[Senate Hearing 116-545]
[From the U.S. Government Publishing Office]
S. Hrg. 116-545
REDEFINING REALITY: HOW THE
SPECIAL DIABETES PROGRAM IS
CHANGING THE LIVES OF AMERICANS
WITH TYPE 1 DIABETES
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HEARING
BEFORE THE
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
__________
WASHINGTON, DC
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JULY 10, 2019
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Serial No. 116-09
Printed for the use of the Special Committee on Aging
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
47-373 PDF WASHINGTON : 2022
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SPECIAL COMMITTEE ON AGING
SUSAN M. COLLINS, Maine, Chairman
TIM SCOTT, South Carolina ROBERT P. CASEY, JR., Pennsylvania
RICHARD BURR, North Carolina KIRSTEN E. GILLIBRAND, New York
MARTHA McSALLY, Arizona RICHARD BLUMENTHAL, Connecticut
MARCO RUBIO, Florida ELIZABETH WARREN, Massachusetts
JOSH HAWLEY, Missouri DOUG JONES, Alabama
MIKE BRAUN, Indiana KYRSTEN SINEMA, Arizona
RICK SCOTT, Florida JACKY ROSEN, Nevada
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Sarah Khasawinah, Majority Acting Staff Director
Kathryn Mevis, 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 Robert P. Casey, Jr., Ranking Member 3
PANEL OF WITNESSES
Griffin P. Rodgers, M.D., M.A.C.P., Director, National Institute
of Diabetes, Digestive and Kidney Diseases, National Institutes
of Health, U.S. Department of Health and Human Services,
Bethesda, Maryland............................................. 5
Aaron J. Kowalski, Ph.D., President and Chief Executive Officer,
JDRF, New York, New York....................................... 7
Victor Garber, Actor, New York, New York......................... 8
Ruby Anderson, Children's Congress Delegate, Yarmouth, Maine..... 10
Adriana Richard, Children's Congress Delegate, Milton,
Pennsylvania................................................... 11
APPENDIX
Prepared Witness Statements
Griffin P. Rodgers, M.D., M.A.C.P., Director, National Institute
of Diabetes, Digestive and Kidney Diseases, National Institutes
of Health, U.S. Department of Health and Human Services,
Bethesda, Maryland............................................. 33
Aaron J. Kowalski, Ph.D., President and Chief Executive Officer,
JDRF, New York, New York....................................... 45
Victor Garber, Actor, New York, New York......................... 52
Ruby Anderson, Children's Congress Delegate, Yarmouth, Maine..... 55
Adriana Richard, Children's Congress Delegate, Milton,
Pennsylvania................................................... 58
Statements for the Record
Senator Susan M. Collins, Chairman, Opening Statement............ 63
National Indian Health Board Letter.............................. 65
REDEFINING REALITY: HOW THE
SPECIAL DIABETES PROGRAM IS
CHANGING THE LIVES OF AMERICANS
WITH TYPE 1 DIABETES
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WEDNESDAY, JULY 10, 2019
U.S. Senate,
Special Committee on Aging,
Washington, DC.
The Committee met, pursuant to notice, at 9:33 a.m., in
Room 106, Dirksen Senate Office Building, Hon. Susan M. Collins
(Chairman of the Committee) presiding.
Present: Senators Collins, Tim Scott, McSally, Hawley,
Braun, Rick Scott, Casey, Blumenthal, Jones, Sinema, and Rosen.
Also present: Senator Shaheen.
OPENING STATEMENT OF SENATOR
SUSAN M. COLLINS, CHAIRMAN
The Chairman. The hearing will come to order.
Good morning, everybody. It is wonderful to welcome all of
you here to Washington, DC. This is our 11th Children's
Congress, and it is always a privilege to work with JDRF
families, whose commitment to promoting life-changing research
to prevent, treat, and ultimately cure Type 1 diabetes inspires
me.
I want to welcome not only our Ranking Member, Senator
Casey, and Senator Scott from Florida, but also we have a
special guest, and that is the Co-Chair with me of the Senate
Diabetes Caucus, Senator Jeanne Shaheen of New Hampshire, so
thank you for joining us here today as well.
Let me shorten my opening comments this morning because we
do have votes beginning at 11 o'clock, and I want to make sure
that we have time to hear from all of our witnesses.
As I said, I want to begin by welcoming the more than 160
children who have traveled to Washington from all across the
country to share your personal stories. You will tell us what
it is like to live with Type 1 diabetes, just how serious it
is, and why it is critical for Congress to fund the research
necessary to discover better treatments, more effective
technology, and, ultimately, a cure.
Your personal stories really matter. They motivate Senators
and Members of the House to get involved in the cause. In my
case, one of my very first meetings as a brand-new Senator was
with Maine families with children with diabetes, and I will
never forget this 10-year-old little boy looking up at me, and
he told me that he wished he could take just 1 day off from
having diabetes--his birthday or Christmas, but of course, he
could not, and that really touched me, and it led me to start
the bipartisan Senate Diabetes Caucus.
I want to give a special welcome to two delegates from
Maine: Ruby Anderson from Yarmouth, who is going to be
testifying, and Lydia Bryant from Ellsworth. I am very proud
that you are here representing our great State.
Since the last convening of the Children's Congress 2 years
ago, we have made remarkable strides with new technological
discoveries that are already changing the lives of people with
Type 1 diabetes. We celebrated the FDA approval of an
artificial pancreas system for children ages 14 and older. Now
the artificial pancreas is also available for kids who are ages
7 to 13, opening the door for better day-to-day management of
diabetes.
Today's research represents tomorrow's cure. Just last
month, a new study, the first of its kind, illustrated the
potential of an immunotherapy drug to delay the onset of Type 1
diabetes by an average of 2 years. What a significant
breakthrough.
These advances have only been possible due to our
bipartisan commitment to funding diabetes research. Since I
founded the bipartisan Senate Diabetes Caucus in 1997, Federal
funding for diabetes research has tripled, and these research
dollars are yielding results. We now spend more than $1 billion
on diabetes research.
The Special Diabetes Program, in particular, has
contributed to phenomenal discoveries, especially advancements
in technology. This program provides an additional $150 million
each year for T1D research, and another aim of this program is
equally important: The Special Diabetes Program also studies
diabetes in American Indians and Alaskan Natives, who
experience Type 2 diabetes at nearly three times the rate of
the national average, so the Special Diabetes Program is
important both for people who have Type 1 and also for Native
Americans and Alaskan Natives.
Over the past 22 years, the Special Diabetes Program has
contributed $2.8 billion to improve the lives of people living
with diabetes.
By the end of September, we must pass legislation to
reauthorize the Special Diabetes Program, and that is what you
need to tell all the Members of Congress. It has strong
bipartisan support; 68 Senators signed a letter to Senate
leadership that Senator Jeanne Shaheen and I authored
advocating for this program, and I am pleased to report to you
that just last week the Senate HELP Committee, on which I
serve, approved a 5-year authorization of the Special Diabetes
Program. That is the longest authorization ever, so that is
really good news.
Finally, let me just say that I am very concerned about the
spiraling cost of insulin. The cost of managing diabetes is
growing at an alarming rate. Between 2012 and 2016, average
insulin spending for patients with Type 1 diabetes nearly
doubled, and last year, a father from Maine testified that he
turned to drug importation from Canada after the price of a 90-
day supply of insulin for his son with Type 1 tripled to $900.
I am going to put the rest of my statement in the record so
that we can expedite the hearing, but let me just end by
telling you two things.
First, until last fall I had no personal connection at all
with Type 1 diabetes. Then my nephew married a young woman who
has Type 1 diabetes and has her own blog, so I feel like I am
now officially a part of the JDRF family, and, second, it is
truly inspiring to look out and see this wave of Carolina blue.
I did the best I could to come close to matching it, but your
passion and hope for a cure are contagious, and together I am
confident that we will continue the progress and achieve that
goal.
Thank you.
Senator Casey.
OPENING STATEMENT OF SENATOR
ROBERT P. CASEY, JR., RANKING MEMBER
Senator Casey. Thank you, Chairman Collins, for holding
this hearing. We are grateful to be back again with so many
delegates of the JDRF Children's Congress. I want to welcome
you back to the Senate. I know many of you have been here over
many years now.
I am pleased to welcome four delegates from Pennsylvania:
Adriana, whom I will introduce a little bit later, as well as
Joey, Libby, and Mairead and their families.
It is so important that you have joined us because finding
a cure for Type 1 diabetes requires a combined effort from
people of all ages and backgrounds. Advances in treatment and
our understanding of Type 1 diabetes has come a long way.
As Chairman Collins mentioned, in just the past decade,
more and more people have gained access to continuous glucose
monitors and, more recently, the use of the artificial
pancreas. In large part, this progress is due to those of you
in this room--young and a little bit older than young.
We are grateful that you are here again to bring a sense of
urgency to this issue. Many of the advocates who have traveled
to Washington before to press for funding for this program are
doing so again today, and we are grateful.
We are pleased to report, as Senator Collins said, the
extension of the funding is already in the works, and I was
proud as a member of the Health, Education, Labor, and Pensions
Committee--so-called HELP Committee--to support the 5-year
extension of the reauthorization of the Special Diabetes
Program.
This sets up the possibility for the longest extension
ever. We need to make sure that the full Senate passes it, as
Senator Collins said, by the end of September and also that the
House does the same.
By securing stable funding for medical research, that is
just one part of the agenda. We must also be sure that each
individual and family can afford lifesaving treatment.
During a hearing last year, this Committee took a
magnifying glass to the rising cost of insulin, and just
recently, the Committee concluded a three-part hearing series
on the cost of prescription drugs.
It will not surprise anybody in this room that the cost of
insulin featured prominently during those hearings as well. Let
me summarize why there is such an urgency to address the price
of prescription drugs as it applies to today's hearing.
Number one, the rising cost of prescription drugs is not
occurring in isolation. It is part of a larger challenge that
many Americans face every day trying to make ends meet.
``Flat wages and high costs'' might be the fastest way to
say it. For so many families, the cost of prescription drugs is
like a bag of rocks thrown on their shoulders every day, in
addition to the other bags of rocks they are carrying around:
high health care costs, college tuition, child care costs, and
the like.
We have lots of work to do to make sure that we are focused
on and get results on lowering the cost of prescription drugs.
We know that less costly insulin is about, oh, maybe only 100
years overdue.
As we will hear today, the price an individual or family
must pay for a vial of insulin is also impacted by health
insurance coverage. That is why the Affordable Care Act and
Medicaid are critically important to shield families from very
high and onerous out-of-pocket costs for insulin.
In Pennsylvania, because of Medicaid, insulin for most
children is fully covered. That should be the case in every
single State, and so today I am introducing the Affordable
Health Care for Children with Disabilities Act, which will
encourage States to adopt policies that Pennsylvania put in
place over 20 years ago.
We have got a sacred responsibility to children and to
young adults--and to their parents who are here today--as well
as those across the country, to do everything in our power to
make sure that we are doing everything we can to make life
better.
Thank you to Chairman Collins and all of our delegates and
parents and friends and advocates. We are so grateful you are
with us today.
Thank you.
The Chairman. Thank you very much.
Our first witness today is a familiar face to our
Committee, Dr. Griffin Rodgers, the Director of the National
Institute of Diabetes and Digestive and Kidney Diseases, at the
National Institutes of Health. Dr. Rodgers assumed his position
in 2007, and he has testified before us I believe six times at
six different Children's Congress hearings. It is always a
great pleasure to hear from him and to get an update on the
research that is being done.
Next we are pleased to welcome Dr. Aaron Kowalski. Dr.
Kowalski is the new president and CEO of JDRF, and he is the
first person with Type 1 diabetes to lead this organization. He
has a strong research background, having served as the
organization's chief mission officer.
Our next witness you may recognize from Broadway or his
numerous roles on television and in major motion pictures such
as ``Titanic'' or ``Argo.'' He is the award-winning actor
Victor Garber, and we are so pleased to have him with us today.
He has received--I hope I have these statistics right--five
Emmy nominations, four Tony Award nominations, and one Screen
Actors Guild Award, and there is another that--maybe I got
those statistics wrong, but he has received a lot, let us put
it that way, because he is such an extraordinary actor, and he
also has, which is most pertinent to this hearing, Type 1
diabetes, which he has managed for almost 60 years.
Then we will hear from my constituent, Ruby Anderson, who
is joining us today from Yarmouth, Maine. Now, I have met Ruby
several times, and it was really fun looking at the pictures of
her when she was even much younger than the 9 years old that
she is now, and she is a great advocate for better treatments
and working toward a cure or means of prevention, so I am
delighted to welcome you, Ruby, here today. It is great to have
you.
I will now turn it over to the Ranking Member to introduce
our final witness from his State.
Senator Casey. I am pleased to introduce Adriana Richard.
Adriana is 16 years old, a resident of Milton, Pennsylvania.
She is joined here by her mom, Kristy. She traveled pretty far
to get here. Northumberland County is not an easy ride, a
couple hours at least, and we are grateful you are here.
Adriana has lived with Type 1 diabetes since she was 5
years old, and like delegates here today, she has not let the
disease slow her down. Along with excelling at her school work,
she educates her peers about Type 1 diabetes and also through
Instagram created an online support group. She serves as a
member of the JDRF Teen Task Force where she mentors newly
diagnosed children. She has even published a book about living
with Type 1 diabetes entitled, ``The Real T1D.''
Adriana, thanks for being here, and thanks for being a
dedicated advocate with JDRF and for bringing your testimony
here today and your example and helping us create a sense of
urgency to get the job done here in the Senate. Thank you.
The Chairman. Thank you.
Dr. Rodgers, it is a pleasure to have you back.
STATEMENT OF GRIFFIN P. RODGERS, M.D., M.A.C.P.,
DIRECTOR, NATIONAL INSTITUTE OF DIABETES, DIGESTIVE
AND KIDNEY DISEASES, NATIONAL INSTITUTES
OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES, BETHESDA, MARYLAND
Dr. Rodgers. Thank you. Chairman Collins, Senator Casey,
members of the Committee, thanks for this invitation to testify
and for your strong support of Type 1 diabetes research at the
NIH, including the Special Diabetes Program, or SDP.
The SDP has enabled us to take on challenges and to conduct
critical trials that were unlikely to have been done with our
regular appropriation or by the private sector, and I am
pleased to be testifying along with Dr. Kowalski, and I would
especially like to recognize my other fellow witnesses--Ruby
Anderson, Adriana Richard, and Victor Garber.
All of you here today and the people you represent across
the country are the true heroes in advancing diabetes research.
NIH research studies would not be possible without your
participation, your passion, and your commitment.
In 2 years since I last testified, major scientific
advances have come from the long-term, sustained investment in
the SDP. Just last month, NIDDK Type 1 Diabetes TrialNet
reported truly exciting results. For the first time ever, early
preventive treatment was shown to delay clinical Type 1
diabetes.
Now, in this study, people at high risk for the disease
were treated with a drug targeting the immune system and had a
striking 2-year delay in the progression to clinical Type 1
diabetes. That is 2 years they did not have to take insulin.
That is 2 years they did not have to check their blood glucose,
2 more years of good health toward preventing or delaying Type
1 diabetes complications.
It is important to note that this trial, which relied on
screening thousands of people to identify those eligible to
enroll, would not--I really should say could not have been
conducted outside of TrialNet. Looking ahead, there is a queue
of other promising agents to prevent Type 1 diabetes
progression, and we plan to test those with TrialNet.
There is also good news for people who are working every
day to manage their Type 1 diabetes. Since I last testified,
several continuous glucose monitors, or CGMs, have been
approved by the FDA, including the first CGM that does not
require a fingerstick calibration, the first fully
interoperable CGM, and the first fully implantable CGM. Each of
these received NIDDK or SDP support during their development.
These approvals come on the heels of the 2016 FDA approval
of the first hybrid artificial pancreas. The early development
of this device and, in fact, much of the research toward the
development of artificial pancreas technologies have been
significantly spurred by SDP support, and going forward, our
goal is to develop multiple artificial pancreas technologies so
that all people with Type 1 diabetes can choose what is best
for them.
Importantly, SDP fills a critical gap by studying
populations under study by industry, such as young children and
older adults. In addition, SDP supports--NIDDK recently funded
research to develop an artificial pancreas system customized to
the need of pregnant women. We want to make sure that people
use and benefit from new technologies, so our research is also
focusing on incorporating these devices in clinical care and
looking for new ways to enhance their usability.
As everyone here knows, managing technology is not a cure.
We are also supporting research toward a cure, including
understanding the autoimmune attack in Type 1 diabetes, and
since I last testified, there has been progress in our ability
to study single cells in the pancreas. This is giving us never
before seen insight into Type 1 diabetes and how it progresses,
and we can now visualize at the same time and study the
interactions of individual insulin-producing beta cells and
other pancreatic cells and immune cells involved in this
autoimmune attack.
Complementing this effort is exciting research to develop
islets on a chip like the one you see before me here. This is
empty, but this chip can contain beta cells, blood vessels, and
other components of the islets needed to function in the body,
and this tiny but mighty chip, developed with SDP support, can
allow us to test new therapies very quickly and efficiently and
determine which are likely to be beneficial in clinical trials,
and we are excited about applying other cutting-edge
technologies in Type 1 diabetes. For example, artificial
intelligence and machine learning approaches hold great promise
for clinical applications such as diagnosing diabetic eye
disease. Research to combat these and other complications is
critical to improving people's health and their quality of
life.
As I hope my testimony has highlighted, our efforts were
significantly strengthened by the last SDP renewal, which
allowed scientists to pursue their long-term research projects
without interruption.
With the incredible progress already achieved through the
SDP and the promise for future research, we are really
extremely hopeful that we can reach our goal of preventing and
curing this disease.
I would be pleased to answer any questions you may have.
Thank you.
The Chairman. Thank you very much for such encouraging
testimony. The trials that are underway are so exciting.
Our next witness is Dr. Kowalski. Dr. Kowalski.
STATEMENT OF AARON J. KOWALSKI, PH.D.,
PRESIDENT AND CHIEF EXECUTIVE OFFICER, JDRF,
NEW YORK, NEW YORK
Dr. Kowalski. Thank you. Chairman Collins, Ranking Member
Casey, and members of the Committee, thank you all for
welcoming us here today.
The JDRF Children's Congress delegates sitting here before
you, these amazing kids, all have Type 1 diabetes, or T1D, an
autoimmune disease that destroys the cells that make insulin in
their pancreases. I too live with Type 1 diabetes, as does one
of my brothers, Stephen.
These amazing children and their parents work very, very
hard to manage T1D. It is very difficult, but today we can live
healthier lives than ever before because of research funded by
the Special Diabetes Program. As a scientist by training and
now as president and CEO of JDRF, I can tell you that your
leadership and the strong bipartisan support for SDP has led to
numerous research breakthroughs, transforming lives and
bringing us closer to our ultimate goal: cures for Type 1
diabetes.
Just last month, as Dr. Rodgers pointed out, a clinical
trial showed that a new artificial pancreas system supported by
the SDP has helped people maintain more consistent and
healthier blood glucose levels. Also, the FDA approved the
first continuous glucose monitor and insulin pump that can work
interoperably. This will allow for people with diabetes to
select component devices of their systems without having to put
together a do-it-yourself system. This choice is critical as
people with diabetes achieve better outcomes when they can
choose the tools that are right for them.
This progress builds on the success of the first artificial
pancreas system which came to the market in 2017, thanks to
your leadership, Senator Collins, which has had a major
positive impact for our community, and of course, to stay
healthy we need access to these advances, and we need access to
affordable insulin. It is unacceptable for anyone to ration
insulin due to cost. We need the Government and the private
sector to act now.
I want to thank Senator Collins, Senator Casey, Senator
Shaheen, and so many others for your commitment to this issue.
It is so incredibly important.
As Dr. Rodgers noted, last month we had exciting news in
immunotherapies. A clinical trial funded by the SDP and by JDRF
published results in the New England Journal of Medicine that
found a drug can delay the onset of Type 1 diabetes for 2 years
in children and adults. This is so important. The delay in
onset is likely to have long-term benefits that will have a
tremendous impact on our community and the overall health care
system. This progress is thanks to leadership and foresight to
invest in multi-year funding in SDP research.
While there is great progress, we are here because there is
still important work to be done. The SDP must continue to
invest in innovative immunotherapy and beta cell therapy
research. We need to understand why the immune system goes awry
and how we can eliminate these attacks.
We need to understand better what triggers Type 1 diabetes.
An environmental determinant study has screened more than
425,000 children to understand what factors trigger the onset
of Type 1 diabetes. This SDP-funded study is more than halfway
through, and it is crucial that it be finished. I cannot
overstate how important this trial is.
At the same time, we need to reduce the burden from kidney
and heart disease. Senators, let me tell you that this research
is too important to have an expiration date. In 2017, when the
SDP renewal was delayed, there were real implications. Within
TrialNet, enrollment was postponed in a promising prevention
trial. By the time the funding was in place, some of the people
who would have been eligible had since developed full-onset
Type 1 diabetes and were no longer eligible to participate in
the trial. We cannot allow this to happen again.
We are so grateful for the outstanding leadership of the
Senate Diabetes Caucus Co-Chairs Senator Collins and Senator
Shaheen, who championed a letter in support of the SDP and has
been signed by 68 Senators. The Special Diabetes Program is
making a real difference in every life here impacted by Type 1
diabetes. We need Congress to re-enact a 5-year renewal of the
program and keep researchers working without interruption so
that when these children are my age, they can say they used to
have Type 1 diabetes.
Thank you.
The Chairman. Thank you very much for your testimony.
Mr. Garber, welcome, and thank you so much for being here
today.
STATEMENT OF VICTOR GARBER,
ACTOR, NEW YORK, NEW YORK
Mr. Garber. Thank you. Chairman Collins, Ranking Member
Casey, and members of the Committee, thank you for inviting me
to testify today. It is an honor to be here with the JDRF 2019
Children's Congress.
I was diagnosed with Type 1 diabetes when I was 11 years
old, nearly 60 years ago, but I remember vividly that my
diagnosis was a traumatic event for my family, and especially
for my mother. I have a distinct memory of her standing on the
porch as my father drove me to the doctor. The fear and
desperation in her eyes remains an indelible image in my mind.
Whenever I meet the mother of someone with Type 1, I am
brought back to that moment and to that confusion, panic, and
uncertainty, which is why I am so determined to do everything I
can to help find a cure for this disease. I am here today, with
these amazing delegates, to implore you to keep supporting
advances in Type 1 research, by supporting a long-term renewal
of the Special Diabetes Program. It has been said before, and
it will be said again.
After my diagnosis, I was kept in the hospital, where I
learned to inject oranges with insulin syringes, until I was
brave enough to try it on myself. My new and confusing diet
consisted of weighing food on a small scale and deciphering
carbohydrate ratios. I have no idea what that is, which is why
I am still guessing today. In those days, we had to boil
syringes to ensure sterility and test blood sugar levels with
urine in a test tube. We have come a long way, but not far
enough.
As I adjusted to my new reality, I was determined that I
would not be deterred from living the life I envisioned. When I
was 16, I left home to pursue my show business dream. I was a
folk singer, dishwasher, played tiny parts on TV shows and
movies. Hard enough for any teenager, but balancing blood
sugars, with inexplicable highs and lows, making healthy food
choices, getting proper rest was daunting. I can only say that
my determination and will kept me from just giving up.
Thanks in large part to the Special Diabetes Program,
living with Type 1 diabetes today is vastly different from when
I was a teenager. My access to amazing diabetes technology,
like a continuous glucose monitor that can be used with
different types of insulin pumps, gives me constant information
to help avoid blood sugar highs and lows, and I am so fortunate
to be able to afford insurance that allows me to choose the
best insulin pump and glucose monitor for my specific
lifestyle. This should be everyone's right.
My anxiety level has--I have not got much time. My anxiety
level has decreased somewhat since those days. Living an
erratic life in movies, television, and theater has become more
manageable thanks to funding for the Special Diabetes Program
which made all these things possible. However, it is imperative
that Congress provides a long-term renewal of the program,
which will ensure that critical research can continue unimpeded
and enable more life-changing breakthroughs for the children
you see here today.
Finally, I would be remiss if I did not tell you how
concerned I am about the skyrocketing cost of insulin. The idea
that someone has to ration insulin in 2019 due to greed and
avarice is unconscionable. No mother in the U.S. should lose
her son due to insulin rationing, and no father should have to
rely on buying insulin from Canada to keep his child alive. I
am lucky, extremely lucky, to have good health insurance, but I
am paying more than I should be for the life-saving drug that I
would die without. Senators, this is simply unacceptable.
Dealing with Type 1 diabetes is already hard enough. Chairman
Collins, Ranking Member Casey, Senator Shaheen, and others of
this Committee, I want to thank you for addressing the insulin
pricing issue head on and beg you to keep up the fight to bring
down these costs.
As you do, please keep your commitment to the research our
community desperately needs to find a cure for Type 1 diabetes.
A cure. We need you to keep the momentum going by renewing the
Special Diabetes Program before it expires at the end of
September and put it on stable funding for years to come. If
you do that, you will make it easier for all these delegates to
live their dreams and enable them to thrive without the fear of
Type 1 diabetes holding them back.
Thank you, Chairman Collins, Ranking Member Casey, and
members of the Committee, for your support and your time today.
The Chairman. Thank you so much for your testimony.
Ruby, you are up.
STATEMENT OF RUBY ANDERSON, CHILDREN'S
CONGRESS DELEGATE, YARMOUTH, MAINE
Miss Anderson. Chairman Collins, Ranking Member Casey,
Senators, thank you for inviting me to talk to you today.
My name is Ruby Anderson. I am 9 years old and just
finished third grade at Yarmouth Elementary School in Yarmouth,
Maine.
I was diagnosed with Type 1 diabetes just before my second
birthday. I do not remember not having Type 1 diabetes, but I
am lucky because I have devices that can help me manage my Type
1 diabetes.
I have been using an Omnipod insulin pump since I was about
3 years old. It has no tubes, which I like, and I do not have
to take shots, but sometimes it hurts when I have to change my
pod every 3 days.
I also have been using the Dexcom G6 continuous glucose
monitor for over a year. I love it. Things have gotten a lot
easier. Now I can just check my numbers on my phone. My mom
even lets me ride my bike to school because now she can see my
numbers on her phone wherever she is.
Before the G6, I was checking my blood sugar up to 10 times
a day. Now, I still have to prick my finger, but sometimes not
for weeks, but as great as my pump and G6 are, T1D is still
really hard to manage. I have to count carbohydrates in
everything I eat, make sure I am giving myself enough insulin
to keep my blood sugar from going too high. If I give myself
too much, I go low. Even if I do my very best, my numbers can
still be way off and I do not feel good.
My G6 and pod sometimes alarm when I am in class, at home
doing homework, playing lacrosse with my friends, and swimming
at the beach. It even went off one time on an airplane. That
was awkward.
When it goes off, I have to stop and check my numbers. I
will have to eat or drink when I am low or take more insulin if
I am high. My parents, my brother and sister, and friends and
teachers all help me if my numbers are too high or too low.
I wish my diabetes would just disappear, and Senators, I do
not want my brothers and sisters to get Type 1 diabetes.
We need more research to find a cure. We need even better
devices. We need to figure out what causes Type 1 diabetes so
we can stop it.
All of the kids here at JDRF Children's Congress need you
to continue to support us.
When I grow up, I want to be a scientist--partly because
Type 1 diabetes research is so important, and if they have not
found a cure for diabetes by then, I will.
When we have a cure, I am going to have a party and invite
everybody in the whole entire world. Senator Collins, you will
be first on my list.
The Chairman. Thank you.
Miss Anderson. Thank you for listening and for all you do
for kids like me.
The Chairman. Thank you so much.
Dr. Rodgers, sign her up right now, and I am coming to that
party.
Adriana, welcome. We are delighted to have you here.
STATEMENT OF ADRIANA RICHARD, CHILDREN'S
CONGRESS DELEGATE, MILTON, PENNSYLVANIA
Ms. Richard. Chairman Collins, Ranking Member Casey,
Senators, thank you for asking me to speak here today.
My name is Adriana Richard. I am 16 years old and from a
small town in central Pennsylvania called Milton.
I am a proud member of the JDRF Central Pennsylvania Teen
Task Force. Last year, we raised over $10,000 with our JDRF One
Walk team.
I wrote a book, ``The Real T1D,'' and started an Instagram
account to share my T1D story because I am one of many living
with diabetes every day. I am not the only one going through
this.
I go to diabetes camp most summers. It is my favorite time
of year because I am not judged and I can be myself.
I am here today to share my voice as an advocate for people
with T1D because I have been motivated by the struggles I have
experienced.
See, I was diagnosed with Type 1 diabetes when I was 5
years old. All I remember from my diagnosis was that my parents
were scared for me. I am the oldest of four kids and the only
one in my family with diabetes. In elementary school, I was
sometimes teased for being different or for always being with
the nurse. School is already a stressful environment and having
diabetes only makes it more difficult. I have gone through some
hard times.
A few years ago, I was having really bad lows, which means
my blood sugar was getting dangerously low, but the thing is I
did not know it. I felt fine. I also had really bad highs. In
fact, one especially bad time I had DKA, or diabetic
ketoacidosis, and was hospitalized. I felt really sick and was
in a lot of pain. DKA is very serious as it can lead to a coma
or worse.
I was constantly battling diabetes and managing my everyday
life with no breaks. I was physically and emotionally
exhausted, and basically suffering from burnout.
Thankfully, I have been able to manage T1D better over the
last year, primarily since I got my Dexcom CGM. It catches my
highs and lows before they get bad, and I can check my levels
on my phone. It also alerts my parents, which is a huge relief
because sometimes I miss the alarms on my phone when I am
asleep.
Before, I had to check my levels right before going to bed
and hope that I would not get too low during the night. Now, I
feel much better when I wake up in the morning.
My life with Type 1 diabetes is easier with this
technology, which is thanks in part to funding from the Special
Diabetes Program.
That is why I am here to ask you to support the SDP. It
needs to be renewed.
We are so close to finding cures for diabetes, and if we
stop research now, there is no way we will ever find it. Until
then, we need the SDP for research to help our everyday lives
with Type 1 diabetes to help scientists and engineers invent
things like CGMs that have changed my life.
In fact, after Children's Congress, I will be taking the
driver's test to get my license. I am excited and my parents
are, too, knowing that my CGM will help me more easily manage
my blood sugar levels while I focus on navigating the roads in
Milton.
Senators, people with Type 1 diabetes can do anything we
set our minds too. We just have extra responsibilities.
The research funded by the SDP helps people like me--all of
us here today--handle those responsibilities and will
ultimately give us a cure.
I am grateful that as a resident of Pennsylvania the cost
of my insulin is zero dollars because it is fully covered as a
life-sustaining medicine under Medicaid. Thank you, Senator
Casey, for your interest in expanding this program broadly so
that kids with diabetes in other States may also benefit.
Thank you all for listening to my story, and thank you for
your support of people with Type 1 diabetes.
The Chairman. Thank you. Thank you very much, Adriana.
Ruby, you have such a joyful, positive attitude, and you
participate in everything. You do not let your diabetes stop
you at all. Could you tell us what advice you would give to
another child who has just learned that they have Type 1?
Miss Anderson. I would say to be brave and not let diabetes
get in your way.
The Chairman. I think that is great advice. It really is.
Dr. Rodgers, I was struck as you went through how the
technology has changed and the many advances that have been
made possible by the Special Diabetes Program, and in the more
than 20 years that I have headed the caucus and worked as an
advocate for Type 1 diabetes, I have noticed a tremendous
change in the technology. I think about how bulky and big the
initial pumps were and here we are now with the artificial
pancreas and the closed loop with the continuous glucose
monitor, and it truly is amazing.
I would like you to focus a little bit more on the
prevention side. I am really excited about the TrialNet results
that you described. Could you tell us what most excites you
when you look at prevention and cures?
Dr. Rodgers. Absolutely. The long-term support of the
Special Diabetes Program has really allowed us to invest in the
critical infrastructure necessary for TrialNet to do its--set
up these prevention trials. Conducting prevention trials
requires identifying and enrolling people at risk for Type 1
diabetes who have not yet developed clinical disease, so
finding these people is crucial, and it requires screening a
lot of people, so far we have screened over 200,000 people at
risk, including 15,000 annually now, and as Dr. Kowalski said,
if you can find them, there is a window of opportunity before
they actually develop the clinical disease that you can use for
testing them in crucial trials. If you miss that window, then
they would have to go into a different trial.
As a result of that exciting work that was just reported
last month, the next trial is obvious. You want to see whether
these particular drugs might have a benefit if you give it a
second time, but we have really a whole host of drugs that are
in a queue that are just as promising as this one that with the
infrastructure that has been created by the Special Diabetes
Program and TrialNet, they are ready to go, but of course, we
would not want to start a trial unless we have the funding to
know that we can complete it, but thanks for your strong
support.
The Chairman. Thank you. That is very encouraging.
Mr. Garber, you have emerged as a voice in the diabetes
community for those who have really been affected by the
skyrocketing cost of insulin, and we talked a little bit about
this this morning, but it is ironic that you are from the very
birthplace of insulin, in London, Ontario, and insulin was
first discovered in 1921 and has been used in various forms to
treat diabetes for nearly a century, and that is why I am
personally so outraged by the tripling of price. It just does
not make sense to me.
As a Canadian now living in New York State, what is your
reaction to the extraordinary lengths that some families are
having to go to get the insulin their children need?
Mr. Garber. You know, I was not really as conscious of it
until like a year ago when I started hearing--I knew it was a
difficult situation, but when I realized what the--I was on
insurance, so I was always--I was paying, you know, what seemed
an okay amount of money, and then when I--actually, the woman
whose son was rationing insulin, that is what really sent me
over the edge. I could not believe it, and part of it is
because I was not really paying attention, and I thought this
is unimaginable, this is unconscionable, and so I just got--I
have just been--and everywhere I go now, people are just
saying, ``What is happening?'' I do not really understand how
pharmaceuticals--I do not understand the--I think there are too
many middlemen that are benefiting. Meanwhile, these children
are dying. I do not get it. I just do not get it, and yet, you
know, in other States, there is no cost for insulin, so what
does that tell you?
The Chairman. Well, it is unconscionable, and I want you to
know that our Committee devoted an entire hearing to the cost
of insulin, and we passed a bill--Senator Casey and I are both
on the Senate HELP Committee, and we passed a bill that has
several measures in it to deal with the rising cost of
prescription drugs, but the insulin example is the worst
because it is not as if a whole lot of R&D went into the
initial investment.
Mr. Garber. Right. Yes, you know, I think I mentioned to
you it was sold for a penny, the patent, in London, Ontario.
The Chairman. Right.
Mr. Garber. So that no one would ever be denied insulin,
and that just has to come back.
The Chairman. Thank you.
Senator Casey. Thank you, Chairman Collins.
I want to start by commending the work of the delegates
and, in particular, commend and salute the testimony by Ruby
and Adriana. I am trying to think if at the age of 9 or the age
of 16 I could do what you have done today, and I am certain the
answer is no, and I just am grateful that you are willing to do
this, but also I want you to know not only in the work you are
doing as advocates on this issue, but more broadly, you both
have a very bright future, and we may put you in charge of some
other projects before you leave Washington.
I want to note for the record as well, as you know, when we
have a hearing like this, Senators will be back and forth and
in and out, so I hope when someone is here and then leaves you
do not attribute that to a lack of interest. Senator Jones, for
example, just indicated to me as he left he has got to go to a
classified hearing in the Armed Services Committee. He is
hoping to be back, and I think that is true of a number of
Senators, so we are grateful that people can see that back and
forth when they are balancing hearings and different issues.
I wanted to start, though, with Adriana, not only because
she is from Pennsylvania but that sure helps to have the first
question, but it is pretty clear to all of us, as is true, I
think, of every one of your fellow delegates, that you have not
allowed diabetes to control your life, and you have indicated
over and over again by way of your example and by your
testimony and otherwise that that is the case.
You mentioned in your testimony that you published a book
on what it is like to live with T1D, and you have actually
given it that title. You have also used Instagram and other
platforms and methods to make sure that you are helping to
reduce the stigma. In fact, I just left the hallway that you
and I were in, you were doing a television interview, and you
sounded really good on television.
You have used every possible resource, every possible
opportunity to get the message out. You have also taken on the
role as a mentor as part of the JDRF Teen Task Force, as I
mentioned, so I guess one of the questions I have is: What
questions do you get, Adriana, when you are interacting with
young people or interacting with adults? Are there common
questions? Are there common concerns? Or is there a message
that you want to reiterate today that comes from those
questions?
Miss Richard. Yes, so the question I probably get asked
mostly all the time is what is on my arm because of my CGM, or
what is on my hip because of my pump. I could be in a store
just walking around, and a little girl or a little boy will
point at it. I just make it a point to go up and just talk to
them and explain to them what it is.
The other one would probably be that diabetes is from
eating too much sugar. I get that all the time, which is not
true at all. Diabetes is an autoimmune disease. It is not
caused by eating too much sugar or being overweight.
Senator Casey. Well, it is important to repeat those
messages, especially in Washington, and we are grateful you are
willing to do it.
I wanted to turn to Dr. Rodgers. I am sure that I share--
and I think I speak for a lot of people--the gratitude of
everyone in this room when I say thank you for your leadership
at NIDDK. The work being done by researchers across the country
to find a cure for T1D is very promising. In your testimony,
you discuss that these researchers keep moving closer to that
elusive cure. Some of the work that is happening at research
institutions in Pennsylvania and I know other places is
inspiring and promising.
Could you highlight some of that new and promising
research? I will ask you to start with Pennsylvania and go
beyond there if we have some time.
Dr. Rodgers. Sure. I will try to be brief. Absolutely.
Researchers at the University of Pennsylvania, for example, are
part of the SDP-supported Human Islet Research Network, or HIRN
for short, including something called the ``Human Pancreas
Analysis Program.'' They are developing some very novel
techniques to understand the single cells inside of the
pancreas and how they change with respect to the progression of
the disease.
As you understand this at a single cell level, you can
begin to think about new targets for either delaying the
progression or potentially curing the disease if you can halt
that progression, and the people at the University of
Pennsylvania are really doing an outstanding job.
Another example is in Pittsburgh. The University of
Pittsburgh actually serves as one of these TrialNet sites that
I talk about in my testimony. They are lining up the patients,
getting them in this cure for new preventive strategies, and we
are really excited about the TrialNet and the participation of
people in Pittsburgh.
Senator Casey. Thank you very much, Doctor.
The Chairman. Senator Braun, welcome.
Senator Braun. Thank you, Madam Chair.
This is important to me. I have learned a lot about
autoimmune diseases over the years, Crohn's and colitis,
digestive disorders, asthma, neurological. Why this is so
important is because if we find the secret to what causes Type
1 diabetes, I think we are going to unravel a host of other
diseases in finding a cure. That is why I think it is so
important you keep doing what you are doing and that we stay on
point here.
In my own business, I tried to address health care and the
cost of it, referred to where we should not be rationing
medicines that are so important. We should not be grappling
with the cost of insurance that is overwhelming. I took on the
insurance companies nearly 11 years ago myself, and it was a
wrestling match that you would not believe, but there are ways
to address it, and what we want to do is keep the best of our
health care system that gives us technology and breakthroughs,
but somehow drive the costs down, and it would take a whole
other time period, but you can do that through being engaged in
your own well-being, emphasizing wellness over remediation,
finding transparency and getting competition among the
providers so that we can keep the best of what we have got and
not contend with some of the things that are the worst about
our current system.
The other thing would be current budget woes here. This
should be something we should never have to consider whether we
would have enough money to fund, along with many other things
that, you know, center around disease, disasters, some of the
things that we should never be worried about how do we pay for
that, because to me it is an important part of what the Federal
Government should do. We are in the context of running trillion
dollar deficits here, and one thing as a mainstream
entrepreneur, I hope to weigh in on how we get this place in
better health so that we can always be there for good causes
like this.
The question I want to drill in on, when it comes to the
particular disease of Type 1 diabetes, what I have learned is
there is generally a genetic predisposition to almost all of
these autoimmune diseases and an environmental trigger that
might be part of it. Can you explain to us--and I like the fact
that you are getting down to single cell analysis. That seems
like that might get us on the right trail. When it comes to
Type 1 diabetes, is it more of a genetic predisposition or an
environmental trigger or that mysterious combination of both?
Dr. Rodgers. That is an excellent question, Senator Braun.
Type 1 diabetes is a disease that is largely genetic. In fact,
Type 1 diabetes, we know more about the genetics of Type 1
diabetes. Ninety percent of the attributable genetic risk is
already known for Type 1 diabetes. First-degree relatives of
people with Type 1 diabetes, there is about a 15-fold increased
risk of developing the disease, and that is why we screen their
relatives of people with Type 1 diabetes in order to put them
in these prevention trials once they develop it.
Now, you are right. Just because you have the genes and
that genetic risk does not mean that you are going to
absolutely develop the disease. There is something in the
environment that triggers that risk and makes that risk a
reality, and that is the reason that we have an ongoing study
called ``TEDDY.'' In Government, everything is an acronym.
TEDDY stands for The Environmental Determinants of Diabetes of
the Youth.'' In this study, we had to screen about 425,000
individuals in order to get 6,000 individuals who we are going
to be following from birth through the age of 15. That is going
to end in 2025, and in them we are collecting all types of
samples--blood samples, urine samples, saliva, stool samples.
We are getting medical records on them. We are understanding
about outbreaks, you know, within their schools and other
environments, and from that and all these samples that we are
collecting, we are doing these studies called ``omic
technology'' and using big data to analyze what it is in the
environment that is actually triggering that. If we knew and it
turns out that it is a virus, for example, it is likely that we
can make vaccines to prevent people from developing the
immune--or if it is something in the diet, for example, one can
suggest dietary restrictions.
I would say that Type 1 diabetes is the best example of
this combination of genetic risk with environmental factors,
and we will understand that by 2025, what those--and it is
probably not just one factor. It is probably multiple factors.
Senator Braun. Thank you. I have got to go to an
Environment and Public Works Committee meeting where we are
talking about roads and bridges, but thank you for the
attendance. Since I have been here 6 months, this is the best
showing of any Committee. It is important to keep up the
passion so that we get the message, and again, I think you lead
in the autoimmune category, and if we find the cure, it is
going to benefit a lot of other ailments as well.
Thank you so much.
The Chairman. Thank you.
Senator Sinema.
Senator Sinema. Well, thank you, Chairman Collins and
Ranking Member Casey, for hosting today's important hearing on
the Special Diabetes Program. I also want to give a shout-out
to our Children's Congress delegates, especially to Grant from
Gilbert, Arizona, and Rachel from Flagstaff. Are they here? Hi.
I saw Rachel. Is Grant here? Oh, my gosh. You can do that all
day. Hi, Grant.
Grant, age 5, was diagnosed with Type 1 diabetes just a few
days before his second birthday. He was recently recognized for
raising almost $50,000 for JDRF, and he would like to be a
firefighter when he grows up, but he is already a hero to so
many of us in Arizona.
Rachel, age 16, is managing multiple chronic conditions,
but that has not slowed her down. She likes to hike, lift
weights, and has excelled in both varsity volleyball and
swimming. I could take some swimming tips from you. You are
really an inspiration to me.
Grant and Rachel are two young Arizonans who are in D.C.
today representing more than 750,000 Arizonans living with
diabetes. I am grateful for their advocacy and look forward to
working with them to ensure Arizonans get the health care they
need.
I also would like to thank our witnesses for their
testimony and now jump into a few questions. My first question
is for Dr. Kowalski, but I would encourage any of our witnesses
to weigh in.
In 2019, the Arizona Department of Health Services
published its first-ever Diabetes Action Plan. The report noted
that not all health plans in Arizona cover diabetes self-
management education, which are programs that help patients
learn about managing their diabetes. I am proud to co-sponsor
legislation introduced by Senator Shaheen and Chairman Collins
which would expand access to diabetes self-management education
programs for Medicare beneficiaries.
As innovative technologies and new smart insulins become
available, education will be crucial to helping patients make
informed choices about their care and learn about financial
assistance programs if needed.
Dr. Kowalski, what barriers prevent patients from accessing
diabetes management resources? And what more can be done to
ensure this education is available to all newly diagnosed
patients with diabetes?
Dr. Kowalski. Thank you, Senator. That is an excellent
question because diabetes is a unique disease in that you are
dosing a very dangerous drug every day on your own and only see
the doctor every 3 to 6 months, so you are doing this, and it
does require significant education.
There are barriers. Cost can be a barrier. We have heard
about the cost of insulin, but it is really insurance coverage
for diabetes treatments across the board, whether it is pumps
or sensors or education and doctor's visits. It is a barrier
for many families.
Then there is simply not enough diabetes educators and
diabetes endocrinologists who specialize in Type 1 diabetes out
there. In a State like Arizona where folks may have to drive
long distances, take off from work, that is a significant
burden on families.
Every family in this room knows that education plays an
incredibly important role when you are making a decision with a
drug that, if given too much, can cause hypoglycemia and be
very dangerous, so these programs play a significant role in
the health of our community.
Senator Sinema. Thanks.
My next question is for Dr. Rodgers. Your testimony placed
a high priority on research on the impact of new technologies
in special populations, such as children, older adults, and
pregnant women. I agree, and I also believe that that means
increasing our investment in the Special Diabetes Program for
Indians.
Since the program was created in 1997, diabetes rates among
Native populations have dropped by 54 percent, and tribes have
the resources to more effectively manage diabetes-related
complications such as kidney and heart disease. For example,
the Navajo Nation's Special Diabetes Project runs the Window
Rock Sports Center as a community resource to educate members
on diabetes management and offer free health assessments.
Can you share with the Committee any specific insights from
recent research that would be of interest to our tribal
partners? And are there barriers to including more tribal
members and other populations in research and clinical studies?
Dr. Rodgers. Thank you. Well, as you mentioned, the Special
Diabetes Program, and as Chairman Collins mentioned, has the
additional Special Diabetes Program for Indians, or SDPI, and,
of course, working in consultation with the Indian Health
Service and the Tribal Leadership Council, they have
coordinated the provision of care in many sites, which actually
explains the drop in some of the complications that we have
seen, but nonetheless, Native Americans have the highest risk
for Type 2 diabetes of any populations actually in the country.
We have been working closely with the SDP program that we
have in conjunction with our sister organization, the CDC, to
do a study called ``SEARCH'' in which we are looking at the
onset of diabetes in individuals up until the age of 19,
diabetes in youth, and we are seeing a growth in Type 2
diabetes in Native American populations. Having this early
information provides us to get them involved more in preventive
trials and in treatment trials, because I can tell you that
Type 2 diabetes in children is an extremely severe disease as
well. SEARCH also has indicated one other thing, which is
actually a followup to Senator Braun's comment, that we are
seeing an increase in the incidence of Type 1 diabetes across
all groups over the last 10 years, but particularly in certain
underrepresented groups previously, particularly non-Hispanic
whites--or, I am sorry, the Hispanic population, and in them,
the genes are different, which means that there is not the
standard--the genes that I talked about in terms of this
genetic risk, which means that there is something in the
environment that is even triggering the autoimmune disease at a
greater frequency, and that is something that we have to
understand, how these subpopulations are reacting to the
environmental changes, and hopefully with the continuing
support of the SDP we can understand the heterogeneity of the
disease as it affects different groups.
Senator Sinema. Thank you.
Thank you, Madam Chairman.
The Chairman. Thank you.
Senator Scott, we are delighted to have you here today.
Senator Tim Scott. Thank you, Madam Chair.
To the panel, thank you all for being here this morning. To
the kids, God bless you. It is certainly encouraging and
exciting to see so many advocates participating in this
country. I will say that your advocacy is powerful. I am an
advocate for you all because of a friend of mine who was
diagnosed around 9 years old, a guy name Billy Siegler, who
today is 53 years old, married. His son is now looking at going
to the Medical University of South Carolina, perhaps in part
because of his father's challenge of Type 1 diabetes, so your
future is incredibly bright.
One of the things I love about the hearing today is that we
are witnessing around the country, hopefully folks are
watching, powerful advocacy come to life, and there are three
advocates from South Carolina who are here today that I would
like to highlight, and one of the things I have learned by
reading through so many of the bios is that you all are not
just advocates for Type 1 diabetes. Many of you are advocates
for Type 2 diabetes. You are also advocates in many different
ways, and the three individuals that I will talk about are
classic examples of what is possible. Hannah from Lake Wylie,
South Carolina, is 17 years old. Is she here with us? There she
is.
Hannah was diagnosed at 8 years old. She now enjoys
participating in cross country and track and field not only
from an athletics perspective but also a Type 1 diabetes
advocate perspective. Through participating in sports, she has
been able to spread awareness about T1D to her peers as well as
the prevention of Type 2. Thank you for your advocacy.
We also have with us Katie, who is 14 years old. She was
diagnosed at 5. She lives in Charleston, South Carolina, my
home town. Is she here? Thank you. God bless you. She is a
talented musician. This is pretty impressive. Is this accurate,
Katie? Let me know if I am embellishing at all, okay?
Politicians do that sometimes. Not me, of course, but you
are good at many instruments, including the piano, organ,
cello, guitar, and percussion. I will have you know that when I
was in the third grade, I played the cello, and they came and
took it back.
I am not sure what that says about me, but it is nothing
positive.
She and her entire family advocate for Type 1 diabetes
funding with other JDRF advocates.
William, who is age 14, from Summerville, South Carolina.
William, what is up?
Master Wimberly. Hey.
Senator Tim Scott. How you doing, man?
Master Wimberly. Good.
Senator Tim Scott. Go Green Waves.
Master Wimberly. Oh, yes.
Senator Tim Scott. All right. All right.
For those of you not from South Carolina, Green Waves is a
wonderful high school to attend in South Carolina.
William was diagnosed at 3 years old. William is an honor
student. Honor student, you make really good grades? William is
an honor student. He is also a very good tennis player.
Accurate? Awesome, awesome. These kids are so humble. We could
use some of that in Congress. Thank you very much.
When William is not on the tennis court or in the
classroom, you can find him enjoying the outdoors, particularly
the water, or on the golf course. William is also an active
advocate for diabetes. He is involved in a number of events.
One of the things I am so excited about when I listen to the
stories and I hear and read about the involvement is if we can
have more folks like you all helping us understand and
appreciate the significant impact that funding can have on
combating the disease, I think we can make not steps forward
but leaps forward.
Let me use the balance of my time, Dr. Rodgers, to ask you
a question about the advancements that have happened over the
last 4 or 5 years, and then in a perfect world with proper
funding, what could their lives be like in 20 years?
Dr. Rodgers. Well, the advances that have happened in the
last 4 years have really been extraordinary. Following the
first FDA approval for an artificial pancreas, there are at
least four that we are currently studying, four important
international studies using various combinations of these
technologies, including one technology that not only develops
or delivers insulin but also glucagon in a manner very
analogous to what the pancreas does, for example, the ability
to have interchangeable parts, interoperability that Dr.
Kowalski mentioned, and using these technologies now, we really
want to push the limit to put these in real life situations
over extended periods of time, over broader age groups is what
we are currently testing, and so hopefully the results of those
research efforts will be useful for kids here so that they will
be able along with their health care provider to pick the best
instrument and AP technology that will be useful for them.
Again, that is just technology. We really are sort of
looking at cures, and so other things that have happened in the
last few years is actually thinking about a way to get the
cells that make the insulin from an individual and get them
back in terms of transplantation by using the person's own
cells, encapsulating them in a device that would be impermeable
to the immune attack that occurs as a way to correct them.
Of course, in the prevention arena, you have heard about
what we mentioned, this one treatment. There are several others
just lined up that we think, you know, within the next several
years might be more readily available.
Ultimately, we want to find a cure, and that cure can be
directed at whatever that trigger is that turns on the immune
system in each individual. That we would like to learn in order
to prevent that from happening. I think that that is a real
possibility for the kids who are assembled before you today,
and I am very excited about that possibility.
Senator Tim Scott. Thank you very much.
Mr. Garber, thank you for your willingness to be an
advocate, and we do miss you on ``Legends of Tomorrow.''
The Chairman. Thank you very much.
Senator Rosen. Well, thank you, Madam Chair. Thank you all
for being here. I have to tell you, this is, I want to say, the
best-looking, the most enthusiastic, the most passionate,
infectious in a good kind of a way, group that we have had
before us, and I know that whatever you all do, from what you
have learned here through your advocacy, your passion, your
commitment, your willingness to stand up, you are going to be
great, whatever your future is, and I have got to give a shout-
out to a couple Nevadans. Where are you, Charlie Bell, Ashley
Bellows? Let us see. Oh, there you are down here. Go, Nevada,
and they are great advocates for what they are doing here for
JDRF and for all the other things in their life, and every
parent here, any parent watching out there, be very, very proud
of these young kids.
What I want to say is that the Special Diabetes Program, of
course, combined with the hard work of JDRF has really paved
the way for innovative research on Type 1 diabetes, leading to
new therapies, innovative technology, and progress toward a
cure. This progress is particularly meaningful to Nevada
because diabetes is an increasingly common condition that
affects Nevadans at higher rates than the national average.
Excuse me. I have allergies today.
Roughly 12 percent of adults living in Nevada have one of
the two types of diabetes. Last week, I visited the Reno Sparks
Indian Colony. They have a tribal health clinic there. We
discussed the higher rates of diabetes among tribal members.
Diabetes has a heavy impact on patients at this clinic. It is a
stark reminder of why we must continue to invest in critical
programs to ensure the patients have access to the best care
possible.
To the doctors here today, I want to talk a little bit
about the artificial pancreas, where that is at, how it is
going to help kids in the future.
Dr. Rodgers. Well, thank you for your question. The
artificial pancreas, just to the extend the previous comments,
really I think it is going to have a great benefit. As it
constantly monitors glucose from minute to minute and changes
that occur with exercise and diet, it can appropriately adjust
the insulin infusions, and there are multiple artificial
pancreas technologies that are becoming available. We are
supporting some of the pivotal trials in some of those, but we
are also, with SDP support, supporting advances for even the
next generation of artificial pancreas, and I think that that
will make the people who sit in front of you, make their lives
much simpler.
We have to understand that there could be technology that
is available, but if people do not use it or are unable to use
it, then that can create barriers, and so at least from the
standpoint of usability, we are putting a tremendous amount of
investment into studies to understand how to make these more
usable ultimately for patients.
Senator Rosen. Well, I want to tell you, I just came from a
wonderful event called ``Girls Who Code,'' and it is about the
future of not just girls who code but innovation technology and
the next gen taking on careers in STEM, so artificial pancreas,
research, studies, analytics, everything you do, how can we be
sure to help you continue to invest, have the people pipeline
to do the kinds of research that you need? How is a STEM
education for these kids here going to help them and all of us?
Dr. Rodgers. It absolutely will help. I have to say that I
personally spend a fair amount of time going to high schools
and to colleges talking about the importance of STEM education.
For example, just take the artificial pancreas. You would think
that you--obviously, you need a bioengineer to try to devise
the micro circuitries and other things, but it also takes
computer engineers. It takes people with strong mathematic
information and education. It also takes chemists and people
skilled in biochemistry to devise the next generation of smart
insulins and smart glucagons and other drugs that would man
those pumps, and people who are sort of thinking about
something that I mentioned, artificial intelligence and deep
machine learning, because it is with these advances that people
who participate in just their usual care, we can learn from the
groups almost instantaneously, and this information can
actually be fed back to improve the lives of people using the
current technologies.
Senator Rosen. We can take your passion, your imagination,
your intelligence, and if we put you into these careers where
you can use them, you can create a future of possibly no more
diabetes.
Dr. Rodgers. Exactly.
Senator Rosen. Thank you. I appreciate it.
Dr. Rodgers. Thank you.
The Chairman. Thank you very much, Senator Rosen.
Dr. Kowalski, in your testimony you discuss not only the
impact on families, but also the great cost-saving potential of
the research that has resulted from the Special Diabetes
Program. That is why I think this investment is one that really
pays dividends, both in improving the health care and health of
all of these young people, but also the impact on the Federal
Government. For example, the adoption of the artificial
pancreas technology in adults could save Medicare $1 billion
over 25 years. You mentioned that another SDP-funded trial
related to the slowing of the progression of early kidney
disease in people with Type 1 could save literally billions of
dollars in the Medicare program.
What additional research and development has similar cost
savings potential?
Dr. Kowalski. Thank you, Senator Collins, because such an
important benefit of this funding is the economic benefit. Of
course, to the families it is huge, but to our economy,
reducing the high blood sugar of diabetes reduces the risk of
diabetes complications, and we fear these complications such as
eye and kidney disease--as you point out, we can reduce
significant burden to Medicare due to end-stage renal failure.
I must say to Senator Rosen's question about artificial
pancreas systems, my brother and I have been on a hybrid closed
loop for 3 years each. Thank you again for your leadership. It
is really transforming lives here. My brother used to have
severe hypoglycemia challenges. Each hospital visit due to a
severe hypoglycemic episode on average is about $20,000, so
these technologies, you have the long-term complications of
diabetes, but the short-term complications like severe
hypoglycemia or, as Adriana pointed out, diabetic ketoacidosis,
also is very costly to the Government, to employers, to
insurance companies, so this is tangible, real benefit on a
personal level, but also on an economic level.
The Chairman. That is a great example. It is also why I am
always puzzled if an insurance company denies coverage for a
device that is going to help keep people healthy. That just
does not make sense to me not only from a compassion standpoint
or a health care standpoint, but economically it does not make
sense for the very statistics that you mentioned.
Ruby, I want to go back to you. In a recent article that
was in the Portland Press Herald, your mom said, ``We make
diabetes-related decisions probably every 15 to 30 minutes all
day, every day, and through the night. It is relentless.'' You
do not let that get you down. You are a very active fourth
grader. I am told you play a variety of sports. You enjoy art,
you love playing with friends and exploring, and that is so
encouraging to everyone.
How have you been able to remain so active while also
making sure that you take care of your health?
Miss Anderson. I make sure that I bring like stuff for when
I go low, and I always pack an extra pump, and I just--
sometimes I just ignore diabetes.
The Chairman. I think that is true of a lot of the children
here. You just live a normal life, and you get some help from
your teachers and school nurse, too, don't you?
Miss Anderson. Yes.
The Chairman. That must help out also.
Adriana, I was struck that you mentioned in your testimony
that when you go home, you are taking your driver's test. First
of all, I want to wish you the best of luck. I failed the first
time, so if at first you do not succeed, try again. How has
diabetes technology allowed you and your parents to feel
comfortable with this upcoming change and responsibility?
Miss Richard. Definitely, so I have the Dexcom so my
parents can watch my blood sugars wherever I am at, and I know
that it is going to help me feel more safe and help them make
me feel--have them be like more okay with it, so if I was low,
they can just give me a call, and it can also hook up to like
anything Bluetooth, so as long as I like--when I am in my car,
my alerts will go through the car, so they are really loud,
which will definitely help.
The Chairman. That is great. I think that is a great
example of the difference that technology can make, and as I
said, for someone who has worked on this issue for decades, the
advances in technology are so exciting, and I have seen that
with other Maine families that I have worked with.
Senator Casey. Thanks very much. I wanted to start by
highlighting the legislation I mentioned earlier. For those of
you who do not know about the Pennsylvania example I cited,
this bill that I have introduced--will be introducing today, I
should say, will be an expansion of Medicaid where the Federal
Government would initially pay 90 percent of the Federal match.
Some will say, oh, well, we should not do that. Some will say
we cannot do that. We will have the usual arguments, but we
have expanded Medicaid once, and a lot of people got health
care, and we should do it again for children who have
disabilities, and in this case, it would help children with
Type 1 diabetes.
The way it works in Pennsylvania is children are benefited
by a special pathway. In this case, these are children who meet
the Supplemental Security Income, so-called SSI, disability
criteria, so they meet the criteria in that program for a
disability. However, their household income, the household they
live in, exceeds the SSI limits that would make them eligible
for Medicaid, so we would change that. We would treat the child
with the disability as a household. Simple as that. Right now
70,000 children in Pennsylvania benefit. I think this should be
a national program, not just in Pennsylvania or a few States.
We are going to be continuing to work on that, and we will
talk more about it, in addition to, of course, pushing the No.
1 priority for today, which is the reauthorization of the
Senate program.
I wanted to end my questions with Adriana, where I started.
Adriana, you have become a role model, and Ruby has as well,
and I know there are other role models in this room today for
so many people in your community and for young people
especially, but I want to ask you, who is the most important
role model for you after your diagnosis?
Miss Richard. Right after I was diagnosed? It was probably
my Nana, because she has Type 2, so she was always just like
there, and she knew exactly what was happening, how to calm me
down, tell me everything was going to be okay. She was probably
my closest person after I was diagnosed.
Senator Casey. We are happy to hear that, and I am sure you
serve in that role for a lot of people today, so thank you.
I know in the interest of time I will cut my questions
short and move forward.
The Chairman. Thank you very much for all of the work that
you have done, Senator Casey.
I also want to salute Senator Jeanne Shaheen for all of her
work. She is unable to come back. She has a granddaughter with
Type 1, and she and I have worked as a bipartisan team because
diabetes does not discriminate. It does not care if you are a
Republican or a Democrat or an Independent or Green or
whatever, and that is why this should continue to be a
bipartisan cause, and it always has been. I have always had a
Democrat as my Co-Chair of the Diabetes Caucus since I founded
it back in 1997, and I am pleased to have Senator Casey as a
strong member of it as well.
I want to thank each of our witnesses for being here today.
It is thrilling to have Victor Garber here to tell us what it
is like to grow older with Type 1 diabetes, and his example is
really encouraging to all of us.
The work that is being done at NIH and Dr. Rodgers'
longstanding commitment and working so closely with us on the
Special Diabetes Program has been wonderful.
Dr. Kowalski, I think it is wonderful that JDRF now has a
president and CEO who understands firsthand the challenges of
Type 1 diabetes. You have had excellent leaders in the past as
well, but we are delighted to work with you.
Of course, most of all, I want to thank all of the
delegates who are here today, but especially Ruby and Adriana,
who are so articulate and, you are right, Senator Casey, I
cannot imagine at their ages being able to come before a Senate
Committee and testify and help us better understand.
I also want to do a shout-out to some families in Maine who
have really educated me on this issue. I believe that I first
met Ruby and her mom through the Sweeney family, and I have
watched their son, Aidan, grow up from age 4 to now he is 17.
He testified at age 4 before one of the Children's Congress,
and they are great advocates.
The Seer family, who have a summer cottage very close to
mine, have three members of their family with Type 1 diabetes.
Now, as I mentioned, my new niece, Nicole Wiesendunger,
also is a tremendous advocate for people who Type 1.
I mention these families--and there are so many more--
because I want all the delegates who are here from across the
Nation to know what a difference your advocacy makes. You are
the reason that we could get more than 60 Members of the Senate
to sign the letter on the Special Diabetes Program. You are the
reason that we were successful in getting an extension in
Committee for 5 years. You are the reason that we have been
able to invest billions of dollars in research that has made
such a difference in your lives and will continue to make a
difference in the lives of others, but we could not do it
without you, and I am inspired by that sea of blue that is out
there, so when you go forth today and you visit your Members of
Congress, tell them what it is like to have diabetes, but also
give them a little nudge to help us on the research and on
renewing the Special Diabetes Program, because, believe me, it
is really hard for them to say no to you, and I am sure that
you will all make a huge difference. You touch me every time
that you are here, and you help me redouble my own commitment
to finding more effective treatments, a cause of diabetes so
that we can prevent it, and the many causes most likely, and
ultimately a cure, and that day we will have the big party that
Ruby has mentioned, but again, be encouraged because the
difference between 1997 and 2019 is absolutely enormous, so we
are making good progress.
I want to thank all of you for being here today, and I want
to also thank my staff, which worked extremely hard on this
hearing, and also the people at JDRF who were wonderful in
cooperating with us and bringing all these children from all
over America to Washington, so I know that this sea of blue is
going to take over the halls of Congress today, and that will
bring us closer to the dream that we all share, and that is an
end to diabetes.
Committee members will have until Friday, July 19th, to
submit additional questions for the record. There may be a few,
and we will pass them on your way, but again, I thank you and I
now yield to Senator Casey.
Senator Casey. Thank you, Chairman Collins, for both
convening this hearing and for your great advocacy on this
issue for so many years. We want to thank our witnesses, both
doctors. Mr. Garber, we want to thank you in particular for
bringing your personal story and in particular the story about
your mom and to refer back to the two words you used, the fear
and desperation that you saw that day is something that we all
need to be reminded of, and I think because of the
advancements, because of the work that you and others have
done, a lot of moms may not have that same fear and
desperation. We are grateful for that inspiration.
To Ruby and Adriana, you have got a bright future, and as I
said before, we are going to put you in charge of some other
projects while you are here. We have got to get things moving
in the Senate, so we will give you that assignment later.
I want to thank the delegates from JDRF. In particular--and
I did not do this earlier. This is my failing because my
colleagues were doing it about when they introduced members
from their States, so I want to ask Joey, Libby, and Mairead to
put your hands up, if I can see them.
The Chairman. Over there.
Senator Casey. Oh, great. Thank you. Thanks for doing that.
I should have done that earlier.
We know that for our witnesses, especially the younger
witnesses, it is challenging to testify before Congress, and we
are grateful that you did this, and you are certainly equal to
any of the witnesses we have invited to testify on any hearing.
I also know that you will have a successful day ahead of
you. As Senator Collins said, it is much more compelling and
persuasive when you appear at the doorway of a Member of
Congress than when one of us is appearing as a colleague, and
you will be able to make the case about the importance, the
urgent importance of reauthorizing the Special Diabetes Program
and also making sure that we make the case to get it through
both chambers and to get it signed into law.
We look forward to working with you on that
reauthorization, continuing the support that we will provide on
investing in research and addressing the rising cost of
insulin, and we are grateful for your presence today.
Thank you very much.
The Chairman. Thank you.
Senator Blumenthal has just arrived. Obviously, we are
about to adjourn the hearing, and we are halfway through the
vote, so if you could ask one question quickly, that would be
great.
Senator Blumenthal. You know, I will skip my questions. I
will submit them for the record.
I just want to thank you, Madam Chairwoman and Ranking
Member Casey, for having this hearing. Again, most important, I
thank everyone who is attending this absolutely packed room,
which is very inspiring--believe me, very inspiring. I was here
earlier, and I have had various other Committee meetings,
including Armed Services, but I just want to State my
unequivocal support for this measure and also for efforts to
reduce the costs of insulin. This astronomically rising cost of
a life or death medicine is reprehensible. It is a disgrace for
this country that we cannot act more quickly and effectively,
and in the presence of so many young people who are so
inspiring to us, I think you have given us the impetus to try
to do more and do it better, so I thank you all for being here
today, and I particularly want to thank members of the
Connecticut delegation, Logan Merwin and Emma DelVecchio, and
all of the advocates and activists who are here today. When
people say to me or ask me what can we do to improve the State
of our democracy, they should come and see this kind of showing
this morning.
Thank you very much.
The Chairman. Thank you very much, Senator. Thank you.
I note the delegates are getting tired and the vote is on.
The photographer has asked that we come down and get a couple
of photos with the sea of blue, and so we are going to do that,
but this hearing is now adjourned. Thank you so much.
[Whereupon, at 11:13 a.m., the Committee was adjourned.]
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APPENDIX
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Prepared Witness Statements
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Statements for the Record
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Opening Statement
Senator Susan M. Collins, Chairman
"Redefining Reality: How the Special Diabetes Program
is Changing the Lives of Americans with Type 1 Diabetes"
July 10, 2019
Good morning everybody. It's wonderful to welcome all of
you here to Washington D.C. This is our eleventh Children's
Congress and it is always a privilege to work with JDRF
families, whose commitment to promoting life-changing research
to prevent, treat, and ultimately cure Type 1 diabetes inspires
me.
I want to welcome not only our Ranking Member Senator Casey
and Senator Scott from Florida, but also we have a special
guest, and that is the co-chair of the Senate Diabetes Caucus,
Senator Jeanne Shaheen of New Hampshire, so thank you for
joining us here today as well. Let me shorten my opening
comments this morning because we do have votes beginning at
11:00 and I want to make sure that we have time to hear from
all of our witnesses.
As I said, I want to begin by welcoming the more than 160
children who have traveled to Washington from across the
country to share your personal stories. You will tell us what
it's like to live with Type 1 diabetes, just how serious it is,
and why it is critical for Congress to fund the research
necessary to discover better treatments, more effective
technology, and, ultimately, a cure.
Your personal stories really matter. They motivate Senators
and members of the House to get involved in the cause. In my
case, one of my very first meetings as a brand new Senator was
with Maine families with children with diabetes, and I'll never
forget this 10-year-old little boy looking up at me, and he
told me that he wished he could take just one day off from
having diabetes-his birthday or Christmas-but of course he
could not, and that really touched me and it led me to start
the bipartisan Senate Diabetes Caucus.
I want to give a special welcome to the two delegates from
Maine - Ruby Anderson from Yarmouth, who's going to be
testifying, and Lydia Bryant from Ellsworth. I'm very proud
that you are here representing our great state.
Since the last convening of the Children's Congress two
years ago, we have made remarkable strides with new
technological discoveries that are already changing lives for
people with Type 1 diabetes. We celebrated the FDA approval of
an artificial pancreas system for children ages 14 and older.
Now the artificial pancreas is also available for kids who are
ages 7 to 13, opening the door for better day-to-day management
of diabetes.
Today's research represents tomorrow's cure. Just last
month, a new study, the first of its kind, illustrated the
potential of an immunotherapy drug to delay the onset of Type 1
diabetes by an average of two years. What a significant
breakthrough.
These advances have only been possible due to our
bipartisan commitment to funding diabetes research. Since I
founded the bipartisan Senate Diabetes Caucus in 1997, federal
funding 2 for diabetes research has tripled and these research
dollars are yielding results. We now spend more than $1 billion
on diabetes research.
The Special Diabetes Program, in particular, has
contributed to phenomenal discoveries, especially advancements
in technology. This program provides an additional $150 million
each year for T1D research, and another aim of this program is
equally important: the Special Diabetes Program also studies
diabetes in American Indians and Alaskan Natives, who
experience Type 2 diabetes at nearly three times the rate of
the national average, so the SDP is important both for people
who have Type 1 and also for Native Americans and Alaskan
Natives.
In total, over the past 22 years, the Special Diabetes
Program has contributed $2.8 billion to improve the lives of
people with diabetes.
By the end of September, we must pass legislation to
reauthorize the Special Diabetes Program and that's what you
need to tell all the members of Congress. It has strong
bipartisan support, 68 Senators signed a letter to Senate
leadership that Senator Shaheen and I authored advocating for
this program. I am pleased to report to you that just last week
the Senate Health Committee, on which I serve, approved a five
year authorization of the SDP. That's the longest authorization
ever, so that's really good news.
Finally, let me just say that I am very concerned about the
spiraling cost of insulin. The cost of managing diabetes is
growing at an alarming rate. Between 2012 and 2016, average
insulin spending for patients with Type 1 diabetes nearly
doubled. Last year, a father in Maine testified that he turned
to drug importation from Canada after the price of a 90-day
supply of insulin for his son with Type 1 tripled to $900.
I am going to put the rest of my statement in the record so
that we can expedite the hearing, but let me just end by
telling you two things. First, until last fall I had no
personal connection at all with Type 1 diabetes. Then, my
nephew married a young woman who has Type 1 diabetes and has
her own blog, so I feel like I'm now officially a part of the
JDRF family, and second, it is truly inspiring to look out and
see this wave of Carolina blue. I did the best I could to come
close to matching it, but your passion and hope for a cure are
contagious, and together I am confident that we'll continue the
progress and achieve that goal.
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