesterday. We look forward to the real possibility of
the House passing it. We urge you to pass it. And we look
forward to working with this committee and the Congress to
realize the ambition of the Alzheimer's Association, its
vision, a world without Alzheimer's disease.
Mr. Pallone. Thank you.
[The prepared statement of Mr. Johns follows:]
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Mr. Pallone. Mr. Hall.
STATEMENT OF ERIC J. HALL
Mr. Hall. Chairman Pallone, members of the committee, thank
you so much for convening this hearing and for inviting the
Alzheimer's Foundation of America to testify. I am Eric J.
Hall. I am the AFA's founding president and chief executive
officer, and I am truly honored to be here to testify on behalf
of our member organizations and families that we care for
across the country.
AFA was formed in February of 2002 to provide optimal care
and services to individuals confronting dementia, and to their
caregivers and families, through member organizations dedicated
to improving quality of life. Today our membership consists of
more than 1,400 organizations, including grassroots not-for-
profit organizations, government agencies, public safety
departments, and long-term care communities.
Our services include a toll-free hotline staffed by
licensed social workers, educational materials; Care Advantage,
which is a free quarterly family caregiver magazine that right
now reaches about 1 million readers; professional training
programs; AFA Teens, which is a Web-based support and
scholarship program; and our National Memory Screening Date. As
a foundation, our money is generated and disbursed by grants to
service organizations as well as respite grants to families who
are in need.
Recognizing the severe fiscal challenges facing our Nation,
it is more important than ever to leverage available private-
sector resources in a cost-effective manner to support public-
sector initiatives. AFA makes substantial investments in care
and services to tackle the enormous challenges associated with
Alzheimer's disease and related dementias for both individuals
and their family caregivers.
But the needs of the population are going to overwhelm our
resources in the years to come. The National Institute on Aging
reports that as many as 5.1 million Americans over 65 are,
today, dying of Alzheimer's disease, and those numbers are
projected to increase dramatically in the coming years. The
rapidly rising costs associated with this disease will put an
enormously heavy burden on families, businesses, and government
economically.
It is our opinion that increased investment in preventing,
treating, and/or curing chronic diseases of the aging, such as
Alzheimer's disease, is perhaps the single most effective
strategy in reducing national spending on health care. Chronic
diseases associated with aging account for more than 75 percent
of Medicare and other Federal health expenditures.
Unprecedented increases in these diseases as the population
ages are one reason why the Congressional Budget Office
projects that total spending on health care will rise to 25
percent of the U.S. GDP by 2025.
Simply put, our Nation does not have the luxury of time to
wait to address the health research needs of this population.
Standard & Poors' recent report titled ``Global Aging 2010: An
Irreversible Truth,'' stated that no other force, no other
force is likely to shape the future of national economic
health, public finances, and/or policymaking at the
irreversible rate at which the world's population is aging.
Standard & Poors believes that the cost of caring for people
will profoundly affect growth prospects and dominate public
finance policy debates worldwide.
As we have learned from the experience that we have all had
with polio, heart disease, HIV/AIDS, cardiovascular, and other
diseases, medical research and breakthroughs can have a
profound impact on reducing health care costs.
As the extension of life expectancy from age 47 in 1900 to
almost 80 in 2000 demonstrates, medical advances enormously
increase national productivity and prosperity. Yet those
benefits can only come about if NIH makes the needed
investments and research aimed at preventing, treating, or
curing age-related diseases and extending healthy life.
AFA, again, recognizes the serious fiscal challenges facing
our Nation, which will require Congress to carefully scrutinize
future funding priorities. We believe it is critical to
leverage critical resources within the private sector,
including not-for-profit organizations such as our own, to
support proven, cost effective initiatives, and that is why we
will all need Congress to be our partner.
This subcommittee and the full Energy and Commerce
Committee have played a critical role in overseeing and
supporting the mission of the NIH, and we respectfully urge
your support for continued commitment to NIA's important
research. AFA is seeking $1.4 billion, an increase of $300
million in fiscal year 2012 National Institute on Health budget
specifically for the National Institute of Aging. This funding
is the minimum essential to sustain the research needed to make
progress in attacking the chronic diseases that are driving
mass increases in our national health care costs. That level of
funding would make the NIA's baseline consistent with
comparable research initiatives conducted elsewhere under the
auspices of NIH.
If NIA funding is not significantly increased, we stand to
lose a generation of more young and emerging investigators in
aging and Alzheimer's disease. This would be an enormous waste,
since the NIA is poised to accelerate the scientific
discoveries that can be translated quickly into effective
prevention and efficient health care to reduce the burden of
this silver tsunami of age-associated chronic diseases.
Breakthroughs from NIA research can lead to treatments and
public health interventions that can delay the onset or slow
the progression of costly connections such as heart disease,
stroke, diabetes, bone fractures, age-related blindness,
Parkinson's, and indeed Alzheimer's disease. From a budgetary
perspective alone, such advances could save trillions of
dollars by the middle of this current century.
At the Alzheimer's Foundation of America, our incredible
strength and our quick success has come from collaboration. AFA
looks forward to working with members of the subcommittee to
address the important issues raised in today's hearing and, in
the long term, to end the devastation caused by Alzheimer's
disease.
Mr. Pallone. Thank you. Thank you, Mr. Hall.
[The prepared statement of Mr. Hall follows:]
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Mr. Pallone. Dr. Cantillon.
STATEMENT OF MARC CANTILLON, MD
Dr. Cantillon. Mr. Chairman, members and staff, thank you
for the opportunity to present testimony on this very important
topic. I am Dr. Marc Cantillon, the executive director of the
Coalition Against Major Disease of the Critical Path Institute,
also known as C-Path.
I am a practicing physician and a neuroscientist, with 15
years' experience in research and drug development at the NIH,
academia, nursing homes, and within the pharmaceutical
industry.
C-Path is a nonprofit organization founded in 2005 by the
FDA and the Arizona community in order to build collaborations
that identify more reliable and efficient methods to test new
medicines' applied regulatory science.
As you have heard, in spite of the exciting laboratory
discoveries in Alzheimer's research, we lack full translation,
we lack new medicines that could significantly alter the course
of the disease. And, indeed, we have seen huge Alzheimer's
disease drug trials fail. Nevertheless, there is reason for
renewed hope.
Across the hall into science is a proverb written up that I
would like to quote. ``Where there is no vision, the people
perish.'' Proverbs.
Thanks to the work of this subcommittee, the FDA Amendments
Act of 2007 included a provision for the FDA to create the
Critical Path public-private partnerships. We are extremely
grateful to Congresswoman Marsha Blackburn of Tennessee,
Congressman Elliot Engel of New York, and Congresswoman
Gabrielle Giffords of Arizona for their leadership on this
legislation.
The Coalition Against Major Diseases, or CAMD, was one of
the first of these partnerships launched by the FDA, and it is
already creating and identifying new tools that will speed the
safe development of new medicines for Alzheimer's and other
neurodegenerative diseases.
CAMD seeks to recreate the sense of urgency and open
collaboration that made the unprecedented rapid progress
against AIDS possible. Sharing of knowledge was the hallmark
and is generally accepted as the reason that the rapid and
enduring success was secured against that epidemic. Created by
C-Path and the Engelberg Center of the Brookings Institute,
CAMD is a consortium that currently includes scientists from 12
major pharmaceutical companies, NIH scientists, as well as
experts from patient organizations such as my colleagues here
today, the Alzheimer's Association and Alzheimer's Foundation.
The FDA, along with the European Medicines Agency, the EMA,
and indeed the Japanese PMDA, provide advisers to our over 250
scientists who participate in CAMD by sharing what they know
about Alzheimer's disease and how they can better test new
therapies.
CAMD's accomplishments have already changed the way we
attack this devastating disease. Firstly, CAMD researchers
compare the way that they and other researchers score dementia,
scored dementia in a clinical trial, and subsequently corrected
over a dozen inconsistencies. Now it is possible for them and
for EMA and FDA to compare results directly from study to
study.
This is a great example of applied regulatory science
because it improves the quality, the accuracy, and efficiency
of decisions made by both the regulators and the regulated
industry of the pharmaceutical industry.
A first ever, CAMD was able to pool the data from 11
clinical trials conducted by several different pharmaceutical
companies. This has created the largest publicly available
Alzheimer's disease database in the world, and it describes the
natural course of the disease in over 4,000 patients. Over 200
teams of scientists around the world are already using this.
For example, modeling. In the past, former scientists had
to design trials based on their clinical experience or data
within the company or what they read in the medical literature.
This database allows the individual patient-level data to show
progression over time in this number of patients. This is far
more precise than their clinical experience or what they can
glean from the medical literature.
This database also allows them to more accurately predict
the outcome for a particular trial, or how long the trial must
be, or how many patients must be included; indeed, how genetic
subsets of the population might respond differently, et cetera.
CAMD is now working with NIH and with academic centers to pool
their data in the same standardized database to further enrich
this as a leading-edge tool.
CAMD is also helping define the FDA's new qualification
process described in the new guidance. In this work, CAMD
submits data and requests that the FDA accept certain brain-
imaging tools or cerebral spinal fluid tests as qualified for
identifying patients much earlier in their disease when there
is still brain function to be saved.
Yes, there are many reasons for hope. The Critical Path
public-private partnership is improving the applied regulatory
science for Alzheimer's at the FDA. However, we do need your
help. Understaffing is a serious problem throughout the FDA and
is especially serious for CAMD. The FDA needs your support to
be able to dedicate the required number of scientists and staff
to participate in CAMD and other Critical Path partnerships.
This is the kind of applied critical science that is changing
the way drugs are tested and evaluated today, so that
Alzheimer's can be prevented, not just slowed.
I thank you for the opportunity to provide this testimony,
and everybody in the CAMD thanks you for your leadership and
foresight in authorizing the FDA's Critical Path public-private
partnerships that are giving new hopes to patients and families
at risk for this devastating disease. I would be happy to
answer any questions.
[The prepared statement of Dr. Cantillon follows:]
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Mr. Pallone. Thank you, Doctor.
I thank all of you. We will take questions from the
members, and I will start with myself, and I will start with
Dr. Morrison-Bogorad.
Scientists know Alzheimer's attacks the brain long before
people exhibit cognitive decline. But the specifics are crucial
because, so far, drug after drug has failed to effectively
treat Alzheimer's in people who already show symptoms. I know
you suggested that that was part of the problem, that perhaps
the answer is earlier treatment before you actually have the
signs of the disorder. So what I wanted to ask is why are
biological markers, whether gene mutations or pathological
brain changes, important to the development of effective
treatments for Alzheimer's and what research is NIA conducting
to better understand these markers? I am sort of going back to
that same issue that you mention, is perhaps we should be
starting earlier but then we would have to know if people have
the disorder.
Ms. Morrison-Bogorad. It is probably one of the items that
we are pushing most of our effort into these days, because we
do think that understanding the earlier stages of Alzheimer's
disease is very important and we have thought that ever since
we reissued the request for applications for funding our
Alzheimer's disease centers across the country. Because about 8
years ago now we said to them, forget about late stages of
disease. We want you to really, really concentrate on the
earlier stages.
So we have thought about this for quite a long time; and,
obviously, one of the things that held us up is not being able
to identify preclinical stages. That is one of the things that
is really being addressed by the Alzheimer's disease in your
imaging initiative, especially in people who aren't yet showing
symptoms or in people who are developing mild cognitive
impairment, which is a precursor to Alzheimer's. Researchers
working together with industry and people funded by us are
identifying markers in the cerebrospinal fluid, and these
markers are lowered beta-amyloid and higher levels of protein
called tau that signal that a person is approaching the stage
of mild cognitive impairment.
The other technology which has been developed by ADNI and
by others is actually being able to look at in the brains of
individuals cerebral amyloid plaques through positron emission
tomography, through imaging. And this is perhaps the most
amazing breakthrough over the last several years because that
has allowed us to see that in a number of folk, older folk,
older than 65 or 70, about 20 percent of these folk who
otherwise would have been thought of as normal, who are quite
normal cognitively, have levels of amyloid plaques in their
brain that in some cases are equivalent to a person with
Alzheimer's disease who can't at the moment function for
themselves.
So the CSF markers and the brain markers are two ways we
have of identifying preclinical disease which we didn't have
before, and they could be used to identify people who have got
markers in the brain, amyloid in the brain for earlier clinical
trials than we are able to do right now. So I agree. It is
really, really, really important that we develop these markers
and that we use them to do more efficient clinical trials in
the preclinical stage.
Mr. Pallone. I had a second question, but I maybe would
prefer if anybody else would want to comment on this issue
because I think it is pretty important. Would any of the others
like to----
Mr. Johns. I simply add that what Marcelle has said is
certainly one of the most exciting areas that is occurring in
Alzheimer's research today. She has indicated that we have
worked together on this at the Alzheimer's Association
International Conference on Alzheimer's Disease over the
summer. There were significant findings released on this very
front. It is potential to go to the point where we can actually
identify Alzheimer's presymptomatically in the future. It is
not ready for the clinic. That is for the lab at this point.
That is a significant set of advances that are very important
to us.
What is of course very important is that we have a parallel
in treatments. Right now, we are making faster advances on the
diagnostic science than we are on treatment side. So what we
really need to do is catch that up. And that is one of the most
important reasons for the additional funding that is really
needed for Alzheimer's disease.
Mr. Pallone. Thank you.
Mr. Gingrey.
Mr. Gingrey. Mr. Chairman, thank you.
I think I will shift then to the treatment aspect of it and
maybe come back to very interesting things that the two of you
have just talked about with regard to early diagnosis.
Dr. Cantillon--I hope I did better. I know I botched that
up pretty bad the first time--I have a lot of respect that the
FDA, the Food and Drug Administration, performs. With that
being said, I am interested in exploring how the FDA drug
approval process might be improved in the hope it may help spur
a greater drug development for diseases such as Alzheimer's.
I think I mentioned in my opening remarks that I have
introduced legislation along with my colleagues here on the
committee, Energy and Commerce Committee, Health Subcommittee,
bipartisan, Mr. Green and Ms. DeGette on the Democratic side
and myself and Mr. Rogers from Michigan on this side, the GAIN
Act. This is in regard to the shortage of antibiotics. So a
different disease, a different category of drugs, but equally
as important. Can you tell me, Dr. Cantillon, how applying
scientific advances such as the use of biomarkers or drug
development tools might aid in drug development in this
country?
Dr. Cantillon. Yes. Thank you for that question.
So, actually, as a medical director of Alzheimer's and
other programs with Schering Plough over the last couple of
years before CAMD, I did sit on an industry advisory group for
this ADNI trial that Dr. Bogorad was speaking about. So I was
giving some advice into the choice of the instruments and that
these markers were being developed, had my hat on in terms of
both drug development and facing the FDA with a package for an
approval for a treatment.
The trouble is when you are coming from a drug developer's
point of view, this is all very cutting edge. And as I said in
my testimony, the science by itself is truly not enough. It is
not enough to have exciting markers that may predict something
that is going on in the brain if it can't be harnessed into a
path and the development steps to use a new drug and prove
that. I will give you an example.
So we talked just now about the cerebrospinal fluid. We
know there are certain proteins that can indicate both the
disease and perhaps even the type of progression predictive. We
would take that and we are taking that and in a collaborative
way with the whole field. So we are just one collaboration that
I had mentioned. Look at the evidence for that in a critical
way, in a scientific manner.
The regulatory science part is having our regulatory
scientific colleagues internationally review that in a context
of use. Does that allow you to choose a population for a trial
who are not yet demented? So to call somebody demented, you
don't need to be a doctor. It is very clear that the person
does not have their brain functions in the same way for memory
and so forth. To find somebody that is very early in the
disease or even hasn't fully shown clinical symptoms, you need
these markers.
Can we ask for FDA regulatory approval that these are
standardized in such a way that they can become a tool, a
standard tool publicly available to any company in this country
or anywhere else? Can take off the shelf and put into a program
such that, by using this tool, they don't have to defend that
tool when they go in front of the FDA? That process has already
been done in this qualification. And instead they can focus on
their own particular drug that then fits into this pattern and
can use that patient population, for example, to show
progression over time. Do those people who have low tau, high
tau, low a-beta or a particular brain picture with amyloid, do
they progress faster than others and can you show a difference
in the people who were on drug and off drug? That is how the
whole development process can make use of this science and
translate it into something that the FDA can then approve or
not approve.
The FDA did put out a guidance document partially from
working with us just 2 months ago, and in that the steps are
laid out very clearly. Essentially, it is show us the evidence.
Very similar----
Mr. Gingrey. My time is rapidly drawing to a close, but let
me quickly ask you, do you think it is important that such drug
development tools--biomarkers--that they first receive approval
by the FDA before being used by industry and the agency to
measure the safety and efficacy of the drug? Do you think that
the FDA would have to approve this off-the-shelf kind of
testing ahead of time?
Dr. Cantillon. The FDA has the possibility just to approve
for commercial use or other use, but that is not within the
context of use that we are talking about. The context of use
would help that tool help define a particular population. So,
for example, let me give you another--for another consortium.
We developed some markers for renal injury, for kidney injury.
They were brand new, and they could allow a drug developer or
anybody to show if something was happening very early on before
the kidney actually was destroyed. These markers went through
this qualification process and are being very widely used by
all companies, including my former one, to make decisions about
drug development. When they go to the FDA, they don't need to
defend those markers for kidney. They have already been
approved. So it takes a lot of that work away and you can focus
on the drug.
Mr. Gingrey. Doctor, thank you. That does answer my
question. And I will yield back, Mr. Chairman.
Mr. Pallone. Thank you.
The gentlewoman from the Virgin Islands.
Mrs. Christensen. Thank you. Thank you, Mr. Chairman.
Dr. Morrison-Bogorad, given the disproportionate impact of
Alzheimer's on minorities, is the National Institute of
Minority Health and Health Authority Research, which was
formally the center among the NIH institutions that you are
collaborating with? And, also, how diverse are the participants
in the clinical trials?
Ms. Morrison-Bogorad. It is again something that we paid
particular attention to, especially in our flagship clinical
trials, the Alzheimer's disease clinical consortium, and there
we have made a rule that a certain number of people in each
clinical trial that we run there are minorities. And that has
been extraordinarily helpful because it has meant that I think
a fifth of the folk who participate in certain of these studies
are minorities. So it is amazing what a little rule will do.
And we certainly have got quite a vibrant program in
epidemiology looking at Alzheimer's disease in minorities and
comparing that with Alzheimer's disease. And I would say at the
moment the results are somewhat equivocal because many of the
ways in which you define Alzheimer's disease are also very
dependent on things like the education of the person who is
taking the tests. And many older African Americans, of course,
for other reasons haven't had the education that they should
have had and so they don't do as well on these tests as they
should. It doesn't mean they have Alzheimer's, however.
So this is a very, very thorny issue and we have gotten a
number of very good researchers working on that to actually try
and tease out what part of the minority burden of Alzheimer's
disease is real--and I do believe some of it is because some of
the possible things that cause Alzheimer's disease are, as you
are aware, much more prevalent in minority communities, things
like heart disease. But I do believe that some of the numbers
are a little bit over, perhaps larger than they should be
because of this issue on how to determine Alzheimer's disease
in people with different backgrounds.
Mrs. Christensen. That is interesting, because my
impression is that it is underdiagnosed rather than
overdiagnosed in minorities. And I will let anybody comment on
that.
But I wanted to ask Mr. Johns, if I can get this question
straight, because I know this hearing is really about getting
funding for Alzheimer's. And, Mr. Johns, I heard your argument
very clearly about the need for an increased investment in
Alzheimer's to reduce the cost of health care eventually and to
perhaps even save Medicare. We have been trying to get CBO to
score prevention for a while, actually introduced legislation
to have them do that when they are asked by the committee. So,
without having scoring in place for prevention, how do you
foresee getting the funding needed, especially in a Congress
that is committed to cutting spending? And how important do you
think scoring prevention is to this particular issue?
Mr. Johns. Well, certainly, as you say, the fact is that
CBO won't score what I would describe as a game changer. That
is a problem I know for all of us when we have interest in what
would be effectively R&D for our country. We really have--
beyond the immediacy of Alzheimer's, we have what is a
potential brain drain in our country as a result of research
being attracted overseas. While it isn't specific to
Alzheimer's, it is generic and related to Alzheimer's, as well
as other medical research.
So we have as a country to face what is, first of all, a
significant problem in that larger regard with medical research
but very specific in Alzheimer's; and, of course, we have the
challenge of facing our economic realities and also then
funding something that cannot be scored. We recognize fully the
difficulties of this, but we can also see from the projections
we have done--and we have gone to outside sources at the
Alzheimer's Association to develop what are these data. We have
actually used the CMS data on expenditures on Medicare and
Medicaid. We have taken those to Dartmouth. We have had the
Lewin Group look at all these data and what we have identified
is that $20 trillion cost over the next 40 years.
One of the problems we have as a country, of course, is
actually addressing problems that are longitudinal. Those of
you sitting across from me know that better than I in terms of
how hard it is to make those things work. But we certainly know
it, too, the Alzheimer's Association and any of us here sitting
on this side who are trying to change the course of Alzheimer's
disease. We have to find the national fortitude to address this
already enormous problem. Everyone who has the disease today
will die with it or of it. We do not have a treatment that
stops or even slows it. The devastation of the disease at a
human level for all of us who have experienced it personally
and for all of those who haven't, we recognize just how bad
that is.
I don't have the easy answer to your question, but the
scale of the problem, the enormity of the issue begs for us to
find a way to answer the question so that we can address this
now. We are running out of time.
One of the things that Marcelle mentioned is that the
science community believes ever more that we need to intervene
sooner, that the plaques entangles of the disease are deposited
earlier in life, at least 10 years before the symptoms
manifest. If, in fact, we don't make these investments
relatively soon, the baby boomers, 10 million of whom will have
this disease, will be a lost cause. And the devastation at a
human level and the economic toll will be solidified if we
don't move relatively soon.
Mrs. Christensen. Thank you. Thanks.
Mr. Pallone. I thank the gentlewoman.
Next, we have our Alzheimer's hero here, who actually
sponsored both of the bills that you mentioned, Mr. Johns, the
one that I guess is now in the House for action hopefully next
week, as well as the larger bill. Mr. Markey.
Mr. Markey. Thank you, Mr. Chairman, very much; and I thank
our witnesses so much for your participation here today.
Robert Browning wrote, grow old with me, the best is yet to
be. But the truth is that for millions of millions of Americans
the golden years are now the worst years because of Alzheimer's
and the family caregiver who has to help. So this is now at 4
million or 5 million Americans already an epidemic since, as we
know, not only does the Alzheimer's patient have the disease,
but one family member has it as well as. So about 10 million
Americans right now are living with it on a daily basis in
their homes or in some facility. And when it goes up to 12
million times 2, 24 million, 25 million people, the caregiver
and the patient, it is going to be an incredible moment in
American history. So we have an incredible responsibility here
to make sure that we put in place a plan.
And, Mr. Chairman, you made reference to it, which is that
the National Alzheimer's Project Act, which I introduced on
this side along with Christopher Smith, the co-chair of the
Alzheimer's Task Force, passed the Senate last night. And
Senator Bayh and Senator Collins did an excellent job in
framing it up and we will be able to pass that next week on the
House floor. And then we will have a plan. We will have
something that makes it possible for us to put in place
something that is the plan to attack this disease. And it is
long overdue, but it is a good beginning.
So let me ask you this, and maybe you could reflect upon
it, Mr. Johns, if you could. Last year, the Federal Government
spent $122 billion on helping people with Alzheimer's, but we
only invested $469 million in finding the cure, and we know we
are only at the beginning of an explosion of the bills that are
going to come in across America for the Federal Government to
help families with Alzheimer's. Can you reflect upon that, give
us your insight as to how big it is going to become and why it
is imperative that we act now?
Mr. Johns. Certainly. And let me thank you, Mr. Markey, for
your authorship of NAPA and the input and leadership of yours
and the committee's in moving that forward.
Certainly Alzheimer's is already costing $172 billion in
total, the $122 billion you talked about from the Federal
Government. Incidentally, at the Medicare level, Alzheimer's is
driving 17 percent of the Medicare budget----
Mr. Markey. Say that again.
Mr. Johns. Seventeen percent of the Medicare budget is
driven by Alzheimer's today. The total cost for Alzheimer's
again to the country and other dementia is, by the middle of
the century, in excess of $1 trillion per year; and by far the
bulk of that will be the Federal Government's cost projected
from today's levels with no changes. So that it simply won't be
affordable not only on the economic front but again on the
human front.
We can't accept what will happen to families. We don't have
the ability to deal with the end-of-life considerations of the
long-term care. Families at some point, dedicated as they are,
with 70 percent of the people who have Alzheimer's living at
home and cared for at home, at some point that other percentage
as a result of the fact that families, no matter how much time
they spend, the 24 hours a day that they often spend as
caregivers, especially toward the end of life, is no longer
enough or they are simply not capable of handling the
difficulty of the care at home so that we are not equipped at
this point. As you indicated, we don't have a plan for any of
these things at this point. NAPA will hopefully address that,
but we are just not prepared as a country to handle any of
these problems at the scale they are going to rise to.
Mr. Markey. This is just something that is not as well
understood as it should be. My mother had Alzheimer's, and she
was a valedictorian. My father was a milkman. And my father
always said it was an honor that my mother married him. And he
used to say, as well, if the strength of your brain determined
who got Alzheimer's that he would have had it and my mother
would have been taking care of him. But we know that this is an
equal opportunity disease. At age 80, 82, 84, 86, 88, my father
kept her in our living room with the arms of a milkman, arms
the size of my legs; and he was able to do it.
But for many families it becomes exhausting. You can't do
it. There is a point beyond which you need help and that helps
comes increasingly from the Federal Government in the form of
$122 billion a year right now.
But I don't think actually we are going to be able to solve
the Federal budget deficit if we don't dramatically increase
the Federal investment in research. It will be a trillion
dollars a year just for Alzheimer's care in another 15 years,
and it is just a number that is going to increase
exponentially. And despite the efforts of people like my father
and other families all across the country, these people are
heroes, but heroes need help and they need hope. And only the
National Institutes of Health, really the institutes of hope,
really give people the courage to keep on going.
So this whole effort is absolutely--I think it should be
the number one issue, to be honest with you, just from a
budgetary perspective. From a humane perspective, yes. Coupled
with the Alzheimer's Breakthrough Act, which I have introduced,
and the HOPE Act, the Health Outcomes, Planning and Education
Act, which we have to focus on, we have to put in place the
kind of ingredients of this plan that make it possible for us
to solve this problem. And I commit to you, all of you, that I
am going to continue to just work my heart out to make this
something that becomes real in people's lives; and I cannot
thank you enough all of you for your support.
And, Mr. Chairman, I thank you for conducting this hearing.
I don't think there is a more important subject for us to be
discussing as Americans.
Mr. Pallone. Thank you. And thank you for all you do, Mr.
Markey, on this and other issues.
Mr. Engel.
Mr. Engel. Thank you. Thank you very much, Mr. Chairman.
Right in the nick of time.
First of all, I want to thank everyone on the panel. This
is certainly a very, very important and--and something I have
had a lot of concern about. I think that--what all my
colleagues have said--this is what we ought to be spending
money on when we talk about some of the other issues. I think
we should all agree on issues like this.
Mr. Chairman, I want to ask unanimous consent to insert my
opening statement in the record.
[The information was unavailable at the time of printing.]
Mr. Engel. Let me ask Dr. Cantillon--first of all, thank
you for your comments. I was told the comments you made before,
and I deeply appreciate your saying that. The Critical Path
Initiative is certainly something that is near and dear to my
heart. I have strongly supported public-private partnerships,
and I am pleased to learn that this program has been very
effective in tackling diseases like Alzheimer's.
You mentioned in your testimony, Doctor, that one way
Congress can be helpful is to provide the resources to
increasing staffing levels at FDA; and, as I mentioned before,
I couldn't agree more. We need to increase resources for the
FDA to help them bring drugs to market. But, given the limited
resources we are working with, I was wondering if you could
address other ways that we might help break down the barriers
to translational research and help fill in the gap that has
opened up between biomedical researchers and the patients who
need their discoveries, which we unfortunately referred to as
the valley of death.
Dr. Cantillon. Indeed, thank you and thank you for your
support for these partnerships.
I think that the partnership, the public-private
partnerships, are certainly a major part of the answer in this
fiscal environment. So we have all said several times that this
is about to bankrupt our country and many other aging countries
around the world and there aren't unlimited funds either to put
into any one particular disease. And maybe we need to look at
an innovative science and an innovative way of answering some
of these questions that have come up.
So the FDA is going to be faced with a lot of the new
science arriving in different ways. Part of what we have been
working together with them was to put a process in place to
translate this science, not just, let us say, from the test
tube to the rat, but all the way through to a new medication at
the very end. In other words, to make a process available to be
able to gather the evidentiary information.
The FDA doesn't have but a few handful of staff that we
deal with on a very regular basis and, as I mentioned, are
indeed a part of our consortium; and the Europeans, in fact,
are in a similar situation. So what I was referring to is
basically stretching the dollar and the people that we have.
Part of what we are doing and seek to do more of is in fact
build an in-kind work, and there is a lot you can do with that.
There is a lot of scientists, just like there was a lot of
data, who have been siloed, be it within government--I used to
be at NIH--or within companies.
Once a trial has failed, that data is essentially put on
the shelf somewhere. Definitely with the kind of tools we are
talking about, those data can be re-examined, at the very
least, and perhaps there will be some pearls in there. But they
also can be mined for the learnings that are there and shared.
That is public and belongs to all of us.
So what we put together are these various methods to do
that. It is, I would say, an innovative tool to get people to
give up their silo thinking, look at a precompetitive space for
companies and even for academics, that they actually don't own
the data that they have generated, that it belongs to the
people. And if we can set it up that way, have it as a
database, for example, as I mentioned, but also the other
tools, then that is freed for the best minds in the world to
attack and that is actually a very efficient way of doing that.
Mr. Engel. Thank you for pointing that out. It certainly is
a shame if research is put on the shelf and no one else can get
to it or look at it. This has to be a collaborative effort,
obviously, and thank you for pointing that out.
I would like to ask a question of Mr. Hall and Mr. Johns.
As I am sure you are aware, the Patient Protection and
Affordable Care Act, which is referred to as health care
reform, that we just passed here, we were doing this for as you
know almost 2 years. There was a provision in there that
improves access to home and community based care for patients.
We know that these services greatly improve the quality of life
for Alzheimer's patients.
Health care reform, as we know, strengthens the long-term
care system for chronic and other long-term neurological
conditions both by eliminating the arbitrary caps on treatment,
which we did--that was one of the crowning glories of this
bill--and by expanding coverage to include preexisting
conditions, which is the second pillar that is so important in
this bill.
In an effort to improve upon existing programs that
positively impact Alzheimer's patients and help you provide
services, can you give us some insight as to how these
provisions will improve your ability to provide services for
Alzheimer's patients and their families? And can you also
address what other Federal programs exist to help you deliver
services to more patients?
Mr. Johns. Well, I personally think that all of our
constituents are in a position, especially, as I mentioned
previously, that 70 percent or more of people are cared for at
home. All of our constituents who are in a position to be at
home need additional assistance. As we see how all this
unfolds, we will learn better exactly how it can best serve the
individuals who are in those situations. So we certainly always
have high hopes for what would help to be a better care at
home.
Because we know, as I mentioned a little bit earlier, that
we do not have the capability to really accommodate all the
folks who would ultimately perhaps need to go to long-term
care. So additional ways to find ability to handle people at
home is critical to the entirety of the Alzheimer's
constituency.
Mr. Hall. Additionally, I think we all agree that the
longer we can prolong institutionalization the better it is for
the Federal budget, for sure. But families do need an enormous
amount of support. The conversation we have had here around
research is pivotal. There is no doubt we need to find a cure
as quickly as possible, and any amount of money that we can put
towards this disease would be an enormous win at this point.
But the reality is that a cure does not seem to be coming
anytime soon, and so it does rely on care, and it does rely on
those families. So any type of provision that supports
individuals with the disease and cares for them and provides
for them the greatest quality of life for the longest period of
time is great.
But also, too, we are recognizing the support that is truly
needed for caregivers across the country at this point, at this
juncture where we are in relationship to a cure is really the
critical step. It is what we need to do.
Mr. Engel. Thank you. Thank you, Mr. Chairman.
Mr. Gingrey. Mr. Chairman, just very quickly--and I know
the afternoon is getting long, and I appreciate our witnesses
who have done a wonderful job. I guess I would direct this to
Mr. Hall. Can you talk about the benefits of early detection as
it relates to both the financial realities that patients face
and for making end-of-life decisions?
Mr. Hall. Sure. The Alzheimer's Foundation of America hosts
and is the initiator of National Memory Screening Day, and the
reason that we do that is really just to sort of educate the
public as a whole and then to allow individuals to participate
in memory screenings across the country. That isn't a diagnosis
for Alzheimer's, but rather is looking to see if there is an
indication of I guess the most common manifestation of
Alzheimer's disease, which is memory problems. That initiative
to us is really important because of the fact that it points to
a possible early diagnosis of this disease. It is really
critical because our experience at the Alzheimer's Foundation
of America is that our phone calls, our e-mails in the volume
that we receive, every single one of those families is in
crisis and chaos. So they are really scrambling now to figure
out what does Alzheimer'sdisease care look like? What am I now
responsible for as a family? What is required of me legally,
financially? What is required of my time?
Early diagnosis in our interpretation is really important
because, one, I think some of the treatments that are available
right now are able too offset the progression of the symptoms
of the disease and therefore the person enjoys--the person with
the disease enjoys a higher quality of life for a longer period
of time.
And I have to tell you, traveling the country--and I am
sure Harry could say the same thing--We have not met one single
family anywhere that hasn't said that all they wanted was one
more good day with their loved one who is in the grips of
Alzheimer's disease. If we can prolong one more day, I think
that is a win. That is what we have right now.
But, additionally, planning in this situation is enormous,
educating, empowering the family unit so that they understand.
It is generally one in four individuals caring for every person
with Alzheimer's disease. But also then enabling organizations
to surround those families, to hold their hands, to walk with
them on the journey and support them, to connect those families
at the point of diagnosis with those necessary resources,
instilling hope, which is probably the greatest missing link in
Alzheimer's disease.
At least by surrounding a family with hope you are doing
just that. You are giving them a lifeline, and you are letting
them know that they are not going to be alone in the process.
That takes care of an enormous emotional toil for a family,
which is probably the biggest piece of the picture.
And then if you are able to bring in other resources of
financial planning and legal planning and what all this looks
like as far as care in the future, those are enormous wins in
alleviating the burden, the stress, depression for caregivers.
Mr. Gingrey. Thank you.
Mr. Pallone. Thank you. That concludes our questions, but I
just want to thank you all of you. It is obvious from listening
to the questions and your testimony how important this is both
now and in the future. We do plan to move the one bill that
passed the Senate on the House floor next week; and, of course,
the larger bill will have to wait for another time. But this
is--I just want to stress how important really and how we
really plan to prioritize this. So thanks a lot.
Let me mention that you may get additional questions from
the members to answer in writing. The members are supposed to
submit those within the next 10 days or so, but you may get
those and the clerk will notify you of that.
But, without objection, this meeting of the subcommittee is
adjourned.
[Whereupon, at 3:21 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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