[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]





                 THE GLOBAL CHALLENGE OF ALZHEIMER'S: 
                   THE G-8 DEMENTIA SUMMIT AND BEYOND

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

                                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

                               __________

        Printed for the use of the Committee on Foreign Affairs





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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
                                 ------                                

    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

                              ----------                              
                                                                   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

                              ----------                              


                      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:]


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    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

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                     Material Submitted for the Record


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   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


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