[Senate Hearing 114-858]
[From the U.S. Government Publishing Office]


                                                     S. Hrg. 114-858

                        AGING IN SOUTH CAROLINA:
                         BIOMEDICAL RESEARCH IN
                           THE PALMETTO STATE

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

                                HEARING

                               BEFORE THE

                       SPECIAL COMMITTEE ON AGING

                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS


                             FIRST SESSION

                               __________

                        CLEMSON, SOUTH CAROLINA

                               __________

                           SEPTEMBER 2, 2015

                               __________

                           Serial No. 114-12

         Printed for the use of the Special Committee on Aging
         
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        Available via the World Wide Web: http://www.govinfo.gov
        
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                       SPECIAL COMMITTEE ON AGING

                   SUSAN M. COLLINS, Maine, Chairman

ORRIN G. HATCH, Utah                 CLAIRE McCASKILL, Missouri
MARK KIRK, Illinois                  BILL NELSON, Florida
JEFF FLAKE, Arizona                  ROBERT P. CASEY, JR., Pennsylvania
TIM SCOTT, South Carolina            SHELDON WHITEHOUSE, Rhode Island
BOB CORKER, Tennessee                KIRSTEN E. GILLIBRAND, New York
DEAN HELLER, Nevada                  RICHARD BLUMENTHAL, Connecticut
TOM COTTON, Arkansas                 JOE DONNELLY, Indiana
DAVID PERDUE, Georgia                ELIZABETH WARREN, Massachusetts
THOM TILLIS, North Carolina          TIM KAINE, Virginia
BEN SASSE, Nebraska
                              ----------                              
               Priscilla Hanley, Majority Staff Director
                 Derron Parks, Minority Staff Director
                         
                         
                         C  O  N  T  E  N  T  S

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                                                                   Page

Opening Statement of Senator Susan M. Collins, Chairman..........     1
Opening Statement of Senator Tim Scott, Member of the Committee..     3
Opening Statement of Representative Jeff Duncan..................     5

                           PANEL OF WITNESSES

Wayne Roper, President of South Carolina Biotechnology Industry 
  Organization (SCBIO), Greenville, South Carolina...............     8
Martine LaBerge, Ph.D., Professor and Chair of Bioengineering, 
  Executive Director of Clemson University Biomedical Engineering 
  Innovation Campus (CUBEInC), Clemson University, Clemson, South 
  Carolina.......................................................    10
Joseph A. Helpern, Ph.D., Professor and Vice Chairman for 
  Research of the Department of Radiology and Radiological 
  Sciences, Medical University of South Carolina, Charleston, 
  South Carolina.................................................    12
Reverend Jerry Welch and Nancy Welch, Retired Minister and 
  Counselor diagnosed with early-onset Alzheimer's Disease, 
  Anderson, South Carolina.......................................    14

                                APPENDIX
                      Prepared Witness Statements

Wayne Roper, President of South Carolina Biotechnology Industry 
  Organization (SCBIO), Greenville, South Carolina...............    29
Martine LaBerge, Ph.D., Professor and Chair of Bioengineering, 
  Executive Director of Clemson University Biomedical Engineering 
  Innovation Campus (CUBEInC), Clemson University, Clemson, South 
  Carolina.......................................................    37
Joseph A. Helpern, Ph.D., Professor and Vice Chairman for 
  Research of the Department of Radiology and Radiological 
  Sciences, Medical University of South Carolina, Charleston, 
  South Carolina.................................................    42
Reverend Jerry Welch and Nancy Welch, Retired Minister and 
  Counselor diagnosed with early-onset Alzheimer's Disease, 
  Anderson, South Carolina.......................................    44

 
                        AGING IN SOUTH CAROLINA:
                         BIOMEDICAL RESEARCH IN
                           THE PALMETTO STATE

                              ----------                              


                      WEDNESDAY, SEPTEMBER 2, 2015

                                       U.S. Senate,
                                Special Committee on Aging,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:20 a.m., at 
the Strom Thurmond Institute at Clemson University, 230 Kappa 
Street, Clemson, South Carolina, Hon. Susan M. Collins, 
Chairman of the Committee, presiding.
    Present: Senators Collins and Scott.
    Also present: Representative Duncan.

                 OPENING STATEMENT OF SENATOR 
                   SUSAN M. COLLINS, CHAIRMAN

    The Chairman. The Special Committee on Aging will come to 
order.
    First, let me say what a great pleasure it is to be in the 
State of South Carolina with my great friend, Senator Tim 
Scott. I am Senator Susan Collins from the great State of Maine 
and I came all the way from Maine to be here today because 
Senator Scott and I share a deep commitment to issues that 
affect our seniors, so I want to begin this Special Field 
Hearing of the Senate Committee on Aging today by thanking 
Senator Scott for your leadership in requesting this field 
hearing to examine issues that are of crucial importance not 
only to seniors here in South Carolina, but throughout our 
Nation.
    It is a pleasure to be in the Palmetto State to participate 
in today's hearing, and I want to also welcome Representative 
Jeff Duncan, who is joining us and whose district I believe we 
have the pleasure of being in.
    It is interesting for me in just a short visit here to 
observe how much the Pine Tree State of Maine and the Palmetto 
State have in common. We most of all have very friendly people. 
We have traditions of forestry, farming, fishing, 
manufacturing, and in the winter, another thing that Maine and 
South Carolina have in common is a lot of Mainers. Many of our 
Mainers escape our winters by coming to South Carolina. We do 
not mind, if they do not stay too long and return to Maine, and 
we would encourage you to do the reverse.
    It is a great pleasure to serve with Senator Scott on the 
Aging Committee. His commitments and contributions to the 
Committee's work are many, and he is such a terrific Senator 
who cares deeply for his constituents. Today's hearing is a 
testament to his belief that more can and should be done to 
address the diseases that disproportionately affect our 
seniors.
    One of the things that I enjoy most about serving as 
Chairman of the Senate Aging Committee is that we deal with 
what I call people issues, issues that truly affect people in 
their daily lives, and through the Committee, we have the 
opportunity to help improve the lives of our seniors, those who 
care for our seniors, and those who will one day be our 
seniors.
    Among my highest priorities as Chairman is to highlight the 
importance of biomedical research for diseases like Alzheimer's 
and cardiovascular disease that take such a devastating toll on 
Americans and their families. Investments in biomedical 
research not only improve the health and longevity of 
Americans, but also provide ongoing benefits to our economy and 
the Federal budget.
    According to many economic analyses, there is a roughly 
two-to-one return on investment for Federal support for 
biomedical research. Investments in research at the National 
Institutes of Health and other research centers spur job 
creation and are also critical to our competitiveness in the 
global research environment.
    It is clear that South Carolina understands this. I look 
forward to learning more today about the collaborative and 
innovative research being done in this State in conjunction 
with NIH grant funding and public-private partnerships. In 
fact, your Lieutenant Governor, whom we are honored to have 
here today, talked to me about the collaboration that exists 
and the fact that the silos have been broken down so that there 
is more cooperation, and that is what is needed.
    As the Senate Co-Chair of the congressional Alzheimer's 
Task Force, I am particularly interested in breakthroughs in 
Alzheimer's disease, which has had such a devastating effect on 
5.2 million Americans and their families, including 81,000 
South Carolinians. In addition to the suffering that 
Alzheimer's causes, it costs the United States more than $226 
billion annually, and Medicare and Medicaid pay 68 percent of 
that cost. Yet, we are spending less than three-tenths of one 
percent of this amount on research. We are now spending about 
$600 million a year. Help is on the way. In the Appropriations 
Committee this year, we were able to secure another $350 
million, which will bring us closer to the billion dollar mark, 
and unless an effective treatment is developed before 2050, 
that cost will soar to $1.1 trillion as the Baby Boom 
generation grows older. Clearly, Alzheimer's research funding 
is disproportionately low compared to its human and economic 
toll.
    I look forward in this hearing to hearing about the hopeful 
research for Alzheimer's patients and their families and from 
two people who are personally affected by Alzheimer's, Reverend 
Jerry Welch and his wife, Nancy, who are here with us.
    There are other illnesses of major concern to the people of 
this State. South Carolina has the unfortunate distinction as 
being part of the stroke belt, with unusually high rates of 
stroke and other forms of cardiovascular disease. I look 
forward to learning what we can do to better understand, 
prevent, and treat stroke and cardiovascular disease, and also 
to figure out why there is such a disparity in the impact on 
African American citizens in this State versus Caucasian 
citizens, where African American citizens are 48 percent more 
likely to die from stroke than are Caucasian citizens.
    The other issue that I hope we will touch on today and that 
I know Mrs. Welch can speak to is the role of caregivers. They 
have become so important as our population is aging, and yet 
there are fewer and fewer professional caregivers that are 
available, causing more of the burden to fall on family 
members. I have authored legislation to require the Secretary 
of Health and Human Services to develop a national strategy to 
recognize and support family caregivers. This will not cost us 
money. It can be done out of existing resources. It involves 
the kind of collaboration among all the agencies, private 
organizations, and listening to family caregivers.
    Again, I am delighted for the opportunity to join you today 
and I will now turn the gavel officially over to my friend and 
colleague, Senator Tim Scott.

                 OPENING STATEMENT OF SENATOR 
               TIM SCOTT, MEMBER OF THE COMMITTEE

    Senator Scott. Thank you, Senator. Thank you for making the 
time to be in our great State. There is no doubt that we are 
blessed by your presence, and as a member of the U.S. Senate, 
it has been my privilege to get to know you as a person and to 
understand and appreciate the value of your leadership. You 
have demonstrated the key components to leadership. You have 
compassion, you are always prepared, and you have been, as you 
know, one of my most cherished treasures in the U.S. Senate.
    We certainly should give her a round of applause for taking 
the time to be here.
    The Chairman. Thank you.
    Senator Scott. Thank you.
    Senator Collins has been committed to the issues 
surrounding aging for as long as I have known her. If you have 
been impacted by Alzheimer's or your family has been impacted 
by Alzheimer's or cardiovascular issues, would you please raise 
your hand.
    [Show of hands.]
    The Chairman. Wow.
    Senator Scott. Take a look around the audience. One of the 
things that I believe is so important is that as we discuss the 
issues of Alzheimer's and cardiovascular disease, one of the 
things that becomes present for me is that almost every family 
is impacted by Alzheimer's or cardiovascular disease.
    I think of my grandfather, who was either 94 or 95 last 
Tuesday, and the impact that his diseases have had on our 
family and, frankly, when you think about the caregivers, I 
think about my mother spending every other night at his house 
helping to provide care through the night, and then she goes to 
the hospital and works as a nurse's assistant, and my aunt does 
that every other night, as well, and so, just the stress and 
the challenge facing so many American families needs to be 
highlighted, and your legislation just seems the appropriate 
legislation for us to say thank you and also to provide ways to 
support those caregivers in a very powerful way.
    I know that Reverend Welch has been doing that, as well. 
Even though he suffers from the disease, he is involved in 
organizations that provide assistance for those folks.
    We know that Senator Collins will be back to the Palmetto 
State, for sure. That was a question as well as a statement.
    The Chairman. Absolutely.
    Senator Scott. We look forward to seeing you soon.
    The Chairman. Thank you.
    Senator Scott. I would also like to take the time to thank 
the audience and our witnesses for participating in today's 
panel and discussion. I know this will be a great opportunity 
for us to highlight all the wonderful work being done in my 
home State here in South Carolina, and it will also give us a 
chance to examine the ways our Committee, the Aging Committee, 
can be helpful to ensure the innovation in the field of aging 
can continue to flourish.
    Whether it is the foothills of the Upstate, the broad 
rivers of the midlands, or the stunning beaches on the coast, 
not to mention the world's best food across our State, as 
reasons why so many seniors are moving to South Carolina. 
Currently, 15 percent of our residents are over the age of 65, 
with that number expected to increase over upcoming years as 
more and more seniors call South Carolina home.
    Unfortunately, our State has some work to do in terms of 
managing the chronic conditions that impact our seniors. Over 
71 percent of Medicare beneficiaries in our State have two or 
more chronic conditions. Unfortunately, we know that means 
higher cost and poorer health, as 94 percent of Medicare 
spending is spent on those seniors with at least two chronic 
conditions. However, all of this data puts our State in a 
unique position to conduct research and develop medical 
innovations that allow seniors to better manage chronic 
conditions and improve the way care is delivered, especially in 
a manner that allows seniors to remain in their homes and live 
their healthiest lives.
    Our State is home to some pretty amazing medical 
institutions. We have got Clemson, the Medical University of 
South Carolina, the University of South Carolina, among others. 
These institutions have teamed up with our state's leading 
health care systems to provide and to develop coordinated 
solutions to ease the impact of the burden of disease in our 
State. I am looking forward to hearing from our witnesses about 
the work that is being done, what the future holds, and the 
role this Committee can play.
    Before we proceed to our witnesses, I would like to take 
this opportunity to thank Clemson University for hosting us 
here at the Strom Thurmond Institute. Clemson University has 
been one of the Nation's leading research institutes in 
biomedical research for the past 50 years. In fact, Clemson is 
recognized as the birthplace of the field of biomaterials, 
things like heart valves and joint replacement, which has led 
to some truly remarkable advances in health care.
    This campus is also home to the Clemson University 
Institute for Engaged Aging, led by Dr. Cheryl Dye, which 
provides the nexus for Clemson faculty to conduct research to 
promote quality of life for older adults, making it 
particularly fitting that we would be able to host this field 
hearing here.
    Again, we are very grateful to have the opportunity to hold 
this hearing right here, at Clemson University, and thank you 
to President Jim Clements for being such a wonderful host.
    It is also certainly appreciated that we have the attention 
and the time of our Lieutenant Governor, Henry McMaster, as 
well as South Carolina Representative Gary Clary.
    Now, I am honored to introduce my good friend, Congressman 
Jeff Duncan. Today's hearing is particularly significant to 
Jeff, not just because Clemson University is your alma mater--
--
    Mr. Duncan. Yes.
    Senator Scott. You went here.
    Mr. Duncan. I did.
    Senator Scott. You played football here.
    Mr. Duncan. I did, 1988 graduate.
    Senator Scott. I thought it was 2007?
    Mr. Duncan. No.
    Senator Scott. I do need my glasses--Jeff is not only a 
member of the Class of 2010, but when we came into Congress 
together, Jeff and I were roommates, so I have a special 
affinity for Congressman Duncan, but more important, I wanted 
to dedicate this hearing in the honor of Jeff's father, John 
Duncan, who passed away recently of complications associated 
with Alzheimer's disease. It is important to note that today, 
September 2, would have been your father's birthday, so a 
timely hearing, a very important topic, and in honor of your 
father, thank you for being here. I am glad that we are 
tackling this issue together.
    Representative Jeff Duncan.

        OPENING STATEMENT OF REPRESENTATIVE JEFF DUNCAN

    Mr. Duncan. Thank you, Senator Scott. Chairman Collins, 
thanks for coming to Clemson, South Carolina, in the Third 
District, and holding such a very valuable hearing that has 
personal interest to me and my family. I think it is timely and 
I want to thank you for doing that and allowing me to share the 
dais with you today to talk about something that is dear to--
and something I have learned a lot about, really, just within 
the last 24 to 48 months, because my dad's dementia and 
Alzheimer's really progressed rapidly, and so, I look forward 
to hearing from the witnesses and learning more as we tackle 
this issue as a Nation.
    I want to thank Clemson for the work that they have done, 
and the Office of Aging under the Lieutenant Governor's Office, 
because as the Senator said, South Carolina is seeing an influx 
of retirees, so our population as a State is getting older as a 
percentage of the population.
    Biomedical research has increasingly become an important 
issue, touching the lives of all American citizens. As we 
delved into the 21st Century Cures Act this year, which passed 
the House--I am not sure where it stands on the Senate side--
learned more and more about the impacts of a lot of different 
diseases, Alzheimer's being the one that I was interested the 
most, and the impact it has on the Federal Government, the 
impact it has on American taxpayers, the impact it has on the 
health care system, the impact it has on the retirement system, 
the impact it has on families and individuals.
    Disease has no party affiliation and distributes its 
devastating effects on humans equally. Though vast majorities 
are fortunate to escape the more devastating illnesses while 
young, all of us will, in one way or the other, require 
treatments for diseases that we once thought were incurable. 
Unfortunately, some of the most heart-wrenching diseases still 
have yet to be cured. Diseases like Alzheimer's will in some 
way touch every American and every family. I think the number 
of hands that were raised in the room when the question was 
asked earlier is indicative of how Alzheimer's, as one disease, 
touches the lives of so many Americans.
    It is estimated that 5.3 million Americans are living with 
Alzheimer's today. As the size and proportion of the U.S. 
population age 65 or older continues to grow at greater rates 
every year, so will those living with this disease. It is 
interesting to note that by 2025, the number of people age 65 
or older with Alzheimer's will reach 7.1 million. That is a 40 
percent increase from where we are today. In South Carolina, 
81,000 people are stricken with the illness. By 2025, the 
number will explode to 120,000 people estimated. That is a 48 
percent increase, so as South Carolinians, we must confront 
this growing wave today before it consumes our friends and 
loved ones tomorrow.
    A little bit about my situation. My father passed away 
April 14, dementia progressing to full-blown Alzheimer's. He 
died of complications as a result of Alzheimer's. I watched as 
my mom struggled with not having a power of attorney to access 
the funds that were going to be critical for taking care of my 
father. I watched as my father became more and more aggressive 
due to the Alzheimer's disease, which necessitated at some 
point in time him being moved out of the home. I watched as my 
mom struggled with making that decision to actually place my 
father in an assisted living facility, possibly separated from 
her. I watched as she struggled with the understanding that 
that would gobble up vast amounts of their retirement resources 
and what that may mean to her future. I watched as my dad 
became aggressive and required to be taken to the hospital 
against his will.
    I share this with you because these are things that 
Americans face every day, families, caregivers face every day 
as they deal with this terrible disease. Hard decisions. I 
think everyone wants to keep loved ones in the home and be a 
caregiver, but if you look at the data, oftentimes, the 
caregiver dies first because of the physical toll that being a 
caregiver takes on that person. That is the unfortunate side of 
Alzheimer's that is not discussed enough in the statistics that 
we talk about. These are real struggles.
    I was a proud supporter of the 21st Century Cures Act as we 
direct more of the NIH resources and other research resources 
from the Federal Government toward looking at these diseases 
that are going to be very, very costly for Americans. That is 
why hearings like this conducted by the House and the Senate 
are so important, so that we can educate ourselves as 
policymakers, but we can also educate average Americans on what 
the toll is to the Federal budget, what the toll is to the 
State budget, and what the toll is in the real human capacity 
and real human numbers and struggles that they have.
    I appreciate Senator Scott holding this hearing in honor of 
my father, John T. Duncan, Senior, a 1961 graduate of Clemson 
University. He would have been proud that we were having this 
hearing today at his alma mater. He would be proud that Senator 
Scott and I--he loved him, as I do and we all do--he would be 
proud that Tim was holding this hearing today, as well, and he 
would be proud of me sitting on the stage delving into this, 
and so, his birthday was today. It is tough.
    Tim, thank you so much for letting me be a part of this. 
Thank you.
    Senator Scott. God bless you and your family.
    Mr. Duncan. Thank you. God bless you.
    Senator Scott. Now, I would like to take the time to 
introduce our panel of distinguished witnesses.
    First, we will start with Mr. Wayne Roper. Mr. Roper is the 
President of SCBIO, an organization supporting South Carolina's 
life science industry, which connects companies, institutions, 
affiliates, sponsors, and founding members with life science 
industry programs. Mr. Roper brings a unique perspective as a 
witness due to his involvement in all areas of biomedical world 
in the State.
    Prior to serving as the President of SCBIO, Mr. Roper 
served as the Chief of Staff for Congress member Bob Inglis, 
SC-4, so he is certainly familiar with the dysfunction--I mean, 
the work that needs to be done in Washington, DC, to ensure 
that innovation in this field is not stifled. Thank you, Mr. 
Roper, for being here with us today and I look forward to your 
testimony.
    Next, we have Dr. Martine LaBerge--good?
    Dr. LaBerge. Good.
    Senator Scott. Okay, excellent. When it is French, you want 
to make sure that you get it right. Dr. LaBerge serves as a 
professor within the Department of Bioengineering at Clemson 
and, as well, as the Department Chair. She is also the Interim 
Dean of the College of Engineering and Science. As Department 
Chair, Dr. LaBerge has developed the South Carolina 
Translational Medical Technology Program, a collaboration 
between academic and research universities in the 
Bioengineering Alliance of South Carolina and partner hospitals 
developing clinically relevant medical technology.
    Dr. LaBerge has also received numerous honors and awards, 
including the South Carolina Governor's Award for Scientific 
Awareness. We are thrilled to have her here with us today to 
represent Clemson's Department of Bioengineering, as it is 
widely recognized as a pioneer in the field of bioengineering 
and one of the oldest programs in the world.
    Next, we have Dr. Joe Helpern from my hometown of 
Charleston. He is a Professor of Radiology and the Vice Chair 
for Radiology Research at the Medical University of South 
Carolina. Dr. Helpern is a North American Editor of the Nuclear 
Magnetic Resonance in Biomedicine, a member of the Scientific 
Advisory Board for the Institute for the Study of Aging, the 
Treasurer of the Executive Committee of the Experimental 
Nuclear Magnetic Resonance Conference, and has served on 
numerous NIH committees and study sections. He has authored and 
published more than 90 scholarly papers and has received 
numerous awards for his work.
    Finally, we have Reverend Jerry Welch and his wife, Nancy. 
Reverend Welch and his wife, Nancy, also join us from Anderson, 
South Carolina. Reverend Welch was diagnosed with Alzheimer's 
about eight years ago, after his daughter, who works with 
Alzheimer's patients, noticed he began to exhibit some of the 
symptoms of the disease. He is an active participant in Rhodes 
Respite Care, a local faith-based program to help those with 
moderate memory impairment to exercise their minds and their 
bodies while giving a respite to their caregivers. I want to 
thank both Reverend Welch and his wife for being here to 
discuss the patient and caregiver perspective of such a 
challenging disease.
    Without objection, any written statement you have prepared 
for today will be made part of the record.
    I will recognize each of you for remarks in the same order 
in which I introduced you. Our preference is that you keep your 
presentation to five minutes--we will give you 30 seconds or so 
extra, if necessary--so we have time to get to your questions 
and have some dialog.
    Mr. Roper, you are now recognized for the first five 
minutes.

             STATEMENT OF WAYNE ROPER, PRESIDENT OF

             SOUTH CAROLINA BIOTECHNOLOGY INDUSTRY

        ORGANIZATION (SCBIO), GREENVILLE, SOUTH CAROLINA

    Mr. Roper. Thank you. Madam Chairman and members of the 
Committee, we welcome you to South Carolina, the Palmetto 
State. We appreciate the chance to discuss some of the 
country's most extensive aging research right here in South 
Carolina. This is taking place through private industry, 
entrepreneurs, research at our three research universities, and 
a lot of collaboration among all organizations.
    I also want to say ``hey'' to our Senator, Tim Scott, and 
thank him for bringing the focus to our state's life science 
committee and for thinking twice about singing at my son's 
commencement at USC.
    There clearly can only be one William ``Wee Gee'' Howard.
    Senator Scott. Amen.
    Mr. Roper. This morning I mentioned, only in passing, 
promising research at the University of South Carolina and the 
Medical University of South Carolina in Charleston along with 
other organizations. Martine is going to cover Clemson very 
well, and she is a member of the SCBIO Board and certainly is a 
tremendous contributor to us as we try to work on some of these 
cures and therapies.
    Our focus at South Carolina Biotech Industry Organization 
is private industry. SCBIO represents those entrepreneurs, 
researchers, and executives who are moving therapies to market 
to relieve suffering and improve lives. Research can be 
impressive, but it changes nothing until it gets to patients, 
and that is the focus of SCBIO. We are a non-profit business 
association dedicated to growing life science businesses and 
the full ecosystem it takes to move innovative therapies and 
cures to market.
    Toward that end, I want to point to the most important 
streamlining of more than a decade of government regulated 
process to get therapies to patients and that is the House-
passed 21st Century Cures legislation which Congressman Duncan 
mentioned. H.R. 6 is a major legislative milestone and, in this 
day and age, an impressive bipartisan margin of 344 to 77. We 
strongly urge H.R. 6 as a model for how it modernizes clinical 
trials, brings patients at the center of treatment decisions, 
improves coordination between the regulating agencies, and 
importantly, increases funding for the National Institutes of 
Health and the Food and Drug Administration.
    You know how critical the NIH is as a launching point for 
what has become an explosion of discovery in biomedical science 
and data-driven health care under the excellent leadership of 
Francis Collins. For the FDA, years have seen its mission 
expand and funding constrained, but it is critical to 
increasing a safe but efficient throughput of therapies and 
cures for startup companies. Neither of these agencies should 
ever again be put through sequestration.
    In South Carolina, SCBIO members are launching new 
companies that are moving therapies to market. They include 
CreatiVasc, a company recognized by the FDA as one of three in 
the country with breakthrough technology for an arterial port 
system for kidney dialysis patients, an area where there has 
been no innovation in 40 years.
    In diabetes, Perle Bioscience of Charleston is moving to 
clinical trial a combination therapy that hopes to eliminate 
the need for insulin shots for certain Type one diabetes, and 
Neuro-Quest, it is an Israeli-based technology with North 
American headquarters right here in South Carolina with a 
promising technology for an affordable early diagnostic blood 
test for Alzheimer's disease, before the symptoms ever become 
clinically apparent. As you know, Alzheimer's can be 
progressing for 12 to 13 years before they are observable in a 
clinical setting. There are many drugs which are making an 
impact, but the fact is, they are making an impact on a disease 
that has been a decade in ongoing. If we can get earlier 
intervention, those drugs may be more effective.
    Increasingly, we are seeing an explosion of health IT 
companies developing smart phone apps for compliance, 
monitoring, and real-time information that is going to be the 
heart of the new health care industry and wellness industry and 
is the greatest hope for quality of life for elderly citizens 
being able to live at home.
    South Carolina truly has distinguished work in stroke-
related therapies and neurotechnology. At MUSC, Dr. Robert 
Adams chairs the SmartState Center of Excellence in Stroke 
Treatment and the Center for Biomedical Research Excellence in 
Stroke Therapies. His REACH MUSC network now puts 80 percent of 
South Carolinians within an hour's drive of advanced Internet-
based stroke intervention. They are now able to quickly fly, 
because of this, fly certain stroke patients to MUSC to remove 
the arterial blockage in time to stop a lot of stroke damage.
    All you have to do is look at aging research in South 
Carolina and know the importance of NIH funding, nearly $80 
million in South Carolina, and what a significant effort is 
being made in all facets.
    At the University of South Carolina, more than $35 million 
from the NIH and other agencies support more than eleven 
centers and specific projects on aging, and these include Dr. 
Sue Levkoff's SmartHOME Center, working across disciplines to 
extend healthy independent living, and the Assisted Robotics 
and Technology Lab to develop improved robotic and assistive 
technologies. USC also has one of the most extensive registries 
of Alzheimer's patients. At MUSC, the Center of Aging is one of 
the longest established at the University, with $33 million in 
research among 68 affiliated faculty members from all six 
colleges.
    South Carolina's collaborative prowess is also evident in 
what is a one-of-a-kind, really, in the Health Sciences South 
Carolina, one of the Nation's first statewide data warehouse 
systems. It includes all seven of the largest health care 
systems and the research universities partnering together to 
bring data to the research in health care outcomes. HSSC is now 
partnering with North Carolina in a $15 million study funded by 
Duke Endowment on using data-driven innovations to improve 
health outcomes in our states' high rates of diabetes, stroke, 
obesity, and heart disease.
    Further detail I have on the efforts here are in written 
remarks.
    The Chairman. Thank you, Mr. Roper.
    Next, we will hear from Dr. LaBerge.

       STATEMENT OF MARTINE LaBERGE, PH.D., PROFESSOR AND

          CHAIR OF BIOENGINEERING, EXECUTIVE DIRECTOR

          OF CLEMSON UNIVERSITY BIOMEDICAL ENGINEERING

        INNOVATION CAMPUS (CUBEInC), CLEMSON UNIVERSITY,

                    CLEMSON, SOUTH CAROLINA



    Dr. LaBerge. Chairman Collins, Senator Scott, and 
Representative Duncan, welcome to Clemson University. This is a 
privilege and honor to speak before you this morning. I thank 
you for the opportunity to provide testimony about the impact 
of the exciting research led by my colleagues to ensure that 
older Americans can fulfill a longer, healthier, and 
independent life.
    As South Carolina's land grant institution, Clemson 
University has tackled the socio-economic burden of aging 
through an integrated approach. The result is significant with 
impactful outcome, economic development, and workforce 
education.
    Clemson presents an extensive portfolio of research 
programs and partnerships for aging-related research. We 
partner with the Medical University of South Carolina, the 
University of South Carolina, and the Greenwood Genetic Center, 
along with the Greenville Health System. As you can see, there 
are a lot of people here in this agenda.
    Clemson is at the forefront of medical device and 
technology research. Our Department of Bioengineering, as 
Senator Scott mentioned, is recognized worldwide as the leader 
of biomaterials and its birthplace, so for more than 50 years, 
our bioengineers have developed technologies improving 
artificial joints, implant fixation, fracture fixation, and 
heart valve replacements currently used in patients worldwide.
    Clemson develops innovation to meet special needs of the 
aging population. More than 600,000 knees are replaced, or the 
replacement is performed yearly in the United States. By 2030, 
this number will exceed three million. Our Engage Knee System, 
developed by Dr. Desjardins and his team, is designed to 
address problems of the elderly. Along with diseases of the 
mind and diseases of the cardiovascular system, arthritis is 
also a very debilitating disease.
    Who does not know, as you mentioned, a family member, a 
friend, a neighbor who suffers from heart disease? My mother 
passed away from congestive heart failure in the recent months. 
Heart disease is the leading cause of death in the United 
States. One in four Americans dies of heart disease yearly. Our 
researchers developed new technology to increase a lifetime of 
medical devices, such as heart valve, endovascular stents, and 
blood vessels, among many others.
    Approximately 25 percent of Americans over age 60 have 
diabetes. In 2012, the direct cost of diabetes was $176 
billion, largely attributed to glucose monitoring. Clemson 
bioengineering students Kayla Gainey, Tyler Ovington, and Alex 
Devon developed a new, inexpensive type of test strip so that 
diabetics can be provided with low-cost testing equipment they 
need to manage their blood sugar.
    In partnering with the State, we built the Clemson 
University Biomedical Engineering Innovation Campus. CUBEInC is 
located on the campus of Greenville Health System. At CUBEInC, 
we translate our clinically relevant technology to help 
patients finding new ways of treating their illness associated 
with aging. This is where actually we are doing the economic 
development that Clemson has a very large arm for in South 
Carolina. Clemson and CUBEInC play a key role in the growth of 
South Carolina's biotech industry.
    The Clemson University Institute for Engaged Aging, as you 
mentioned, Senator Scott, in your introduction, led by Dr. Dye, 
has definitely provided a platform and a nexus to promote 
quality of life for elderly adults. Faculty explore aging from 
the cellular level to the built environment from the cell to 
the house so that you can have aging individuals who are living 
more independent life. They are working through the South 
Carolina SeniorSMART program, supporting mobility, activity, 
rehabilitation, and technology.
    Dr. Dye and her team have developed and implemented 
projects using community volunteers as health coaches. Health 
coaches mentor peers in self-management of chronic conditions. 
These efforts have yielded improvements in the health of elders 
with hypertension and in the knowledge and skill of health care 
providers.
    Today at Clemson University, more than 150 researchers and 
scientists are conducting biomedical research that relates to 
aging. The cited examples are few, but they all have something 
in common, the quest for funding. Federal support for 
biomedical technology and aging research must keep up with 
inflation, as you mentioned, and Federal support for 
translational research and accelerated innovation must be given 
priority in addition to basic science.
    In closing, I thank you for the opportunity we were given 
to share with you our engagement and truly our excitement for 
health-focused research. We are committed to transform economic 
development and develop the workforce needed to assure the 
competitiveness of the United States and, obviously, South 
Carolina in health care. South Carolina is the ultimate aging 
in place destination. We are daily reminded of the potential 
impact of our work.
    You must know that this is not in my text, but I am doing 
within my five minutes--that Maine has the largest number of 
individuals with 65 years and older. Following that is South 
Carolina, Georgia, Florida, and Arizona, so they migrate to 
South Carolina, and then our counties that are the most 
populated with elderly are very close to here--Oconee County, 
Beaufort, and you also have Georgetown in Senator Scott's 
districts. As you see, we are very well positioned to 
understand the needs of our citizens.
    Senator Scott. Thank you very much.
    Dr. LaBerge. We look forward to working with you and 
meeting the agenda of the Special Committee on Aging. Thank you 
for this great opportunity.
    Senator Scott. Thank you very much.
    Dr. Helpern.

        STATEMENT OF JOSEPH A. HELPERN, PH.D., PROFESSOR

        AND VICE CHAIRMAN FOR RESEARCH OF THE DEPARTMENT

            OF RADIOLOGY AND RADIOLOGICAL SCIENCES,

             MEDICAL UNIVERSITY OF SOUTH CAROLINA,

                   CHARLESTON, SOUTH CAROLINA

    Dr. Helpern. Chairman Collins, Senator Scott, and 
Congressman Duncan, thank you for inviting me here today to 
speak to you and the audience about aging research in South 
Carolina.
    If I may, I would like to take a moment to provide a brief 
framework of the topic that we are discussing here today. This 
may seem like an obvious statement to many, but the incidence 
of many diseases increases rapidly with aging. In fact, 65 
percent of all the people who will die today in the world will 
die of age-related diseases. In the United States, this 
percentage is closer to 90 percent. The problem is that aging 
is a co-factor in many diseases, including cancer, heart 
disease, Type two diabetes, hypertension, and the most obvious 
one, Alzheimer's disease.
    Within this broad definition of aging, MUSC has an equally 
broad portfolio of aging-related research. Of course, NIH plays 
a significant role in supporting this research, with grants 
ranging from traditional individual investigator, R01s, they 
are called, to larger center grants. However, our aging 
research is also supported by the Alzheimer's Association, the 
American Heart Association, the American Cancer Society, the 
U.S. Army, as well as numerous other corporations and various 
other foundations.
    Our total aging research portfolio of approximately $33 
million in direct costs is divided almost evenly between NIH, 
corporate, and other agencies. These grants span all colleges 
within MUSC, with the College of Medicine being the largest, at 
86 percent, and the College of Nursing being the fastest 
growing.
    In aging-related research, MUSC's NIH portfolio provides 
approximately $11.7 million in total direct costs. This NIH 
support is critical for our research mission for several 
reasons, but it has been on the decline over the past few years 
due to pressures on the availability of NIH funds. Competition 
for NIH grant funding is fierce, with the success rate for 
competitive grants being a significant challenge and near an 
all-time low. The level of NIH funding also affects our ability 
to recruit top scientists to MUSC, as NIH funding is used as a 
means of ranking a university.
    One challenge for MUSC in securing additional NIH funding, 
especially in the area of Alzheimer's disease and aging in 
general, is the lack of an Alzheimer's disease research center 
in the State of South Carolina. Such a center--it is called 
ADRC--would make MUSC significantly more competitive in funding 
from the National Institutes on Aging, as it would provide the 
necessary clinical focus for the recruitment and management of 
research subjects. NIH provides funding specifically for ADRCs. 
However, we would need to first seed such a center at MUSC for 
several years before applying for such funding, as a proven 
track record is critical for successful NIH funding.
    I am going to interject a personal story here. I moved from 
New York University, where I was the Vice Chair of the 
Department of Radiology--NYU is the largest private university 
in the United States--where I had two NIH-funded grants, and I 
moved them to South Carolina, to MUSC. One of them was focused 
on ADHD and one of them was focused on AD. I am now, the first 
time in my career, not funded by NIH at all. I am on the front 
line of training graduate students and training post-docs and I 
find myself without any NIH funding. Part of the problem is the 
infrastructure that we have here at the university with regard 
to recruiting patients. My latest grant review stated it was 
one of the most productive groups in the field of AD research, 
but they did not believe we could recruit the research patients 
at MUSC. This is a heartbreaking finding.
    Back to the written statement, research funding in the area 
of aging-related diseases has a positive impact on the citizens 
of South Carolina. Aside from providing a means for our 
citizens to participate in the latest advances in aging 
research, a focus on aging research also attracts top 
clinicians and scientists to work at MUSC.
    With the current pressures of securing research funding, 
particularly in the beginning of an individual's career, we 
have had to think creatively to develop alternative revenue 
streams for supporting research, including philanthropy. In an 
attempt to address this challenge, approximately one year ago, 
a colleague of mine from New York and I established something 
called Donor's Cure Foundation. Donor's Cure Foundation is a 
501(c)(3) charitable foundation, now licensed in almost all 50 
states. It provides a mechanism to engage the public in 
supporting research through crowdfunding.
    Donor's Cure attempts to at least partially fill the gap in 
funding important medical research, particularly for pilot 
projects and for early career scientists. Researchers use 
Donor's Cure to explore new creative ideas that they can 
eventually fund through a larger grant mechanism, such as NIH.
    Donor's Cure teaches researchers to share what they do with 
non-scientists, an often overlooked but important skill set, 
and communications, I believe, between scientists and the 
general public needs to be improved. The general public needs 
to understand more about the importance of medical research, 
and I think if they did, they would support an additional 
funding for medical research.
    As a result, non-scientists get a glimpse into what 
research is really like and can be personally invested in 
finding a cure. In this way, we open the communication line 
between researchers and the general public, making donors 
partners, not just check writers.
    Currently, our supporting institutions include MUSC, the 
Foundation for Research Development, the Medical College of 
Wisconsin, the State University of New York Upstate, Harvard 
and Massachusetts General Hospital, the University of 
California, and the University of Washington in St. Louis.
    Thank you for inviting me today.
    Senator Scott. Thank you.
    Reverend Welch and Mrs. Welch, you have your five minutes 
now.

          STATEMENT OF REVEREND JERRY WELCH AND NANCY

             WELCH, RETIRED MINISTER AND COUNSELOR

             DIAGNOSED WITH EARLY-ONSET ALZHEIMER'S

               DISEASE, ANDERSON, SOUTH CAROLINA

    Reverend Welch. Five minutes?
    Senator Scott. Yes, sir.
    Reverend Welch. I think my time would be best used if you 
just asked me some pointed questions. I have had Alzheimer's 
for years. I have been in treatment. I have been very fortunate 
in my treatment, and I do not want to waste your time, so if 
you have any--and you cannot ask me anything too personal.
    Senator Scott. Sounds great.
    Reverend Welch. Have you got any questions? Has anybody got 
any questions?
    Senator Scott. In a few minutes, we will have an 
opportunity to ask each panelist questions, so we will get you 
the questions. We are currently in the opening comments from 
the witnesses, so if you have no opening comments--Mrs. Welch, 
do you have any before we head to the questions?
    Mrs. Welch. Any comments? Well, is this on?
    Senator Scott. Yes, ma'am, it is.
    Mrs. Welch. Okay. First of all, I owe you an apology and 
thank you all for coming. The reason you do not have any 
comments from me is because--confession, I did not probably get 
back to your aide as quickly as I needed to at all.
    Senator Scott. No problem.
    Mrs. Welch. Anyway, I was listening to Congressman Duncan 
saying that he had--his father had Alzheimer's and what a 
difficult time his mother had had. I have not had that 
experience because we did have long-term care insurance and 
also because my parents had died earlier and then we got, you 
know, for each of us, so we did not have that experience, but I 
just cannot imagine what anybody else would have gone through 
as a caretaker other than what I have. I mean, it is really 
difficult, although probably my husband does not think so, and 
we have a lot of support. He goes to the respite care twice a 
week, which is wonderful, and because of Gail, we know a lot 
about it, or Gail Marion. It is a hard life.
    Reverend Welch. Do I have a little time?
    Senator Scott. Yes, sir, you have some time, absolutely. 
About three minutes.
    Reverend Welch. My secret was I got detected early and I 
got care early, and I am still in care, and that is a critical 
thing. I go for therapy every week, pretty much, and so I have 
always got someone to talk to. I do not get stuck in a rut.
    If this is about getting more money allocated for 
Alzheimer's research, I am a hundred percent for it. I just do 
not know what to do about it.
    As I say, I got good treatment. I have still got good 
doctors. I go for therapy, psychotherapy, and maybe that is my 
message. When a family gets diagnosed with Alzheimer's, make 
sure the person that got the diagnosis goes for therapy after 
they get on their feet, which I am doing now, and make sure the 
family goes, the entire family, because you have got a 
professional to talk to, and you do not start drinking too 
much, or you do not get depressed, or you do not get angry, why 
did God do this to me, and so and so over here. It is living 
free.
    Mrs. Welch. I do have one more comment.
    Senator Scott. Yes, ma'am.
    Mrs. Welch. It totally left me now. I am sorry. I do not 
know what it was.
    Reverend Welch. This is the State of our lives.
    Senator Scott. All right. Well, at this point, we will 
start asking some questions, and we will have an opportunity to 
engage the panelists on some of the topics that we think are 
important for us moving forward.
    Mr. Roper, thank you for your investment and your work on 
collaboration. What are some of the barriers in attracting and 
encouraging investment in medical research from the private 
sector? You will note that both myself and
    Senator Collins serves on the Committee on Aging as well as 
HELP, which is Health, Education, Labor, and Pensions, so we 
are going to spend a lot of time--we are in a unique position 
to try to take the information that we gain from you all and 
apply it, frankly, and one of the questions we have is the 
public-private partnerships, so how do we get more invested 
from the private sector, from your perspective?
    Mr. Roper. Senator, when we talk about startups, and 
startups usually are the people who take the research and they 
try to apply it to a medical need, and that takes investment, 
and we talk about the term ``de-risking'' an investment. That 
means that you will draw more money to invest in a technology 
if you can reduce the risks, and one of the big risks is 
regulatory risk. How long is it going to take to get regulatory 
approval? How straight is that path? How quickly will we know 
whether this meets the criteria?
    NIH is great and important for researchers, but for private 
industry, the FDA is the bottleneck and the point of regulatory 
risk for a lot of investment. That is a key function.
    Senator Scott. Dr. Helpern, would you like to add anything 
on the issue of private partnerships as it relates to the 
501(c)(3) process and looking for ways to use the crowdfunding 
mechanism to attract more resources?
    Dr. Helpern. Well, as far as if you are asking what are the 
challenges and how could we move faster, I would agree, the 
regulatory burden is unbearable. It--the regulatory burden, in 
general, in my office, where I have my own laboratory which I 
have three or four post-docs, a couple of graduate students, 
and several technicians, probably a total--other faculty totals 
maybe 15 to 20 people--I spend probably 60 percent of my time 
in processes of writing and answering regulatory issues with 
regard to grants and IRBs, other formal organizations that I 
have to respond to and report to just to keep the lab running. 
That is how serious it is, so I think, if I had to name one 
thing, it is the regulatory burden.
    Senator Scott. Thank you very much.
    Mrs. Welch, currently, over 250,000 people in the United 
States serve as caregivers for loved ones, much like yourself. 
When you estimate the value of that caregiving in dollars, not 
just in love and affection but in real dollars, it exceeds $4 
billion of uncompensated care, which is a tremendous amount of 
an investment on behalf of family members. In addition to that, 
that represents about 300 million hours providing unpaid care 
to Alzheimer's patients in 2014.
    My question to you and perhaps the Reverend as well is are 
you aware of any innovations in the area of the biomedical 
industry that could improve the quality of the care that is 
being delivered and/or ease the burden, and if not specifically 
in the biomedical, the bioengineering space, do you have any 
recommendations on ways to provide greater support to 
caregivers around our country.
    Mrs. Welch. I remember what I was going to say now. To 
answer your question, no, I do not, but what I was going to say 
was there is very little support for the caregiver and also for 
the patient. When somebody gets Alzheimer's, it is almost like 
there is just nobody there, and even your best friends--we do 
have two who are still in contact with us on a regular basis, 
but the reality is that--and even your children, and I love my 
children, but two of them flew the coop way out to California a 
long time ago and they are not that interested. We have one 
daughter who lives in Anderson and who is a social worker, so 
she is very supportive, but there is very little support.
    Senator Scott. Okay. Well, I have about 30 seconds left on 
my questions before we get to the next round. Reverend, I know 
that you volunteer at a respite care, a faith-based 
organization that provides some respite care. Would you comment 
on how helpful that organization and/or similar organizations 
would be to providing some type of relief for caregivers, 
either Mrs. or Reverend Welch?
    Reverend Welch. Well, I volunteer and I am a patient----
    Senator Scott. Yes, sir.
    Reverend Welch. I have Alzheimer's, and Gail Marion back 
here is in charge of our program----
    Senator Scott. Yes, sir.
    Reverend Welch. She would have some things she could 
enlighten you on, but the power of a group for people that are 
struggling with Alzheimer's and memory loss is very powerful. 
We get together two times a week, and a lot of it is just 
socialization. There is not a big program. You know, we talk. 
We have a good time. Sometimes, we have a program, but it is 
the relationships, because when you get Alzheimer's, you look 
around, all of a sudden, your friends are gone, your job is 
gone. It is amazing.
    Mrs. Welch. And your car is gone.
    Reverend Welch. Your car is gone. Your freedom is gone. 
Once they take your car.
    Senator Scott. Those keys are important.
    Reverend Welch. You are a prisoner.
    Senator Scott. Keys are very important. My grandfather has 
encouraged me to know that.
    Reverend Welch. I apologize for being dramatic about it, 
but----
    Senator Scott. Yes, sir.
    Reverend Welch. Once the car is gone, it is bad, and the 
worst thing about it, now that I am on a rant here----
    Senator Scott. Well, before you get on your rant, sir, we 
certainly know that, as I want to be a pastor one day, perhaps 
in my future, we get three closings, but my time is up. We are 
going to come back to you for your second closing in just a few 
minutes.
    Reverend Welch. You need to ask for more time.
    Senator Scott. Yes, sir.
    Reverend Welch. You deserve it. You deserve it.
    Senator Scott. God bless you, sir. We will take that up 
with the Chairwoman when we get back to D.C., but right now, 
Senator Collins, it is your time.
    The Chairman. Thank you very much, Senator Scott.
    Doctor Helpern, one of the problems that people have is 
getting diagnosed accurately and early enough with 
Alzheimer's--and I can see that the Reverend Welch is nodding 
in agreement to this--because there is not a simple way right 
now. I know in the case of my family members, it has been 
cognitive tests that were given to determine whether or not 
they had Alzheimer's. Could you update us on the potential for 
imaging to help us bring about earlier and more accurate 
diagnosis of Alzheimer's. Can imaging show us the plaques, the 
tangles in the brain? Can imaging show that areas of the brain 
may have shrunk? Could you tell us about the promise of imaging 
helping us get to earlier diagnosis, and equally important, 
more accurate diagnosis?
    Reverend Welch. Well, the problem is enormous.
    Dr. Helpern. Thank you. I feel like this is kind of a 
planted question for me.
    The Chairman. It was not, though, but it is of huge 
interest to me and so many others.
    Dr. Helpern. Well, yes, there are tremendous advances being 
made in imaging technology. You know, the brain is one of the 
hardest organs to study. We cannot take it out, look at it, 
probe it, poke it, and then put it back in. We have to do 
everything hands off, so non-invasive technologies like MRI are 
very important for us to continue to develop for these kind of 
purposes.
    Everyone knows that there has been PET imaging developed, 
positron emission tomography, for imaging plaques in the brain, 
but my own personal view here is that our attention on the 
deposition of plaques in the brain has just been too lopsided. 
There is more to Alzheimer's disease than amyloid plaque, and I 
think it has been a mistake in our part to focus so much 
attention on amyloid plaque, and in fact, it is one of the 
reasons why drug companies are now backing off from the 
development of different drugs, because approaching imaging 
plaque and looking for plaque early on has not paid off. The 
clinical trials in removing plaque have not been successful.
    Developing ways to image plaque earlier and earlier is not 
the direction that I would go and that many people are going. 
What we are doing is looking at changes in the brain that occur 
prior to any kind of clinical symptomology whatsoever. The 
concept would be inspecting a building before it crumbles. If 
you went inside a building, an apartment complex that was about 
to crumble, you might be able to detect cracks in the bearing 
walls and you might be able to detect cracks in the ceiling 
because things are imminent. Things are changing rapidly.
    That same analogy, we want to apply to imaging, so we want 
to use MRI to look for things that are going wrong in the brain 
prior to any kind of clinical symptomology. In my particular 
area of expertise, we are looking at ``miling'' the wiring in 
the brain. There is a school of thought out there that 
Alzheimer's disease can be thought of almost like a bandwidth 
problem. In other words, it is a computer analogy that it 
cannot process the information that we have in the same speed 
that we used to, and, therefore, that is where the memory 
problems come from.
    It is not necessarily one, you know, my idea versus this 
idea, but we need to open our eyes to different approaches to 
looking at this disease much earlier than when the clinical 
symptoms already start, and MRI is one of those technologies 
that could be advanced most rapidly.
    The Chairman. Thank you.
    I know from talking to scientists across the country that 
it is something that the focus on the amyloid plaques is 
misplaced, or that that is one factor, but that I believe there 
is a protein that may transmit, called tau, may be playing a 
bigger role. It may be all of the above. It may be neither, and 
it is one reason that we need to increase the investment in 
research so we can explore these alternatives.
    Dr. Helpern. Right. I wanted to mention a couple of facts. 
First of all, if we image people for plaque, 25 percent of the 
people, of normal controls, normal people, elderly people 
walking around that have no plaque that we can detect, a 
significant number of those subjects then go on and get 
Alzheimer's disease, so 25 percent of the people that we could 
image, we do not even detect, even if we had a method to detect 
plaque.
    Just because there is plaque in the brain does not mean you 
have Alzheimer's disease. There are other reasons why plaque 
develops in the brain. It is no question that plaque is an 
integral part of the disease process, but there are other 
things that we could be looking at, and there is, speaking 
honestly, at the level of NIH and other organizations, kind of 
a good ol' boy on the bus system. If you are not looking at 
plaque, you do not get included in the communications, so when 
we propose alternative ideas, they are kind of pooh-poohed away 
because it is not mainstream, and we have to stop that, and 
particularly in this disease, and start looking outside the 
box, if you will.
    The Chairman. Very interesting.
    Just one quick question for Mrs. Welch, who is one of the 
40 million family caregivers that we have in our country. I 
know from personal experience watching in my family what 
compassion and endurance that takes.
    I am curious whether you would have known about this faith-
based group that is providing some respite care for you and 
help for your husband had you not had a daughter who was 
involved in treating people with Alzheimer's disease, because 
what I find in Maine, particularly in rural Maine, is there is 
such an absence of help for family caregivers, which is one 
reason I have introduced my bill, and there is not respite 
care, or if it exists, people do not know how to access it. 
Would you have known how to access this care but for your 
daughter?
    Mrs. Welch. Well, yes, I would have, because I have known 
Gail Marion for many years, and so it was interesting. Just a 
little aside, I called her and I said, I do not know how I am 
going to get Jerry there. Would it be okay if he was a 
volunteer? You do not know this.
    Senator Scott. New information.
    Mrs. Welch. She said, what a wonderful idea, and so then 
one day, Jerry came out to me. He was agreeable, and then one 
day we were walking out of the respite care and he said, ``I do 
not know if I am a patient or I am a volunteer,'' and I said, 
well, you are both.
    The Chairman. Thank you. Thank you.
    Mr. Duncan. Will the Chairwoman yield?
    The Chairman. Yes.
    Mr. Duncan. From my own personal experience, I give a plug 
out to the National Alzheimer's Association in that we did not 
utilize them soon enough. They had resources for giving my mom, 
who was a primary caregiver, a break, but we were too late 
contacting them, and I would urge anyone that experiences 
Alzheimer's to reach out early enough, because there are 
resources there that I believe, from my understanding, that 
could assist in that area of your question, and so I certainly 
appreciate the resources that they offered to my mom, but we 
just did not take advantage of them, and I think that is 
probably the case of so many families, that they do not reach 
out early enough and they do not take advantage of the 
resources that may be available, and I yield back. Thank you so 
much.
    The Chairman. Thank you. The Alzheimer's Association does 
do a wonderful job, as do the Area Agencies on Aging in trying 
to connect people, but I still think there is also, in states 
like ours where people are so family oriented and self-reliant, 
there sometimes is a natural tendency not to reach out and try 
to handle it yourself, and I think that is really hard.
    Thank you, Madam Chairman.
    Senator Scott. Yes, ma'am.
    Probably and perhaps my last five minutes of questions, and 
Senator, if you have any further questions, as well. As I think 
about the conversation that we are having and the importance of 
early detection, early diagnosis, your daughter seeing the 
signs early on, this question is for the entire panel, anyone 
who wants to take a stab at it.
    Someone else mentioned the ability to have a blood test 
that shows a predisposition to it. Can we perhaps reemphasize 
the importance of early detection and perhaps name a few of the 
ways that we can do so. You were fortunate enough to have a 
daughter who was involved in caring for Alzheimer's patients. 
Perhaps it is the imaging, maybe it is the blood test, but I 
would love just to have a synopsis on a few ways for early 
detection. Then I have one final question for Dr. LaBerge.
    Yes, ma'am.
    Mrs. Welch. I do not know----
    Dr. Helpern. You know, early detection is difficult. We are 
designing experiments right now for early detection in imaging. 
The problem is, we want to go out and take a cohort of, say, a 
hundred to a couple of hundred normal elderly subjects and we 
do not know who are going to get Alzheimer's disease, develop a 
test that we can do, and then we have to watch them for a 
period of time to see who is going to develop Alzheimer's 
disease in order to correlate the test, the early diagnostic 
test. We cannot go out and study Alzheimer's disease and 
develop a test for early diagnosis. It is too late, so that is 
the quandary of developing early detection methods. It is a 
very labor-intensive process of studying large numbers of 
normal subjects and watching them progress with age.
    There are biomarkers in the blood, in the CSF. We can 
detect them in the brain. Mostly, it is beta amyloid that 
people are trying to detect. There are new techniques for 
imaging tao, something called tao in the brain, but we have to 
look, as I said--I am repeating myself--we have to look beyond 
the amyloid markers, because there are other markers that we 
can investigate, but too much of our resources, I believe, has 
been going into one area. Thank you.
    Senator Scott. Dr. LaBerge----
    Dr. LaBerge. Yes, sir.
    Senator Scott [continuing]. a question on health care 
collaboration. It seems like your program, the medical 
translational technology program, has been successful and has 
really brought together many shareholders in the area of 
bioengineering and research. You also mentioned the fact that, 
I believe the number that you mentioned was $176 billion on 
diabetes. Is there a significant correlation between 
Alzheimer's and the acceleration of other diseases, and if so, 
will the collaborative work that you are seeing happen in South 
Carolina help to reduce those costs?
    Dr. LaBerge. The cost of health care has always been a big 
burden for everybody, and when we do reform of health care, it 
is always associated with cost, so when bioengineers or 
engineers work in team with Dr. Helpern, who is a basic 
scientist working in the brain diseases, or when we work with 
industry, our work here is focused on translation.
    I mentioned quickly that it is important to have Federal 
dollars invested in the research, but if this technology that 
Dr. Helpern is developing is not going to end up in the hands 
of clinicians, it is not going to do much, so it is not dollars 
that are really well invested, so the collaboration is very 
important.
    What we are doing in Greenville, and this is not just a 
Greenville project, this is a South Carolina project--the State 
has invested a lot of money in there--is making sure that, as 
scientists, as engineers, we are working with clinicians, with 
health caregivers, so that they can actually tell us what the 
problems are. A lot of research money has been invested without 
really knowing that it could benefit patients.
    I would say, nowadays, there is definitely a definite 
argument in order to secure funding, so once you have the 
funding, you need to be able to funnel it through the system so 
that it will end up with a product, a technology, an assay that 
you will be able to detect, or pre-Alzheimer's stages.
    What we have done in this State is like we talked a bit 
about the SmartState program that the State has established. 
The SmartState Senior, or the SeniorSMART program that Dr. Dye 
is part of is aimed at doing something like that. It has just 
been really recently that--or, actually, it is because of you, 
and I really got invested in Alzheimer's and aging by preparing 
for this hearing, discovering what our group is doing and how 
we can help our colleagues to develop their technology.
    Even though now I cannot tell you that what we are doing is 
going to help Alzheimer's, what it is going to do is making 
sure that those patients are more mobile. If we know that 
exercise also helps delay Alzheimer's onset, if we can put 
someone who has arthritis and a knee replacement get more 
active sooner, maybe the onset of the disease will take more 
time. I do not know if the Reverend has done exercise when he 
was younger, but if he had arthritis, he was not able to do it.
    The same thing with congestive heart failure. I mean, heart 
disease is hypertension. Diabetes leads to that. If we do not 
have enough technology, medical devices, even replacing 
tissues--you know, organ printing is not really a dream 
anymore. That exists. You can actually replace tissues and put 
patients more back on their feet sooner, healthier, happier. 
They will have less depression and then they will basically 
overcome their brain disease, as well.
    As you can see, this is an integrated approach, really 
taking aging and health as a matter of everybody, because we 
all suffer from that from our own families. Ourselves, too, we 
are all aging, you know. Aging is from birth to whenever we 
depart. It is really a project--let us call that a project that 
I think your Committee has an impact in different aspects of 
what the United States is all about. This is education. This is 
health. This is regulatory with FDA, and this is definitely 
NIH, and we forgot NSF. A lot of the basic work needs to be 
done at NSF.
    That with interagency projects that now for funding or 
taking a little bit more empowerment, I think you really need 
to make sure that it also involves patient advocacy on this so 
that we really understand what their needs are and we can 
provide for them. I will say it would be a good use of 
taxpayers' dollars.
    Senator Scott. Thank you very much.
    The Chairman. Doctor LaBerge, I want to thank you for the 
work that you are doing on diabetes. Another hat that I wear in 
the Senate is I founded the Senate Diabetes Caucus back in 1998 
and we have been able to work together to triple research 
funding. That is the kind of work we need to do on Alzheimer's, 
and there are some interesting connections where there is some 
experimentation going on with inhaling insulin and Alzheimer's 
has been called the diabetes of the brain by some, so I am very 
interested in the work that you are doing.
    Let me do just one final question for Mr. Roper, and that 
is the average age of a first-time NIH grant recipient today is 
42. That is up from 36 in 1980. Dr. Francis Collins, who 
regrettably is not a relative, although I wish he were, the 
head of NIH, has told us in Congress that he is worried that we 
are losing an entire generation of younger scientists who are 
seeking opportunity outside of our country to do their 
research. Do you have any suggestions for us on how we can make 
sure that we keep that talent here in the United States?
    Mr. Roper. Well, the House-passed version does have an 
Innovation Fund of $10 billion--$8.5 billion that was really 
geared toward encouraging and funding young scientists, and I 
think that those efforts are the right direction to--you have 
to put some money to attract them, and it has to have some 
sense that this is not a two-year thing and then it is gone 
that you are constantly being jerked around by government 
budgetary processes that leave you uncertain about where your 
life work is going to be continued or not, but the Innovation 
Fund, I think, is a great start.
    The Chairman. Thank you.
    I have often thought we should have multi-year funding in 
this area so people would not have that uncertainty about 
whether the grant is going to be renewed. Doctor.
    Panel Member. If I could add, and because I am in the area 
where I am training these young scientists, one of the things 
that we could do differently at NIH--a couple of ideas, and 
they are not just mine--would be to provide more training 
grants, so these are called K awards, and they pay the salary 
of the individual, of the young faculty person. Most of the 
problems that we have with regard to the research in 
universities is coming up with supporting the salary of a 
faculty member early on in their career. These are not large, 
very large grants, but having more availability or directing 
more of those funds toward the K awards, K23, et cetera, where 
they can pay for their salary for the first five years--or not 
all of their salary, it is a good portion of their salary--so 
that they can develop their program and build it would be 
great.
    The other area is to--and this is a 30,000-foot 
observation--is to stop focusing so much on specific projects 
that I have to define every little single detail in order to 
get reviewed. The NIH ought to be funding more senior people as 
investigators. We know you are doing good science. Here is some 
money to support your laboratory for five years. At the end of 
five years, we will review what your progress has been in the 
field, and if it is good, we will give you another five years 
of funding.
    Every time we turn around and we want to try something, 
like finding an early marker, we have to stop, collect 
preliminary data, write a grant, submit it, get it reviewed, 
but from the initial idea to the funding, it is a three-year 
cycle every time we come up with a new idea.
    The Chairman. Thank you very much.
    I want to thank all of our witnesses today. You added 
enormously to our understanding, and thank you, Senator Scott, 
for inviting me here.
    Senator Scott. Absolutely.
    Thank you, as well, to all the witnesses for your 
participation today. We certainly appreciate the investment of 
your time and your energy and your expertise.
    I would say, without objection, members will have five days 
to submit additional material for the record and written 
questions for witnesses to the Chair. I would ask each of you 
to respond as promptly as possible to any written questions 
from members that we forward to you.
    This hearing is adjourned.
    [Whereupon, at 11:40 a.m., the Committee was adjourned.]
   
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                                APPENDIX

   
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                      Prepared Witness Statements

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