[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
A REPORT ON THE G8 DEMENTIA SUMMIT
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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
SECOND SESSION
__________
JANUARY 15, 2014
__________
Serial No. 113-159
__________
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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
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Page
WITNESSES
Richard J. Hodes, M.D., director, National Institute on Aging,
National Institutes of Health, U.S. Department of Health and
Human Services................................................. 5
Mr. George Vradenburg, chairman and founder, USAgainstAlzheimer's 24
Mr. Harry Johns, president and chief executive officer,
Alzheimer's Association........................................ 39
LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING
Richard J. Hodes, M.D.: Prepared statement....................... 8
Mr. George Vradenburg: Prepared statement........................ 30
Mr. Harry Johns: Prepared statement.............................. 42
APPENDIX
Hearing notice................................................... 56
Hearing minutes.................................................. 57
Written responses from Richard J. Hodes, M.D., to questions
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........................ 58
The Honorable Christopher H. Smith: G8 Dementia Summit
Declaration and Communique submitted for the record............ 62
A REPORT ON THE G8 DEMENTIA SUMMIT
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WEDNESDAY, JANUARY 15, 2014
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 2 o'clock
p.m., in room 2200 Rayburn House Office Building, Hon.
Christopher H. Smith (chairman of the subcommittee) presiding.
Mr. Smith. The subcommittee will come to order. And we will
be joined shortly by some of my colleagues, but I thought I
would start because of the delay. And, Dr. Hodes, I want to
apologize to you and the other witnesses and everyone here for
that delay. We did have two votes, and such is life on Capitol
Hill. So thank you again for your patience. I do appreciate
that.
On December 11th, the G8 convened a dementia summit in
London to examine and presumably harmonize the various national
action plans on the growing international crisis of Alzheimer's
and other forms of dementia. The outcome appears to indicate a
coalescing around the U.S. plan to make significant headway on
addressing dementia by 2025, which would have significant
implications globally, particularly in low- and middle-income
countries where increasing aging populations and numbers of
people with dementia strain limited resources.
On January 4th, 2011, President Obama signed into law the
National Alzheimer's Project Act, or NAPA, requiring the
Secretary of the Health and Human Services to establish a
National Alzheimer's Project. Among other provisions of that
law, the administration was mandated to create and maintain an
integrated national plan to overcome Alzheimer's disease;
coordinate Alzheimer's disease research and services across all
Federal agencies; accelerate the development of treatments that
would prevent, halt, or reverse the course of Alzheimer's
disease; improve early diagnosis and coordination of care and
treatment of Alzheimer's disease; improve outcomes for ethnic
and racial minority populations that are at higher risk for
Alzheimer's disease; and coordinate with international bodies
to fight Alzheimer's globally.
That congressionally mandated plan apparently found favor
with the G8 which endorsed that plan as being comprehensive and
forward-looking. But even before the summit, the U.S. national
plan on Alzheimer's led nearly a dozen other nations to adopt
their own national strategies. According to the testimony at
this subcommittee on November 21st at the pre-summit hearing,
this comprehensive approach is vital to meeting what is a
looming global health crisis.
The World Health Organization and Alzheimer's Disease
International's 2012 dementia report estimates that there were
35.6 million people with dementia, including Alzheimer's
disease, worldwide in 2010. This number is projected to nearly
double every 20 years, increasing to 65.7 million in 2030 and
115.4 million in 2050. The global cost of this condition
totaled $604 billion in 2010, according to Alzheimer's Disease
International. To put this figure in context, Alzheimer's cost
would equal the gross domestic product of the 18th place
country in the world ranked by GDP.
While other G8 countries may pledge funding to address
Alzheimer's and other forms of dementia in the developing
world, we are facing an impending global health crisis over
Alzheimer's and other forms of dementia. The 2014 Federal
budget request for U.S.-funded global health programs was $8.3
billion. The focus is on achieving an AIDS-free generation and
ending preventable child and maternal deaths through the
administration's Global Health Initiative. Under this budget,
maternal and child health would receive $680 million, malaria
$670 million, TB programs $191 million, and neglected tropical
disease programs $85 million. Pandemic influenza and other
emerging threats would receive $47 million.
WHO estimates that more than half of global dementia cases
are in low- and middle-income countries where cases are
projected to explode. Across Asia, Latin America, and Africa
these developing countries are expected to see 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 cases to be
found in those countries. So how will this impact our foreign
aid portfolio, especially as regards global health funding?
We need to better understand the level of international
cooperation our Government can expect in the search for early
detection techniques, prevention, and treatment of Alzheimer's
and other forms of dementia. There has been collaboration among
scientists across borders on HIV/AIDS, but how much can we
expect on the various forms of dementia? Many countries in the
developing world don't even have surveillance adequate to
provide reliable statistics on the incidence of Alzheimer's and
other forms of dementia. Given the negative impact of the brain
drain, they may not be able to be the active, effective
partners we need them to be in this area. However, without
their help, it will be difficult to even formulate programs to
help such nations cope with this growing health threat.
These are questions we hope to have addressed, if not
answered, at today's hearing. The administration was unable to
participate at the subcommittee's November 21st hearing, but we
have the head of the National Institute on Aging to provide the
administration's view on what the summit produced. We are also
joined by two representatives from the NGO community, both with
long and distinguished careers and advocacy efforts that have
really made a difference, who also participated in the London
summit to give us a private sector view of those proceedings.
We will need more than rhetoric to deal with this crisis.
As more of us live longer worldwide, the threat of developing
Alzheimer's or some other form of dementia grows exponentially.
We cannot afford to have a robust domestic program to fight
this condition and find that our international efforts are
undermined by the failure of other donors to play their proper
role in this effort.
I would like to now yield to my good friend and colleague
Ms. Bass for any opening comments that she might have.
Ms. Bass. Thank you, Chairman Smith, once again, for your
leadership of this subcommittee and for holding this hearing
which is of importance to all of us. I also want to thank our
witnesses this afternoon and applaud them for their ongoing
contribution to the U.S. leadership and robust global
engagement in this field.
I am struck by the number of people worldwide who are
currently living with dementia, which I understand ranges from
36 million to some 44 million people, many of whom live in the
developing world. The fact that the United States is engaged
with other nations in addressing the challenges of dementia is
therefore highly encouraging to me as a legislator and speaks
to the common goal needed to resolve the medical conundrum that
is dementia.
I believe it is fair to say that here in the U.S. all of us
have been touched by stories of families--I know I certainly
have--friends and neighbors caring for elderly relatives
diagnosed with dementia. Many of these caregivers could not
have done so without the tireless support of professional
health workers and caregiver support groups. Such is the
devastating impact of dementia. All of us wait in anticipation
for a cure.
At this time I want to thank--I know my colleague
Congresswoman Maxine Waters will be attending soon. I want to
thank her for her leadership on this issue as she serves as the
co-chair of the congressional caucus on dementia.
Representative Waters has kindly agreed to address this hearing
today in my stead. And I know both of you, you were co-chairs
because I believe you founded the caucus on dementia.
Mr. Smith. Ed Markey did, but he asked me to join him.
Ms. Bass. Oh wonderful. Well, I know that Representative
Waters will be joining us soon and I will get information from
the two of you when it is over. So thank you very much.
Mr. Smith. Thank you so very much, Ms. Bass.
I would like to now introduce our very distinguished first
witness, and without objection I would ask unanimous consent
that the G8 dementia summit declaration as well as the summit
communique be made a part of the record.
Dr. Richard Hodes, if you don't mind, Doctor, I would like
to wait another minute because I know three or four other
members are on their way and I would hate them to miss your
testimony, if that is okay with you. So we will stand in a
very, very brief recess because I know there are at least three
members that are on their way.
[Recess.]
Mr. Smith. I would like to yield to the co-chair of the
Alzheimer's caucus, my good friend and colleague, Congresswoman
Maxine Waters, from California.
Ms. Waters. I would like to thank Chairman Chris Smith, the
co-chair of the Congressional Task Force on Alzheimer's
Disease, as well as Ranking Member Karen Bass, for organizing
this hearing and inviting me here to participate. As the
Democratic co-chair of the Task Force on Alzheimer's Disease, I
know how devastating Alzheimer's and other forms of dementia
can be for individuals and families. As populations age, more
individuals are likely to be affected by Alzheimer's and other
forms of dementia. According to the World Health Organization,
Alzheimer's disease is the most common form of dementia
accounting for 60 to 70 percent of the dementia cases
worldwide.
Here in the United States Alzheimer's disease is the sixth
leading cause of death and it affects over 5 million American
families. One in nine Americans age 65 and older has
Alzheimer's, and one in three Americans age 85 and older
suffers from this disease. The Alzheimer's Association
estimates that more than 7 million Americans over age 65 will
have Alzheimer's by the year 2025. Every 68 seconds another
person in the United States develops Alzheimer's.
Caregiving for dementia patients is especially difficult.
More than 15 million Americans provide unpaid care for a person
with Alzheimer's disease or another form of dementia.
Caregivers include spouses, children, and grandchildren.
Caregivers face a variety of challenges ranging from assisting
patients with feeding, bathing, and dressing to helping them to
take their medications, managing their finances, and making
legal decisions.
Alzheimer's and other forms of dementia present growing
challenges not just in the United States but also in many
countries around the world. According to data compiled by the
Congressional Research Service, more than 35 million people
worldwide suffered from dementia in 2010. By the year 2050 that
number is expected to more than triple to over 150 million
people. The World Health Organization estimates that more than
half of global dementia cases are in low- and middle-income
countries. The Congressional Research Service projected that by
2050 about 9 million people in Africa, 16 million people in
Latin America, 29 million people in South and Southeast Asia
and 31 million in East Asia will suffer from dementia.
Alzheimer's disease and other dementias present special
challenges in low- and middle-income countries. In high-income
countries like the United States, institutions and programs
like Medicare, Medicaid, nursing homes, adult day care, and
other social services provide critical support to dementia
patients, their families and caregivers. However, in most low-
and middle-income countries, public medical and social services
for people with dementia are rare. Consequently, care for
individuals with dementia in these countries is almost
exclusively the responsibility of their families.
The G8 dementia summit brought together national leaders
from the United States, the United Kingdom, France, Canada,
Germany, Italy, Japan, and Russia to discuss a coordinated
international response to dementia. I look forward to hearing
from the witnesses about their experiences at the summit. I am
especially interested in plans to coordinate efforts to enhance
dementia research, treatment, and caregiver support activities.
I am also interested in plans to work with low- and middle-
income countries to prepare them to respond to the needs of
growing numbers of families affected by dementia.
Once again I would like to thank my colleagues, Chairman
Smith and Ranking Member Bass, and I yield back the balance of
my time.
Mr. Smith. Thank you so much, Ms. Waters.
I would like to now introduce Dr. Hodes. And I know that
others will join us shortly, at least they told us they would.
He is the director of the National Institute on Aging at the
National Institutes of Health. A leading immunologist, Dr.
Hodes was named director of NIA in 1993 to oversee studies of
the basic clinical, epidemiological, and social aspects of
aging. Dr. Hodes has devoted his tenure to the development of a
strong, diverse, and balanced approach to research focusing on
the genetics and biology of aging, basic and clinical studies
aimed at reducing disease and disability including Alzheimer's
disease and age-related cognitive change, and investigation of
behavioral and social aspects of aging.
STATEMENT OF RICHARD J. HODES, M.D., DIRECTOR, NATIONAL
INSTITUTE ON AGING, NATIONAL INSTITUTES OF HEALTH, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Hodes. Thank you, Chairman Smith and Congress. Thank
you very much for the opportunity to speak with you. What I
will try to do is provide a background of the challenge we
currently face in terms of a needy world and the accompanying
challenges of cognitive change and Alzheimer's disease, and in
particular the way in which the recent summit in London of the
G8 helped to reinforce international effort and collaboration
toward that end. May I have the next slide, please.
This is just a dramatic illustration of what has happened
to the demographics, the age profile of the world. It just a
global statistic showing here from 1950 to the present. And you
can see the 1950 at the left. That upper curve began showing
that the world's population under 5 was some 14 percent or so
of the world's population. The lower line, which is very low in
1950, is the proportion of people over 65, and you can see that
is down around 5 percent. There has been a remarkable change in
these proportions over time so that somewhere within this
decade for the first time in human history there will be more
individuals over 65 than there are children under five. And
those curves will keep on happening so by 2040 and 2050 we will
have larger and larger proportions of the population at risk
for diseases such as Alzheimer's, and notably, we talked about
the challenge societally, fewer and fewer individuals at
younger ages capable of providing the kind of care that is
currently provided informally by family members in large
proportion.
The next slide is last year's very careful study of the
cost of Alzheimer's disease in the United States. In 2010, the
first bar, illustrates the direct medical care costs over $100
billion. The next two bars, minimum and maximum estimates of
informal care costs, giving a total cost, interestingly, that
is in excess of what we currently pay for cardiovascular
disease or cancer and with the trends, is projected to continue
as you see here in 2040 as the number of people at risk for
Alzheimer's increases. The next slide.
On that background is noted a very important event, was the
passage of the National Alzheimer's Project Act which mandated
a national plan. The goals of the plan are illustrated here.
The first one highlighted is the prevention and effective
treatment of Alzheimer's disease by 2025, toward which we have
focused public and scientific input to the formulation of a
number of goals and benchmarks. The other targeted goals refer
to optimized care and quality, patient support, enhanced public
awareness, and then tracking improvement along these lines.
And the next slide is an illustration of the goals that
came through in the communique and declaration from the G8
summit, notably with very strong overlapping consistency with
the goals espoused in the U.S. plan. An ambitious goal here of
again the 2025 target for identifying a cure or disease
modifying intervention or therapy. So a very important event, I
think, was the coalescence of international opinion behind this
goal and a commitment to do all that is necessary in order to
achieve it. And the next slide.
Importantly, in order to achieve it is the sharing of
information to allow the coordination of efforts. And in the
next slide, an example of the very real measures that are now
in place to help international collaborations of this
particular effort, one which was the outcome of a collaboration
between the Alzheimer's Association and the National Institute
on Aging which established an ontology of a way to categorize
all of the research that is supported internationally for
Alzheimer's-related research. It is a database which allows
investigators, nations, planners and funders to understand
current cross-sectional and trends in research and to maximize
the opportunities therefore for filling gaps and for maximizing
collaboration. At the G8 summit itself there was a commitment
to the G8 nations to participate even more fully in the
establishment of this database and its use and coordinating
research activities.
Next slide. To illustrate some of the ways in which broad,
organized programs of international collaboration around
Alzheimer's disease are currently in place, and I will just
show you three examples. This is one that was based on the
Health and Retirement Study, a U.S. study that looked at
population of retirement age and beyond, looked at variables of
health, family structure, economics, and so it became a
population-based study for understanding the risks and effect,
the incidence over time, trends and cognitive change in
Alzheimer's disease, the family and caregiver situations
involved in these populations, and importantly has provided a
template then for international efforts across the world,
indicated by the map here, so that a large proportion of the
world's population on all continents now is engaged in studies
through largely NIH support, at least the level of catalyzing
these studies with coherent and harmonized measures so that we
can begin to understand worldwide the incidence, the challenge,
the societal and economic context in which dementia will occur
over years to come.
The next slide is an example of another international
effort, ADNI. This is the Alzheimer's Disease Neuroimaging
Initiative, a really landmark public-private partnership in
which the U.S. public support through the National Institutes
of Health along with private sector and involvement both from
pharma, from imaging, from biotech, has set out to understand
the early changes that occur in Alzheimer's disease to allow
intervention at early stage, well before symptoms, where there
is the best chance to achieve an outcome. The fact that you see
reflected here worldwide is that having established this in the
United States with the very important leadership of the
Alzheimer's Association again, worldwide ADNI now has in all
the nations, parts of the world illustrated here, parallel
efforts. The same studies go on to measure, combine the power
of the measurements on many people to test whether the course
and characteristics of Alzheimer's is the same in the United
States as well as worldwide, another effort to try to
synchronize and harmonize worldwide efforts.
And finally in a third example, the next slide, one area
where enormous progress has been made is in genetic
discoveries. In the last year alone there was a doubling of the
number of known genetic risk factors, feasible only through
international collaborations involving large numbers of people
in all of the nations shown here. So yet another example of
understanding whether the disease and its genetics are similar
worldwide, and recruiting experts worldwide into this
collaborative effort. The next slide.
So there will, in terms of the most concrete mechanism of
follow-up from the summit, be a series of legacy meetings. The
UK will host one on social impact investment, Japan on new care
and prevention models, Canada and France on academia-industry
partnerships, although all nations will be participating in
these. And announced and accepted at the G8 summit was the U.S.
leadership in a meeting which will occur in February 2015 in
association with an international summit on Alzheimer's
research which will convene the broad international community
to coordinate efforts that may come forward from that meeting
of experts and scientists. The next slide please.
And just a reminder of that summit, February 2015, this
will repeat the summit that was held in 2012 in terms of its
format. It will bring national and international experts
together to establish priorities for Alzheimer's research, and
as noted will have the very particular feature of a session
which will involve leadership from international funders and
supporters of Alzheimer's research to assure the best
coordination of efforts.
I thank you for the opportunity to speak and would be happy
to address any questions you might have.
[The prepared statement of Dr. Hodes follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
----------
Mr. Smith. Dr. Hodes, thank you very much for your
testimony and for your leadership. Let me ask you a few opening
questions and then I will yield to my colleagues for any
questions they might have.
In reading the action plan, and you talked about it in your
testimony, your written testimony as well, it does talk about,
and you mentioned it, the three venues that will be held,
Japan-led, UK-led and Canada and French-led. Are there dates
yet for those?
Dr. Hodes. I am not aware of fixed dates.
Mr. Smith. You also note in the action plan it calls upon
WHO and OECD to identify dementia as an increasing threat to
global health. Now as we all know, the director general of WHO
was there, Dr. Chan. And I am wondering, have they been? Has
WHO made this a serious part of their portfolio or are they on
the threshold of doing so? Because they have done some reports
in the past and I have certainly read them and I know you----
Dr. Hodes. I do not know further of any action taken by WHO
since that important statement at the G8 summit.
Mr. Smith. Okay. So that will be an ongoing case of
advocacy on our part to ensure that----
Dr. Hodes. Certainly we will play a role as we do in WHO
affairs, yes.
Mr. Smith. Now in the list of action items it talks about
the UK establishing a new global envoy for dementia innovation.
I wasn't sure what that was. I looked and I am not sure. How do
you define that? Or how do they define it?
Dr. Hodes. The intent here as best I understand it is that
the UK will identify an envoy whose responsibility will be to
attempt to correlate public-private international partnerships
toward a common fund of resources in support of Alzheimer's
research. And I think that outline is the extent of the notion
to date. The UK will appoint. The rest of the nations were in
full agreement with there being such an individual to take the
lead in collaborating international public-private
partnerships.
Mr. Smith. We were all thrilled that the G8 is doing this
and that the UK initiated it, but I am wondering if there are
any thoughts to expand it to the G20 and then by extension to
the rest of the world--Brazil, China, India, Mexico, South
Africa--large populations obviously with large numbers,
increasingly large numbers of dementia cases who make up G20
but not G8. Is there an effort to try to bring them into the
fold?
Dr. Hodes. Absolutely. As you saw in some of the examples
that I cited there was international representation far beyond
the G8. Our plans for the G8 legacy meeting, in fact, will call
for invitations far beyond G8, and there are many more nations
in that, currently involved in Alzheimer's research who are
being asked to contribute to this ontology database that I
mentioned. But without question, G8 was a very important set of
leadership nations but all of our international efforts will
extend far beyond that for broader international partnerships.
Mr. Smith. One of the bullets in your testimony is to
increase the number of people involved in clinical trials and
studies on dementia. Obviously domestically that will include
African-Americans. It will include all people from every ethnic
group in all of the G8 countries. But is there any effort to
try to include Africans and those who might not usually be part
of these trials? Because we have been noticing, especially
where longevity is now becoming a positive statistic, people
are living longer obviously, that we are going to see a huge
epidemic of dementia, for want of a better word, in places like
Africa, with a decreased ability to cope with it.
Dr. Hodes. The challenge, if I can summarize it quickly, in
carrying out the kinds of intervention, clinical trials which
are currently happening is that the greatest emphasis is on
analyzing people who are at high risk for disease long before
there are symptoms of the disease, and tracking biomarkers such
as through brain and neuroimaging, genetic analysis and so on.
It is currently challenging to do these kinds of studies
tracking such markers in nations that do not have the
infrastructure for that kind of imaging. The way in which we
are trying to do it though is illustrated in one study that
attempted to maximize this. This is a study looking at
individuals with early onset of genetically determined
Alzheimer's disease. Due to specific mutation they have brain
changes detectable decades before they have disease. There is
the largest familial cohort of these in the South American
country of Colombia which is relatively less developed in terms
of its biomedical research infrastructure.
So in this case, NIH, together with partners are supporting
studies in which those individuals will be studied both through
establishing capacity in Colombia and through travel to the
U.S., as one of the examples I can cite in which a generally
less well developed country can be supported for research, as
demanding as it is, in cases where this is particularly
important to the research effort.
Mr. Smith. You testified that the international genomic
Alzheimer's project has discovered 11 new genes connected with
the condition. How will these discoveries advance
identification, prevention and treatment of Alzheimer's, and
with the collaboration that now has gone into a much greater
area of cooperation, have we already seen some things that we
were not aware of coming out of some of the other countries
that are part of this initiative? Are we saying, hey, we didn't
know that, give us the information on that?
Dr. Hodes. Well, in fact, the information that led to the
description of these 11 new genes came only when we were able
to look at enough subjects with and without disease that could
be provided by international investigators. No single country,
no single population of available data had the power to
identify these new genes. You asked the very important question
about what happens next once we identify genes as risk factors.
An important observation of the genes described so far is that
they tend to fall into families or pathways. Many of them are
related, for example, to inflammation, others to transport of
membranes.
When we have these clues, this drives the next generation
of research which looks at ability to intervene and change the
variables that are determined by these genetic risk factors and
to look for clues that these are targets then for eventual
clinical intervention. This is a difficult and challenging
road, but each one of these new genes and gene pathways we
identify provides a new potential target for next efforts at
intervention.
Mr. Smith. Let me just ask you one final question with
regards to money. Are we appropriating sufficient amounts of
money for research for Alzheimer's and are the other countries
doing likewise? It seems to me that one of the greatest models
we have is PEPFAR because the United States led and other
countries did indeed follow and now the whole world is on the
same page trying to mitigate the scourge of HIV/AIDS. And I am
wondering if this G8 summit was the catalyst and whether or not
we do indeed have a Manhattan-type mindset to really eradicate
or at least find a therapy for dementia by 2025.
Dr. Hodes. Well, I think it is certainly clear that the
scientific opportunities that we have before us in areas of
Alzheimer's research are vast and that the current fiscal
constraints that we have are without question providing an
important determinant in what research we can carry forward. We
are gratified by the additional funding in 2012 and 2013 which
added to our ability to carry out important studies. We are
hopeful that there will similarly be an increase in funding
available. The scientific opportunities, I think it is fair to
say, in direct answer to your question, far exceed our current
ability to fund all of the meritorious ideas, and we remain
committed, understanding the reality of fiscal limitations, to
doing the very best we can with resources available.
Mr. Smith. I know it is perhaps a difficult question for
you to answer, but could you give us any kind of sense of how
many laudable projects fall off the table because they cannot
be funded because there is insufficient funding?
Dr. Hodes. I can give you just an overview in the sense
that currently at NIA for Alzheimer's research, as for all of
NIH, the success rate for applications is in the range of 15
percent, of all applications received. I think there is wide
agreement that meritorious, outstanding applications are fairly
uniform through nearly double that amount. So one could safely
say if we did no more than fund all the meritorious
applications that we have before us, even without taking
measures to more actively solicit additional applications, that
we could fund twice as much research as we are currently able
with the resources in hand.
Mr. Smith. Do you have hope that the G8 summit will produce
a catalyzing effect? We saw with HIV/AIDS, once the bidding war
in a positive sense started, countries began to step up to the
plate. The Global Fund swung into action, and in every aspect
it was like, we are going to resolve this. We are going to stop
this pandemic, as Henry Hyde called it, the prime sponsor of
the PEPFAR program, he called it the black death of modern
times. And it wasn't until that started that we moved into a
situation where real resources were being brought to bear. Do
you think the G8 summit may have that consequence?
Dr. Hodes. I think what I can say comfortably is that we
have an enormous responsibility to show in the abstract and
also in specifics that there are scientific opportunities
before us that are likely to provide the kind of progress
necessary to achieve this goal of intervention here by 2025. I
think that the G8 summit was a landmark in that it brought
together scientists who could make the very specific case with
specific plans underlying those aspirations, and that this was
embraced as you saw by the common goal across nations, having
met, I think, the important obligation to show that there is a
real plan in hand with a rational approach to conducting
research that will take us to the goal in mind.
I think we now stand and are hopeful that policy makers
will take maximum advantage of the information we can provide,
ask us to provide more than we can and leave to your hands what
we hope will be a translation of these opportunities into
research and real progress toward that goal and timeline.
Mr. Smith. Thank you, Dr. Hodes.
Mr. Weber?
Mr. Weber. Gosh, I don't know where to start. Dr. Hodes,
you said in Colombia you all had identified, was it the largest
biofamilial group?
Dr. Hodes. Yes.
Mr. Weber. Okay.
Dr. Hodes. So there were discoveries in the 1990s which
uncovered a very rare but tragic and informative population in
which a mutation in a single gene, actually one of three
different genes, caused Alzheimer's disease in anyone who
inherited that disease, Mendelian Inheritance so-called, 50
percent of the offspring of somebody with that gene would have
the gene. If you have the gene, 100 percent certainty of
getting the disease age 50s, 40s, even 30s. One such large
family exists in Colombia. It is known exactly what the
mutation is in those individuals.
It is known that if you look at people with no sign of
disease at all and do brain scans in their 30s, that
individuals who have not inherited the gene all have a normal,
if you will, brain scan and particularly without evidence of
amyloid plaques. But the individuals who were in their 30s, who
were not destined to have Alzheimer's disease for another 15 or
20 years but who have the gene, already show clear
abnormalities in their brain scans. This means there is an
opportunity to try to intervene with treatments before
potentially irreparable damage has been done to the brain, long
before symptoms by using experimental treatments and tracking
the biomarkers, like brain scans, to see if these treatments
are effective. Because this is such a large population, it is
an enormous scientific opportunity. It is also a population as
you can imagine just desperate to be a part of a search for a
goal.
So in collaboration with investigators in the United States
and in Colombia, with support from private sector as well as
NIH, these individuals will be studied for interventions
beginning, years to a couple of decades, before they actually
develop disease to see if we can make progress in arresting the
underlying pathology of Alzheimer's disease.
Mr. Weber. Okay, you said a large group. Is that, and you
may not know the exact numbers, I mean is it 5,000, 20,000,
150,000?
Dr. Hodes. The number of people in these families is in the
range of 3,000. Approximately 500 will be studied.
Mr. Weber. Okay. And then you said, the chairman said, and
I came in late so forgive me, I didn't hear all of your
testimony, but you discovered 11 new genes?
Dr. Hodes. Yes. New genes that are risk factors for
Alzheimer's disease. And important to distinguish the kinds of
genes we just talked about, three genes which guarantee that
one will unfortunately, tragically, have Alzheimer's disease if
you inherit that gene. These are real Alzheimer's causal genes.
All the rest of the genes we talk about are risk factors. That
means if you have the bad variant, the bad allele of that gene,
your probability of having Alzheimer's disease increased. It is
not 100 percent, but it is a signal that something about that
gene is involved in the process of Alzheimer's disease.
Mr. Weber. So these are not new genes, we have just
discovered the link to Alzheimer's.
Dr. Hodes. That is fair enough to say.
Mr. Weber. Right.
Dr. Hodes. Since the solving of the human genome all the
genes are there, you're exactly right. What has been done is to
show that these are linked to Alzheimer's disease.
Mr. Weber. How many is that? Ninth grade physical science
for me was way too far back. How many genes are there?
Dr. Hodes. In the range of 25,000.
Mr. Weber. 25,000, okay. So how do you intervene and change
an individual who has inherited these genes? Does it take diet?
I mean, how does that work?
Dr. Hodes. Well, just as an example of the kind of logic
that is followed, if one finds that a number of these genes
seem to be in pathways for inflammation and if there is
evidence as there is that inflammation may play a role in the
brain of those with Alzheimer's disease, one takes this and
uses it to design interventions that may, for example, decrease
or modify inflammation in the brain to see if this will have a
positive effect on the course of disease. So it isn't
necessarily a sign that that person with that variant is the
only one for whom that intervention makes sense, it is saying
that the pathway involved in Alzheimer's is identified by these
variants and mutations and it is those pathways which then
become the target for experimental interventions.
Mr. Weber. Are all the other countries involved in this,
are they, and I hate to use the word co-equal partners based on
population, but how do we measure their seriousness, like the
chairman asked? There has not been enough money. How do we get
them to the table?
Dr. Hodes. Well, in some specific cases, such as the
example of genetics, there are clear and strong international
collaborations already. In terms of having the full scope of
international collaboration in Alzheimer's research, one of the
initiatives that we mentioned, an international Alzheimer's
research database that was generated by NIA in collaboration
with the Alzheimer's Association is in the process of compiling
all of the research supported nationally, internationally, by
government and private and philanthropic agencies.
This, for the first time, provides an opportunity to go
online and ask any of the questions that you would like to for
a given nation, a given organization, and a given area of
research would change over time what is the level of support to
many purposes. One is to address perhaps the question you have
asked about the distribution of support internationally, but
even at the level of the individual scientist or funder, want
to go on to see if there are gaps, if there are important areas
of research that are being underdeveloped. And to look at this
across nations and even coordinate the efforts of nations to
invest with the same database, the same understanding of where
we stand now and what the needs are.
Mr. Weber. And part of your comments, you said we are
interested in learning from other countries' successes. And so
I guess my question is, are we?
Dr. Hodes. I think there are categories of research carried
out in an individual laboratory which then become
internationally shared and inform all of us. So in that respect
some of the discoveries of genes or underlying processes,
whichever country they arise in, are communicated
internationally and inform all of us. And this is one of the
important commitments and it came out of G8 as well, to enforce
or inform a culture of data sharing so that when information is
made available it is made available as quickly as possible to
all nations.
In the area of the underlying basic biology of Alzheimer's
disease we look at diverse populations to see if there are
differences in risk factors across countries. These do inform
all of us. I think in that respect we are learning by
international comparisons. For example, there are two that I
can cite. There was one study that was called the Indianapolis-
Ibaden study. African-Americans of Nigerian descent from around
the area of Ibadan compared to residents in Ibadan for genetic
and clinical manifestations of Alzheimer's disease have
revealed different influences of genes in environment. Similar
study looking at Japanese immigrants to Hawaii and comparing
with their Japanese populations who remain in Hawaii.
So these are some of the examples by which we can learn the
effects of environment and their influence on genetic
predispositions or protective factors as well. I think these
areas of research, and these are only examples, do provide the
positive answer that yes, we learn from the experiences
internationally. In terms of the health and retirement survey
which I mentioned, we are just beginning now to have the
capacity to look in countries internationally at their health
status, their incidence of new cases of Alzheimer's disease,
their relationship to family structure, how care is being
provided.
This is the first step in learning from one another and
learning lessons to even have that information, but in recent
years, as that particular map that I illustrated showed, we are
making enormous progress in having studies that are
interpretable in a similar and common way across countries both
developed and developing internationally.
Mr. Weber. And how is that information shared? Is it done
through summits, through publications quarterly, through emails
instantly? How is that information shared?
Dr. Hodes. Yes, I mean all of the above. And perhaps some
of the more organized examples that we provide are in the
databases that I mentioned. Easy to see in genetics, for
example. So in 2012 as part of the Presidential initiative and
enhanced support for Alzheimer's disease, there was money
committed to sequencing the genomes of people with Alzheimer's
disease and control people who did not have Alzheimer's. The
sequencing, the DNAs collected, the sequencing is done. As soon
as it is done and quality control is completed, they are posted
in an international database. The first group announced in
December. The next in a month or two.
So they are instantly, these data, instantly available and
announced as such to the scientific communities. This is a
prototype of the way we attempt to not only have the data
available as quickly as possible, but in a place where people
know to look for it and where the ability to manipulate those
data is maximized.
Mr. Weber. And is there a parallel track for independent
companies, drug research companies? Are they at the same time
racing to discover this at the same time?
Dr. Hodes. Oh, there are areas of research in which there
is a great deal of competition. Certainly the drug companies
are doing some things independent of, for example, Federal NIH
efforts, but some of the large prevention trials which are
being funded in the last year or two with current and enhanced
U.S. funds from and through NIH have important collaborations
and co-funding by industry. This is most obvious in the cases
of course where there is an intervention of something that is
proprietary.
But the Alzheimer's Disease Neuroimaging Initiative, a very
large initiative designed to identify the earliest changes in
Alzheimer's disease--brain images, biomarkers--is being
supported by extensive contribution from industry, NIH. All of
that with no selective advantage to anyone, the data become
immediately available and posted to all. It is perceived by all
involved to be of such advantage to both private sector and
public that this common good and goal, has to the credit of
all, I think, led to essentially instant access to these data.
Mr. Weber. Okay, I think I have exhausted my pea brain.
Okay.
Mr. Smith. Dr. Hodes, just a couple of final questions. The
point of developing an international action plan for research,
what does that look like and who would take the lead? Is that a
WHO lead or is that a U.S. lead? Will there be people actually
tasked for research or it will be just a broad-brush set of
bullets on a piece of paper? And secondly, are existing U.S.
resources sufficient to implement these goals since there will
be a great deal of sharing and collaborating? You answered the
question about research dollars, but what about to implement
this new global summit agenda?
Dr. Hodes. So just to outline the way in which the research
agenda in the United States has been developed or presented, we
recognized with the national plan an enhanced need to bring to
bear the best of international expertise in deciding priorities
and strategies in order to pursue these research areas. This
was done in a summit in May 2012 and there were some 500
participants. The outcome was a series of recommendations by
this international group of experts as to where the priorities
lay.
Those priorities and goals were translated into milestones,
what it would take to achieve them, what kind of research on
what schedule. This has all been shared with the national and
international research community and we are in the midst of
tracking progress toward them, funding and supporting that
research as best as we are able. Currently, international
funders have access to the same information. Through the
efforts of NIA in collaboration with the Alzheimer's
Association we are convening annual meetings and more frequent
than that, teleconferences, of international funders of
Alzheimer's research trying to invite and encourage common
planning around these milestones.
So I think a well-developed, evidence-based plan with
targets, goals, milestones developed through the U.S. to the
degree to which this can be implemented at an international
level, I think we will see in some of these meetings to come
are able to muster international support behind them. So the
process, I think, is there. The international collaboration
remains, I think, to be optimized, but I think the will has
been expressed at G8 and subsequently in a very positive sense.
And the way in which the resources of all of these
countries might contribute to this common plan and achieving
these common milestones is exactly the kind of planning that
one would like to see. It has not yet occurred. Again, I think
the G8 is a step toward expressing international will, not just
by the G8 nations but then they as emblematic of a broader
international community to converge on common goals.
Mr. Smith. Thank you. Dr. Hodes, I have some additional
questions but I will submit them for the record and I know
other members will as well. So thank you so much for your
leadership and for your testimony today.
I would like to now ask Mr. George Vradenburg who is the
chairman and cofounder of USAgainstAlzheimer's, an education
advocacy campaign committed to mobilizing America to stop
Alzheimer's, and convener of the Global CEO Initiative on
Alzheimer's. He also directs Leaders Engaged on Alzheimer's
Disease, a coalition of Alzheimer's-serving organizations.
Through the Vradenburg Foundation he has supported the
Alzheimer's Disease International World Alzheimer's Reports and
the NIH global Alzheimer's Research Summit. 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
a kind national strategic plan. And prior to December 2003 he
held several senior executive positions in a large media of
companies.
We will then hear from Mr. Harry Johns who became president
and chief executive officer of the Alzheimer's Association in
2005. He has worked to build momentum for the cause by working
to increase awareness and understanding of Alzheimer's,
emphasizing progress through clinical studies, focusing on
public policy and advocacy, and targeting high impact research
in detection, treatment and prevention of Alzheimer's. The
Alzheimer's Association international conference is the world's
largest meeting on Alzheimer's research. In 2011 he was
appointed by the Secretary of Health and Human Services to the
Advisory Council, and before joining Alzheimer's, Mr. Johns
spent more than 20 years with the American Cancer Society.
STATEMENT OF MR. GEORGE VRADENBURG, CHAIRMAN AND FOUNDER,
USAGAINSTALZHEIMER'S
Mr. Vradenburg. Thank you, Chairman Smith and Congressman
Weber, and thank you for convening again this very important
follow-up meeting to the one that you held 2 months ago just
prior to the G8 summit.
You asked at the outset, Mr. Chairman, what the private
sector view is toward the G8 summit. And I would say that it is
a potentially transformative event, potentially transformative.
It set a global goal of stopping this disease by 2025, it set
in place some key landmarks in terms of an international
research plan and innovation platform, and it also committed to
collectively and significantly raising the level of public
resources devoted to research.
Now those commitments are yet to be fulfilled, and of
course one of our roles, or at least I see my role, is trying
to press to make sure that those roles are fulfilled. We will
have during 2014 and early 2015, a series of legacy workshops
that will follow on, and each of those should be designed to
set some very clear action plans in place that could be done at
an international level so that we move this pile forward, not
just for the 5 million Americans in the United States but for
the now 44 million people around the world.
Prime Minister Cameron gave a very eloquent, very
passionate speech in which he analogized this G8 summit to the
one held in Gleneagles by the UK several years ago which
stimulated and accelerated the efforts against HIV/AIDS. So he
positioned this summit precisely as you have positioned this:
That is to begin to get the globe to attack this problem as a
global problem affecting tens of millions of people around the
country.
Fifteen years ago, it was U.S. leadership that helped
mobilize the global community to combat HIV/AIDS. The G8's
embrace of a goal to develop a cure or disease modifying
therapy by 2025, which is the United States' goal, signals that
U.S. leadership is once again becoming critical to another
global effort, this time to stop Alzheimer's. Now just a word
on vocabulary here. In the United States, we tend to call this
Alzheimer's and other dementias referring to the entire field.
The rest of the world tends to call this dementia of which
Alzheimer's is a major portion. So by use of Alzheimer's or
dementia I encompass the same scope.
As we discussed in November, the parallels between the
scale and scope of this disease and global HIV/AIDS are
striking. Shortly after our November hearing and just before
the G8 summit, Alzheimer's Disease International updated its
prevalence figures based upon new studies in China, sub-Sarahan
Africa and new population estimates from the U.N. Those
estimates indicate that they now believe that 44 million people
have this disease, a 22-percent delta over what they estimated
before. And if current trends remain as they are, they estimate
75 million cases by 2030 and 135 million cases by mid-century.
To put those in context, 44 million people with dementia is
larger than the populations of Canada, Poland or Argentina, and
135 million projected by 2050 is a number that exceeds the
population of Japan and nearly that of Russia, the tenth and
eleventh most populous countries. Those numbers somewhat
understate the impact of the disease since they do not account
for family and other caregivers which, based upon U.S.
experience, means that the total number of persons impacted by
this disease may be three or four times the numbers that are
actually attributed to those with Alzheimer's themselves.
And as you have mentioned before, perhaps equally
concerning is the fact that 62 percent of these cases currently
are in low- and middle-income countries with an estimate that
it will move to 70 percent by 2050. Think about the scale of
the disease and the caregiving burden it will have on economic
development gains made in global efforts against poverty and in
our efforts in women's empowerment since most of the caregiving
burden is borne by women. So this is an economic development
issue not just a health issue.
The HIV/AIDS epidemic spurred leaders in the U.S. and the
world to respond with a global fund to treat AIDS, tuberculosis
and malaria as well as PEPFAR as you have already mentioned.
Often overlooked however is Congress' leadership in driving
both of those programs. In the summer of 2000, Congress passed
and President Clinton signed into law the Global AIDS and
Tuberculosis Relief Act. That law authorized an aggressive U.S.
response to HIV/AIDS and established the World Bank AIDS Trust
Fund, among other things, which subsequently led to the
succession of funds that we have today. So it was Congress'
leadership in driving this that in fact caused those funds to
come into existence.
What have we learned from the HIV/AIDS experience? Peter
Piot, the former head of UNAIDS, the person responsible for
driving the global effort against that disease, turning it from
an epidemic to a manageable disease, calls Alzheimer's the next
great epidemic and a public health time bomb. With Alzheimer's,
we are on the verge of a humanitarian crisis that is
potentially larger than the threat posed by HIV/AIDS. Beyond
the public health challenge, we are also on the front edge of
an economic and fiscal crisis. The cost of Alzheimer's to
health care and social support systems is huge and growing,
already at more than 1 percent of global GDP. And Alzheimer's
is a significant driver of the growth in entitlement spending
in the developed nations as well resulting from the rapid aging
demographic.
In its 2010 report entitled, Global Aging: An Irreversible
Truth, Standard & Poor's, who does rate sovereign debt quality,
identified global aging as the dominant threat to global
economic stability. Without sweeping changes to age related
public spending they think sovereign debt will soon become
unsustainable. When you overlay the spector of nearly 140
million persons with dementia by mid-century together with
their caregivers, the need for a coordinated and robust action
for a range of health, economic and fiscal reasons at the
global level is apparent.
Now the G8 dementia summit set out the basis for a global
plan and global funding mechanisms to respond to this
challenge. The G8 nations including the U.S. committed to
identify cure or disease-modifying therapy for the disease by
2025; to increase collectively and significantly, their words,
the amount of public funding for dementia research to reach
that goal; to develop a coordinated international research
action plan; to encourage innovation in discovery and care; to
develop national incentive structures to encourage those
innovations; and to report on those commitments to ensure
progress is made. The UK committed to appoint a global dementia
envoy which, as Dr. Hodes mentioned, is patterned on the fact
that there were global envoys around HIV/AIDS; to stimulate
innovation; and to coordinate international efforts to attract
new sources of financing including a possible public-private
and philanthropic fund to support global international action
on dementia.
The G8 ministers did commit to a series of legacy workshops
in 2014 and 2015 to assure that action plans are developed,
executed, and have the intended effect. And I think it is the
part of the NGOs, one of our responsibilities to ensure that
those occur, that the action plans are developed and that we
report them back to you, subject to your calling us again after
those legacy workshops are held.
I would urge this Congress to embrace the commitments by
the G8 health ministers and to lay the foundation for an
aggressive engagement by this country in a global action plan
and corresponding global funding mechanism just as you did
nearly 15 years ago for HIV/AIDS. Just as our national plan to
address Alzheimer's focuses on research, care, services and
support for caregivers, so too can a global strategic plan. A
global action plan should also set international norms for
research, care, long-term support and services so nations can
learn from each other about what is expected, what is possible
and what mechanisms can be adapted from higher-performing
nations for implementation in lower-performing nations.
One example of what a global action plan might embrace is a
reform of the clinical trial infrastructure. At the G8 summit
and related follow-on events, a clear consensus emerged from
industry, academia, and government that reforms in the clinical
trial process would be a major step forward to reducing the
time, cost, and risk associated with developing disease-
modifying Alzheimer's therapies. It takes far too long and
costs way too much money to recruit and enroll patients in
trials, to assemble the needed infrastructure anew with every
drug candidate, and to conduct the trials only to see the hand-
crafted trial infrastructure and learning for that trial
dismantled and lost so it is not available to other drug
companies and other drug candidates.
Recognizing this, the Global CEO Initiative, which I
convened, working with the New York Academy of Sciences, has
made addressing this gap to develop a global Alzheimer's
clinical trial platform a top priority for 2014. Such a
platform will be the type of groundbreaking initiative that
could be supported with a global strategy and fund. A global
funding mechanism to drive this innovation, to broaden the
targets of attack on this disease and to scale improvements in
quality care delivery is essential to drive this action plan.
Low- and middle-income nations do not have the biomedical
infrastructure needed to advance research but are necessarily
experiencing the same humanitarian and economic costs of this
disease, so they should contribute to a global fund even if
they may not be able to conduct the research themselves in
their own countries.
One thoughtful idea put forward by Drs. Ron Petersen and
Nick Fox, which I would recommend as well, is to ask each
nation to contribute 1 percent of the cost of care that that
society is sustaining for Alzheimer's to research. Based upon
current numbers that would imply a global commitment to
research of about $6 billion a year. Now that sounds like a big
number, but that is less than what we invest in the U.S. alone
for cancer research. It is equal to the amount committed by the
U.S. alone to global funds for HIV/AIDS and other infectious
diseases. So we are talking about a global fund equal to what
the United States itself is investing in cancer or investing in
other global funds.
At the present time, notwithstanding significant
investments to research and other diseases, no individual
nation or small group of nations appear to be willing alone to
bear even the minimum level of investment needed to attack this
disease, either because of fiscal constraints, internal
political barriers, or to strategically reprioritize research
investments toward Alzheimer's innovations.
Beyond traditional public investment, the Global CEO
Initiative on Alzheimer's, again working with the New York
Academy of Sciences, is exploring innovative funding mechanisms
that will attract increasing levels of private, philanthropic,
social and financial capital to the Alzheimer's efforts. New
forms of crowd-sourcing, hybrid philanthropic and financial
venture funds, and social impact investing models are emerging
in other fields, and efforts are underway to assess their
applicability to Alzheimer's. In that regard we will be working
with the UK and its dementia envoy among others.
While these clinical trial and financing mechanisms are
still in early development, they signal the willingness, and
indeed, the eagerness of the private sector to work arm-in-arm
with governments to address this global Alzheimer's epidemic.
And they signal the potential power of a comprehensive global
action plan and fund that unifies the diverse stakeholders
invested in finding a solution to this disease. Domestically,
we must continue to lead the world and deliver on our
commitments at the G8 dementia summit by aggressively
implementing our own national plan and increasing the level of
public resources to support Alzheimer's research and other
programs.
While government budgets remain constrained, our taxpayers
are already paying dearly for Alzheimer's to the tune of $140
billion annually in Medicare and Medicaid costs attributable to
this disease. At the same time, we spent only $500 million
annually on Alzheimer's research. With that in mind, I would
urge Congress to enforce the commitments in our national plan
and take two actions with regard to research. Build upon the
increase in Alzheimer's research included in the omnibus bill
to double current levels of funding in Fiscal Year 2015. That
is domestic investments. And set a marker consistent with the
international norm I noted above of committing just 1 percent
of the total estimated domestic cost of this disease to
biomedical research.
With total public and private costs in the U.S. estimated
to be about $200 billion annually, this approach would yield
the U.S. national goal of $2 billion in annual research
funding, a target that matches the level of funding estimated
by leading Alzheimer's experts and recommended by the Advisory
Council on Research, Care and Services as the level of public
funding necessary to meet our 2025 goal.
Finally, I think it is worth revisiting a recommendation I
and other members of the Advisory Council have long supported,
a White House-level official tasked with coordinating our
domestic and international efforts against Alzheimer's and
dementia. While I am not a fan of layers of democracy, I
believe strongly in accountability. Congress should consider
creating such a position to coordinate both domestic
interagency efforts, because they are not just HHS, they are
DoD and they are VA, so they are major interagency efforts
domestically, and to coordinate our global leadership role much
as we did with respect to HIV/AIDS.
Chairman Smith, Mr. Weber, I thank you again for convening
this hearing. I urge this committee to continue its oversight
focused on this issue and to strongly consider reaching out to
additional parliamentarians, particularly those in other G8
member nations who share your strong interest in and commitment
to forming a global working group of parliamentarians against
Alzheimer's. Such an alliance would support and indeed, I
think, drive the work of government administrations in
implementing the G8 commitments and expanding this effort.
Thank you very much for reconvening and having me testify
today.
[The prepared statement of Mr. Vradenburg follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
----------
Mr. Smith. Thank you so very much for that very
comprehensive testimony and recommendations. We will follow up
on it and I thank you for it. Your testimony is chock-full of
action items for us and I thank you for that.
Mr. Johns?
STATEMENT OF MR. HARRY JOHNS, PRESIDENT AND CHIEF EXECUTIVE
OFFICER, ALZHEIMER'S ASSOCIATION
Mr. Johns Chairman Smith, Representative Weber, first of
all, let me thank you for holding this hearing, and Chairman
Smith, I want to thank you for your leadership over time on
these issues. The NAPA, National Alzheimer's Project Act, has
made a huge difference already in the progress we are making on
Alzheimer's and your leadership on that has been really
important, as well as the entire Congress. It is an honor to be
here. It was an honor to be on the G8 panels to speak to those
ministers, as were Francis and Richard Hodes.
I just want to talk about three things very quickly in the
limited time we have this afternoon: The G8 and the potential
to advance the cause as a result of it; what the Alzheimer's
Association is doing as a nonprofit in that regard as the
leader in the nonprofit world globally on this issue; and what
the United States can do to advance this cause coming off of
the G8 summit. We have talked a lot about the data, the
statistics. The numbers are staggering of course on this. We
know already that in the U.S., as you heard from Richard Hodes,
that in fact we are going to get to the point--it is already
the most costly condition in the U.S.--where it is going to
cost $1.2 trillion annually just for the care for this disease.
So if you project that at all worldwide you see the kinds of
outcomes that it is going to have. Right now the U.S., North
America and Western Europe take up 70 percent of those costs,
and fully a third here in the U.S. But that is, as you have
already heard, going to grow dramatically across the world and
in lesser-developed countries.
In terms of your question about what is the impact of the
G8, I think the G8 does have the potential to be a milestone as
an event in the progress against this cause, against this
disease. It is ultimately up to what we all do with what
occurred at the G8 to determine whether or not it will be
something that was small as a milestone or much larger. The
kinds of things that were on the G8 communique at the end of
the meeting, the 2025 goal, it is a little less ambitious than
the 2025 goal contained in the U.S. plan but important
nonetheless to get at what would be a cure or treatment by that
2025 date. Again, not quite as ambitious but important, and
important for us to pursue on a global basis.
The increase in research funding that is called for there
is absolutely critical to all of this. If we do not continue to
increase our funding of research we simply will not get there,
as Dr. Hodes indicated. The clinical study participation
increases that are called for in the G8 communique are also
absolutely essential. The two things that hold back research
progress fundamentally are adequate funding and adequate
participation in clinical trials. Sharing data, which you have
heard about previously already this afternoon, is essential to
this. With limited resources worldwide being spent already on
this issue, to duplicate efforts unnecessarily, not in the name
of advancing the science but to duplicate those efforts where
we will not see the additional gains, is simply not useful to
us around the world.
As you heard Dr. Hodes indicate, the Alzheimer's
Association is convening groups worldwide, along with the
National Institute on Aging, to look at the very specific
funding being done by agencies like ours, organizations like
ours, by Federal agencies across the world, so that we can
coordinate and maximize the returns on investment that we are
all making on these things. Through our global research program
at the Alzheimer's Association, we fund into 28 countries
already today and we intend to continue that kind of an effort
on a private basis so that we can extend the advances worldwide
from the best thinking worldwide.
You may have heard the story of the young guy in Mongolia
who took one of those open access classes from MIT and aced it
at 100-percent level with limited other knowledge. Now that is
not an illustration of what necessarily will occur in
Alzheimer's research, but by making available more of the
information across the world we can tap what are the knowledge
bases of those countries as well, because research historically
has not been shared well.
So we are working on even another step in this process
which will take the database that you heard Dr. Hodes talk
about, a database of research projects, to another level which
would be the sharing of all of the data from those projects
worldwide. So we need the cooperation of other governments. We
need the cooperation of other funders. We need our own Federal
Government to see to it that all of those data are shared.
We know that from the convening of our own research
roundtable with all the companies engaged in drug development
and imaging and other kinds of aspects of care in Alzheimer's,
along with the FDA and the European Medicines Agency, that by
putting all of those people in the same room we can see new
outcomes that we otherwise would not see. There is recently an
FDA guidance that has made possible new clinical studies that
previously would not have been a possibility under the old FDA
approach caused directly by putting all of those people in the
same room together to discuss what can be changed. And we will
see advances from that, we believe, in the reasonably near
term.
You asked questions too about what is going to happen after
the summit. We are working with the Alzheimer's Disease
International folks of which we are the sole member in the
United States to convene workgroups across the world,
particularly in our case on research. We will lead a research
workgroup that will transcend the G8 and go beyond those
countries to try to identify, again, how we can best utilize
funding that is available in the world, but also what needs to
be done in those countries where the leadership is not present
the way it is in the United States today.
The worldwide ADNI project, the Alzheimer's Disease
Neuroimaging Initiative that you heard Dr. Hodes talk about, is
one of the best examples of what can be accomplished in a
research effort by sharing those data. There are already more
scientific papers, more scientific output from people who were
not funded in that study than by the people who originally
were. So we have more than doubled the return on investment
from that research and we can do this across all of medical
research and particularly all of it in Alzheimer's.
Now what can the United States do on this? The very basic
leadership of the United States is fundamental to the changes
that will occur in this cause, in this particular disease. You
have talked about it, Chairman Smith, in terms of what happened
in HIV/AIDS, in terms of what has happened in cancer, where I
worked for many years. In many ways I think the model of what
has occurred in cancer has shown us the advantages of research
investment, whereas the model of the HIV/AIDS cooperation
worldwide has shown us how to share those data and information.
The fact is, if we did not have the National Alzheimer's
Project Act we would not have the G8.
In terms of the question about whether or not the G8 will
become the milestone that we would hope it would be, we have to
continue to show the leadership in the United States to advance
this cause, to make the commitments to new research funding.
Because if we do not show that leadership, I am confident at
least that we will not see the kinds of advances that we
otherwise are going to need to have on a timely enough basis to
deal with what is the aging of the population, very
specifically the boomer generation in the United States.
The timeline, as you have already heard, for the
development of drugs is sufficiently long that if we don't make
those commitments now, we are about to hopefully see one that
will advance this, but even others beyond that it is
potentially too late to get the job done for the generations
that will drive the huge levels of cost that you have heard
about from all of us. And seeing to it again that those data
are shared worldwide will be one of the other things, I think,
that this Government can do to make a very big difference in
these advancements.
Just fundamentally, if we make those commitments today
given the advancements that we hear from the scientific
community based upon what we have already developed--you may
not know that the research into Alzheimer's in particular is
only about 30 years old. Cancer has been studied for about 100
years. The science community didn't make the connection between
what was the woman that Alzheimer discovered the disease in who
was 51 years old, so the disease was considered an anomalous
condition of people in middle age. So for 65 years there wasn't
any research done on this. We have a gap then in the
development of the research, but we have learned a lot in those
30 years. We are at the point, potentially a tipping point, of
learning enough to advance those kinds of gains very rapidly.
There is a new collaboration that is taking place with the
United States Federal Government, the Alzheimer's Association,
and with industry. It is called the Accelerating Medicines
Partnership. And the idea of this is to have all those sectors
working together with academia to identify the very best drug
targets. Instead of working alone and in silos, to identify
those together so that we can speed the development of drugs on
the timeline that I am talking about. So if in fact we do that
I believe based upon what I hear from the science community
that we have the very real possibility of making rapid gains on
Alzheimer's and other dementias.
So I thank you again for holding this hearing and for your
leadership on this effort, and look forward to continuing to
work to advance this cause and to find the change in the course
of this disease.
[The prepared statement of Mr. Johns follows:]
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Mr. Smith. Thank you, Mr. Johns. Thank you so very much for
your leadership and again, your very specific recommendations,
as well as an elaboration of what you are doing. It was very,
very helpful.
We are joined by Congressman Chaka Fattah. Chaka?
Mr. Fattah. Thank you, Mr. Chairman. And the chairman and I
have worked together on a number of health related issues
including blood safety and cord blood. He has done a lot of
good. And I appreciate the invitation to join you. This is a
subject that I have an extraordinary amount of interest in. And
I was on the floor, slightly delayed.
We just passed the appropriations bill, or we are getting
ready to pass it, and included in that is language that I have
authored to internationalize the collaboration that we built in
at the Office of Science and Technology, Phil Rubin's work. And
we have created language that would build on the G8 summit and
build on the work of the EU and Israel and so many other
countries and groupings of countries who have started to focus
in on this.
And George, you have been way out in front of this for a
very long time, but I think I wanted to focus in on what you
think the Congress can do. We have the national plan, we put
additional dollars. There is, as you just mentioned, Mr. Johns,
a sense of a tipping point. There are some very important
clinical trials that are taking place now or getting ready to
be launched into second and third phases. I mean, there are
some things going on, but we are not in any way yet where we
need to be.
And so I note in your testimony, George, that you suggest
that the Congress should in a similar fashion as we did with
HIV, build a much more global approach to this effort, and if
there are any other specific recommendations that the chairman
and I and others who are interested in these matters may be
able to focus in on.
Mr. Vradenburg. Well, you said I was way ahead, but I am
following you, Mr. Fattah. You have been in front of this issue
on neuroscience and how to get a White House office focused on
it across agencies and now internationally, and I commend you
on your leadership on these issues. I think that we need to
press forward and periodically have this committee and other
committees of Congress make sure that we are moving forward
during 2014.
It is a critical time as Harry has mentioned, and I agree,
that we ensure that we pick this moment in time and say this is
a turning point not just a dot on a long line, so that we, in
fact, hold accountable for all of the commitments that are made
out there and insist that the U.S. Government demonstrate how
it is that they are moving this forward and using their
leadership to do so. I have suggested to the chair of this
subcommittee that there be a set of parliamentarians. That you
meet with EU parliamentarians, UK parliamentarians, Canadian
parliamentarians, and Japanese parliamentarians to ensure that
there is political backbone to the commitments that are made,
because it is going to take the parliaments of these countries
as well as the national leaders and the health ministers to
ensure that we get to a unified effort. I think that you need
to invite the private sector to the table in a genuinely open
and joint kind of approach, a unified approach.
HIV/AIDS in the end--I am not going to say the end--we
haven't gotten to the end--but with respect to what started to
drive that was the unity of purpose, the unity of effort and
thus the clarity of a combined plan in which everyone's roles
were well defined and where people executed against a plan and
could rely on each other to execute against a plan.
So bringing together all of the stakeholders, now you can't
bring Madison Square Garden, but the leaders of the
stakeholders and make sure the processes are transparent, to
force this development of a global action plan, to authorize
the existence of a global fund, will signal that in fact this
nation is prepared to continue its historic leadership on these
global health efforts and actually move the needle to ensure
that what happened in London doesn't stay in London.
Mr. Fattah. Well, let me ask just two very specific,
concise questions, Mr. Chairman, on this point. So one is, the
EU has a joint clinical trial initiative in which they have
gotten all of the EU countries engaged along with Israel, and
we have not joined in yet. And as a nation I think we should,
because this issue of the clinical trials, which you mentioned
in the testimony as I was coming in, I think, is very, very
important. We have opportunities with inside of the work that
you have talked about in terms of the pharmaceutical community.
I have suggested that not only do we have Alzheimer's, we have
500-plus other diseases and disorders that we haven't come up
with effective treatments for. I am trying to understate this.
And I think we should be much more welcoming in terms of
trying to get the pharmaceutical industry more full-throatedly
involved in this, and even to the degree that we might have to
adjust exclusivity issues, patent issues, in ways that could
provide more of a runway for them in terms of the fiduciary
burdens that they have, or find ways for them to partner, like
what the Alzheimer's Association, you are doing, for them to do
research separate and aside and outside of their fiduciary
burdens so that we can move forward. So if you could react to
just to those two things.
Mr. Vradenburg. The Innovative Medicines Initiative of
Europe has issued a call for proposals to which the response
time is roughly April, to come up with consortia that will
develop a Europe-wide clinical trial network system. They have
invited the Global CEO Initiative, the industry coalition that
I convene, to come up with a North American side to that. And
whether that is a side or whether we develop a global platform
and we work with them, there is enormous momentum on both sides
of the Atlantic and in Japan, but right now it is focused on
both sides of the Atlantic, to do something with clinical trial
efforts in Alzheimer's to develop linked patient registries so
that we know the characterization that has been made of
patients around the world. They get into longitudinal trials
that are well characterized and studied and that in fact we can
populate or pre-populate, potentially, global clinical trial
platforms.
So that project is underway. There is no question it is
going to require some government assistance, but hopefully it
will also involve some private funding since the value creation
is good for industry as well as for governments. Your second
point?
Yes, sure.
Mr. Johns. Well, certainly this issue of improving
participation in clinical studies is absolutely essential. We
know that already the three big prevention studies that are
just getting underway in the United States are going to cause
the need for many, many more people than we previously had
participate. It is important to note here if you don't realize
already that one of the things that has happened is a consensus
in the science community on this particular condition, is that
there is a belief that intervening earlier in the disease is
absolutely essential. So that is going to mean actually a
prevention approach to the disease. The prevention approach
means that many of the people who would need to be accrued into
clinical studies will not have symptoms, will not have the
disease actively in terms of ability to see it other than
potentially on a biomarker scan.
Mr. Fattah. What we think of as early onset is pretty far
along.
Mr. Johns. That is exactly right.
Mr. Fattah. So we need to step in. But my second question
was on this question about patent, lengthening the period of
exclusiveness for treatments and solutions as a way of maybe
taking a carrot approach to a more robust effort among the
pharmaceutical industry. Because right now we are nowhere, we
need to get somewhere, and I am convinced that the academic
side of this is very important. But I also think that the
pharmaceutical industry is going to be as essential as they
were with HIV/AIDS.
Mr. Johns. You are absolutely right, Congressman. Both are
absolutely essential. Part of the problem though has been the
underfunding on the front end of the pipeline. This is critical
to recognize, because the pharmaceutical companies, if we had
sitting here next to us one of the leaders of one of those
companies, I have sat on panels with them previously, they
would also tell you that they need the fueling of the pipeline.
In all diseases, the basic research is not done by the
companies because Wall Street will beat up their stock price.
They won't be able to make the investments in the parts of the
pipeline, the later stages of development that they need to
make. So it is absolutely critical that we tie these things
together, not only the kinds of considerations you are raising
this particular question on but also that investment in the
front end of the pipeline to make all of this work together.
Mr. Vradenburg. You will see in the G8 commitments there is
an explicit commitment: Take stock of our current national
incentive structure for research working in partnership with
the OECD. So there is an invitation to you, Congressman Fattah,
to respond to the G8 by taking stock of our current national
incentive structure. I encourage you to do so.
Mr. Fattah. Thank you, Mr. Chairman for allowing me to
participate.
Mr. Smith. Oh, it is a privilege. And as Chaka said we have
worked together on so many other issues including safe blood
initiatives in Africa, so thank you for your work on
Alzheimer's.
We do have another vote and it is a big vote so we are
going to have to leave momentarily, but I just want to assure
you, Mr. Vradenburg, that I would love to follow up with you on
your idea of this global fund. We just had Mark Dybul testify,
and Mark, as you know, was President Bush's HIV/AIDS czar, then
became the coordinator, and he is now the executive director of
the global fund for HIV/AIDS, tuberculosis and malaria.
And he used the words very similar to what you have used,
the tipping point, Mr. Johns, you have mentioned potentially
tranformational. We are at a tipping point and we could lose
the momentum from the G8 summit if implementation is lackluster
and not optimum. So we will do a series of hearings, I think a
piece of legislation that tries to galvanize not just Congress
but other nations, also, I think your idea of the working
group.
I will be leading the delegation to the OSCE Parliamentary
Assembly in July, and I would like to reach out to my fellow
parliamentarians. There are 57 countries that make up the OSCE
Parliamentary Assembly. They usually send five, six members of
their Parliament, depending on the country. In terms of Russia
it is usually one of the top Duma members, often it is the
speaker. So this would be an ideal time to form, do the advance
work but do as you suggested, a working group within that venue
of the OSCE PA on Alzheimer's, especially using the G8 action
plan as a mobilizing influence so we all go back to our
respective congresses and parliaments to fight for additional
funding and to make sure that our executive branches as well as
our legislative branches are doing all that we ought to be
doing to mitigate and hopefully end this horrible disease.
We do have this vote so I will just ask, I have a lot of
questions but maybe just if there is anything you would like to
leave with us? Your testimonies again are very, very extensive,
again filled with information that this subcommittee and membes
on both sides of the aisle, I know, will go through again and
again to pull out and to see what we can do to be of greater
value in this all-important fight.
Please.
Mr. Vradenburg. I want to just make one quite different
point. One of the scarcest commodities in a field as diverse
and eclectic as this is leadership. And your leadership on
this----
Mr. Weber. We have the same problem.
Mr. Vradenburg. I know you know the problem. And thus when
we see leadership on Cameron's part or on Obama's part or on
your part, we need to celebrate it and say, let's go. Because
we don't need 500 leaders, but we need a sufficiently
motivated, limited number of leaders well positioned to do what
they can do and then to have that leadership group drive
action. And action is the hardest thing to get when you get
some diversity like we have got here with governments globally,
industry globally, care problems not just research problems
globally. This is going to be a challenge of leadership. So
that is the one last point I would make.
Mr. Johns. And certainly what I observed in talking to many
of the members of Parliament from the UK who were there and the
ministers who are part of the Parliament of course in that
system, there was an embrace of this particular issue. From
Cameron on down through that group it was pretty clear that
they have embraced this issue, recognizing the human impact,
the economic impact of the disease if in fact action isn't
taken on a timely enough basis. They made a commitment to
double their investment in research. They are looking at the
kinds of things that will speed drug discovery. They are
looking at the kinds of things that will move clinical trial
participation.
So that kind of leadership that you have already shown and
that make up the presence of the National Alzheimer's Project
Act to taking out those things to the next levels, the next
steps will be absolutely critical, and the U.S. leadership
again in particular will be essential.
Mr. Smith. Let me just ask you very briefly, obviously
yourselves are doing, I don't know how you could do anymore
than you are doing on behalf of Alzheimer's patients, research
and for respite care for those who care, as you mentioned, Mr.
Vradenburg, about the women who are often the caregivers, how
difficult it is for them and so it becomes an empowerment
issue. But it seems to me that one of the tipping points for
additional resources on HIV/AIDS was when the Gates Foundation
and others joined in and saw that their money had such a
multiplier effect. Are you sensing that Gates and others may be
realizing that this is a place where dollars spent now will
multiply many-fold for our older Americans and those of course
who have early onset?
Mr. Johns. They are not particularly from the foundation
that you have mentioned because of the way that they have
defined their particular mission.
Mr. Smith. Mandates can change.
Mr. Johns. Certainly. But we are certainly seeing, the
Alzheimer's Association has been spending a lot of time and
effort in the last several years to raise the discussion in the
American populace. We know that what happened in cancer, for
example, as well as in AIDS, that when it was not discussed,
more so in cancer where it was taboo topic to discuss--there
was a study in 1961 that asked doctors if they told their
patients they had the disease when they made a diagnosis, 90-
plus percent of them didn't tell them. It is unimaginable
today, but it illustrates the condition at the time of what was
a taboo subject to discuss.
Too much of that is still present for Alzheimer's, but we
have made huge gains in changing that national discussion. We
need to change that discussion worldwide too, but we need to
make the advances that will continue to have people embrace
dealing with this disease. Even the business community hasn't
so much wanted to deal with the disease. You don't associate
your product with something that people shouldn't discuss. That
is the way they have seen it, regrettably, previously. We are
seeing cracks in that from the efforts we have made to change
that discussion, so I think that parallels the kind of question
you posed.
Mr. Vradenburg. I would say where I am seeing the appetite
is on the part of the social impact investing movement. This is
a movement that started in the UK but it is beginning to spread
globally. And what it is is that the $10 trillion of high net
worth individual asset management, they do polling of their
client base, and these are everywhere from investable assets of
1 million on up. They ask them, would you like your investments
to reflect your values? And the answer is yes. But guess what?
We have very good systems for measuring financial return on
investment. We have lousy systems for measuring social return
on investment. And if what we can do is to begin to develop a
clear plan that demonstrates if you invest $1 billion, Mr.
Foundation 1 or 2 or 3, you will get this movement on this
unmet need of on the most unimaginable proportions.
And so what we need to do is get that clarity of plan and
demonstrate how the investment of funds will actually have an
impact on something that is going to be the scourge of this
world if we don't get acting. And that is where I sense there
is a possibility here. But what this funding now from these
very high net worth investors want is something that says, I
want to know when I invest I will get a social return as well
as a financial return.
Mr. Johns. Yes, if I can say, and I know you have to go,
Mr. Chairman. One last thing I would say is that in the
question about what can you do, seeing to it that the
administrations--this one, the next one--implement the National
Alzheimer's Project Act as you wrote it, passed it and put it
into place is absolutely critical oversight on your part to be
able to achieve what can be done. Laying out the kind of plan
that George just mentioned, which is laid out in that plan, the
National Alzheimer's Project Act plan, the plan for the country
as a strategic plan for Alzheimer's, is a pathway to changing
this in the United States and for providing the nature of the
leadership we have discussed for the world. That is one thing I
would ask all of you to do. It will make a huge difference.
Mr. Smith. Thank you. And I do appreciate your leadership--
--
Mr. Weber. I am done.
Mr. Smith. Thank you, Mr. Weber. This may sound like a
minor point, but just to get it on the record I did notice that
the signers of the G8 were basically ministers of health or
secretary of health except for us. And Don Moulds, I am sure,
is a very good man, but did anyone take away that an acting
Assistant Secretary for Planning and Evaluation----
Mr. Vradenburg. Start with the proposition that Don Moulds
is a good man, that the Assistant Secretary's position is now
acting, he was acting at the time, but also that Secretary
Sebelius felt that she had some urgent business to attend to in
this country, because she was planning to come. So it did not
reflect any lack of commitment on the part----
Mr. Smith. They----
Mr. Vradenburg. Yes, they did.
Mr. Johns. I did not perceive among the ministers that
there was any ill perception. I too give credit to Mr. Moulds
for representing us well.
Mr. Smith. I just wanted to get that on the record and make
it clear. I thank you again and look forward to work with you
on legislation, and we will see you soon.
Mr. Johns. Thank you, sir.
[Whereupon, at 4:03 p.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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