[Senate Hearing 114-863]
[From the U.S. Government Publishing Office]
S. Hrg. 114-863
DIABETES RESEARCH: IMPROVING
LIVES ON THE PATH TO A CURE
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HEARING
BEFORE THE
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
__________
WASHINGTON, DC
__________
JULY 15, 2015
__________
Serial No. 114-09
Printed for the use of the Special Committee on Aging
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
49-410 PDF WASHINGTON : 2022
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
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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 Claire McCaskill, Ranking Member.... 3
PANEL OF WITNESSES
Isabelle Levesque, Age Ten, Diagnosed With Type I Diabetes at Age
Two, Arundel, Maine............................................ 5
Amelia Cooper, Age Fifteen, Diagnosed With Type I Diabetes at Age
Twelve, Kansas City, Missouri.................................. 6
Kate Hall, Recent High School Graduate and Track and Field
Athlete, Casco, Maine.......................................... 8
Robert S. Amato, Former Runner and Coach, Member of Providence
College Athletic Hall of Fame, Johnston, Rhode Island.......... 9
Griffin P. Rodgers, M.D., Director, National Institute of
Diabetes and Digestive and Kidney Disease, National Institutes
of Health, U.S. Department of Health and Human Services,
Bethesda, Maryland............................................. 11
Habib Zaghouani, Ph.D., J. Lavenia Edwards Chair in Pediatrics,
and Professor, Department of Molecular Microbiology and
Immunology, Department of Child Health and Department of
Neurology, University of Missouri School of Medicine, Columbia,
Missouri....................................................... 14
APPENDIX
Prepared Witness Statements
Isabelle Levesque, Age Ten, Diagnosed With Type I Diabetes at Age
Two, Arundel, Maine............................................ 33
Amelia Cooper, Age Fifteen, Diagnosed With Type I Diabetes at Age
Twelve, Kansas City, Missouri.................................. 35
Kate Hall, Recent High School Graduate and Track and Field
Athlete, Casco, Maine.......................................... 38
Robert S. Amato, Former Runner and Coach, Member of Providence
College Athletic Hall of Fame, Johnston, Rhode Island.......... 41
Griffin P. Rodgers, M.D., Director, National Institute of
Diabetes and Digestive and Kidney Disease, National Institutes
of Health, U.S. Department of Health and Human Services,
Bethesda, Maryland............................................. 44
Habib Zaghouani, Ph.D., J. Lavenia Edwards Chair in Pediatrics,
and Professor, Department of Molecular Microbiology and
Immunology, Department of Child Health and Department of
Neurology, University of Missouri School of Medicine, Columbia,
Missouri....................................................... 65
DIABETES RESEARCH: IMPROVING
LIVES ON THE PATH TO A CURE
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WEDNESDAY, JULY 15, 2015
U.S. Senate,
Special Committee on Aging,
Washington, DC.
The Committee met, pursuant to notice, at 1:37 p.m., Room
G50, Dirksen Senate Office Building, Hon. Susan M. Collins,
Chairman of the Committee, presiding.
Present: Senators Collins, Perdue, Tillis, McCaskill,
Casey, Whitehouse, Donnelly, Warren, and Kaine.
Also present: Senator Shaheen.
OPENING STATEMENT OF SENATOR
SUSAN M. COLLINS, CHAIRMAN
The Chairman. Thank you. Good afternoon. This hearing will
come to order.
First, let me thank everyone for gathering earlier than we
had anticipated. Due to votes being scheduled on the Senate
floor, we wanted to make sure that our young people who are
here today and are the focus of this hearing did not have to
sit for a very long time while members of this Committee went
to vote.
We are holding today's hearing in conjunction with the JDRF
2015 Children's Congress to examine how diabetes affects people
of all ages, with a special focus on Americans with Type I
diabetes and their families.
This is the eighth consecutive Children's Congress that I
have chaired. It has been such a privilege to work with JDRF,
the families, the young people from all across the country
whose commitment to finding a cure is inspiring.
I want to welcome our distinguished panel of witnesses and
the more than 160 delegates to the Children's Congress who have
traveled to Washington from every State in the country and from
around the world to tell us in Congress just what it is like to
have diabetes, how serious it is, and why it is so important
that Congress fund the research necessary to discover a cure.
I want to give a special welcome to the two delegates from
Maine, Isabelle Levesque of Arundel and Mark Hurlbert from
Harrington. Also here is Kate Hall, a remarkable young woman
from Casco, Maine, who was diagnosed with Type I when she was
ten. An outstanding athlete, Kate recently broke a 39-year-old
national high school record in the long jump. She jumped an
astonishing 22 feet, five inches.
As the founder of the Senate Diabetes Caucus, I have
learned a lot over the years about the difficulties and
heartache that this disease causes for so many American
families as they await a cure. Diabetes is a lifelong condition
that does not discriminate. It affects people of every age,
race, and nationality. Moreover, diabetes costs the United
States an estimated $245 billion a year, a cost that is
projected to more than double by the year 2020. It also
accounts for one out of three Medicare dollars. In fact,
medical costs for Americans with diabetes are more than double
those incurred by individuals without diabetes.
These statistics are certainly overwhelming, but what
really motivated me to devote so much energy and time to this
cause is meeting more and more families like our delegates
today, whose lives have been forever changed by diabetes. That
is why it is so important that you have traveled to Washington
today to tell your personal stories. You put a human face on
the statistics.
Since we founded the Senate Diabetes Caucus, funding for
diabetes research has more than tripled, from $310 million in
1997 to well over a billion dollars this year. As a
consequence, we have seen some encouraging breakthroughs and
are on the threshold of a number of new discoveries. Advances
in technology, like continuous glucose monitors, are helping
patients control their blood glucose levels, which is key to
preventing diabetes complications. We are also moving closer
and closer to our goal of an artificial pancreas, which would
revolutionize diabetes care.
While today's hearing is being held in conjunction with the
JDRF Children's Congress, the fact is that 85 percent of those
living with Type I diabetes are adults, and many of them are
seniors. I was surprised and troubled to learn that insulin-
dependent Medicare beneficiaries are being denied coverage for
continuous glucose monitors. As a consequence, we are seeing
situations similar to what we saw with the insulin pumps in the
late 1990's, where individuals with Type I diabetes have had
their coverage for their monitors on their private insurance,
only to lose that coverage when they age into Medicare. Even
though 95 percent of private insurers cover continuous glucose
monitors, Medicare does not, and that is why I have joined
Senator Shaheen, the Co-Chair of the Senate Diabetes Caucus, in
introducing legislation to require Medicare to cover this
important device.
While we are making progress in the battle against
diabetes, this is no time to take our foot off the accelerator.
Earlier this year, we were able to pass legislation to extend
the Special Diabetes Program for two more years, through
September 2017. This provides an additional $150 million a year
for Type I diabetes research over and above the regular
appropriations for diabetes research at the National Institutes
of Health. I am hopeful that this afternoon's hearing will help
to generate even more support in Congress to extend this
important program into the future.
In closing, let me just say, in the years that I have
worked on this issue, I have been so impressed with the changes
in technology and the differences that they have made to the
lives of people living with Type I diabetes, and it never fails
to inspire me when I see all the young people of all ages from
all around the country who come to Washington to share their
stories with us, so thank you so much for being here with us
today.
Senator McCaskill.
OPENING STATEMENT OF SENATOR
CLAIRE McCASKILL, RANKING MEMBER
Senator McCaskill. Thank you, Senator Collins.
In the interest of time, because we obviously have votes
and we are doing this early because of that, I am not going to
give my formal opening statement, but if you would indulge me
for a minute, you guys look so awesome. I am not used to
looking out----
[Applause.]
This is a hearing room that we usually use for Armed
Services hearings, and I am on the Armed Services Committee,
and typically, I am looking out at the audience and it is a
bunch of, you know, dear people who are wonderful leaders and
heroes, but they are kind of stiff people in uniforms, and so,
I have got to get a picture of this for Instagram, okay?
I am so proud of all of you, and I am looking at all of you
in blue, because you are learning firsthand that you can make a
difference, and you are here in Washington because this is your
government and your government needs to listen to you about
what you are living with and what your needs are and the
incredible gaping hole we have in this country. I am fortunate
to serve with Senator Collins, because she and I agree on this,
that we have to invest in medical research. It has to be
something that drives our commitment as a Nation, that we are a
beacon to the world on medical research.
I will only do a couple of shout-outs. Obviously, I want to
shout out to Amelia Cooper, who is going to testify today. She
is from Kansas City. She is probably a Royals fan. I am a
Cardinals fan. We learn to love each other because it is all
one State. She is not a typical 15-year-old, however. Amelia is
a world traveler, having visited 35 countries, a cross-country
skier, a half-marathon finisher, and a published author, and a
person living with Type I diabetes, and we are proud to have
you here, Amelia.
I also want to give a shout-out to someone from my alma
mater, Dr. Zaghouani. He has too many accomplishments as a
pediatrician for me to begin to talk. He is a Chair in
Pediatrics at the University of Missouri School of Medicine in
Columbia with amazing credentials, and thank you for your work.
Then finally, I want to recognize the fact that your CEO of
JDRF is, in fact, from St. Louis, so we have evened out,
Amelia. I bet he is a Cardinals fan, so we are kind of book-
ended here, so St. Louis is very--has a very active chapter,
and, frankly, a lot of you all across my State who have made me
know for many years that this is something we all need to stay
focused on.
Thank you all for being here, and most of all, thank you,
Madam Chairman, for calling this important hearing, and the
Chairman's commitment to this for many years is unmatched, and
I am very proud to be Ranking on her Committee and I am very
proud of the work she has done in this area, so thank you all.
The Chairman. Thank you very much, Senator, and I just want
to echo what you said. This is not our typical hearing----
Senator McCaskill. No, no.
The Chairman [continuing]. and it is a great one--not to
say that we do not have wonderful hearings all the time.
Senator McCaskill. We are going to get in trouble here----
The Chairman. I know.
Senator McCaskill [continuing]. before this is over.
The Chairman. You are right.
We will now turn directly to our panel of witnesses. It is
my great pleasure to introduce Isabelle Levesque from Arundel,
Maine. Isabelle was diagnosed with Type I diabetes at the age
of two. She is an extraordinarily active girl who enjoys
reading, arts and crafts, playing soccer and softball, camping,
fishing, and music.
Senator McCaskill has already introduced our second
witness, Amelia Cooper.
Third, we will hear from Kate Hall. Kate has become quite a
star in the State of Maine. As I mentioned in my opening
statement, she recently broke a 39-year-old national high
school long jump record with an astonishing jump of twenty-two
feet, five inches.
Senator Donnelly, I had to have her show me just how long
that was.
She was diagnosed with Type I diabetes at age ten, but she
is yet another shining example of someone who has not let this
lifelong disease stop any of her goals or ambitions.
We are next going to hear from Bob Amato, and I am going to
be turning to Senator Whitehouse to introduce Bob. Senator
Whitehouse.
Senator Whitehouse. Thank you, Chairman. It is a pleasure
to be here. This is the most inappropriate Aging Committee
hearing I have ever seen, and it is terrific to see this blue
sea of young faces.
I want to express my appreciation to Jordan Delisle of
Rhode Island, who came and advocated this morning in my office
and did a wonderful job. She is here with her mom, Loriann.
I want to recognize, as Senator McCaskill did, the
leadership that Chairman Collins has shown on this issue for a
long time. There is an enormous amount of support in this room
for the continuous glucose monitoring, and the bill to make
that a part of Medicare is Senator Collins. She has led a
letter to the Appropriations Committee to support diabetes
research, and we are all happy to be Senator Collins' wingmen
on this issue--wingmen and wing-women, if that is a word, on
this issue.
I get the pleasure of introducing a panelist here today,
Bob Amato of Rhode Island. Just like some of the other
witnesses who Chairman Collins has already introduced, Bob was
diagnosed with Type I diabetes at a very young age. The
difference is that he has been living with the diabetes for 67
years. Bob refused to accept that having----
[applause].
Even back then, Bob refused to accept that having Type I
diabetes meant that he could not lead an active life. He became
a runner and eventually the track coach at Providence College
in Rhode Island. In fact, Bob was admitted into the Providence
College Athletic Hall of Fame in 2009. He was one of the most
successful coaches in the history of Providence College,
finishing with an astounding career record of 162 wins, 14
losses, and one tie. I am very pleased that Bob could be here
today to share the successes and the challenges that he has
experienced living with Type I diabetes.
Bob, to you and your family, welcome. We look forward to
hearing about your experiences.
Thank you, Madam Chair.
The Chairman. Thank you.
Senator Donnelly. Madam Chair, I have a question.
The Chairman. Yes.
Senator Donnelly. Would the former track coach of
Providence College like to offer a track scholarship to the
young girl sitting next to you?
The Chairman. I think he is too late. Believe me, that
occurred to me, whether I should seat them next to each other
or not.
Senator Donnelly. PC is a great college.
Chairman Collins. After we hear from the coach, we will
hear from Dr. Griffin Rodgers, the Director of the National
Institute of Diabetes and Digestive and Kidney Diseases at the
National Institutes of Health. It is a great honor, Doctor, to
welcome you back. You have testified at our previous hearings
and it is always so interesting to hear your update on the
research and the technology, so thank you for joining us again
this year.
Finally, we will hear from Dr. Habib Zaghouani, and Senator
McCaskill has already introduced him.
I do want to acknowledge Senator Shaheen, who has joined
us. She is the Co-Chair of the Senate Diabetes Caucus. She has
a granddaughter with Type I, and I believe her granddaughter
and daughter are going to be with us today, too, so welcome.
Senator Shaheen. Thank you.
The Chairman. We will start with our first witness now, and
that is going to be Isabelle, so Isabelle, please begin your
testimony, and thank you so much for coming from Maine to be
with us today.
STATEMENT OF ISABELLE LEVESQUE, AGE TEN, ARUNDEL, MAINE,
DIAGNOSED WITH TYPE I DIABETES AT AGE TWO
Ms. Levesque. Thank you, Chairman Collins and Senator
McCaskill, for inviting me to testify today. My name is
Isabelle Levesque. I am 10 years old and live in Arundel,
Maine.
I was diagnosed with Type I diabetes, or T1D, when I was
two years old. My diagnosis was the start of a very different
childhood. My mom and dad began a routine of ten to twelve
finger pricks and six insulin shots each day to keep my blood
sugar in a healthy range. As of today, I have pricked my finger
over 28,000 times, changed my pump site over 1,400 times, and
changed my sensor over 400 times. Can you imagine having to
stick a needle into your skin 30,000 times in just eight short
years?
My family says that I am a happy child, but it is hard when
you have to deal with diabetes everyday. Type I diabetes is
something you can never stop thinking about. I constantly have
to put my life on pause to test my blood sugar. This can happen
at any time--during my favorite movie, at school, when I am
swimming, or in the middle of a soccer or softball game.
Sometimes I even have to come out of a game to recover from a
low blood sugar when I feel my team needs me the most. It is so
frustrating. Cold weather activities are difficult, as well,
because I do not always feel my low blood sugars when playing
in the snow. I have been as low as 26 and did not even know it
until my parents had me check.
I am here as a JDRF Children's Congress delegate because I
need your help. I want to see a cure for diabetes in my
lifetime, and all of my friends here today do, too. My family
and I have spent the last eight years fighting for it and we
need Congress to continue fighting with us by funding research
through the Special Diabetes Program.
My family and I work hard to raise funds for T1D research
and to teach my community about the difficult disease. We do
our part. My walk team, Strides for Isabelle, has been the top
fundraising team in Maine for five out of the last seven years.
I am proud to say that we have raised over $100,000. Also, last
summer, I helped organize a concert which I played my guitar in
to increase my community's understanding of the impact of
diabetes.
The money we have raised has gone toward research into new
treatments for Type I diabetes, and hopefully, we will one day
find a cure. From this research has come technology that has
made it easier to live with diabetes. One technology I use to
track and manage my blood sugar is called a continuous glucose
monitor, or CGM. I have been wearing a CGM since I was three
years old. Before I had a CGM, it was really hard for my mom
and dad to know if my blood sugar was high or low, so they
pricked my finger constantly throughout the day and used a test
strip to check. For a three-year-old, and even now, this CGM
has made a huge difference. Although this device has helped me
to stay healthy, there is much more to be done and a cure is
still needed.
When I grow up, I want to be a teacher. To help make this
dream of mine be a reality, it is important that Congress
continue supporting T1D research. Thank you.
The Chairman. Thank you very much. That was perfect. You
did a great job.
Amelia.
STATEMENT OF AMELIA COOPER, AGE FIFTEEN,
KANSAS CITY, MISSOURI, DIAGNOSED WITH
TYPE I DIABETES AT AGE TWELVE
Ms. Cooper. Thank you, Chairman Collins, Ranking Member
McCaskill, and members of the Committee for inviting me to
testify today. My name is Amelia Cooper and I was diagnosed
with Type I diabetes, or T1D, three years ago, at age twelve.
As you all know, the teenage years can be a little rough,
with pressures to fit in, figure things out, and find your way.
At a time when many of my peers are worrying about their hair,
clothes, and social schedule, I must focus my attentions on
things vital to my health. Each day, I have to carefully
monitor and manage my blood glucose level, which is not easy,
since exercise, diet, and many other factors all have an
impact.
Despite these serious challenges, I have many reasons to be
grateful. Thankfully, I was diagnosed with T1D after Frederick
Banting discovered insulin. Thankfully, I was diagnosed with
T1D after insulin pumps and continuous glucose monitors were
invented. Thankfully, I have learned how to manage my diabetes
without allowing it to manage me, even though it is not always
easy.
It is only through a very strict blood sugar management
routine and advancements in diabetes treatments and devices
that I have been able to live my life to the fullest.
Thirty-five: The number of countries I have visited, and
still counting. Thirteen-point-one: The number of miles in a
half-marathon. I have completed two so far. Ten: The number of
things I wish my parents knew when I was diagnosed with T1D. I
wrote this article as a published author in the blog diaTribe.
Four-plus: The number of years after college that it takes to
become a doctor, like my Dad, who I look up to. That is my
dream job. One, as in Type I, the number associated with my
disease. I am hopeful through Congress's support we will move
from Type I to Type None.
Through advances in medicine, my life has gotten easier,
healthier, and safer. I use an insulin pump and a continuous
glucose monitor and I am well aware that these advancements
took much time, research, and funding to become a reality.
While I have never participated in a formal clinical trial,
I am very excited about a recent research project that I
conducted. I have always been curious as to how and why my
blood sugars are so irregular when I ski. Changes in altitude
and prolonged activity can be very hard on blood sugar control,
and after researching the topic, I realized there was an
opportunity to design a study to evaluate the changes my body
experiences when I ski compared to my friends without diabetes.
The results, which showed that--wait. Sorry. The results,
which were presented at this summer's American Diabetes
Association meeting in Boston, showed that despite strenuous
activity, altitude caused an increased demand for insulin by
more than a third. Most importantly, I showed that my blood
sugars could be in the same range as my friends with careful
monitoring and planning of my carbohydrates and insulin
requirements. The use of a continuous glucose monitor was
especially helpful in preventing hypoglycemia and ensuring safe
blood sugars prior to riding a chairlift or skiing.
My project obviously does not compare to those responsible
for the significant progress being made for the life-changing
treatments for T1D, projects on beta cell encapsulation and
artificial pancreas technology, treatments I hope to have
available in the years to come, but my project does represent
my strong desire to make an impact. I am not someone who can
just stand by when there is so much to be done to improve my
quality of life and that of all of my friends before you today.
In closing, I ask for your support in this fight to cure
diabetes. Thank you, Chairman Collins, Ranking Member
McCaskill, and members of the Committee for your time today.
Senator Whitehouse. Madam Chairman, before we go on to the
next witness, may I ask unanimous consent that the record of
this hearing reflect something that the people behind Amelia
might not have seen, which is that throughout her testimony,
she virtually never looked down at her notes, which is far
better than most adults----
Senator McCaskill. I just hope she does not run against me.
I am in trouble if that happens.
The Chairman. That really was extraordinary testimony and
we thank you so much for being here today.
Now, we are going to turn to another extraordinary young
woman, Kate Hall.
STATEMENT OF KATE HALL, RECENT HIGH SCHOOL GRADUATE AND TRACK
AND FIELD ATHLETE, CASCO, MAINE
Ms. Hall. Good afternoon. My name is Kate Hall and I am
from Casco, Maine. Thank you, Chairman Collins, Ranking Member
McCaskill, and members of the Committee for the honor of being
here today to speak about my experience living with Type I
diabetes and Type I diabetes as an athlete.
I was diagnosed with Type I diabetes when I was 10 years
old. At first, it seemed as if I would never understand every
little detail that was involved in having diabetes. I had to
adjust to taking shots of insulin, checking my blood sugar
several times a day, learning how to count carbs in everything
I ate, and learning how to deal with high and low blood sugars
correctly.
However, the thing that stood out to me the most was being
benched during my first soccer game after my diagnosis. That
really made me realize that diabetes was not going to ever stop
me from doing the things I loved most. I thought, I am not
sitting out on anything ever again if I can help it. I am
figuring this thing out.
Type I diabetes is challenging, particularly when it comes
to what I love doing most, track and field. The events I
compete in, the long jump and the short sprints, require
rigorous daily training, but for me, because I live with Type I
diabetes, keeping my blood sugar in a healthy range as much as
possible is just as important a part of my training and success
as anything else I can do to prepare for competitions.
Managing my diabetes can be really hard at times, and I
realize I cannot figure everything out on my own. I need help
from doctors, my parents, diabetes technology, and researchers.
Being a competitive track and field athlete, there are many
tiny details involved that people have to do in order to get
the best results possible. Some of these things include staying
hydrated, eating well, sleeping well, training the right way,
and warming up correctly to prevent injury. Not only do I have
to do all of these things, but making sure my blood sugar is at
a good level is another thing to add to that list.
Whenever I am training or competing, I have to take my
blood sugar several times before I run in order to make sure it
will not go high or low. If it is high or low, I need to
quickly do what I need to do to get it to that perfect level so
it does not negatively affect me. During my training or
competition, I try to check my blood sugar every half-hour to
ensure a high or low blood sugar will not affect my
performances.
If my blood sugars do become too high or low, which has
happened several times, my pH level changes and I occasionally
get muscle cramps. These muscle cramps are very painful and
prevent me from competing the rest of the day or even the rest
of the week. When this happens, it is extremely frustrating to
think that my diabetes is preventing me from doing what I love
the most, even when I try my hardest to control it.
I wear an insulin pump and was using a continuous glucose
monitor until we changed health insurance companies. With most
private health insurers covering CGMs these days, I am hopeful
that my current plan will update its policy so I can use a CGM
again. These devices help me spend more of my day in a healthy
blood sugar range and also helps me focus on training and
competing.
Thankfully, new technology, diabetes management devices,
and also the support of my family and health care team have
allowed me to pursue my passion and become a world ranked
junior athlete. I was able to end my high school long jump
career this year by breaking a 39-year-old national high school
record with a jump of twenty-two feet, five inches, at the New
Balance Nationals last month. My jump also broke the U.S.
junior record set in 1982 and surpassed the automatic
qualifying standard for the 2016 Olympic trials. I also
finished third in the 100-meter event with a time of 11.37
seconds.
My dream is to one day represent the United States at the
Olympics. This fall, I will begin training at Iowa State, and
although I will be far from home and working with a new team of
coaches, one key part of my life remains unchanged, the
challenges of managing my Type I diabetes every single day.
Technology is important, but those of us with Type I
diabetes need more. We need the scientists to help us figure
out even better treatments and a cure for this disease. That is
why my family and I are grateful for the funding that Congress
has provided for Type I diabetes research.
Chairman Collins, we thank you for your leadership. All of
us with Type I diabetes are counting on Congress to help us
figure it out. Thank you.
The Chairman. Thank you. Kate, I just want to say
personally how proud I am of you. It was just thrilling to hear
of your success and setting new records, and to do so while
coping with a very complicated illness is even more impressive.
Ms. Hall. Thank you.
The Chairman. Most of all, you really inspire all of the
children who are here today to know that they, too, can achieve
their dreams, so thank you for coming.
Ms. Hall. Thank you.
The Chairman. Mr. Amato, welcome.
STATEMENT OF ROBERT S. AMATO, FORMER RUNNER AND
COACH, MEMBER OF PROVIDENCE COLLEGE ATHLETIC
HALL OF FAME, JOHNSTON, RHODE ISLAND
Mr. Amato. Chairman Collins, Ranking Member McCaskill,
members of the Committee, thank you very much for this
opportunity to speak before you. My name is Bob Amato and I am
from Johnston, Rhode Island.
When I was first diagnosed with Type I diabetes, It was 67
years ago, I was approximately seven years old. Thinking at
that time were that people such as you guys were not able to
compete. No athletics. No gym. That was difficult. I did not
accept that, and I sought some guidance from Joslin, the
Elliott P. Joslin Clinic, and again, some guidance from my
parents, and I was able to prove that particular concept a
fallacy, a fallacy to the point where in 2009 I was entered
into the Providence College Hall of Fame for Athletics for both
the running, my running accomplishments, and accomplishments as
a coach.
As a coach, I had the privilege of coaching two world
champions, 16 Division I All Americans. Our teams competed and
won 16 New England Championships. My coaching colleagues
selected me to the Coach of the Year 15 different times. That
was what I would hope for when I was told it could not be done.
I was able to find success despite the daily challenges of
diabetes because I always used--now this is important, the
term--the latest technology, the latest technology. Now, you
have got to picture that when I first came down with diabetes,
the needles--are you ready for this one--the needles were
metal. We had to sharpen them on a stone. The syringes were
glass. Blood--testing urine was the method of determining blood
glucose, and now, we are up to the insulin pump and the
technology is just fantastic.
About 15 years ago, I began to realize that the normal low
blood sugar warnings were no longer happening. All of you know
that when you have a low blood sugar, you are either a little
bit tired or you are a little shaky or things happen that are
not normal, but at this point in my diabetes career, after 67
years, those body signals are gone, and that provides me with
some pretty big dangers.
I needed to find a way to manage that situation. I was
fortunate that the JDRF funded research program using the
continuous glucose monitors, the CGMs, took place in Boston,
and I was one of the first to start in on that, and we spent
about a year with that program. It was great. I went from not
realizing what was going on with regards to insulin reactions,
as we used to call them, low blood sugars, hypoglycemia--you
guys are all familiar with that--to now knowing ahead of time
what to do and how to correct it. It also enabled me to control
my diabetes better, which, again, is very, very important, so a
new technology helped me with a situation that was really
dangerous.
As a result of the JDRF study and other studies, the CGMs
were endorsed by leading clinics throughout the country, the
Endocrine Society, the American Diabetes Association, the
American Association of Clinical Endocrinologists. I do not
know what they are. They are great organizations, I know, but
we cannot relate to them, but what I can say is that almost
every insurance agency--almost every one--is now on board.
There is still a tragedy, and that tragedy is Medicare will
not cover these things. I appealed to Medicare over a period of
four solid years. The folder that I have is thicker than this.
However--however--I received notice that, last November, that
it was okay. The judge found in my favor. Well, I had the
pleasure of coaching, again, as I said, two world champions.
The feeling I had at those two world champions' successes was
exactly the same when they told me, we find in favor of you,
but that was not all the difficulty. Two months later, they
took it back. They said no, and I was heartbroken, but I have
not given up. I have not given up, and that is what I hope you
guys will do as you are going through school, high school,
later on in college, and so forth. Do not quit.
Now that I depend on Medicare for my diabetes, the CGMs
that could save my life--almost saved my life when I was
wearing them, numerous times--and again, as I say, I will not
accept the CMS's decision--those are the administrators of the
Medicare program. The CGM can mean literally a difference
between life and death. I am going to explain one instance.
Now, you have got to remember, we are trying to show the
technology has helped me for 67 years to be healthy and strong
and successful, and now, they have taken that technology away.
I was driving on the interstate between Boston and Rhode Island
when, not knowing, a reaction, low blood sugar occurred. My car
started to move back and forth on the highway. I did not
realize that. An 18-wheeler did realize it, truck. He saw what
was happening and he took and pushed my car off the road into
the median. When the technicians took my blood sugar, it was
extremely low. That gentleman saved my life.
That did not have to happen. That did not have to happen. I
could have been--the CGM is what I am trying to get at. If that
was--if I had had that, I would have known ahead of time and
things would have been taken care of. I could have taken care
of it.
Now, about a month ago, I had a chance--things have been
difficult now that we are back out of the situation. About a
month ago, I had a chance to go back to visit Providence
College. I went up there alone.
The Chairman. Mr. Amato, I hate to cut you off, because
your story is----
Mr. Amato. No, that is fine.
The Chairman [continuing]. absolutely fascinating. I am
just worried because of the vote scheduling.
Mr. Amato. I understand.
The Chairman. If I could ask you to wrap up, that would be
great.
Mr. Amato. Well, Chairman Collins, I would like to thank
you, thank you for the opportunity of just being here and
pleading for this particular situation, and I hope that the
vote that will be taken and those that have been on assignment
with you will continue, and if anyone has any questions, and I
know you do not have the time for this, but if you do have
questions, please be free to contact me and I would be glad to
talk with you.
Thank you.
The Chairman. Thank you so much. Thank you for your
compelling testimony.
Dr. Rodgers, it is great to have you back.
STATEMENT OF GRIFFIN P. RODGERS, M.D.,
DIRECTOR, NATIONAL INSTITUTE OF DIABETES AND
DIGESTIVE AND KIDNEY DISEASE, NATIONAL
INSTITUTES OF HEALTH, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES, BEHTESDA, MARYLAND
Dr. Rodgers. It is good to be back. Chairman Collins,
Senator McCaskill, and members of the Committee, thank you for
this invitation to testify today.
Type I diabetes is a lifelong disease that affects
Americans of all ages, including seniors, and on behalf of the
National Institutes of Health, I am pleased to report that our
research investment continues to improve the lives of people
with Type I diabetes. Through coordinated efforts with our
research partners, the JDRF and the ADA, as well as with the
support of the recently renewed special statutory funding
program for Type I diabetes, we are helping children sitting
here today and all people with Type I diabetes live healthier
lives and longer lives.
I am pleased to report that since I testified before you,
this Committee, just two years ago, we have made significant
scientific advances that are putting us closer to reaching our
ultimate goal of preventing, treating, and ultimately curing
Type I diabetes and its complications, and with the renewal of
the Special Diabetes Program through Fiscal Year 2017 that you
alluded to, we are also looking forward to taking advantage of
future opportunities that I would like to briefly describe for
you today.
Before I highlight some of these advances, I want to
certainly acknowledge the important contribution that my fellow
witnesses have made, and I want to thank you for your personal
testimony that you are not letting Type I diabetes define you
as a person, and I am pleased to share the table with Dr.
Zaghouani, who, I am sure, shares the research goals of
preventing, treating, and ultimately curing Type I diabetes. I
would also like to thank all of those here today representing
Americans of all ages with Type I diabetes.
I am happy to report that the outlook of people with Type I
diabetes is better than ever. People with the disease have new
and emerging technologies and treatments to help them manage
their disease, and because of research conducted by NIDDK's
landmark Diabetes Control and Complication Trial, or DCCT, and
its follow-up study called EDIC, we know that early and
intensive blood sugar control is key to reducing the risk of
the devastating complications of the disease.
Just this year, for example, we learned from the DCCT EDIC
that people with Type II diabetes who intensively controlled
their blood sugar levels early in their disease are more likely
to live longer than those who do not, and further emphasizing
the importance of early and intensive blood sugar control.
However, as everyone here today knows, controlling blood
sugar is easier said than done. It is extremely challenging and
burdensome, and it also is limited by the potential for acute
episodes of hypoglycemia or dangerously low blood sugars. A
promising approach to overcoming this barrier is the artificial
pancreas, which is a device that can sense blood sugar levels
and automatically administer insulin.
I am pleased to report that with the Special Diabetes
Program support, there has been tremendous progress in this
area just last year, with researchers testing portable
cellphone-based devices in real world settings. For example, in
one setting, the use of an automated bihormonal bionic pancreas
for five days and five nights by adults and adolescents led to
lower mean blood sugar levels and reduced episodes of
hypoglycemia.
Another study found that in adolescents' unsupervised
overnight use of artificial pancreas for 21 nights led to
improved blood sugar controls during the day and the night and
reduced the number of episodes of this nighttime hypoglycemia,
and because of the tremendous progress artificial pancreas
technology holds, great promise in the near term approaching to
help manage Type I diabetes while improving their health.
However, it is not a cure. Replacing or restoring the
function of the beta cells would be the biological cure. In
another area under vigorous investigation, one strategy to
replace these beta cells is via islet transplantation. Our
collaborative islet transplant registry has shown both safety
and efficacy outcomes that have improved from the year 2007 to
2010, compared to, for example, 1999 to 2006.
Additional research progress areas have been made, both by
NIDDK and the NIAID co-led Clinical Islet Transplant
Consortium. They have completed a pivotal trial, a Phase three
trial, and have reached another end point in a second Phase
three trial, and we really look forward for these exciting
results to be submitted to the FDA toward licensing pancreative
islet product for transplantation.
Now, a current barrier for using islet transplantation is
the scarcity of donor islets for transplantation, and here
again, another major advance to overcome this difficulty has
been recently reported by reporters in the NIDDK's Beta Cell
Biology Consortium, who have achieved a longstanding goal of
Type I diabetes research. They have discovered a way to create
large numbers of these glucose responsive insulin producing
beta cells, and we think with further research, such cells
could possibly be used for transplantation to restore insulin
producing capacity in patients with Type I diabetes.
NIH has also made important strides in research to combat
diabetes complications. For example, a recent trial conducted
by the National Eye Institute's Diabetic Retinopathy Clinical
Research Network compared three drugs with widely differing
costs for treating diabetic eye disease. The results show that
in people with mild eye, or mild vision loss, all three drugs
were equally effective. These results can inform clinical
decisions and lead to more personalized treatment for diabetic
eye disease while having significant cost implications, and
importantly, the drugs were found to improve vision, which
could certainly make a difference in the quality of life that
people with diabetes share.
One other point I want to make is that the NIDDK and the
CDC have developed a Search for Diabetes in the Youth study as
a result of these special diabetes funds, and this search
program has shown that Type I diabetes in people under the age
of 20 has risen by 21 percent--the incidence has risen by 21
percent--during the years 2001 to 2009. These data suggest that
there are some environmental factors, or factor or factors,
that is contributing to disease risk, and our study of the
Environmental Determinants of Diabetes of the Youth, or our
TEDDY study, which is now following 6,000 kids from birth until
the age of 15, we hope will very soon get a handle on what
these environmental risk factors are.
I know that the time is limited, so let me just end there
and just say to Chairman Collins and Senator McCaskill and
members of the Committee, thank you for this opportunity to
testify before you today. The NIH is grateful for your
continued support of Congress, for our public and private
partners, and for the unwavering efforts of the clinical study
volunteers. We look forward to continuing our vigorous support
of research to build-upon our recent scientific advances toward
the goal of allowing people of all ages with Type I diabetes to
live long and healthy lives, free of the burden of this
disease.
Thank you for your attention, and I certainly look forward
to answering any questions that you might have.
The Chairman. Thank you very much, Doctor.
Dr. Habib, as I am going to call you.
STATEMENT OF HABIB ZAGHOUANI, PH.D., J. LAVENIA
EDWARDS CHAIR IN PEDIATRICS, AND PROFESSOR,
DEPARTMENT OF MOLECULAR MICROBIOLOGY AND
IMMUNOLOGY, DEPARTMENT OF CHILD HEALTH AND
DEPARTMENT OF NEUROLOGY, UNIVERSITY OF
MISSOURI SCHOOL OF MEDICINE, COLUMBIA, MISSOURI
Dr. Zaghouani. Chairman Collins, Ranking Member McCaskill,
and members of the Special Committee, I am delighted to be
here, and I think the speech I am going to give is more
educational and hopefully to convince you how to invest in
research more and more so we can get the cure and get these
children become Type None, Amelia, not Type I.
All right, so Matthew, can I have the first slide. Thank
you, so please, if you focus on the slide, the poster, so Type
I diabetes is an autoimmune disease. What that means is that
the immune system, which is there to protect us from infection,
from cancer and other diseases, in fact, make mistakes and then
attack the beta cells, so the bugs are the immune system, and
the flowers, the dead flowers, are the beta cells, and so, when
the immune system, or the bugs, attack the flowers, or the beta
cells, they die. There is no more insulin and, therefore, sugar
cannot be taken for the cells. The cells cannot have energy.
Therefore, they cannot function.
We started by looking at how to get the bugs away so that
they do not attack the beta cells so that we can get insulin
again, and when we did that, we succeeded when we tried to get
the immune system away before the mice developed Type I
diabetes, but we failed when we tried when diabetes is
established.
We had to use a little bit of thinking. In humans, the
diabetes is diagnosed when it is established, so we had to
establish a technology or an approach that can reverse the
diabetes, and when we looked harder, we understood that the
immune system, when it attacks the beta cells, it also attacks
the blood vessels that connect the beta cells to the rest of
the body, so they can no longer distribute the insulin or it
cannot get things to them to produce insulin. The blood vessels
here are represented by a pipe, and if you look at the pipe, it
is broken, so it is leaking.
In order to fix the disease--next slide, please, so the
thought was, in order to fix the disease and to cure it, you
cannot just eliminate the bugs. You have to fix the pipes, and
so, if you eliminate the bugs with a drug and you fix the pipe
with stem cells, then you can get the flower to flower again
and produce insulin and cure the disease, and this is the
experiment we set to test, and we did. Next slide, please.
What we did here is we have a sick mouse in the upper
panel, left side, and so we are going to treat it or give it a
drug to eliminate the immune system that attacks the beta
cells, and we gave it adult stem cells that we can get from the
blood or the bone marrow, and watch what happened to the mouse,
and surprisingly, what we found--that is a schematic
representation. It is a mouse from the Internet. We made the
mouse happy. It is back on its scooter.
I am hoping--I am hoping that we can get you all back on
your scooters and your skis and your everything.
Thank you, so that is--two more minutes, thank you--for me.
We looked at the pancreas, a specific islet. Now, we are
looking at the lower panel, the little dots. If you see, there
is a brown dot in the diabetic mouse. That is the only leftover
beta cells producing insulin. It is very little. You can barely
see it. After we gave it this treatment, look how the insulin
became--the islet became full of insulin, and that is what we
want to do. That is what the experiment is aimed at.
We were able to cure Type I diabetes. You would not need to
give yourself insulin anymore if this pans out and if we have
funding and research to continue and develop programs that will
take us there, so that is the science part of it. You can
remove that.
What I want to say here is I have been doing research for
20 years on Type I diabetes and I have been making progress,
and now that we are getting closer to really make the
difference, I find myself really in trouble funding-wise. I
have to spend 70 percent of my time writing grants, and so far
this year, I have not been successful. I would rather spend my
time doing the research rather than writing grants, and writing
again the same thing, and writing again the same thing, and get
nothing.
My advice or opinion is that, Chairman Collins, you made
the statement, you said, we keep pushing the accelerator. Well,
Chairman Collins, Senator McCaskill, Senators, keep pushing
that accelerator. You will not get a police ticket. You will
get a cure for Type I diabetes.
The Chairman. Thank you very much.
Thank you all for your excellent testimony.
Isabelle, you talked about that you have worn a continuous
glucose monitor since you were very young, since, I think, age
three. Does it send a signal to your parents on their phone or
in some other way if your blood sugar is getting too low?
Ms. Levesque. It does not matter if my blood sugar is high
or low, or no matter, like, what my blood sugar is saying. I
have a little iPhone in my bag and my CGM reads there, and then
my iPhone sends all my numbers to my parents, so even if they
are, like, across the globe, like, they can still see my
numbers.
The Chairman. That is great, and it shows how important it
is, as Mr. Amato says. It is truly a life-saver.
Kate, you talked about your family changing health care
plans and then you lost coverage for your CGM, is that right?
Ms. Hall. Yes.
The Chairman. I want you to know that we are working very
hard with your insurer and we have got some people for you to
call, and I am hoping we can get that situation taken care of--
--
Ms. Hall. Thank you so much.
The Chairman [continuing]. for you.
Ms. Hall. Thank you.
The Chairman. Can you describe the difference for you
between having a CGM and not having one?
Ms. Hall. Yes. I mean, it makes a big difference, in
general, but especially with competing, I need to know what my
blood sugars are every single moment, because it can go low in,
like, 10 minutes without even me realizing, so usually, like,
either one of my parents or my trainer will be able to see what
my blood sugars are the whole time that I am competing, and if
it says that I am going low, then I can make the adjustment
before it goes low so I will not have those muscle cramps, and
it makes a huge difference, so it has been tough not having it
recently, so, hopefully, it works out.
The Chairman. Thank you.
Dr. Rodgers, did Medicare officials at CMS consult with you
before they made the decision to not have coverage for CGMs for
Medicare beneficiaries?
Dr. Rodgers. Chairman, I am unaware of any CMS officials
contacting us on that--on this. I am in agreement with the
comment that former Commissioner Hamburg of the FDA made that,
really, as agencies, we should work together on this entire
scheme.
Very recently, we held a Diabetes Interagency Coordinating
Committee, which NIDDK chairs, and we presented information
about glucose monitoring, particularly in older adults, and the
proposals that came out of that meeting were presented to a
group of experts and they uniformly agreed that this is really
a high area for research priority, and so, they think that this
is very important to move forward with.
The Chairman. Thank you. I think it is absolutely
incredible that Medicare officials did not consult with you,
the foremost expert that we have at NIH overseeing this
research, nor did they consult with the FDA, which approved the
device, before deciding that it was just a precautionary or
safety device and, therefore, was considered non-medical.
Mr. Amato, it sounds like it certainly was medical for you
and literally a life-saver. Would you agree with that?
Mr. Amato. Absolutely. Yes, Senator Collins. Yes, I would
have to agree with that, and I saw those two terms,
``precautionary'' and ``medically necessary'' over and over
again. It is still not believed to be medically necessary, at
least in the data that has been sent to me, so we will just
keep our fingers crossed that we can convince them.
The Chairman. Well, as I mentioned in my opening statement,
Senator Shaheen and I have a bill to mandate the coverage and
we will--I cannot speak for my colleagues, but I am pretty sure
we will all be pushing very hard on that.
Finally, Amelia, you said in your testimony that there were
ten things that you wished your parents had known when you were
diagnosed. I am almost out of time, but could you tell me the
top thing that you wish your parents had known?
Ms. Cooper. I think that the top thing that I wish they had
known is that when I go low, I get upset or angry or something,
but then every time I got angry or upset or something, they
automatically jumped to the conclusion that I was low, and
after a while, it got kind of annoying.
The Chairman. Thank you very much.
Senator McCaskill.
Senator McCaskill. You needed them to know that you could
just be angry.
Ms. Cooper. Yes.
Senator McCaskill. Having children, I certainly understand
that.
Let me start with Dr. Zaghouani. In your testimony, you
talk about the need to involve pharmaceutical companies in
clinical Type I diabetes research. Is there any way at the
Federal level, is there anything that we could do to encourage
that kind of collaboration?
Dr. Zaghouani. I think you can. The pharmaceutical
companies, they take risk when they test a drug or do a
clinical trial, and when they succeed, they make money, but I
understand--ten years ago, I understand Merck spent $400
million to generic one drug. I do not know if that is still
true now, so there is a lot of risk. I think if the government
can help create an incentive for them to take that risk, I
think that will push us forward toward a cure.
Senator McCaskill. Dr. Rodgers, we know that research
dollars are scarce. NIH has been living under a dark cloud now
for several years because of our cutting back on funding to
NIH, and it is my understanding that there is an effort to
ameliorate that somewhat this year. We still are not going to
get back to the kind of increases that I think we need to be
embracing to stay in our dominant position in terms of medical
research around the world.
Does NIH and NIDDK--how do you decide what research studies
that you fund, and are you giving priority to clinical studies
that have a better chance of translational impact both in terms
of quality of life for people like the young people in front of
me and for the Federal Government saving money, for example? I
mean, all you have got to do is turn on cable TV--not for Type
I, but for Type II. There is no question that glucose
monitoring is one of the drivers of our debt at this point
because of the costs of monitoring, and all the ads for buying
monitoring machines that is all being paid for by the Federal
Government.
Dr. Rodgers. Well, Senator McCaskill, you raise a very
important point, and certainly the prevalence, the burden of
the disease, the number of people affected, but also the expert
input that we get, the unique scientific opportunities that we
may have at a particular time, all factor into the types of
trials that we conduct, when we conduct them, how expensive
they are.
There are other aspects sort of in your question that there
are potential opportunities, for example, that one would think
the private sector would be more involved in, related to a
question that was just mentioned.
For example, the special diabetes statutory funding has
allowed us, for example, to work with our sister organization,
the National Eye Institute, to conduct a study of three
commonly used drugs for the treatment of one of the major
complications, diabetic eye disease, and for example, this
network--of these particular treatments that I had mentioned
during my testimony, one costs about $2,000 per injection, one
costs $1,200 per injection, and one costs $70 per injection,
and these were given to people that had mild vision loss, over
half of whom enrolled in this trial, and it is important to
indicate that all of the results were quite substantial in
terms of the improvement, but all three of these drugs had
nearly equivalent effects.
Now, obviously, because of the financial aspects of this--
this is not a particular study quite likely that a private
sector pharmaceutical company would be likely to fund, but it
is a kind of thing related to the question that you asked----
Senator McCaskill. Right, so let us go all in on the $70,
right
Dr. Rodgers [continuing]. or therapies----
Senator McCaskill. Yes.
Dr. Rodgers. I want to caveat, though, it is for people
with mild disease.
One other example, again, because of the Special Diabetes
Program, we are actually able to now fund a trial called
Prevention of End-Stage Renal Disease, or Renal Loss, or the
PERL trial, using a fairly safe and quite effective drug called
allopurinol. It is actually now a frequently used drug for the
treatment of gout, because there is fairly good indication that
this may prevent the progression of kidney damage to end-stage
renal disease in which patients would, of course, have to
undergo Medicare coverage.
If we are able to show in this trial that this safe and now
generic drug can effectively prevent the disease in Type I
diabetes, it will likely save tremendous amounts of funds
moving forward, and it may have application in the broader
setting, Type II diabetes, where the complications are quite
similar.
Senator McCaskill. Thank you very much.
Dr. Rodgers. Thank you.
Senator McCaskill. Thank you, Madam Chairman.
The Chairman. Thank you.
Senator Tillis.
Senator Tillis. Thank you, Madam Chair.
Thank you all for being here and for your testimony and for
your advocacy on the Hill. I had an opportunity today to meet
with some North Carolinians. I do not know--I see Rachel up
here in front, and Trinity down there, and Turner. I know the
others are in the room. I think on behalf of all North
Carolinians, we appreciate you all wearing Tar Heel blue today.
I want to--Mr. Amato, you mentioned something that, as I
was speaking with my guests in my office, when we look at the
need to provide coverage for CGM, I think we have to take a
look at benefits in economic terms that, I think, far outweigh
the cost, because when we look at your situation--in fact,
Stella--Ms. Cole, I think, is her last name, mother of Stella,
a young girl, four-year-old, I think, who was in my office
today--she was just relating a story about an automobile
accident that occurred, and actually, her car was damaged as a
result of someone who was obviously in circumstances similar to
what you described.
I think as we go forward and we build support for coverage
for CGM, we really need to articulate a lot of the hidden costs
that probably are not being taken into account that in my mind
far outweigh the cost of actually providing the device, not the
least--the greatest benefit, obviously, is for Rachel's mother
to be able to track her while she is playing volleyball, and
Kate, similar to you, know whether or not she has a situation
she needs to deal with, but also because I think it makes great
fiscal sense, so I look forward to moving forward and
supporting efforts to do that.
Kate, I also want to pick on you for a minute. I hear that
when you set the juniors record for long jump, you were down in
North Carolina.
Ms. Hall. Yes.
Senator Tillis. Just something in the air down there. You
ought to consider coming back, but can you tell me again about
some of your experiences where in real time the device has had
an impact on you personally?
Ms. Hall. Yes. Well, I first got it a couple of years ago
and right from when I got it, I noticed a huge difference, and
then it really helped me control my blood sugars, and not only
that, just, especially when competing, it really, really,
really helped me, the CGM. It just--it tells me when it is
going high or low and I can keep it with me all the time, so
instead of having to check my blood sugar every half-hour at a
meet, I can just look at that and know where it is heading and
grab something to eat real quick, or give insulin, and I do not
get any muscle cramps and it helps me immediately, so it is
very, very helpful.
Senator Tillis. Thank you.
Dr. Rodgers, I know with the younger generation, Isabelle
was very matter-of-factly talking about the integration with
her iPhone, the ability to broadcast her levels real time to
her parents, but what sorts of challenges do we have with
seniors also taking advantage of this, and what kind of
adoption rates do we see among seniors versus the more youthful
population we have present today?
Dr. Rodgers. The adoption of these new technologies are
certainly that seniors are embracing, perhaps not at the level
that we see in the younger generations. I would say with the
CGM in particular, there is a fair amount of data to recognize
that hypoglycemia, very low blood sugar levels, among people 65
or older with Type I diabetes is a previously substantial
unrecognized problem in terms of how often it occurs. It seems
to be a major contributor to emergency room visits, for
example, and when you mention the hidden costs, when comparing
costs, imagine what the cost is having to return to emergency
rooms repeatedly versus the costs of that type of care.
Having said that, though, I mean, this is one of these
areas, and again, with the Special Diabetes Program, we
recognize that we have to bring new talent into this field, not
only in making these technologies more miniaturized and easier
to use, but we have also been bringing in people with knowledge
of behavioral science, because it is one thing to have the
technology, but to get the people to use it may provide its own
challenges, and to get it being used more effectively, for
example, particularly with older individuals who may be
suffering with visual problems, with hearing loss, et cetera.
Senator Tillis. Well, thank you.
Dr. Rodgers. These are issues that we are working on.
Senator Tillis. My time is up, but one thing I would
really, Madam Chair, I would like to spend some time on, or if
the information is available, get access to it, but I really
think to build our case for providing coverage for CGM that a
look at the fully burdened cost of not doing it is critically
important.
When you think about seniors' care, it is particularly--so,
my mother is 82. She lives alone. She does not have diabetes,
but I do know of many seniors that are living independently,
and the likelihood that they can continue to live independently
if they happen to have diabetes can be not only the monitoring
that they themselves could see, but a family member or
caregiver that may not be resident but be in a position to
provide care, and when you take a look at possibly the level of
additional cost by not being able to live independently, or the
emergency room and other complications that could result by not
having active monitoring, I think that you can really see the
basis for building a compelling case for coverage.
Thank you.
The Chairman. Thank you, Senator Tillis.
Senator Donnelly.
Senator Donnelly. Thank you, Madam Chair, and thank you to
all of you for being here. I would like to mention my Hoosiers
who are here with me from Indiana, Christian Allen, Aidan
Sullivan, Soren Horvath.
To Kate, you will find on your way back from Iowa to Maine
that you drive through Indiana along the way.
I have a home-cooked meal ready for you when you come back
through Indiana.
Charlie Kimball, who came in third in the Indy 500, lost by
maybe a car-length, Charlie Kimball is a Type I diabetic who
drove that race car for 500 miles in 100-degree weather and did
an extraordinary job, and one other thing, Madam Chair, I
wanted to let you know a young man from my home town, his name
is Gabe Martinez, and Gabe has had Type I since he was very,
very young, and about two years ago, I told Gabe, I said, we
will cure Type I diabetes--he is a huge Cubs fan--and, I said,
we will cure Type I diabetes before the Cubs win the World
Series.
His father said, ``You have to do a lot better than that
for us.''
To all of you--Dr. Rodgers and Dr. Zaghouani--Dr.
Zaghouani, how do we protect those islet cells from the immune
system when we put those islet cells back into the body to go
to work?
Dr. Zaghouani. No, there is no transplantation of exogenous
islet cells. It is the flowers themselves, that they have their
own seeds. They rejuvenate again.
Senator Donnelly. You are bringing the islet cells that are
already in your body----
Dr. Zaghouani. Back--yes.
Senator Donnelly. Okay. How do we keep those cells from
being attacked by the immune system?
Dr. Zaghouani. Outstanding question, so you have juvenile
kids and one of them develops the disease and the other one
does not, and the reason for that is because there are
environmental factors that applied for one, not for the others,
so in order for the disease to happen, you have those
environmental factors to be there. It is like a hurricane in
the ocean. You have thousands of events that happen and they
have to come together for the hurricane to occur. The same
thing with islets, so once you fix them in the same person,
unless you have those all events, or environmental factors
happen again, you do not need, basically, to do anything for
the immune system.
Senator Donnelly. So is this something that you----
Dr. Zaghouani. This is my opinion.
Senator Donnelly. How would you get it rejuvenated again?
Is it an injection or----
Dr. Zaghouani. No, there are seeds.
Senator Donnelly. Okay.
Dr. Zaghouani. Once you fix the blood vessels, I think, and
you eliminate the immune system that attacked the beta cells,
the seeds, or the stem cells, endogenous stem cells, not the
ones that we give--the ones we give are for blood vessels--
those, they will regrow and mature and----
Senator Donnelly. If we do that, that would enable all of
these youngsters to go to Type None.
Dr. Zaghouani. That is what I hope.
Senator Donnelly. How long do you think that is until it
would be able to be on the market?
Dr. Zaghouani. If you put the money----
Senator Donnelly. I am not looking for a guarantee. I am
just looking for a neighborhood.
Dr. Zaghouani. Well, my answer is, the more money you put,
the faster it goes.
Senator Donnelly. There you go, so then, how much will it
cost to get it done next week?
We are incredibly grateful for that effort and we will make
sure that the funding is there for you to keep this moving
along.
Dr. Rodgers, I want to note that behind you are a whole
bunch of your team from the NIH, and I would like them to stand
up, who have done such an extraordinary job in doing the
research over the years.
Dr. Rodgers, what is the most pressing thing you need from
Congress right now? Obviously, funds. What kind of funds do you
need to get this to a place where we do not have another
Child's Congress, or the Child's Congress two years from now is
a celebration of having found a cure?
Dr. Rodgers. Well, I think, as Dr. Zaghouani mentioned,
certainly, we have a lot of very good investigators with a lot
of very good ideas, and that, unfortunately, at the present
level of funding, we are only able to entertain and
successfully fund maybe one in five or perhaps one in six of
those. We think there is certainly room for other outstanding
ideas, and because, obviously, in this particular case, we want
to be thinking about a multi-prong approach.
We want to be able to develop new sources of cells to
implant. We want to, at the same time, because we know so much
about the genetics and who is susceptible to developing this,
we want to continue to determine what that environmental factor
is that has increased the incidence by 21 percent in a short
period of time. We now the genes have not changed. It must be
something in the environment. If we can find what it is in the
environment, if it is an infectious agent, we can develop a
vaccine. If it is some that could either protect against
developing the disease or it can actually cause the disease. If
it is something in the diet, then dietary modification could be
in effect.
For people who have the existing disease, we want to--is in
their early stages of autoimmunity, we want to selectively try
to turn and reverse that autoimmune disease and use fairly
selective manners, which you have heard from Dr. Zaghouani, not
completely wiping out the immune system, because it is there
for a reason, but selectively going at the cells that are
attacking those beta cells. This is what we are learning,
especially with the addition of this Special Diabetes Program.
For people that have the existing disease for longer
periods of time, we want them to live a more comfortable life,
so to try to prevent them from developing the complications.
Senator Donnelly. Thanks.
Mr. Amato, you are an inspiration to all of us, and to you
young kids, we hope to beat this thing so when you are Mr.
Amato's age, this is just a memory from long, long ago.
Thank you, Madam Chair.
The Chairman. Thank you.
It is a great pleasure to call upon Senator Shaheen, the
Co-Chair of the Diabetes Caucus.
Senator Shaheen. Thank you very much, Chair Collins, both
for your leadership as Chair of the Diabetes Caucus and for the
work that you are doing on this Committee, and thank you for
letting me squat at this hearing, because I am not normally a
member of this Committee, but I very much appreciate being able
to be here.
I want to thank all of you delegates who are part of the
Children's Congress, because you are absolutely the best
advocates for helping all of us who want to see a cure for
diabetes and want to see the best new treatments available.
I want to recognize Skye Archibald and her family from
Exeter, New Hampshire, who is here as part of the Congress, and
also Senator Collins was kind enough to recognize my daughter
and granddaughter, Stefany and Elle Shaheen, who have been very
much a part of the Children's Congress in the past, who are
here today with their diabetes service dog Coach, and to all of
you who have testified, thank you very much for your work and
for your willingness to share your stories today.
You know, Mr. Amato, I cannot agree more with what Senator
Collins and Senator Tillis said about the importance, not just
of making sure that Medicare funds the CGM because it is the
right thing to do, but it is the economic thing to do, and I
just want to quote from a study that was done called,
``Diabetes Research and the Public Good'' by two economists,
and it points out that diabetes cost the United States $245
billion in 2012, and that cost is expected to double by the
year 2020. Medicare costs from diabetes were $104 billion in
2012 and they are projected to increase to $226 billion by
2020.
The increased costs are attributable in a large way to
diabetes' role as the leading cause of kidney failure, adult
blindness, non-traumatic amputations, and nerve damage, stroke,
and heart attacks, and those things happen because people do
not get the treatment that they need, and a CGM is part of that
treatment. There is no doubt that we should fund that, and
hopefully, with everybody's help here, we can get that
legislation passed to make that happen.
Dr. Rodgers, I wanted to ask you, you and Dr. Zaghouani
talked about a number of the promising research that is going
on to address diabetes. I wonder if you could speak to what you
think is the most promising immediate breakthrough that we are
looking at that will make a difference in treatment.
Dr. Rodgers. Well, I think prevention certainly is a major
part of that.
Senator Shaheen. Or prevention.
Dr. Rodgers. Yes. Yes, and I view this in terms of
prevention of either preventing people who are genetically
susceptible to this disease from developing it based upon what
I mentioned before and this TEDDY study, the Environmental
Determinants of Diabetes of the Youth, is likely to answer
that. In the intermediate term--this is a 15--this is a study
of kids from birth to the age of 15, but we already are
developing important knowledge from that study.
Preventing people who have those genes and who have
actually begun to show signs of autoimmunity, our TrialNet
study is beginning to use certain types of drugs to actually
reverse that autoimmune process to allow those beta cells to
last longer, and we know the longer they last, the less likely
it is that individuals with Type I diabetes will develop
serious complications.
For the people with the diabetes, this artificial pancreas
that is linking the insulin infusion with continuous glucose
monitoring, brought together by some sort of, I should not
say--some sort of computer device, typically on phones now, on
portable phones, is really the best technology, because we know
keeping the blood sugar in line is really the best way to
prevent these complications.
As I mentioned, just in the last two years, we have had
such great success at this that it is quite likely, working
with our friends at the FDA, that many of these devices will be
approved, and so that is really, in the short term, I think,
the likelihood for the best success with the largest impact.
Senator Shaheen. Thank you very much.
I am almost out of time, but I wonder if I could get Amelia
and Isabelle to tell me, what is the best advice that you would
give to someone who has just been diagnosed with Type I.
Ms. Cooper. Well, the advice that I would give is to
educate your friends and family members as quickly as you can
about your disease, because if you get them involved, it takes
the pressure off and it just--it is better for your safety and
your mental health.
Senator Shaheen. Thank you.
How about you, Isabelle.
Ms. Levesque. I would say that, like, keep trying to raise
money and make sure, like, no one stops you from doing anything
just because you have Type I diabetes. Always, like, do what
you dream of.
Senator Shaheen. That is great advice.
Thank you, Madam Chair.
The Chairman. Okay, Senator Casey, try to top that.
Senator Casey. I will not even try, but thanks so much,
everyone, for being here. We should have more hearings like
this where we not only have testimony, but also questions and
then audience participation and reaction. That is pretty rare,
so we are grateful.
I wanted to give a shout-out to some Pennsylvanians that I
met with earlier today, Ethan Howard from Wayne, Pennsylvania,
Evan Wickersham from West Chester, Julia O'Leary from
Lancaster, Kathryn Talerico from Pittsburgh, and Madyson Huston
from Waterford. Can you give them a round of applause.
We had some pictures, and because they were so mobilized
and so effective and such good advocates, I figured they could
come back here and solve our appropriations problems and work
on foreign policy, whatever, so we are grateful for that.
I first want to apologize for being late and missing a good
bit of the testimony, but we are grateful to have this chance
to talk for a minute. I will not be long, because I was late.
I wanted to make sure. Sometimes, we have an exhaustive
discussion of a topic, and often Senators can leave here
without getting a to-do list, or at least one that is
emblazoned in our minds, and I just wanted to ask, before we
get to our younger witnesses on the left side of the table--my
left, your right--but, Doctor, I just wanted to go back to you.
What would you hope, if you had a short list, what would you
hope that the Congress would do, not only in the near term,
but, say, over the next couple of years, in terms of short-term
assignments and longer-term commitments, as well.
Dr. Rodgers. Well, Senator Casey, I want to say that I am
very grateful for all of the support that Congress has actually
given to the NIH and identifying biomedical research as an
area, moving forward, that is of great interest. As I mentioned
earlier, we have such great ideas out there, but unfortunately
in recent years have not been able to have the opportunity to
bring in as many new ideas and investigators as we certainly
would like, so in the short term, again, I want to thank you
for the support that we have learned about and we hope that as
that progresses forward, that I will be happy in two years to
report to you what has happened with that incremental support
that we have received.
We in NIDDK really want to focus on all aspects of this,
from prevention, to early intervention, to making certain that
the primary and secondary complications are considered, because
it really is the secondary complications--the eye disease, the
kidney disease, the non-traumatic amputations, the neuropathy--
that is really contributing greatly to the cost, that $245
million, that Senator Shaheen referenced. That is really
driving the cost of this, both for our young as well as our
older population, and so, we are keenly aware of that and we
are really targeting our efforts in all of these categories.
Senator Casey. For anyone else, we only have about a minute
and a half, but I want to make sure you had a moment. Anyone
else on the panel who----
Dr. Zaghouani. I think my answer is very short, the same I
gave to Senator Donnelly, is funding.
Senator Casey. Mm-hmm.
Dr. Zaghouani. Funding, and funding again.
Senator Casey. That is an important to-do list, part of a
to-do list.
Dr. Zaghouani. Yes.
Senator Casey. Well, before--I know I am almost out of
time, but Isabelle, I wanted to ask you about how your friends
have helped you throughout the early years of your life when
you have the challenge of not just getting through school, but
also dealing with a significant health challenge. Can you
describe how your friends have helped you?
Ms. Levesque. My friends are, like, very helpful. When I
was in preschool and kindergarten, my Mom came in and she
helped me explain to the class, like, why I was always, like,
getting pulled aside, so they were not getting confused, so
now, they, like, know that I have it and they are very, like,
helpful, because, like, sometimes, my pump rings and they go
and tell the teacher and they say, ``Oh, Isabelle's pump is
ringing. I think she needs to go to the nurse,'' so, they are
very, like, helpful.
Senator Casey. Well, I am going to give applause to your
friends. How about that.
Thank you.
The Chairman. Thank you.
Senator Warren.
Senator Warren. Thank you very much, Senator Collins.
Like Senator Casey, I apologize for being late. We are kind
of running multiple things at once, but I had to come and join
this group again this year and to say a special thank you to
Senator Collins for pulling us all together. This is really a
terrific annual event.
I also want to say a special shout-out, since we are all
getting to do that, to Jeffrey D'Angelo from Plymouth,
Massachusetts. Where are you, Jeffrey? I cannot see in this sea
of blue. Good to see you, Jeffrey. All right.
We have all been talking about the cost of diabetes. Type I
diabetes, it imposes, obviously, a terrible personal cost on
our kids, on our families, and the financial costs are
staggering. Nearly 40 percent of families with diabetic
children experience financial strain, and care for Type I
diabetes costs our health system an estimated $15 billion a
year.
I want to start on the cost question from a different
direction. Dr. Rodgers, if we could delay the onset or reduce
the severity of Type I diabetes so that millions of Americans
could stop buying insulin, glucose monitors, test strips, if we
could stop paying the costs of doctors' visits, to emergency
rooms, about what do you estimate we could save every year?
Dr. Rodgers. Well, Senator Warren, there is no doubt that
if we could prevent diabetes from occurring and reduce the
severity of the disease, that would result in a tremendous cost
savings, and I think organizations like the JDRF have actually
cost estimated what that would result in, at 10 percent or at
20 percent.
The NIH has not made any of those cost estimates, to my
knowledge. What I can tell you, though, and as I referred to
before, a major cost is associated with these secondary
complications--the eye disease, the kidney disease, the non-
traumatic amputations, and we think that certainly with--we
have already, and I mentioned previously some of the benefits
that we see in terms of cost effectiveness in the treatment of
these secondary complications. One could potentially do
estimations on those, but I do not have, sitting here today, a
good estimate to tell you how much precisely we could----
Senator Warren. Okay. I take it, though, based on some of
the estimates that JDRF have given us, a 10-percent reduction
would be about $3 billion. In other words, a lot of money that
we are talking about here, and when you combine it with the
devastating human cost, you think it would be a no-brainer to
invest more money in research on diabetes.
Let us pin this down just a little bit more. Dr. Rodgers,
you direct the National Institute of Diabetes and Digestive and
Kidney Disease, so how much money do you have for your work
compared, and inflation adjusted, with what you had 10 years
ago?
Dr. Rodgers. That is a question that--if one were to
include, in addition to our regular appropriations, as well as
the Special Diabetes Program appropriations, because of
inflation, NIDDK has lost about 24 percent in our buying power
over that----
Senator Warren. Here we are, we see the costs imposed, and
yet you have got, effectively, about 24 percent less money to
work with than you had 10 years ago for the kind of research
that you are doing, and as we know, you are not alone. NIH
funding overall is down 25 percent since 2003. That means for
NIH we are investing about $12.5 billion less in medical
research this year than if we had just kept up with inflation
over the last decade.
Now, last week, the House passed the 21st Century Cures
Act, which includes the Cures Innovation Fund that is meant to
give NIH about $1.9 billion per year for the next five years.
Now, that does not fill a $12.5 billion hole, but it certainly
is something.
Here is what I am concerned about in this bill. I am
concerned the NIH may not even get that much. Before this bill
passed the House, a section requiring the appropriators to
continue to fund the NIH at current levels was taken out. This
is called a maintenance of effort provision, and without it,
there is nothing to stop Congress from cutting the NIH's--
adding $1.9 billion at the top, but cutting $1.9 billion from
their base budget, or for that matter, cutting $2 billion from
their budget, or $4 billion from their budget in order to try
to cut government spending overall, and if that happened, NIH's
budget would not actually increase at all, even when the $1.9
billion from the Cures Innovation Fund is added on top.
Let me ask you, Dr. Zaghouani, if the result of the 21st
Century Cures bill is a new fund that gets great fanfare but
does not actually result in any additional money for NIH, does
that help the research community?
Dr. Zaghouani. Actually, I began to downsize my laboratory
because I could not get the appropriate funding to maintain. I
was speaking with the Director of NIH, Dr. Rodgers, and I need
to have three R01 grants, three grants, about $2 million
apiece, every five years, so altogether, in order to maintain
my operation going, so because I could not do it for the last
two years, I have started downsizing, so downsizing is not only
the economics for the people, it is the research that now is
going to be stopping. We cannot make progress, and there is one
more problem. While doing this research is I am training people
to take over when I am out. I can no longer train those people
anymore, so we are hurting ourselves at many, many different
points.
Senator Warren. What you are saying is you cannot maintain,
in fact, you are cutting back, certainly not in a position to
grow the research. Families struggling with diabetes, with
Parkinson's, with Alzheimer's, other serious conditions,
deserve more than lip service from Congress. They deserve real
increases in funding on medical research, and that is what we
need to do.
I introduced a Medical Innovation Act that could boost the
NIH budget by 20 percent. It is not enough, but it is a start.
I hope Senate colleagues will join me in this effort, or
improve the 21st Century Cures bill so that it is really about
additional money, or bring other ideas to the table for more
money for medical research. If we are serious about saving
lives through research and saving money, then Congress has to
step up and make a real commitment of real dollars.
Thank you, Madam Chairman.
The Chairman. Thank you.
I want to thank all of our witnesses today, and
particularly the delegates who have come from every State in
the Union and across the globe to make the case for more
support for diabetes funding. That is a shared goal of everyone
in this Committee.
I would point out that it is because of the efforts of
families all across this country whose children have juvenile
diabetes, or Type I diabetes, that we have been able to triple
the funding for diabetes research since 1997, when we first
started the Diabetes Caucus, and I can see Dr. Rodgers nodding
in agreement. I am proud of the fact that we have extended the
Special Diabetes Program, which focuses on Type I and on
diabetes among Native American populations, that we have been
able to extend that important program.
We could not have done those spending increases that are so
vital to progress without the help of the people in this room,
the people who have testified, the children who have testified
previously at our Children's Congresses in past year, and
without the advocacy of the JDRF, the American Diabetes
Association, and other groups, so we really have come a long,
long ways, and that is why we have the technology that we do.
Mary Tyler Moore for many, many years always came to our
hearings to review the progress and talk about her own life
living with Type I diabetes. She was not able to be here this
year, but she is certainly in the thoughts of many of us. She
once told me that you have to be a mathematician, a physician,
a personal trainer, and a dietician all rolled into one to keep
your diabetes under control, and I think there is a lot of
truth in that.
Fortunately today, we also have some wonderful advances in
technology, and we are going to keep pushing for that as well
as a change in Medicare policy so that when Mr. Amato--when the
young people here become Mr. Amato's age, they are not going to
have the fight that he has had to get the coverage for the CGM,
and we are going to make sure that that happens.
My thanks to the more than 160 delegates and all of their
families, because, after all, it does take the entire family,
who have traveled to Washington to tell your stories. You are
the ones who really make a difference by putting a human face
on this diabetes.
I want to thank everyone at JDRF for your help in
organizing this, the NIH, Dr. Zaghouani for coming, as well,
Mr. Amato, but most of all, our three young people on the
panel, Isabelle, Amelia, and Kate. It was wonderful to have you
here in Washington.
Committee members will have until Friday, July 24, to
submit any additional materials or questions for the record.
I want to thank all the members of the panel who have been
here today and all of you for sitting so patiently so long. I
know that that can be a trial, so thank you, and let us end
this hearing in an unconventional way, by giving a round of
applause to all the delegates who are here.
[Whereupon, at 3:24 p.m., the Committee was adjourned.]
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APPENDIX
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Prepared Witness Statements
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