[House Hearing, 113 Congress]
[From the U.S. Government Printing Office]
THE GLOBAL CHALLENGE OF ALZHEIMER'S:
THE G-8 DEMENTIA SUMMIT AND BEYOND
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HEARING
BEFORE THE
SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH,
GLOBAL HUMAN RIGHTS, AND
INTERNATIONAL ORGANIZATIONS
OF THE
COMMITTEE ON FOREIGN AFFAIRS
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
NOVEMBER 21, 2013
__________
Serial No. 113-119
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COMMITTEE ON FOREIGN AFFAIRS
EDWARD R. ROYCE, California, Chairman
CHRISTOPHER H. SMITH, New Jersey ELIOT L. ENGEL, New York
ILEANA ROS-LEHTINEN, Florida ENI F.H. FALEOMAVAEGA, American
DANA ROHRABACHER, California Samoa
STEVE CHABOT, Ohio BRAD SHERMAN, California
JOE WILSON, South Carolina GREGORY W. MEEKS, New York
MICHAEL T. McCAUL, Texas ALBIO SIRES, New Jersey
TED POE, Texas GERALD E. CONNOLLY, Virginia
MATT SALMON, Arizona THEODORE E. DEUTCH, Florida
TOM MARINO, Pennsylvania BRIAN HIGGINS, New York
JEFF DUNCAN, South Carolina KAREN BASS, California
ADAM KINZINGER, Illinois WILLIAM KEATING, Massachusetts
MO BROOKS, Alabama DAVID CICILLINE, Rhode Island
TOM COTTON, Arkansas ALAN GRAYSON, Florida
PAUL COOK, California JUAN VARGAS, California
GEORGE HOLDING, North Carolina BRADLEY S. SCHNEIDER, Illinois
RANDY K. WEBER SR., Texas JOSEPH P. KENNEDY III,
SCOTT PERRY, Pennsylvania Massachusetts
STEVE STOCKMAN, Texas AMI BERA, California
RON DeSANTIS, Florida ALAN S. LOWENTHAL, California
TREY RADEL, Florida GRACE MENG, New York
DOUG COLLINS, Georgia LOIS FRANKEL, Florida
MARK MEADOWS, North Carolina TULSI GABBARD, Hawaii
TED S. YOHO, Florida JOAQUIN CASTRO, Texas
LUKE MESSER, Indiana
Amy Porter, Chief of Staff Thomas Sheehy, Staff Director
Jason Steinbaum, Democratic Staff Director
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Subcommittee on Africa, Global Health, Global Human Rights, and
International Organizations
CHRISTOPHER H. SMITH, New Jersey, Chairman
TOM MARINO, Pennsylvania KAREN BASS, California
RANDY K. WEBER SR., Texas DAVID CICILLINE, Rhode Island
STEVE STOCKMAN, Texas AMI BERA, California
MARK MEADOWS, North Carolina
C O N T E N T S
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Page
WITNESSES
Mr. George Vradenburg, chairman and founder, USAgainstAlzheimer's 5
Mr. Matthew Baumgart, senior director of public policy,
Alzheimer's Association........................................ 16
Andrea Pfeifer, Ph.D., chief executive officer, AC Immune
(appearing via videoconference)................................ 24
LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING
Mr. George Vradenburg: Prepared statement........................ 8
Mr. Matthew Baumgart: Prepared statement......................... 18
Andrea Pfeifer, Ph.D.: Prepared statement........................ 27
APPENDIX
Hearing notice................................................... 40
Hearing minutes.................................................. 41
The Honorable Christopher H. Smith, a Representative in Congress
from the State of New Jersey, and chairman, Subcommittee on
Africa, Global Health, Global Human Rights, and International
Organizations: Statement submitted for the record by the
Honorable Maxine Waters, a Representative in Congress from the
State of California............................................ 42
THE GLOBAL CHALLENGE OF ALZHEIMER'S: THE G-8 DEMENTIA SUMMIT AND BEYOND
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THURSDAY, NOVEMBER 21, 2013
House of Representatives,
Subcommittee on Africa, Global Health,
Global Human Rights, and International Organizations,
Committee on Foreign Affairs,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:15 a.m., in
room 2172 Rayburn House Office Building, Hon. Christopher H.
Smith (chairman of the subcommittee) presiding.
Mr. Smith. We now move to a hearing, pursuant to notice, on
the Global Challenge of Alzheimer's: The G-8 Dementia Summit
and Beyond. And I recognize myself and then I will go to Dr.
Bera.
Good morning. Next month, the United Kingdom will host a
meeting of health ministers from G-8 member countries in London
to discuss strategies to address the global challenge of
Alzheimer's and other forms of dementia. Currently, more than
35 million people worldwide live with some form of dementia. By
2050, this population is projected to triple, in effect, to
more than 115 million people. The total cost of dementia,
treatment and care is estimated to be somewhere on the order of
$604 billion, with about 70 percent of those costs now
occurring in Western Europe and North America. As populations
age across the globe, today's crisis may become tomorrow's, and
will likely become, unless action is taken and cures are found,
tomorrow's catastrophe.
Since our subcommittee's June 2011 hearing on this very
issue, attention has increasingly turned to dealing with this
situation in which people live with dementia, which is more,
frankly, than the people living with HIV/AIDS which is about 33
million. Today's hearing is being held in advance of the G-8
Dementia Summit to discuss the policy of the U.S. Government
representatives should offer at this conference through
recommendations from organizations involved in Alzheimer's and
dementia research and treatment.
Many of us have family members, friends, and
acquaintances--I don't know anyone who doesn't know someone who
suffers from Alzheimer's or some form of dementia. We know the
pain of seeing a loved one lose their grip on present
circumstances and experience relationships built over decades
radically changed forever. Spouses, parents, siblings and other
relatives become unable to care for themselves and we are faced
with the heartwrenching decision on how best to ensure their
care. Sometimes symptoms are too subtle to recognize
immediately. Sometimes they manifest themselves as sudden
changes in personality. However they occur and for whatever
reason they occur, these cognitive changes disrupt families and
change lives permanently for both the people suffering from
these conditions and those who care for them.
The World Health Organization estimates that more than half
of global dementia cases are in low and middle income countries
where cases are projected to grow. The gross national income
per capita in these countries is sometimes less than $1,000.
Countries across Africa, Asia, and Latin America are expected
to see the rapid growth in dementia cases over the next several
decades. In 2010, roughly 53 percent of dementia cases were in
low and middle income countries. By 2050, WHO expects 70
percent of all dementia cases to be found in such nations.
In high income countries, family efforts to care for those
affected by dementia are supported by the administration of
medicines and other professional care services that can be
obtained through private insurance or other government-funded
programs. In the majority of low and middle income countries,
however, low awareness of dementia and its impact are reflected
in a lack of comprehensive government policies and public
resources aimed at addressing these conditions. As a direct
result, care for people living with dementia in these regions
is predominately the responsibility of their families.
Support for people with dementia is funded differently
across the world. In high income countries, roughly 40 percent
of associated costs are borne by the family through informal
care, whereas, in low and middle income countries nearly 60
percent of these costs are covered through informal care.
Health insurance or other social safety net schemes are
typically used in high income countries to alleviate some of
the financial burden associated with care for loved ones with
dementia. These supports are not widely available or affordable
in most low and middle income countries, and the formal social
care sectors in these areas are ill equipped. As a result,
families in these countries are often required to assume not
only the cost of care but also the delivery of that care.
WHO estimates that while 30 percent of people with dementia
live in assisted living facilities or nursing homes in high
income countries, only 11 percent do so in low and middle
income countries. Our Government has worked to enable people in
low and middle income countries to enjoy the kind of prosperity
those of us in the developed world experience. However, trends
indicate that as populations age, they become increasingly
prosperous. With immature health systems, however, and
inadequate health resources, illnesses that primarily afflict
the elderly, such as dementia, risk derailing economic growth
as the productive population attempts to care for their older
loved ones. Estimates indicate that the proportion of people
older than 60 years who will require care will dramatically
increase by the year 2050.
We do have an aging planet. The challenge that will face
the health ministers gathered in London next month is to find a
way to continue to enable increased prosperity in low and
middle income countries while taking into account the drain on
that prosperity from care for an aging population. Foreign aid
to developing countries for health care purposes will change
and we need to anticipate that change now before it becomes an
overwhelming situation. In the United States and the rest of
the developed world, we also must face our own challenges.
As one of our witnesses, Professor Andrea Pfeifer, will
testify, the four pillars of the G-8 Dementia Summit are, 1)
building public-private cooperation networks; 2) business
coordination to prevent dementia; 3) investment in solutions
and treatments; and 4) laying the groundwork for the transition
to an aging society without dementia. This is indeed a tall
order, and cooperation internationally between developed and
developing countries, public-private partnerships, and an
effective transition to a dementia-free world will be
difficult, but not impossible.
We invited experts from the Department of Health and Human
Services to attend, who will attend the G-8 summit, to testify
at today's hearing, but they have declined, at least for now.
We hope to have them appear in a post-Summit hearing to tell us
what that gathering achieved and what the U.S. Government role
in addressing this global challenge, from their perspective,
will be. Meanwhile, we have with us the chief executive officer
of one of the world's leading pharmaceutical companies working
on Alzheimer's treatment research and two advocates for a more
effective response to the challenge of dementia, not only in
the United States, but worldwide as well.
The struggle to meet the challenge of HIV/AIDS has been
tremendous, and in fact this morning I met with Mark Dybul, the
executive director of the Global Fund. The enormous work that
is being done through PEPFAR is a great credit to a concerted
world effort to mitigate and hopefully eradicate that horrible
disease. But we need to, now, in addition to continuing that
fight, look at some of these other huge pandemics that we face
as global citizens, and certainly dementias, and Alzheimer's is
chief among them.
I would like to now yield to Dr. Bera.
Dr. Bera. Thank you Chairman Smith and thank you for--this
is an incredibly timely hearing in advance of the G-8
gathering.
I look at Alzheimer's disease from the perspective of being
a physician and how it impacts not just the patient but the
families and the entire community. And just from personal
experience, having cared for both patients as well as family
members who are struggling to care for aging parents and so
forth, this is an incredibly important issue for us to deal
with, particularly when you look at the numbers. I think, if I
am not mistaken, over 5 million Americans currently suffer from
Alzheimer's disease, and as the baby boomer generation and our
population ages it is going to impact America.
The benefit we have though is we have resources and
infrastructure to help care and help support those families as
they are caring for their loved ones. But as we look at the
developing world, as the chairman pointed out, they don't have
those resources, so much more of the burden falls onto us as
the United States and the developed world to come up with
mechanisms and resources to help the developing world.
Within our country, within my home institution of the
University of California, Davis, the UC system and our academic
research centers, we have to develop an ability to enable the
developing countries to better sort through what are treatable
causes of dementia versus untreatable causes of dementia. We
also have to invest in that research that allows our
pharmaceutical companies to come up with the mechanisms and the
treatments to, if not cure Alzheimer's at least to help
mitigate and slow down the devastating impact of what is right
now an irreversible form of dementia.
I was talking to a constituent of mine who is trying to
care for her aging parents right now, and again, with the
resources we have in the United States she is struggling as her
parents get older and older and their dementia gets worse. I
can only imagine if you were in a country that didn't have
those resources and didn't have those support structures just
how difficult it would be.
Again, I applaud the chairman for hosting and holding this
hearing. I look forward to hearing what the witnesses have to
say. And again I would just encourage all of us here in
Congress to think about how we make those investments in
research, how we make those investments and enable us to come
up with better diagnostic tools and also better therapies and
treatment to slow down dementia as well as hopefully one day
come up with a cure for Alzheimer's disease. So again, I am
looking forward to the testimony.
Mr. Smith. Thank you very much, Dr. Bera.
Vice Chairman Randy Weber?
Mr. Weber. Thank you Mr. Chairman. I too appreciate you
holding the hearing, and I am going to be very short-winded.
Looking forward to the witnesses' testimony. Thank you.
Mr. Smith. Thank you Mr. Weber.
I would like to now welcome our witnesses, beginning first
with, Dr. Andrea Pfeifer is co-founder of AC Immune, in 2003,
where she has been CEO since it was founded. She is a member of
the WEF Global Agenda Council of Brain and Cognitive Sciences
and the CEOi Initiative on Alzheimer's disease. As the former
head of Nestle's global research in Switzerland where Professor
Pfeifer managed a group of more than 600 people, she brings
more than 25 years of senior management experience including
broad R&D, business, and international exposure. Dr. Pfeiffer
is an international expert in biotechnology and a professor in
Switzerland as I mentioned.
Our second witness will be Mr. George Vradenburg who is
chairman and co-founder of USAgainstAlzheimer's, an education
and advocacy campaign committed to mobilize America to stop
Alzheimer's, and convener of the Global CEO Initiative on
Alzheimer's. He also helps direct Leaders Engaged on
Alzheimer's Disease, a coalition of Alzheimer's serving
organization. He has been named by the Secretary of Health and
Human Services to serve on the National Alzheimer's Advisory
Council to advise on the first of its kind National Alzheimer's
Strategic Plan which is mandated from legislation we passed in
the last Congress.
Prior to December 2003, Mr. Vradenburg held several senior
executive positions in large media companies, and I thank him,
because we have met many times that he has been a source of a
great deal of input to this subcommittee on what we ought to be
doing, and I do greatly appreciate that.
We will then hear from Mr. Matthew Baumgart. He is the
senior director of public policy for the Alzheimer's
Association. His portfolio includes overseeing state government
affairs, the public health project for the Centers for Disease
Control, and the public policy department. Prior to joining the
Alzheimer's Association, Mr. Baumgart worked for nearly 18
years in the United States Senate. He was legislative director
for Senator Barbara Boxer where he supervised the legislative
staff, managed all the senator's legislative activities and was
her chief legislative strategist. Prior to working for Senator
Boxer, Mr. Baumgart worked for over 10 years with then-Senator
Joe Biden.
So if we could start with Mr. Vradenburg.
STATEMENT OF MR. GEORGE VRADENBURG, CHAIRMAN AND FOUNDER,
USAGAINSTALZHEIMER'S
Mr. Vradenburg. Thank you very much, Mr. Chairman. Chairman
Smith, Mr. Bera and Mr. Weber, I am here today as the convener
of the Global CEO Initiative on Alzheimer's. It is a coalition
of a number of companies across a number of sectors from
pharmaceuticals to medical food to diagnostic companies to
financial service companies and home health care companies.
Mr. Chairman, you commented about having met frequently.
Much has happened in the last 2\1/2\ years since this committee
had another hearing on the same subject. We have established a
national plan in this country. We have established the rather
bold goal of trying to stop this disease by 2025. The World
Health Organization has judged Alzheimer's and dementia as a
public health priority. OECD has a robust innovation work plan.
Professor Peter Piot who headed the U.N. effort on HIV/AIDS has
called now for a global plan against Alzheimer's and dementia,
viewing it as a challenge to the 21st century much like HIV/
AIDS was at the end of the 20th century. And as you mentioned,
next month at the invitation of Prime Minister David Cameron,
representatives from G-8 nations are gathering in London for
the first ever G-8 Global Dementia Summit.
More than a dozen years ago, the G-8 met in Okinawa to
commit to a global effort to fight HIV/AIDS. It was a turning
point in the world's attention to that disease. And the United
States during the course of the Bush administration stepped up
the Global Fund and the PEPFAR, as you mentioned, and it was
proven to be extraordinarily successful even as we still have
more to do. A similar G-8 commitment to address Alzheimer's and
dementia would make this a pivotal moment in the history of
this disease as historians write of the battle against this
disease in the 21st century.
I have urged the U.S. delegation to use the G-8 summit to
press for the development of a global plan to stop Alzheimer's,
and I am urging today that the U.S. delegation begin to lay the
foundation for a global fund to finance that effort by calling
on nations to contribute 1 percent of their national costs of
caring for those with the disease to a global fund to stop it.
So for the United States, if costs are roughly $200 billion a
year, a 1-percent contribution would represent $2 billion a
year.
A global plan must be actionable, goal oriented, and
updated regularly. It has got to be designed, it seems to me,
to reinforce national plans and strategies. It has got to be
appropriately financed. And it has to enjoy the strong and
sustained backing of government leaders, not just from the G-8
nations, but from the entire range of low, middle income, and
high income countries because the footprint of this disease is,
as you have emphasized, Mr. Chairman, much broader than the
eight nations that are going to be represented in London. So
London should be regarded with the G-8 as a first step.
It seems to me that a plan should focus on critical and
emerging areas in need of global coordination, new financing to
finance Alzheimer's research, drug development and care, for
example, through a global fund, but not limited to a global
fund. Multi-national high-performance infrastructures for
Alzheimer's longitudinal studies and clinical trials to
identify the means of both pharmacological and
nonpharmacological interventions to prevent this disease are
other key elements.
A third element of this plan has to address the critical
issues of basic and regulatory science such as the scientific
development and regulatory qualification of predictive AD
biomarkers. The fourth element of this plan, it seems to me,
has to deal with the new age of technology, and we need to
develop globally interoperative, technology-driven techniques
to thoroughly and expeditiously exploit the voluminous amounts
of big data that are being generated by genomic science and
electronic health records. This needs to be turned to
discovering the mechanisms of action of this disease, those at
risk for the disease and cures for those diseased. And of
course it has to deal with care innovations.
As you mentioned, Mr. Chairman, every country has dealt
with care of those with Alzheimer's in quite different ways.
New technology-assisted mechanisms of monitoring care
management, of care coordination, and potentially care quality
controls, seem to me to permit us now to exchange information
with the rest of the world in terms of the innovations that are
needed to assure quality care across care settings in stages of
the disease, and to make sure they are efficiently delivered.
If we commit to these efforts, the potential value to the
public is huge.
A recent report by RTI International found that if we make
certain reforms in our infrastructure, we can reduce the cost
and risk of developing Alzheimer's therapy by over half, speed
up by nearly 18 months the time to get a therapy to patients,
reduce by millions the number of dementia years of Alzheimer's,
and save hundreds of billions of dollars in public cost. This
is just in the United States.
Excuse me, I am getting over a cold as you can hear, and so
I apologize if my voice breaks like a 14-year-old boy.
These findings underscore what is possible when the
appropriate level of resources, focus, and planning are
directed at this problem. As JFK, whose assassination we
recognize tomorrow, emphasized when he made his moonshot
speech, we do not set goals and regard them as easy. We set
goals that are hard and we do that because it will mobilize our
resources, our intellect, and our focus to solve the problem in
front of us. That is what we need now. Thus, I am urging the
U.S. and other nations to develop a global action plan along
these lines starting at the G-8 summit.
The global CEO Initiative on Alzheimer's will be convening
a meeting on December 12 in London following the December 11
global Summit with the representatives of the key G-8 nations,
as well as with industry and scientific leaders, in order to
turn the political commitments that are made at the G-8 summit
into action plans in 2014.
I am also urging the U.S. to be not only more actively
participatory in these international efforts, but to lead these
international efforts. As you pointed out, Mr. Chairman, the
United States ended up leading the effort against the HIV/AIDS.
We didn't just participate and allow others to lead. We took
the leadership against the global pandemic, and in fact much of
the progress that has been made has clearly been a global
effort, but much of the progress has been made because of the
leadership of the United States.
So the United States can lead not just at the G-8 summit.
There are some workshops that are contemplated in 2014 to
follow up on the G-8 summit, but there is also continuing work
at the OECD in which the United States has not been an active
and engaged participant. And we need to ensure that while the
Prime Minister of England is the President of the G-8s for this
year, his presidency ends at the end of the year and we need
leadership that will continue this effort at a global level
after December 31. And so the United States is, of course, the
natural leader in these areas and should take the lead as we
move forward after the end of this year.
And I would encourage you, Mr. Chairman. You have been
active and you have focused on this important issue, but
international parliamentarians are eager to establish a
regular, ongoing dialogue and conversation among
parliamentarians about what ought to be done. Both in Europe
and Japan, we have talked to them. They are ready, willing and
able to establish with you, Mr. Chairman, an international
parliamentarian group that will begin to focus on this disease
and not allow it to rest simply with the executive branches of
the various countries.
And finally, on research funding, I would urge all of you
to support increases in our own NIH budget, generally, as well
as for Alzheimer's research. Senators Collins and Klobuchar,
last night, introduced a resolution in the Senate to double
Alzheimer's research from its current roughly $500 million to
$1 billion in Fiscal 2015, and then over a period of years to
increase that level of investment to $2 billion.
I would urge a similar action in the House, and with your
leadership, Mr. Chairman, I think that would be a formidable
effort. It is a bipartisan effort. This is a disease that
killed Ronald Reagan. It killed Sargent Shriver. This disease
knows no party. The costs of this disease to our fiscal and our
entitlement programs knows no party, and this is an area where
I think the United States, as it has done in the past with HIV/
AIDS, can do it again with Alzheimer's and dementia. So I thank
you very much for the opportunity to be here this morning, and
I thank you again, Mr. Chairman, for your leadership in this
space.
[The prepared statement of Mr. Vradenburg follows:]
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----------
Mr. Smith. Mr. Vradenburg, thank you very much for your
leadership and for your extraordinarily crisp and incisive
testimony with very concrete recommendations. And you are
right. We just have to lead. I think your point was very well
taken.
Mr. Vradenburg. The scarcest commodity in this field,
Chairman, is leadership.
Mr. Smith. Thank you.
Mr. Baumgart?
STATEMENT OF MR. MATTHEW BAUMGART, SENIOR DIRECTOR OF PUBLIC
POLICY, ALZHEIMER'S ASSOCIATION
Mr. Baumgart. Thank you very much, Mr. Chairman. I would
ask that my written testimony be included in the record.
Mr. Smith. Without objection, so ordered.
Mr. Baumgart. I want to thank you and the members of this
committee for holding this important hearing today on the
global dementia crisis and the upcoming G-8 summit on dementia
research. Mr. Chairman, the Alzheimer's Association is the
world's largest private, nonprofit funder of Alzheimer's
research, and we are also the world's leading organization on
Alzheimer's care and support. Every day, we see what this
devastating disease does to families. We see what it does to
individuals. And we see the heavy toll it takes on family
members.
I want to tell you one particular story of somebody that we
have worked with and we have helped. His name is Randy and he
lives in California, is the caregiver for his mother who has
Alzheimer's disease. And in Randy's words, I know there is
going to be a problem when Mom goes into the bathroom and
doesn't come out for a long time, because she is either too
embarrassed or too proud to ask for help. Randy continues by
saying, I know then that I am going to have to clean up not
only Mom but the entire bathroom. And Randy says he finds
himself often asking, who would have believed that I would be
changing the diapers of the woman who changed mine?
That is Alzheimer's disease. It is not just a little memory
loss. It is not a normal part of aging. It is a devastating
disease that means the loss of anything and everything you have
ever known. And as you noted, there are now over 35 million
people worldwide living with dementia, over 5 million here in
the United States, as Mr. Bera noted. Those numbers could
triple by mid-century; 115 million people globally could be
living with dementia.
In addition to the toll that Alzheimer's disease takes on
families, it also takes a toll on government budgets. A study
published in the New England Journal of Medicine earlier this
year found that dementia was the most costly disease in
America, costing more than cancer and heart disease. And the
estimates are that 70 percent of the costs of caring for people
with the disease are borne by taxpayers through the Medicare
and Medicaid programs. Globally, as you noted, in 2010 the cost
of dementia was $604 billion. If dementia were a country, it
would be the 18th largest global economy.
Mr. Chairman, a global crisis requires a global response.
And here in the United States we began that response in 2010
when Congress unanimously passed, through your leadership, the
National Alzheimer's Project Act, which requires the Federal
Government for the first time ever to have a national strategy
on how to address this crisis. This leadership, here in the
United States must now be extended to a global effort, starting
with the G-8 summit in London on December 11th.
The G-8 summit provides a unique opportunity to tackle
dementia on a global scale. If it is to be successful, we at
the Alzheimer's Association believe that the G-8 nations must
develop a shared vision for addressing and driving dementia
research over the next decade. Specifically, that means there
must be a commitment from each country of the G-8 to increase
its own level of dementia research funding commensurate with
the level of the crisis. It means identifying additional
innovative research opportunities and mechanisms such as
public-private partnerships. It means improved coordination in
dementia research across governments, the research community,
nonprofit organizations as well as private industry. And it
means a commitment to create an environment in each country
that will train, attract and develop the very best scientists.
Finally, we believe that each G-8 nation must commit to
developing its own national dementia plan much as the United
States, the United Kingdom, and France, among the G-8 nations,
have already done. But let us be clear. The G-8 summit is not
the end of the process, it is only the beginning of the
process. As important as it is for the G-8 nations to develop a
shared vision, a shared commitment and a shared strategy, it is
equally important that they commit to action following the
summit. A vision, a commitment and a strategy must be
implemented if we are going to succeed globally.
In closing, Mr. Chairman, I would like to go back to
something that you mentioned, and that is, past efforts on
global cooperation. Because of medical research and medical
innovation globally and cooperatively, millions of people
around the globe have better lives. It has improved the lives
of people who are living with heart disease, with HIV/AIDS, and
with cancer. Now is the time to make dementia a global
priority, and the G-8 summit provides a historic opportunity to
do so. Thank you.
[The prepared statement of Mr. Baumgart follows:]
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----------
Mr. Smith. Thank you very much for your leadership and your
testimony as well, and it couldn't have been better stated. I
do hope that the administration, and I think it is, is paying
close attention to what the advocates who really walk point on
this issue, and you two are chief among them. We did invite HHS
to be here. I am a little bit chagrined that they are not here,
but I give them the benefit of the doubt, as long as they do
the right thing. And we will be doing a follow-up hearing on
what we do next after whatever the G-8 comes to conclusions
about in terms of what their plan of action will be.
And I think your point, the parallels with the HIV/AIDS
pandemic, is just so compelling. I remember when Henry Hyde sat
here and he was the prime sponsor of the Bush-backed bill, he
brought in conservatives, moderates, liberals across the board.
The same thing happened over on the Senate side. But PEPFAR
looked like Mount Everest when it was first introduced, and now
looking back it was like, well, why wasn't that an easy pass?
It wasn't, but it took leadership. And our hope, and you both
have said it, how important it is that we lead. That the G-8
summit is only a beginning, it is not the end. It is not a
little check in the box and then you move on to something else.
This has to be serious and sustained.
And we do have Dr. Pfeifer on line ready to testify, and so
if we could go to her, and then we will go to questions.
STATEMENT OF ANDREA PFEIFER, PH.D., CHIEF EXECUTIVE OFFICER, AC
IMMUNE (APPEARING VIA VIDEOCONFERENCE)
Ms. Pfeifer. Mr. Chairman Smith, members of the committee,
I am honored to be invited today to address the members of the
Committee on Foreign Affairs as you consider potential policies
for discussion at the upcoming G-8 Dementia Summit in London.
Perhaps I will make a few opening remarks. For the past 10
years I have built from scratch the company AC Immune, which is
focused on developing potentials, therapies and diagnostics for
Alzheimer's. We have some notable success of a drug,
Crenezumab, invented by us and developed by Genentech, which
was selected to be tested in the world's first ever prevention
trial for Alzheimer's funded under President Obama's NAPA
initiative.
My passion as a scientist to find a therapy for this
terrible disease is matched by my determination to engage with
key policymakers such as yourselves to pull together all the
key elements of a global action plan similar to what the world
established 30 years ago when faced with the HIV/AIDS epidemic.
In my view, the challenges of Alzheimer's today are on the same
scale if not greater.
Previous speakers have commented on the hard, basic facts
on Alzheimer's disease in the U.S. I would like to draw your
attention to the European situation. We do face exactly the
same problem with Alzheimer's in Europe as in the U.S. The
disease is a terrible human burden with a massive economic
impact. However, at the same time it is heavily under-
researched and the research is under-financed. An estimated 8.5
million Europeans currently suffer from the disease. As in
other countries, the number is projected to nearly double every
20 years as a result of an aging population. Only very few
countries as, for example, France, Sweden, and the UK have
established policies and strategic plans similar to a NAPA in
the U.S.
We are a drug-developing company with a dream on the goal
to find an ultimate cure for Alzheimer's disease facing several
major challenges. We do not know the exact cause of the disease
and the molecular basis. We know, however, that there are
proteins in the body, namely, beta-amyloid and tau which are
ultimately involved in the disease. One of the stumbling blocks
of Alzheimer's treatments seem to be the time of clinical
intervention. Learning from the recent failures of drugs in
clinical development, the scientific community and industry
strives toward very early pre-symptomatic intervention and even
prevention of the disease.
Unfortunately, as you can imagine, delivering a therapy to
people before they are even showing symptoms implicates huge
clinical trials with large patient numbers, incredibly long
timelines and costs that exceed the infrastructure and
possibilities of a single company even if it is a big pharma
company. Some of the most serious challenges which we only are
able to tackle with common efforts are the need for early
diagnostic and well-accepted biomarkers to accelerate clinical
trials, access to patients and the need to share data,
regulatory hurdles and funding.
Europe has very important activities ongoing and I will
mention three important ones. First, the European Medicines
Agency released a concept paper on the need to revise the
guidelines on medicines for treatment of Alzheimer's, for
public consultation until January. A second initiative is a
private-public partnership for AD clinical trials, EPOCH AD,
focusing on cooperation between government, industry and
academia to enhance the drug development process. Third, the
European Commission also created the European Innovation
Partnership, EIP, on Active and Healthy Aging, a stakeholder-
driven approach to innovation in its domain. All of these
activities are highly welcome and can serve as a wonderful
platform on which a global Alzheimer's action plan can be built
on.
I applause for UK Prime Minister Cameron for conveying the
first G-8 summit on Dementia to work on the four already-
mentioned pillars. Building cooperation networks among
governments, regulators, the private sector and nonprofits;
sharing of knowledge leading to prevention of dementia;
investment in solution and treatments; and laying the
foundation for transition to an aging society without dementia.
I am particular enthusiastic and optimistic about the
potential for greater levels of public-private partnership not
limited to one nation or region but rather spanning the world.
Such efforts are necessary if we are to achieve our shared goal
of defeating Alzheimer's disease and dementia which affects the
entire globe and just national borders. It is a global crisis
that merits a global response.
In conclusion, it is my earnest desire to convey to the
committee, Mr. Chairman, that we need the inspiring leadership
of the United States Government to play a key role and be a
role model in facing one of the most severe and complex
challenge of the 21st century. The U.S. could play a cohesive
role in helping to join hands through the G-8 summit and
extending the message across the OECD. The CEO Initiative on
Alzheimer's Disease spearheaded by George Vradenburg can be the
key catalyst of all of these efforts.
Although many differences exist within the international
community, we share an important goal: Finding a cure for
Alzheimer's disease and eliminating the personal, financial and
social burden of this disease. I remain confident that with the
united forces and the lead of your nation in a global action
plan we can achieve this goal. Thank you again, Mr. Chairman,
for this hearing, and I welcome questions.
[The prepared statement of Ms. Pfeifer follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
----------
Mr. Smith. Dr. Pfeifer, thank you very much for taking the
time to address our subcommittee and by extension the U.S.
Congress, and thank you for your extraordinary work on behalf
of Alzheimer's patients.
A couple of questions that I would like to just raise. Do
any of our panelists have a sense as to where--everyone asks me
in my district and I get this every time I am out on the road
particularly when I am speaking about Alzheimer's. How close
are we to a breakthrough on delaying early onset, certainly
recognizing it, but the drugs that are in the mix that are in
the pipeline, is there reason for serious hope that we may be
many years away or maybe just a few? What is your sense on
that?
Mr. Vradenburg. I will give you a view, but I would be very
interested in both the Association and Andrea's view since this
is obviously unscripted. There are several drugs in late stages
of development in the pipeline. They are targeted at mild to
moderate cases of dementia and have not yet been targeted to
earlier cases, at least in the current late-stage trials. And
they are showing a modicum of possibility that we could slow
down the rate of decline. Those drugs are going to be finishing
trials in the roughly 2015-2016 time frame. They will be
before, if those trials are successful, the FDA in the 2016-
1017 time frame, and it is possible that we will have a first
generation drug for mild to moderate victims of this disease in
that time frame.
The world as Dr. Pfeifer has laid out has now begun to
shift its attention to earlier stages of the disease, so the
same drug that is now in trials for mild to moderate dementia
is now going into trial for much earlier stages of dementia,
and if those prove successful then we will have a drug on the
market that may be potentially administerable to patients
before they get any signs of cognitive or functional decline,
and on the current timeline that would probably be in 2018 to
2020 time frame. But I have always said to treat it as the
metaphor of what happens when you try and introduce a new
product. The first time you get a new product it is clunky, it
is expensive. The second generation of that product is better,
it will be less expensive, it will be more effective.
So while I think there is reason for confidence that by
2020 we will have a drug on the market that will have a modest
effect on the progression of this disease, I think that the
prospect of getting a truly effective means of prevention and
treatment is possible, perhaps even likely by 2025, but quite
frankly, dependents highly on funding and focus between now and
then. So I think this is not something that by 2025 is going to
happen with business as usual. It is going to require increased
focus and increased resource in order to get us there.
Mr. Smith. Thank you.
Mr. Baumgart. I would say I am cautiously optimistic, but I
would underscore what George said at the end of his statement.
I think that the scientific community has the ideas, the will
is there, the technology is there. What is lacking is the level
of resources and the commitment that is necessary to get us
there. And so I am optimistic that we can, but it will require
a greater commitment.
The National Plan, as you know, includes a goal of
effectively treating and preventing Alzheimer's by 2025. There
will be interim steps. There will be interim progress. And one
of the great developments of the National Plan so far is that
the National Institutes of Health finally has a blueprint; it
has timelines; and it has milestones for us to reach that goal.
So I think the question now is whether we will, and the
government will, come through with the resources that are
necessary.
Mr. Smith. Dr. Pfeifer, did you want to speak to that?
Ms. Pfeifer. Yes. I just would like to add maybe one aspect
which I consider is enormously important for the progress we
need. As it was mentioned by George and previously also by
myself, the world is changing from intervention treatment
trials to prevention trials because obviously the biggest
impact on society would be if we could actually prevent the
disease rather than treat the disease. Now as we all know there
is no diagnostic means today available which would allow us to
actually select the patients which would eventually get the
disease. So the only way to do that is actually to work with
genetically predisposed population, like, for example, the
Colombia population, in order to really test if prevention is
possible.
So my wish, my dream, would be to have concerted actions
and funding to support research toward biomarkers and better
diagnostic means. Because only if we can, in fact, enhance the
early diagnostics, so diagnostic before the disease started,
only then we can really think about prevention trial which
would really change result. So we need more funding for doing
research in this important area.
Mr. Smith. Yes?
Mr. Baumgart. I would just add, Mr. Chairman, that the
greatest obstacle to progress after funding is the number of
people who are not participating in clinical trials. We need a
lot more participants in clinical trials, not only those with
the disease, but when it comes to things like prevention
trials, we need healthy individuals to enroll in clinical
trials as well. And I know there are some efforts underway, and
the Alzheimer's Association has a trial match program to try to
encourage this. But efforts by the government to encourage
greater participation in clinical trials are also important if
we are going to get there.
Mr. Smith. As I think we all know, the U.N. estimates for
growth in population is almost always about aging. When we
climb to 9 billion or thereabouts, maybe even 10 billion, it is
not about children it is about aging, and people are living
longer, which is all the more reason why the call and the
action plans have to be put into place now as never before,
which is why we are having this hearing.
I wanted to ask you a couple of very quick questions. We
have an hour's worth of voting on the floor that just started
and so I will ask a few questions and then yield to Mr. Weber
because I don't want to have you sit here and wait a full hour.
But the amount of money, the billion dollars that you mentioned
earlier, Mr. Vradenburg. We have tried, as you know, for years,
and we worked very closely with both of you, frankly, to try to
get the Alzheimer's Breakthrough Act passed, to get it up to at
least $750 billion of NIH funding, and we fall far short all
the time despite herculean efforts, bipartisan to the core.
How many good--and Dr. Pfeifer you might speak to this as
well from the European side--how many laudable proposals fall
off the table at NIH or any other research facility or funding
mechanism because the money isn't there? I remember hearing
that one estimate was like three out of four. So we are missing
the opportunity to find what may be as close to a brass ring as
it could be because that project and that focus and that
research proposal did not get funded. If you could speak to
that.
Mr. Vradenburg. Well, I think the number is a lot greater
than that. The current payline is in the teens, which means one
out of six or one out of seven is getting approved, and those
are of projects that have gone through peer review and been
successful. And the only reason that it is even that high is
that the NIH has cut back the amount of those grants so that
the numbers, if you took the level of grants that were funded
several years ago, the number of approved grants would be under
10 percent. So we are talking about a situation where one in
six or seven, perhaps one in ten depending on the size of the
grant, has currently been approved. And those are peer reviewed
grants that are found to have been meritorious.
Your point, Mr. Chairman, one additional point. This is
beyond a health issue as just pointed out by the Sec on Aging.
At our recent Alzheimer's Disease Summit: The Path to 2025 that
we conducted in New York, a member of the Japanese cabinet came
to speak. And her country is beginning to shift its entire
economic strategy from one of manufacturing to one of service
because they are not going to have enough workers at working
age populations in order to support their manufacturing
economy. So over a period of years, they are having to shift
their entire national economic strategy to less labor intensive
jobs, jobs that can be performed by older individuals and
potentially even older individuals from their homes.
So this is an issue of health as Matthew has pointed out
dramatically, but it is an economic imperative for countries as
their age shifts. Western Europe is going through this in
spades on how to adjust to this. And of course, the entitlement
cost spending going through the roof, in part because of this,
suggests that this is a fiscal issue as well. So it is a health
issue. We have not been able yet to engage economic ministers
and finance ministers in understanding the import of an aging
world on the shifts in relative economic strengths of different
countries.
We have seen China change its policy on the one-child
policy because it foresees itself running out of workers in 20
to 30 years. So they are beginning to adjust their social
policies to respond to the demographic changes that you just
referred to. So this is a very, very significant thing for the
relative economic power of countries around the world in the
coming two to three to four decades.
Mr. Smith. Mr. Weber?
Mr. Weber. Thank you, Mr. Chairman. This question is for
the panel. Other countries that are involved, engaged alongside
of the United States, if you will, in this fight? Top three?
Mr. Baumgart. I would say France was one of the first
countries to develop a national plan, and when Mr. Sarkozy was
President there was a commitment from the topmost levels of
government to actually carry out the plan. I would also say the
United Kingdom has a fairly robust and increasing research
program and a commitment to funding research. So those would be
my top two.
Mr. Weber. There is not a third one?
Mr. Vradenburg. I would add Canada. Although it is not a
significant size, they are very actively, very well organized.
Mr. Weber. Okay. Yes, ma'am.
Ms. Pfeifer. Yes. Thank you, Mr. Chairman. Sweden also has
an extremely well-defined plan for Alzheimer's. One of her, I
would say, leading ones in Europe.
Mr. Weber. Okay, thank you. You mentioned costs associated
with Alzheimer's. Is there a per capita cost that has been
demonstrated and nailed down and calculated? What does it cost
per capita in the United States? What does it cost per capita
in Switzerland? What does it cost per capita in France and UK?
Mr. Baumgart. So I haven't actually calculated the per
capita costs. You could calculate it. The estimates are that
the total cost of caring for people with Alzheimer's and
dementia in the United States this year will be $203 billion.
So I haven't actually done the math, but you could do the math
from that.
Mr. Vradenburg. One of the things that the Alzheimer's
Association did very well, they did a study a few years ago,
Mr. Weber, in which they looked at the costs to Medicare of a
patient with dementia, a beneficiary with dementia and one
without dementia. And the cost to the Medicare system is three
times greater for a beneficiary with Alzheimer's than a
beneficiary without Alzheimer's. And with respect to Medicaid,
it is 19.
Mr. Baumgart. It is 19.
Mr. Vradenburg. 19 times more expensive to Medicaid to have
a beneficiary with Alzheimer's than a beneficiary without
Alzheimer's.
Mr. Weber. And Dr. Pfeifer, in Switzerland, same question.
Ms. Pfeifer. Yes. So there are some numbers. The last
numbers which I saw were 60,000 euros per person per year, so
per patient per year. So it is a substantial amount of money.
Mr. Weber. Can you translate the euros into dollars for me?
Mr. Vradenburg. It is about $100,000.
Mr. Weber. About $100,000. Okay. What would you say is the
main focus of the preventive research? Are we looking at brain
health, circulatory health, neurons? What is the main focus of
that research?
Mr. Baumgart. I think there are a lot of areas of focus.
Operating on the principle that what is good for your heart is
good for your brain, there is a lot of research on physical
activity and whether that can slow the progression or even
prevent the disease, if the physical activity is regular and
vigorous in middle age. There are some studies on diet. In
terms of brain health and physical health connection, there are
smoking studies. There have been studies that show that smoking
is also bad for your brain.
Mr. Weber. As anybody with a brain should know that.
Mr. Baumgart. Yes. And so you have a lot of focus on how do
you make the connection between the physical and the mental.
And one other area that is key is the connection between
diabetes and Alzheimer's. We do know there is a connection.
Scientists aren't quite sure exactly how the connection works,
but we do know that you are at increased risk for Alzheimer's
disease in later life if you have diabetes in mid-life. So that
is another area of ongoing research.
Mr. Vradenburg. So the primary focus has been around a
protein called beta-amyloid, and I believe that there is a
cascading effect that occurs with some misfolded proteins that
begin to accumulate into beta-amyloid and then into tau and
then through inflammation into the death of neurons and
synapses. And one of the confounding things here is that there
are many people who live very healthy and very cognitively
active lives well into their 90s who have a lot of beta-amyloid
in their brain, and indeed a lot with beta-amyloid and tau.
And so what scientists are now focusing on as the key
trigger is an inflammatory response that builds off of that. So
the science is looking not just at how to regulate better the
beta-amyloid and tau buildup in the brain, but also potentially
at what is maybe protective, in protecting those people with
beta-amyloid and tau not turning into cognitive disabled
people. So they are looking both at the mechanisms of stopping
the bad stuff and promoting the good stuff.
Mr. Weber. And Dr. Pfeifer, would you like to weigh in?
Ms. Pfeifer. No, I think George perfectly explained what
is, I would say, most advanced belief in what would be the best
targets to cure, hold or prevent the disease. I think what
becomes quite obvious is the basic interaction between the
beta-amyloid and tau. So maybe we actually have to really
tackle both proteins together in combination therapies in order
to really have the benefit of the momentary drug development. A
third aspect comes in. There seems to be quite a few, in fact
30 percent of Alzheimer's patients have also some aspects of
Parkinson's. There is another protein, which is alpha-
synuclein, and this protein seems to be also involved. So I
think when we are looking forward is really to focus on how are
these different elements working together, and it seems more
and more important that you think about combinational therapies
not just monotherapies.
And maybe a last aspect, of course I am referring to my
past. I was actually doing the first Alzheimer's study with
food, medical food, and I do believe that the aspect of
utilizing beneficial foods could be strengthened, because I am
absolutely convinced that prevention could also come from the
food area. And this is maybe an area which we have a bit
neglected in the past.
Mr. Weber. Okay, thank you. That is it, Mr. Chairman, I am
going to head for vote.
Mr. Smith. We are actually out of time. And I apologize,
but I do have just one final comment, two comments I want to
make.
One, Mr. Vradenburg, your thought of more parliamentarians
connecting, I think, is a great one. I am the co-chairman of
the Helsinki Commission, the Commission on Security and
Cooperation in Europe, and we have resolutions and meetings
three times a year. The big one is July. As a result, I think
your recommendation is a good one, I plan on, I will offer a
resolution to try to get each of the parliamentarians, and
usually about 300 show up from 57 countries so it is not
insignificant, to take back this urgent call, and by then we
will have the G-8 summit, hopefully a very strong plan of
action in a cascading way to keep building out this need.
I went back and looked at a bill that I had introduced
working very closely with the Alzheimer's Association and with
you, George, as well, called the Ronald Reagan Alzheimer's
Breakthrough Act of 2005. And the number that we had in there
for NIH was $1.4 billion. And unfortunately, in real dollars we
have actually gone down from where it was then. So it is maybe
not exactly, but in no way has it approximated the need that
exists in marrying up the resources to make sure.
And your point, Mr. Vradenburg, about one out of six, it
may be even worse, peer reviewed proposals dropping off the
table and not getting funded, that is unconscionable, frankly.
So we need to do more. We hope to do more. As you know, Maxine
Waters and I, we are co-chairs of the caucus. Ed Markey who was
the co-chair for years is now over on the Senate side doing his
good work there.
So this hearing launches into G-8, launches into what do we
do as a Congress, and hopefully like combating HIV/AIDS
pandemic, we will come out of the blocks as never before to
tackle and combat and hopefully eradicate this horrible
disease, or at least make serious strides in early onset and
dealing with the issue. So thank you so very much. Do you have
any final comments?
Mr. Vradenburg. Thank you. Thank you, Chairman Smith, for
your leadership in this space and I look forward to working
with you both domestically and internationally on this issue.
Mr. Baumgart. Thank you, Mr. Chairman.
Mr. Smith. Thank you so much. Dr. Pfeifer, thank you so
much----
Ms. Pfeifer. Thank you.
Mr. Smith [continuing]. For coming in from the continent of
Europe.
Let me just finally also say before I, we will take
everything you have said, your testimonies are outstanding. We
will get them to Secretary Sebelius and all the others at HHS
with a letter signed in a bipartisan way with my ranking
member, and ask them to really seriously look--I know you have
other avenues to get through to them, but let them know that we
are watching as well and we are advocates, as are you. But
thank you so much. The hearing is adjourned.
[Whereupon, at 11:12 a.m., the subcommittee was adjourned.]
A P P E N D I X
----------
Material Submitted for the Record
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Material submitted for the record by the Honorable Christopher H.
Smith, a Representative in Congress from the State of New Jersey, and
chairman, Subcommittee on Africa, Global Health, Global Human Rights,
and International Organizations
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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