<DOC>
[109 Senate Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:30602.wais]
S. Hrg. 109-961
THE POTENTIAL OF AN ARTIFICIAL PANCREAS: IMPROVING CARE FOR PEOPLE WITH
DIABETES
=======================================================================
HEARING
before the
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 27, 2006
__________
Available via http://www.access.gpo.gov/congress/senate
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
-------
U.S. GOVERNMENT PRINTING OFFICE
30-602 PDF WASHINGTON DC: 2007
---------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866)512-1800
DC area (202)512-1800 Fax: (202) 512-2250 Mail Stop SSOP,
Washington, DC 20402-0001
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
SUSAN M. COLLINS, Maine, Chairman
TED STEVENS, Alaska JOSEPH I. LIEBERMAN, Connecticut
GEORGE V. VOINOVICH, Ohio CARL LEVIN, Michigan
NORM COLEMAN, Minnesota DANIEL K. AKAKA, Hawaii
TOM COBURN, Oklahoma THOMAS R. CARPER, Delaware
LINCOLN D. CHAFEE, Rhode Island MARK DAYTON, Minnesota
ROBERT F. BENNETT, Utah FRANK LAUTENBERG, New Jersey
PETE V. DOMENICI, New Mexico MARK PRYOR, Arkansas
JOHN W. WARNER, Virginia
Priscilla H. Hanley, Professional Staff Member
Michael L. Alexander, Minority Staff Director
Wilson O. Wang, Legislative Assistant, Office of Senator Lieberman
Trina Driessnack Tyrer, Chief Clerk
C O N T E N T S
------
Opening statements:
Page
Senator Collins.............................................. 1
Senator Coburn............................................... 2
Senator Coleman.............................................. 3
Senator Lautenberg........................................... 18
Prepared statement:
Senator Lieberman............................................ 29
WITNESSES
Wednesday, September 27, 2006
Griffin P. Rodgers, M.D., Acting Director, National Institute of
Diabetes and Digestive and Kidney Diseases, National Institutes
of Health, U.S. Department of Health and Human Services........ 4
Chris Dudley, Chief Executive Officer, The Dudley Foundation..... 7
Arnold W. Donald, President and Chief Executive Officer, Juvenile
Diabetes Research Foundation International..................... 9
Caroline K. Sweeney, accompanied by her son, Aidan T. Sweeney,
Gray, Maine.................................................... 12
Alphabetical List of Witnesses
Donald, Arnold W.:
Testimony.................................................... 9
Prepared statement........................................... 49
Dudley, Chris:
Testimony.................................................... 7
Prepared statement........................................... 43
Rodgers, Griffin P., M.D.:
Testimony.................................................... 4
Prepared statement with attachments.......................... 30
Sweeney, Caroline K.:
Testimony.................................................... 12
Prepared statement........................................... 54
APPENDIX
Andrew P. Rasdal, President and CEO of DexCom, Inc., prepared
statement...................................................... 58
Responses to post-hearing questions for the Record:
Dr. Rodgers.................................................. 60
THE POTENTIAL OF AN ARTIFICIAL
PANCREAS: IMPROVING CARE FOR
PEOPLE WITH DIABETES
----------
WEDNESDAY, SEPTEMBER 27, 2006
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 10:03 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Susan M.
Collins, Chairman of the Committee, presiding.
Present: Senators Collins, Coleman, Coburn, and Lautenberg.
OPENING STATEMENT OF CHAIRMAN COLLINS
Chairman Collins. The Committee will come to order. Good
morning.
As the founder and co-chair of the Senate Diabetes Caucus,
I have learned a great deal during the past 10 years about
diabetes and the difficulties and heartbreak that it causes for
so many families as they await a cure. This hearing will
examine the potential that new technologies have for improving
the care and quality of life for people living with diabetes.
Diabetes is a costly and devastating illness. Nearly 21
million Americans have diabetes, and one in three American
children born today will develop the disease.
Diabetes is a lifelong condition that affects people of
every age, race, and nationality. It is the leading cause of
kidney failure, blindness in adults, and amputations not
related to injury. Moreover, it is estimated that diabetes
accounts for more than $132 billion of our Nation's annual
health care costs and one out of every three Medicare dollars.
The burden of diabetes is particularly heavy for children
and young adults with type 1, or juvenile diabetes. They not
only have the disease from an early age, but must also endure a
lifetime of treatment and related complications from the
disease. It is a disease that they will never outgrow.
I will never forget the first family that I met who had a
son with juvenile diabetes. He was, as I recall, about 10 at
the time. He looked up at me and he said that he wished he
could just take one day off from having diabetes, his birthday
or maybe Christmas. But he knew that he could not. And that
conversation with that little boy is what motivated me to be
the founder of the Diabetes Caucus in the Senate so that we
could push for greater Federal investment in research.
In individuals with juvenile diabetes, the body's immune
system attacks the pancreas and destroys the islet cells that
produce insulin. The average child with type 1 diabetes will
have to take some 50,000 insulin shots in a lifetime. Moreover,
these children and adults must closely monitor their blood
sugar levels throughout their lives with frequent testing.
While the discovery of insulin was a landmark breakthrough
in the treatment of diabetes, insulin is not a cure, and people
with diabetes face the constant threat of developing serious
complications, as well as a drastic reduction in their quality
of life.
Fortunately, however, there are new technologies on the
horizon that hold great promise for treating diabetes.
The fact is that current diabetes technology is inadequate.
Some studies have found that even patients who aggressively
manage their disease--for example, those who measure their
blood glucose levels an average of nine times a day--still
spend less than 30 percent of their day in the normal range.
The rest of the time, unfortunately, their blood sugar levels
are either too high or too low.
This morning's hearing will explore the potential for the
development of a closed-loop artificial pancreas that could
revolutionize diabetes care. The artificial pancreas would link
two existing technologies, the insulin pump and the continuous
glucose monitor. This is a sensor that is used. If we could
bring these technologies together, they have the potential to
dramatically improve blood glucose control, which would in turn
improve the quality of diabetes care and help to prevent the
serious and costly complications of the disease.
In addition to testimony about the personal and economic
toll that diabetes imposes, this hearing will also feature
testimony about the limitations of current technologies and the
promise of new technologies. We will hear why an artificial
pancreas would make such a difference until a cure is found,
and we will discuss the progress in its development. Finally,
we will look at the ongoing collaborative efforts on the part
of the Federal Government, the Juvenile Diabetes Research
Foundation, and private industry to develop these innovative
technologies and make them more widely available.
I look forward to hearing from our witnesses this morning
about what we in Congress can do to help move this effort
forward.
I am very pleased that we have with us today someone who
knows very well the toll that diabetes takes on patients, a
physician, our Senator, Tom Coburn. Dr. Coburn.
OPENING STATEMENT OF SENATOR COBURN
Senator Coburn. Thank you, Madam Chairman. I appreciate
your having this hearing. This is a disease that affects almost
every family in the country, and if you have a family member
with it, you understand the nature of this disease. As a
practicing physician for over 20 years, it is the most
difficult disease that I deal with in my practice. I continue
to see people with it on Monday mornings.
Technology is advancing, but not fast enough. The costs
both in terms of time constraints to individuals and
limitations on what you can and cannot do impact every family
that is out there.
I think we are on the horizon of new treatments, not only
in preventing juvenile diabetes, but also curing it--whether it
be with ductile cell transplants for stem cells or with
automated devices, such as continuous glucose and insulin
pumps.
I look forward to hearing the testimony, and I thank you
for having this hearing.
Chairman Collins. Thank you.
We are also very pleased to be joined by Senator Coleman.
He has come to, I think, every single hearing that this
Committee has had looking at diabetes over the years, and we
are very pleased that he is able to join us this morning.
OPENING STATEMENT OF SENATOR COLEMAN
Senator Coleman. Thank you. Thank you, Madam Chairman, and
thanks for your leadership on this issue. It is important.
We have a very active JDRF group in my State, which is
wonderful. They say Washington is a town of a thousand issues
and a few priorities, and an issue becomes a priority when Moms
and Dads and others step forward and say, this is important and
this is affecting my child. And when you look in the face of
that child and others, you say we have to do better.
What I also find exciting here is the public-private
partnerships. I am a big fan. We cannot do it by ourselves. We
have in Minnesota, for instance, Medtronics doing, I think,
some tremendous, cutting-edge research in this area. But this
really is an opportunity, Madam Chairman, to pull together the
public side, the tech companies, the public entities, the
universities, and others.
And so I am an optimist, and I listen to my colleague Dr.
Coburn and his expertise on this issue. It is probably not
moving fast enough, but I am really hopeful. We have some
really smart people out there, and I think forums like this,
Madam Chairman, really move the ball forward and are critically
important.
So I just want to thank you for your leadership, and I look
forward to hearing the testimony.
Chairman Collins. Thank you.
I am very pleased to welcome our panel of witnesses this
morning. First we will hear from Dr. Griffin Rodgers, the
Acting Director of the National Institute of Diabetes and
Digestive and Kidney Diseases at the National Institutes of
Health. Dr. Rodgers will provide us with an overview of how the
new technologies work and why they are so important. He will
also give us a review of the research funded by NIH in this
area.
Next we are very pleased to hear from Chris Dudley, a 16-
year veteran of the NBA and the founder and CEO of the Dudley
Foundation. Chris would be a stand-out in almost any crowd, and
it is not just because he is almost 7 feet tall. In 1994, he
founded the Dudley Foundation, which encourages all children,
and particularly children with diabetes, to pursue their
dreams. He will tell us about the kids at a basketball camp
that he founded in Oregon for children with diabetes, and he
will also share his personal story of living with type 1
diabetes.
Next we will hear from Arnold Donald, the President and CEO
of the Juvenile Diabetes Research Foundation International. Mr.
Donald will tell us about the JDRF's artificial pancreas
project and will talk about the regulatory and reimbursement
challenges that we face as we attempt to make the technologies
more widely available.
And last, but in my view, first, we will hear from one of
my constituents, Caroline Sweeney, who has traveled to
Washington with her family all the way from Gray, Maine. She
has with her today her three children, including her 4-year-old
son, Aidan, who has diabetes, who was diagnosed at 22 months of
age. And I think her story will tell us why this hearing
matters so much. So, Caroline, thank you so much for traveling
here to share your family's story with us.
We will start with Dr. Rodgers.
TESTIMONY OF GRIFFIN P. RODGERS, M.D.,\1\ ACTING DIRECTOR,
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY
DISEASES, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Dr. Rodgers. Chairman Collins and Members of the Committee,
good morning. Thank you for the invitation to testify today on
the scientific quest to develop an artificial pancreas as a
treatment for diabetes, the progress we have seen, and the
outlook for the future.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Rodgers with attachments appears
in the Appendix on page 30.
---------------------------------------------------------------------------
As the Deputy Director and the Acting Director of the
National Institute of Diabetes and Digestive and Kidney
Diseases, one of the institutes at the NIH, or National
Institutes of Health, within the U.S. Department of Health and
Human Services, I am really pleased to provide you with some
brief highlights of my formal testimony, which I have submitted
for the record.
Before I begin, though, I would like to acknowledge your
leadership, Chairman Collins, in focusing attention on diabetes
research, including the development of new technology that will
benefit patients and their families.
As you indicated, diabetes affects 21 million Americans.
People with diabetes are more likely to die of heart disease or
a stroke, have lower life expectancy, and really face a long-
term threat of severe eye disease, kidney disease, and nerve
damage. Landmark NIH-supported clinical trials and other
clinical studies have demonstrated that carefully controlling
blood glucose or sugar is really the key to reducing the risk
for these serious and costly health complications.
Yet current strategies for diabetes management are far from
perfect. Less than half of diabetes patients achieve
recommended targets for blood glucose control as measured by
the hemoglobin A1c levels. Achieving good control is especially
challenging for people with type 1 diabetes whose disease
attacks the pancreas and robs the patients of their ability to
produce insulin.
Intensive therapy with insulin helps patients achieve
control but really requires numerous daily finger sticks to
check their blood glucose levels. It also requires that
patients carefully calibrate their food intake and physical
activity to calculate their insulin doses, which are
administered by a pump that delivers the insulin under the
skin. Most worrisome, though, is that intensive insulin therapy
raises the risk of sudden episodes of life-threatening low
blood sugar, or hypoglycemia, especially at night and
especially in children. Clearly, improved therapeutic options
are needed.
An artificial pancreas is a device still under development
that would close the loop between glucose-sensing technology
and insulin-delivery technology. Patients would automatically
receive the correct dose of insulin in real time in a way not
currently possible, and in this way the device would mimic how
a healthy pancreas senses the need for insulin and produces the
right amount at the right time, around the clock, to control
blood glucose levels. Some technology could potentially benefit
not just type 1 diabetes but also patients with type 2 diabetes
or other forms of the disease who have to use insulin to manage
their disease.
Recent developments in continuous glucose-sensing
technologies have vaulted us over a major hurdle toward
realizing the artificial pancreas. The NIH has helped to propel
this research, and casting as wide a net as possible, the NIH-
supported investigators in academia and in industry have been
exploring a variety of approaches to glucose sensing.
These studies are cross-cutting, bringing together basic
researchers, mathematicians, engineers, and clinicians at the
same table to work on these advances. As the technology has
bloomed, we have also supported validation and optimization
studies. These multifaceted approaches have really borne fruit
already. Three new minimally invasive, continuous glucose
monitors have recently been approved or are currently under
study by the Food and Drug Administration.
If I can have the first slide,\1\ this shows you an example
of three of those continuous glucose-monitoring devices, and I
think that Chairman Collins indicated one as well. We clearly
know that continuous glucose monitoring facilitates tight
glucose control, and the importance of that fact is indicated
on the right. For every 1-percent fall in the hemoglobin A1c
level, which measures the glucose over time, there is a 37-
percent reduction in eye, kidney, and nerve complications.
Tight glucose control cuts heart disease in half in patients
with type 1 diabetes. Only about 44 percent of people with
diabetes are able to achieve the recommended glucose control
with the current technology.
---------------------------------------------------------------------------
\1\ The chart referred to appears in the Appendix on page 41.
---------------------------------------------------------------------------
I am pleased to note that the NIDDK helped support this
technology development in two of the three devices that are
currently available or being studied. These devices measure
glucose every minute, day and night, from a slender sensor
inserted under the skin and trigger an alarm if the glucose
becomes either too high or too low.
The devices let patients see the current glucose readings,
reducing the need for frequent finger sticks. Importantly, they
can see whether the glucose levels are rising or falling and
how quickly, thereby allowing them to take immediate action to
avoid episodes of either very high blood sugars or very low
blood sugars.
This type of device still has limitations and is under
study to assess the full range of health benefits that it may
provide, but we are really encouraged by published research
that shows the potential of these continuous glucose monitors
to help patients achieve good glucose control and make a
difference in their care now, even before we realize the
artificial pancreas.
If I can have the next slide,\1\ this just gives you an
indication of how patients have benefited from that. If you
look at the upper panel, this is a baseline profile taken for
two consecutive days on a patient who had relatively good
control, as indicated by a hemoglobin A1c value of 7.2.
Indicated in the green box there is the healthy range that we
try to achieve, and you can see that on Day 1, indicated by the
green triangles, or Day 2, indicated by the pink triangles,
that there was a very small period of time that the patient
actually was in that healthy range.
---------------------------------------------------------------------------
\1\ The chart referred to appears in the Appendix on page 42.
---------------------------------------------------------------------------
This patient was entered into a clinical trial and was
given intensive knowledge and education on the use of this
device, and you can see at the 13-week follow-up profile that
there is a much larger period of time in which that patient is
within that healthy range. And you can see that there is only a
small change in the overall hemoglobin A1c value.
These studies are especially important to continue this
technology because the FDA has only approved these devices at
the moment for individuals who are 18 years of age or older,
and so we really need to follow through with these studies,
particularly in young children. And the reason that this is so
critically important is that, in collaboration with one of our
sister Institutes, the National Institute of Child Health and
Human Development, we have developed DirecNet, which is a way
of evaluating this technology in young children. Work is
already ongoing to develop information needed for complex
computer programs that will be necessary, an essential step to
link the sensing with the insulin delivery and thereby close
the loop.
This may first be successful during the night when there
are not as many major changes in either eating or physical
activity that can clearly affect glucose levels. This effort
will be furthered by studies using new monitors in children
admitted to NIH-supported general research centers. And,
finally, insulin delivery technologies are being included in
studies to ensure that they will be compatible and effective in
future artificial pancreases.
Our significant progress to date toward a goal of an
artificial pancreas really reflects effective public-private
partnerships in which NIH and other HHS agencies, working with
industry and with health advocacy groups such as the Juvenile
Diabetes Research Foundation, have clearly worked together very
effectively. We look to continue these partnerships in the
future. For example, NIDDK, together with JDRF, the American
Diabetes Association, and the FDA, convened a scientific
workshop in December 2005 to assess the state of the science of
glucose-sensing devices and insulin-delivery technology, and we
are incorporating these outcomes from that meeting into our
research planning efforts.
To foster new opportunities, we have just released a
strategic plan for research on type 1 diabetes, which will help
in the development of this research program as we move forward
in the field. The plan was developed under the auspices of the
statutory Diabetes Mellitus Interagency Coordinating Committee,
which will continue to coordinate efforts across the NIH and
with other relevant Federal agencies.
Finally, over the past several decades, technological
advances have reduced the treatment burden on patients,
improved diabetes management, and reduced premature mortality
from type 1 diabetes. We can now foresee a future when
technology will be so advanced that we will have nearly
invisible technology in patients. We will continue to foster
vigorous and productive research to achieve this goal. I would
like to again thank you for this invitation, and I am pleased
to answer any questions that the Committee may have.
Chairman Collins. Thank you, Doctor, for an excellent
presentation. Your full statement as well as the statements of
all the witnesses will be entered into the record.
Mr. Dudley.
TESTIMONY OF CHRIS DUDLEY,\1\ CHIEF EXECUTIVE OFFICER, THE
DUDLEY FOUNDATION
Mr. Dudley. Good morning, Senator Collins and distinguished
Members of the Committee. Thank you for the invitation to
appear before you today. Also, thank you for your tireless
leadership, Senator Collins, in championing issues that will
get us to our shared goal of a cure.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Dudley appears in the Appendix on
page 43.
---------------------------------------------------------------------------
My name is Chris Dudley, and I played in the National
Basketball Association for 16 years with Cleveland, New Jersey,
Portland, and New York. I am the proud husband of a beautiful
wife and father of three wonderful, healthy children, ages 7,
6, and 4. I also have been living with juvenile diabetes for
over 25 years.
In 1994, I formed the Dudley Foundation. The following year
we started a basketball camp for kids with diabetes. Ever since
that time, I have been an outspoken advocate for encouraging
kids with diabetes to pursue their passions--whether it be in
sports or other activities. Our foundation emphasizes that kids
can achieve their dreams to be whatever it is that they want to
be, whether it is being a doctor, professional athlete, or even
a U.S. Senator, provided that they take care of their diabetes.
Our goal is to empower these children.
But today I want to express the challenges of having
diabetes and how new technology is imperative to help diminish
both the short- and long-term effects that all those with
diabetes have to face.
I tell children to be proactive and positive in managing
their diabetes, and I will continue empowering them. But,
still, I have to acknowledge that they will face difficulties,
great difficulties, and agree with them that it is a cruel
disease.
I myself have been proactive with my diabetes and yet have
experienced difficulties. I have tested my blood sugar over
40,000 times. I exercise, eat healthy, and follow my doctor's
instructions. I, like all those with juvenile diabetes,
experience unexplained high and low blood sugars. I have had
double vision and have even endured violent seizures. The need
for this new technology is vital. We need help in preventing
erratic blood sugars. Greater control of blood sugar levels is
imperative to prevent tragic accidents, seizures, and long-term
complications. This disease needs to be controlled instead of
it controlling us.
This is a disease you never get a break from. You have to
be aware of this disease every single day. Children have to
overcome the hurdle of diabetes, just as I have, but it was not
and is not an easy hurdle. I have been able to fulfill my
childhood dream of playing professional basketball. I have
walked onto the court to hear 20,000 fans. That feeling is
incredible, and I was blessed to have experienced it. But I
always wished I could play one game without worrying about my
blood sugar, one game where I could just concentrate on the
game and not have to worry about whether my blood sugar was
heading higher or dangerously low, one game where I did not
have to worry about the possibility of a loss of equilibrium,
lightheadedness, double vision, or even the worst case,
seizure.
I tested my blood sugar level 14 times a day on game days
in order to be at my peak for the games. But I still knew that
there were too many variables in the control of diabetes to
feel in total control. This reality is why I am so excited
about today's hearing and about the promise of new
technologies, like the continuous glucose sensors and the
closed-loop system, to help people manage their diabetes
until--until--we find a biological cure.
If I had a continuous glucose sensor when I was in the NBA,
I could have seen the trends in my blood sugar levels and taken
proactive action to keep myself in even better control. As
valuable as the snapshot of a blood sugar test is, it would
have been invaluable to see the whole picture and to know what
direction my blood sugar was heading and, even more
importantly, where it had been. I could have been proactive to
my blood sugar level instead of having to be reactive to the
symptoms.
There are even greater needs for this technology away from
the court. As a potentially life-saving feature, a sensor could
give a warning that the blood sugar level is or is about to be
dangerously low. This would give the person the chance to
adjust their blood sugar level upward, thus avoiding a
potentially fatal car accident. This device could also enable
parents to set the device so it alarms when a child's sugar
level goes too high or too low, giving parents peace of mind
and the ability to sleep through the night and not have to
awake once or twice a night to test their child's blood sugar
for fear of hypoglycemic reaction. Many of our campers' parents
only get to sleep through the night uninterrupted 1 week a
year, and that is the week when their kids are at our camp and
we are the ones checking their blood sugar twice a night.
A lot has changed since I was diagnosed with diabetes, and
I am excited about new technologies that will help people to
better manage their diabetes and hopefully avoid the
devastating complications that can occur over time.
Ultimately, what we all want is a cure, but improvements in
care along the road to a cure would make a tremendous
difference to so many people who struggle every day, and it is
incumbent upon all of us to do our part to help accelerate the
progress on both of these fronts.
I would like to close by reading an excerpt of a letter
recently sent to me from a teenage boy who attended my camp in
August:
``After camp each year, I return to my home in Three Rivers,
California, a community of 3,000 in the southern Sierra foothills. I
have always been the only one in my school with type 1 diabetes. In my
elementary school, there was no school nurse. Each year since I was
diagnosed with diabetes in the spring of my third-grade year, my mom
and I would educate my current teacher, as well as the office staff,
about type 1 diabetes and what to do in the event of an emergency. As
of the 2006-2007 school year, I am a junior and travel 20 miles each
day to my high school. There is a school nurse on the campus one day a
week, and most of my teachers are not even aware that I have diabetes.
My basketball and baseball coaches are informed that I have the
disease, but most are not knowledgeable about it. During my first
season of playing tackle football, my coaches did not give me playing
time because they thought I was `sick.'
``My parents are self-employed, and the medical costs have proven
to be staggering and never-ending. Their monthly health insurance
costs--including supplies not covered--are in excess of $1,000 per
month for our family of four. Ironically, there are new products coming
onto the market that could ease some of the burdens of having type 1
diabetes, but they are cost-prohibitive and our insurance company won't
provide coverage on certain brands or products.
``No child deserves to live with type 1 diabetes with its risks of
debilitating complications looming over them their entire life. And at
a cost of more than a half-million dollars in their lifetime for
medical supplies and care, no child should have to pay that price
either.''
Senator Collins, thank you again for this opportunity. It
has been an honor to appear before you today. I worry every day
that one of my kids will be diagnosed with juvenile diabetes.
And even though I have been very blessed in my life and have
been able to achieve great things even with diabetes, this is
not the life I want for my children. I want this cure for the
children who come to my camp, my children, and all of the kids
who are afflicted with this disease. Thank you.
Chairman Collins. Thank you. Mr. Donald.
TESTIMONY OF ARNOLD W. DONALD,\1\ PRESIDENT AND CHIEF EXECUTIVE
OFFICER, JUVENILE DIABETES RESEARCH FOUNDATION INTERNATIONAL
Mr. Donald. Good morning, and thank you, Senator Collins.
It is truly an honor to be here before you and the other
Members of the Committee, and as Senator Coburn already pointed
out, about an issue that affects so many American families.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Donald appears in the Appendix on
page 49.
---------------------------------------------------------------------------
I would like to thank you not only for your work on the
issue that brings us together today, the promise of a closed-
loop artificial pancreas, but for your truly outstanding
leadership on the wide range of issues that affect so many
people with diabetes.
As you mentioned, JDRF estimates that as many as 3 million
Americans now have type 1, or what was previously called
``juvenile diabetes.'' It is an autoimmune disease in which the
body attacks the cells in the pancreas that sense blood sugar
and produce insulin to convert that sugar into energy. And
because people with type 1 diabetes cannot produce insulin on
their own, they need to inject insulin into their bodies,
either using syringes or a mechanized insulin pump, throughout
the day just to survive.
The financial burden of diabetes is staggering, costing the
Nation and its health care system more than $130 billion a
year. That is because, over time, people with diabetes are at a
staggeringly high risk for complications--complications like
heart disease, kidney disease, blindness, and amputation.
While JDRF's singular mission is to find a cure for type 1
diabetes, we believe that the support of rapidly emerging
technology can play a crucial role in improving the lives of
people with type 1 diabetes and reducing or even eliminating
the complications of the disease.
JDRF has, therefore, launched a new initiative to help
accelerate the availability of an artificial pancreas, and that
is one of our foundation's six cure therapeutic pathways. The
overall goal of the project is to accelerate the development,
regulatory approval, insurance coverage, and clinical
acceptance of an artificial pancreas. The long-term goal is for
broad patient access and a thriving competitive market for
these technologies.
An artificial pancreas, as you know, combines two pieces of
technology that are actually available to people with diabetes
in some form today, although separately: an insulin pump, which
has long been available--though a number of developments and
improvements have been made, with new pumps coming out that
make quality of life a little bit better in terms of ease of
use and convenience--and a continuous glucose sensor, a
promising new technology which provides real-time data about
trends in glucose levels, as Dr. Rodgers pointed out, and
alarms if levels are heading too high or too low. Now, this
information enables people with diabetes to intervene by eating
food or taking insulin to prevent glucose levels from going too
high or too low.
An artificial pancreas would tie these two technologies
together, using a mathematical algorithm to determine how much
or how little insulin is provided to maintain glucose levels in
the normal range 24 hours a day, 7 days a week. There are
incredibly encouraging clinical trials already underway at Yale
Medical School showing that you can ``close the loop,'' as we
say. Researchers in that clinical setting have teenage patients
with diabetes on a closed-loop system that maintains near
perfect blood sugar levels, especially at night. JDRF is
funding this research at Yale and at five other top scientific
facilities throughout the country, testing a variety of ways to
close the loop. Questions about miniaturization, regulatory
approval, insurance reimbursement, and clinical acceptance by
doctors and patients will follow quickly on the heels of the
basic science and resulting medical product development.
Now, even before a closed-loop artificial pancreas is
available, continuous glucose sensors show great promise in
improving the health outcomes of people with diabetes. One
study found patients using continuous sensors spent 26 percent
more time in the normal glucose range. Another found patients
had statistically significant improvements in HbA1c levels, an
important measure of glucose control. Because better glucose
control means fewer complications, JDRF is making accelerating
the availability of continuous glucose sensors a top priority
as we work toward ultimately an artificial pancreas.
Now, over the past decade, research conducted by the
National Institutes of Health and others clearly shows that
blood glucose control is far and away the most important
predictor of the devastating complications of diabetes. The
better the control, the lower the risk of eye disease, heart
disease, kidney disease, and other problems. In fact, lowering
blood glucose dramatically lowers the risk of serious
complications by as much as 75 percent for some of these
problems. Yet recent research shows that even the best
controlled patients with traditional methods are rarely within
the normal blood sugar range. The test-and-inject or test-and-
pump method of controlling blood sugar, though light years
ahead of clinical standards from just a few decades ago, does
not come close to approximating how the human pancreas really
works. To significantly increase blood sugar control, you need
to more closely mimic the human pancreas, and that is an issue
where technology can provide startling answers in the not-too-
distant future.
With tighter glucose control will come reduced risk of
diabetic complications. And here is the power of this issue.
Fewer complications can, arguably, lead to one of the greatest
health advances and financial savings in medical expenditures
in U.S. history. Consider this: Diabetes is among the leading
causes of heart disease, of stroke, of kidney disease, and of
peripheral nerve disease. It is the single largest cause of eye
disease in the United States. It is the cause of more
amputations in the United States than any other reason, save
accidents. Decreasing the rate of diabetic complications in the
United States can mean savings of literally billions of dollars
in health care costs annually.
JDRF's role in all this is to speedup those timetables in
any way possible. We are spending some $6 million on research
to assess the clinical and economic benefits from use of
continuous glucose sensors and testing versions of a closed-
loop artificial pancreas. We are working with regulators to
understand what research outcomes they need to see before
approving these new technologies. We are working with private
insurers and Medicare officials to make certain that when
approvals come, reimbursement will be fast on its heels. And we
are working with physicians and other diabetes care
practitioners to ensure that when these technologies are
available, they will be fully adopted and supported.
This project has in many ways been a perfect example of how
medical research can and should successfully take place in the
United States. The Federal Government, primarily NIH, has
funded basic research showing the benefits of better glucose
control and identifying promising new methods to help achieve
it. Private companies have picked up the ball to begin
developing products and therapeutics they could eventually
bring to the market. And organizations like Juvenile Diabetes
Research Foundation have been filling the gaps, funding
additional research that focuses on concepts like perfecting
the algorithms that can lead to commercially available
artificial pancreas devices or the clinical and economic
studies that can ultimately determine regulatory, insurer, and
medical practitioner acceptance.
This project has also been an example of how different
parts of the Federal Government can work effectively together.
And as I have already mentioned, the National Institutes of
Health has played a critically important role in funding
research making the artificial pancreas possible. The Food and
Drug Administration has made the artificial pancreas one of its
Critical Path goals. The Centers for Medicare and Medicaid
Services has convened an expert panel to advise on these
technologies. And the Congress, under your leadership, has made
this issue a priority, with 68 Senators and 245 Representatives
highlighting the promise of these technologies to HHS Secretary
Michael Leavitt in letters this spring.
We are profoundly grateful for your leadership--
profoundly--and we look forward to continuing to work with you
in the months ahead to achieve an artificial pancreas and help
millions of Americans with diabetes live longer and healthier
lives.
Thank you very much.
Chairman Collins. Thank you for your excellent testimony.
Mrs. Sweeney, we are delighted to have you here today. I
think that your son may set a record in terms of the youngest
witness, certainly before this Committee, if not the entire
Senate. So, Aidan, we are glad to have you here, too. You are a
good waver.
Mrs. Sweeney, you may proceed.
TESTIMONY OF CAROLINE K. SWEENEY,\1\ ACCOMPANIED BY HER SON,
AIDAN T. SWEENEY, GRAY, MAINE
Mrs. Sweeney. Good morning, Senator Collins and Members of
the Committee. I am Caroline Sweeney from Gray, Maine. I am
here today with my 4-year-old son, Aidan. Before I begin, I
want to say a special thank you to you, Senator Collins, for
all that you do to help find a cure for diabetes. You give my
family so much hope that one day my son will not have to
struggle with the daily burden of diabetes. I am proud to live
in Maine and to have you as my Senator. Thank you.
---------------------------------------------------------------------------
\1\ The prepared statement of Mrs. Sweeney appears in the Appendix
on page 54.
---------------------------------------------------------------------------
Chairman Collins. Thank you.
Mrs. Sweeney. On February 10, 2004, my world fell apart. I
had taken my son, Aidan, then 22 months old, to the
pediatrician because he had been up all night drinking water
and soaking diapers. Twenty-six weeks pregnant with my second
child, and tired of waiting for the doctor to return to the
examining room with Aidan's blood sugar results, I opened the
door and was quickly escorted back into the room by the nurse.
I will never forget the look on her face as I asked,
``Everything is all right, isn't it?'' She looked at me with
tears in her eyes and shook her head, ``No.'' Covered in urine,
I held my crying son tightly and gasped for breath as I fell
against the examining table. My son, the child I had longed for
my entire life, was sick--sick with a disease for which there
is yet no cure: type 1 (juvenile) diabetes. Aidan was in
diabetic ketoacidosis, a complication which threatened his
life. My life, but importantly, my son's, would never be the
same. I went through every emotion. I wanted to scream; I
wanted to hit; I wanted to run; I wanted to be numb. Most of
all, I wanted it to go away.
But diabetes never goes away. Aidan is now 4 years old. He
receives insulin through a pump, which he wears on a belt
around his waist, 24 hours a day. The pump is connected to an
inch-long catheter tunneled beneath the skin on his bottom. So
far, we have changed his catheter over 500 times. Not
surprisingly, he does not like the catheters. Most site changes
become bargaining sessions, and despite the anesthetic cream,
he feels every stick. His little bottom is studded with scars.
His fingertips are scarred from being tested up to 12 times
a day. That is more than 11,000 tests in 2\1/2\ years. Like the
site changes, he does not like the testing. Sometimes, Aidan
will run away when it is time to test his blood sugar or hide
his hands behind his back, crying for me not to test him. At
preschool, he has asked his teacher to test his blood sugar in
the bathroom so the other kids will not watch.
Despite his efforts, he can never escape his tests. He is
forced to test his blood sugar everywhere--at preschool, at the
grocery store, at restaurants, at the playground, at friends'
homes, and even in his bed during sleep. The tests are
constant, frustrating, and exhausting. Growth spurts and minor
illnesses can cause his blood sugar levels to rise or fall
unpredictably and change his insulin demands as well. His
emotions shift with every blood sugar fluctuation, making it
impossible to distinguish between ``typical 4-year-old
behavior'' and ``low'' or ``high blood sugar behavior.'' Often
he has been unable to warn me even when his sugars are at life-
threatening levels. Two and a half years into his illness, he
will still sleep through dangerously low blood sugars and be
asymptomatic while awake. And so I test.
And I worry. I am always fearful--fearful that my son's
blood sugar will rise so high that he will enter into a coma or
drop so low that he will seize or even worse. Every night, I
check his blood sugar before I go to bed and pray to God that
he will wake up in the morning. I never sleep through the
night. I keep a baby monitor on my pillow just so I can hear
him breathe. I have found myself running into his bedroom in
the middle of the night, carrying glucagon and a syringe,
thinking that I have heard him seizing. I am always relieved
when morning comes and I hear his little footsteps entering my
bedroom.
I have become not only Aidan's mother but his health care
provider. With each good morning and good night kiss comes a
finger stick. The responsibilities of his diabetes care are
many--endless testing, counting and recording and interpreting
everything that he eats, calculating insulin doses, giving
insulin, changing catheter sites, keeping his supplies in
stock, trying to explain to him just why it is that he cannot
eat the chocolate cake that his friends are eating when his
sugar is too high. The list goes on.
Still, despite diligent care and tight glucose control, I
am aware my son is still more likely to suffer from heart
disease, kidney failure, nerve damage, stroke, blindness,
amputations, and an early death. This is most difficult to face
as a parent. I try to live day by day with my son, but find
myself wondering: Will he one day lose a limb? Will he end up
on dialysis? Will he go blind? Will he live to see the age of
50?
Aidan can only be left in the care of others who are
trained in diabetes, including babysitters and school. Fourteen
weeks after Aidan was diagnosed with diabetes, I gave birth to
our second son, Michael, now 2, and just 3 months ago gave
birth to our daughter, Caitlin. Both deliveries put us in a
state of panic over who would take care of Aidan. Families on
both sides were forced to pick up their busy lives and come to
Maine in the weeks before both deliveries so they could be
trained in diabetes care. I can vividly remember my mother
learning how to operate Aidan's insulin pump while timing my
contractions. While my biggest concern should have been my
unborn child, I could not seem to escape the worry about
Aidan's care.
From the moment little Michael and Caitlin were born, they
have never been able to have my complete attention because of
Aidan's diabetes. Aidan's illness comes first--before nursing,
diaper changes, cries, baths, even hugs and kisses. I recently
realized the impact of this when Michael, my 2-year-old,
insisted on having his blood sugar checked, claiming to have
diabetes, too. Much of his life is also dependent on Aidan's
blood sugars. He knows that if Aidan's blood sugar is high at
dinnertime that he has to wait with the rest of the family
before he can eat. He knows that sometimes Aidan needs to drink
juice really fast and sometimes only he can have juice and
Aidan cannot. He knows that his Mommy and Daddy sometimes stick
a needle into Aidan's bottom and that Aidan does not like that.
I do not know what impact this will have on Michael in the
years to come. I can only try to help him understand the
severity of his brother's disease, while praying that he and
his sister do not one day get diabetes.
As parents, we try from the moment our children are born to
protect them from any harm. Two years ago, I never felt more
helpless when all I could do was hold the tiny hand of my 22-
month-old son in the intensive care unit and pray he would not
die. I vowed at that moment to do everything I could to find a
cure for diabetes. I stand before you today with my son, my
hero, asking for your support in saving his life. While the
continuous glucose monitor and artificial pancreas are not
cures, they can offer Aidan, and children like him, a
tremendous improvement in his quality of life, free from
thousands of finger stick tests, and offer me the gift of
peace--peace in knowing that my son is safe and hopefully able
to live a longer life with this terrible disease.
I encourage Congress to continue to show its support for
these promising technologies and to help ensure that they are
available and accessible to all who could benefit. Thank you.
Chairman Collins. Thank you so much for your eloquent
testimony. It leaves me speechless, and we are not speechless
very often up here, I will tell you that.
You did such a good job of explaining to us that diabetes
has an impact not only on Aidan but on your entire family. And
that is one reason that your testimony inspires all of us to
work even harder for a cure and for the research dollars that
will lead to better treatments and to support what is a truly
impressive partnership with private companies, the NIH, the
Juvenile Diabetes Research Foundation, all working together
toward a common goal.
Mr. Dudley, your testimony also was so eloquent when you
talked about not being able to play a single game without being
worried about the impact on your diabetes. It really hits home
also.
Mrs. Sweeney, it is my understanding that you were a
dietician prior to finding out about Aidan's diagnosis.
Mrs. Sweeney. Yes.
Chairman Collins. Has that made it easier for you to manage
his illness than someone who did not have that background?
Mrs. Sweeney. It probably has made it a little bit easier,
but to be honest, I expected it to make a bigger difference
than it has. Both my husband and I are health care
professionals. My husband is an emergency room physician, the
same emergency room where Aidan had to go after he was
diagnosed. And we both find this just a maddening and
frustrating disease. It does not work the way that we were both
taught.
Chairman Collins. I think that is so telling, that even
people with your expertise in health care have found this to be
such a challenge. And when we look at the charts that Dr.
Rodgers showed us and we hear the statistics, virtually
everyone who has diabetes has a very difficult time controlling
their blood sugar, and yet that is so critical. And that is why
I am so excited about this potential technology.
We know it would help to even out the blood sugar levels
for your son, but can you also give us a sense of how this
technology would make your life a bit easier?
Mrs. Sweeney. It would make my life a lot easier in
numerous ways. One would be sending Aidan off to school. That
has been a big concern of ours. Every day, when I drop him off
at preschool, I have to meet with his teachers to make sure
that they are aware as to how to check his blood sugar, correct
his blood sugar if it is high or low, and give the proper
insulin for his snack. I carry a cell phone with me at all
times so that anyone who is with Aidan at any point can reach
me with questions.
Chairman Collins. Dr. Rodgers, you mentioned in your
testimony that the continuous glucose sensors to date have only
been approved for use in adults. Are you hopeful that they can
be extended so they can be used for children? What is the
barrier in that area?
Dr. Rodgers. Absolutely. As you indicated, the continuous
glucose monitors are only currently available or FDA-approved
for individuals 18 years of age or older. It is certainly
understandable that the manufacturers wanted to get their
product to the market, and it is generally well appreciated
that it takes much longer to get such devices FDA approved.
Your question also speaks really to the importance of
having NIH-supported research to support the types of
investigations that are needed, particularly in pediatric
patients, to move these devices through the approval process.
And it was really for this reason that we developed, in
collaboration with the National Institute of Child Health and
Human Development, the so-called DirecNet, because up until
this time, these devices that we showed had only been tested in
adults. And while we are hopeful that the results and the
efficacy of this device are equally good in children, it is
really important that we have that database, that knowledge to
effectively determine how to best use these devices in
children.
Chairman Collins. I think most of us are motivated by
wanting to help little Aidan and wanting to help Chris Dudley
live lives free of diabetes. But there are also very
considerable economic consequences of this disease. Nearly one
out of three Medicare dollars are spent in treatment of people
with diabetes. I think the estimate that either you or Mr.
Donald gave was $132 billion in health care costs. So this
makes sense, even if you are putting aside your concern for
people, which none of us are, but from clearly a cost/benefit
analysis.
Are we giving you--``we'' meaning Congress--sufficient
funding for projects in this area, which are clearly going to
pay off in lower health care costs down the road?
Dr. Rodgers. Well, we are certainly very appreciative of
the support that you have given us over these years, and we
really try to deploy those resources that the Congress has
generously appropriated to us to the most cutting-edge, the
highest-priority, the most innovative types of research.
I think Mr. Donald indicated in his testimony it is
estimated that the direct and indirect costs of diabetes are
about $132 billion a year. Actually, that number is taken from
an article published in ``Diabetes Care'' in 2003 based upon
2002 numbers. So almost certainly that number is much higher
and likely to continue to rise unless we are able to find
better ways to manage diabetes care more effectively. And the
human toll, as I think you have heard, the human suffering
factor is also a critical point.
So we really have to think every day about the best ways to
manage diabetes, both for the human toll, but also to protect
against the complications which really lead to these
expenditures.
Chairman Collins. Thank you. We are going to do a second
round of questioning, so, Mr. Donald and Mr. Dudley, I will
have questions for each of you on the second round.
Senator Lautenberg.
Senator Lautenberg. Madam Chairman, since Senator Coburn
has been here and he has a professional understanding of what
is taking place, I do not mind if he goes first.
Chairman Collins. Senator Coburn.
Senator Coburn. Thank you, Senator Lautenberg. That is very
kind of you.
Dr. Rodgers, a couple of things. At the NIH, are we working
on genetic identification of those more susceptible to immune
destruction of the pancreas?
Dr. Rodgers. We absolutely are. We have studies currently
ongoing to try to identify the genetic susceptibility factors
related to the development of type 1 diabetes in particular.
Some think that it may be some viral agent. Some think that it
may be some food product. But we are committed to a study that
will follow kids from the time of birth, looking at the most
common susceptibility gene that we currently have, something
related to their HLA locus.
Senator Coburn. Right.
Dr. Rodgers. We will follow them to the age of 15 for the
disease onset to see whether we can determine causation, based
upon very careful surveys of their food intake, viruses, and
other factors. We are collecting a number of samples very
frequently to look for bacterial, viral, and other etiologies.
So that is critically important.
Senator Coburn. This is just a general statement, and you
can take it any way you want. Our health care system in this
country is about disease treatment rather than investing in
health, and we have it wrong. We should be investing in
preventing juvenile diabetes. I do not disagree that we should
be investing heavily in treating it with an artificial
pancreas, but you all have at the NIH $7.2 billion for
prevention research. When I look at diabetes in our country and
you take out type 1, or juvenile diabetes, we know the vast
majority of that is preventable. And yet what we are seeing is
an ever increasing number of people in this country developing
type 2 diabetes, and our approach seems to be to treat the
disease rather than prevent it from ever occurring in the first
place.
As one Senator who is working on global health care reform,
it would certainly seem important to me that we look at our
priorities to make sure we are investing in prevention.
You are familiar with metabolic syndrome. You are familiar
with all the risk factors associated with it. And yet we do not
invest the dollars both in terms of diet, in terms of
education, and in terms of prevention, which is far cheaper
than paying for an artificial pancreas for somebody with type 2
diabetes.
So I think it is very important that you get the message
that we need to be investing in health rather than always
treating disease because we are going to lose. We are never
going to have the dollars to treat the disease if we fail to
invest the dollars in preventing it in the first place.
The second thing, long ago when I was in the optical
business, we worked on research on sorbitol and aqueous humor.
Is there anything going on in that now in terms of continuous
glucose monitoring or sorbitol monitoring in the aqueous humor
that might make a much less invasive glucose-monitoring system?
Dr. Rodgers. We are actually investing and trying to bring
in new talent and new ideas through a variety of strategies.
And, in fact, that area, in actually looking at fluid in the
eye, is one way to optically sort of track glucose, and those
investigations are all in very early phases.
Senator Coburn. For people that are not familiar, we could
actually design a contact lens to put on a child that would
measure the glucose in the anterior chamber of the eye, the
aqueous humor, with a little chip on it that could
automatically communicate to an insulin pump. And so it would
be much less invasive in terms of a device. One of the things
that was not mentioned, especially for your son, is infections.
You are much more prone to infection when you are a diabetic.
And that is because the microvasculature is not there to fight
those infections.
The other question I had on the study with the continuous
glucose monitoring, was that in conjunction with an insulin
pump, or was that in conjunction with individual application of
insulin subcutaneously?
Dr. Rodgers. These were patients who were admitted to a
general clinical research setting, and so in that context, they
were being monitored very carefully, and they were being
treated with an insulin pump.
Senator Coburn. So you did have glucose monitoring with the
insulin pump, but not necessarily monitoring tied to----
Dr. Rodgers. That is right. The loop had not been closed.
Senator Coburn. But when we see that, what we see is that
actually goes and stays in the normal range.
Dr. Rodgers. Absolutely. In fact, you can see in that slide
that despite the fact that there were these wide variations--
particularly in the pre-education period, there were wide
variations--our overall ability to sort of measure what we
think is the average value of control really did not change
demonstrably. It went from 7.2 to 6.8. So we think that these
fluctuations can be almost as important as the average value
over a period of time, and that is why it is critically
important to further research and correlate that with the
specific complications.
Senator Coburn. I would just put out the challenge that
outside of the NIH and outside the CDC, we spend $6.9 billion
on prevention every year in this country through 19 government
agencies. And I think we have it wrong. I mean, if you go out
and ask a typical American, ``Is my being overweight associated
with me developing diabetes?'' Most of them do not make that
connection at all. So, therefore, they do not see an importance
for exercise, weight control, and things such as that.
Madam Chairman, we are going to be working on this next
year to bring bills to the floor that we are going to remodel
the prevention strategy of this country to invest in health and
educate the American people and give them a chance to do that.
I want to say one other thing to Mr. Dudley. One of the
things that is lacking in our country is leadership, and I want
to praise your leadership. You did not have to do what you are
doing, but you chose to do it. And the thing that makes our
country strong, that makes us greater than any other place, is
when individuals stand up and take the lead. They do not wait
on the government to do it. They do not wait on somebody else.
They do not become a victim. What they do is they change and
say, ``I will defeat this by empowering other people.''
And I think what you have done is very laudable. Sure, you
get pats on the back for it, but the fact is that it took real
courage to take this on. It took real finances of your own to
take it on and invest in it. And that is what makes us great.
Your model of leadership should be commended, and I do so
today. I would encourage others. There is not anything that
this country cannot whip if we have great leadership. That is
demonstrated by what you are doing today, so I thank you.
Mr. Dudley. Thank you, and I would like to thank you,
Senators, for your leadership as well in fighting this disease.
Thank you.
Chairman Collins. Thank you. Senator Lautenberg.
OPENING STATEMENT OF SENATOR LAUTENBERG
Senator Lautenberg. Thanks very much, Madam Chairman. I
think this is as important a hearing as we have ever had, and I
commend you for bringing it to our attention to remind us what
happens to lots and lots of people across this country. So I
personally thank you and assume that Mrs. Sweeney's testimony
will wind up in the Congressional Record also so that people
will read and understand what it is like to have a child with
diabetes. We understand love of a child, all of us do. I am a
professional grandfather, and I have 10 grandchildren. The
oldest is 12 and the youngest is three, and what I think about
constantly is thank goodness that they are healthy. I have one
grandchild who has asthma, and we have plenty of allergies, but
nothing like the kinds of things that the Sweeneys go through.
Mr. Dudley, I think you traveled around New Jersey a little
bit in your professional days. We wish you were back there.
[Laughter.]
And I commend each one of you for your testimony. The value
that you bring to the issue is immeasurable. And to know that
we face an epidemic of diabetes, with forecasts of one in three
born in the year 2000 will contract diabetes before their lives
are over, it is a really ominous prediction.
One thing I find, as a grandparent, I instantly fall in
love with little kids, and when you see someone like Aidan, who
suffers from this terrible disease, there is something
fascinating about the faces of those children. They are
especially beautiful, and I see it time and time again because
I meet a lot with families who have a diabetic child and listen
very carefully to their experiences, and I learn things about
not only the pain but the interference in normal life. But
these kids seem to have a special look about them, almost
angelic. And I do not know whether there is just a natural plea
for understanding and help, but they bring it with them. And,
Mrs. Sweeney, your testimony was particularly moving, and we
thank you for being so candid in talking about the experiences
as clearly as you have.
One of the things that I learned when I had a group of
children with diabetes in my office in Newark, New Jersey, I
asked them, ``Well, what is it like? And what are the things
that bother you the most?'' And one child said the pinprick is
the thing that is most bothersome, another said getting ill,
becoming ill in class and having to expose their weakness. But
one little boy, 10 years old, said, ``Well, I cannot go to
sleepovers anymore.'' So I said, ``Well, what do you mean?'' He
said, ``Well, I slept over at a friend's house, and during the
night I got sick. And we woke his mother, and she got mad. And
my parents said I cannot ever go do that anymore.'' And just
something as normal as that is part of the pain and the
frustration.
So I ask you, Dr. Rodgers, can more funds accelerate the
process? Because despite Dr. Coburn's learned view of things,
do you think diverting funds from treatment to research is a
good idea? I think these are all wonderful ideas, but families
who are burdened with this condition are looking for relief as
quickly as it can come. So it is not enough, in my view, to
fund the treatment side instead of the research side; both need
funding. But did you say that you had enough funding to
maintain the quickest pace as thoroughly as you can, or could
you use more?
Dr. Rodgers. Well, Senator, as I mentioned, we are
certainly very appreciative of the funds that we have, and we
really try to deploy those in the best manner, working together
with our other colleagues at the NIH. There is a very broad
portfolio of activity that we try to encompass, not only in
understanding better the basic biology of this disease, the
treatments for people who have the existing disease, but as
Senator Coburn mentioned, also trying to develop ways to
actually prevent the disease.
In the case of type 1 diabetes, we know that there is a
susceptibility, and those studies are the kinds of research
that we would like to certainly do more of. They are long-term
studies--they go out 15 years--in order to understand what
makes someone susceptible to disease, what kind of
environmental factors may contribute to that. And so it is not
a study that you can answer very soon. These long-term studies,
of course, need long-term funding, and we are really committed
to them, and we would certainly like to continue these studies
for the long term because our patients invest in these clinical
trials, and we certainly want to see them through their
fruition.
Senator Lautenberg. Madam Chairman, if I may extend for
just a minute more?
Chairman Collins. Certainly.
Senator Lautenberg. Dr. Rodgers, how do you get data that
are being compiled from commercial--from voluntary
institutions, for example the pharmaceutical industry? What
kind of a flow of data are there that permits you to know what
is happening in the various places and how do you put that all
together?
Dr. Rodgers. There are a couple of avenues in which we get
input on what are really the most cutting-edge activities and
what are very promising areas of exploration. There is a
statutory, mandated Diabetes Mellitus Interagency Coordinating
Committee in which our Institute takes the lead on, and we work
with a number of people from sister agencies within HHS as well
as other Federal agencies, including the VA and so forth. They
bring to our attention cutting-edge research, areas that are
prime for further exploration.
In addition to that, we have an Advisory Council to our
Institute, oftentimes members of academia but also members of
the public, who bring to our attention important developments
and ideas that really are prime for exploration.
And then through frequent meetings that we fund, we bring
in members of the private sector, industry as well, to learn
about where we might invest. In fact, this meeting that we
convened in December 2005, which was entitled ``Closing the
Loop,'' brought in a number of people from industry to discuss
some of the obstacles and opportunities.
And so we get a lot of feedback, and a lot of good ideas
are generated, and then it is a matter of, with consultation
from outside groups and members on our own staff, really trying
to prioritize, given the resources that are available, the best
and most compelling areas of research to explore.
Senator Lautenberg. Madam Chairman, I would ask consent
that my opening statement be included in the record.
Chairman Collins. Without objection.
[The prepared statement of Senator Lautenberg follows:]
PREPARED STATEMENT OF SENATOR LAUTENBERG
Madam Chairman, thank you for your leadership on diabetes--and for
holding today's hearing on the potential for an artificial pancreas.
I have met with some great kids from New Jersey who live with
Juvenile Diabetes. And an artificial pancreas holds great promise for
them.
Twenty-one million Americans have diabetes, according to the CDC.
Children with diabetes are at risk for kidney failure, blindness,
and losing their limbs. And diabetes lowers their life expectancy by 15
years.
In 2002--the most recent year CDC has data for--the total cost for
diabetes care in the United States was more than $132 billion. And even
with all that money spent, we know the current treatments are not good
enough.
Thanks to science and technology, a better treatment is on the
rise.
With an artificial pancreas, kids--and adults--would have their
glucose monitored all day, every day--and the pancreas would send out
insulin when the patient needs it.
It would help a diabetes patient maintain ``normal'' glucose, just
like a pancreas in a person without the disease. It would reduce
diabetes-related illnesses, like kidney disease and stroke. And it
would give patients more freedom--and help them live their life, not
live their disease.
From stem cell research to care for Americans with AIDS, we must
support science anytime it can advance medicine. Today we have that
opportunity. I urge my colleagues to embrace it.
Senator Lautenberg. I would also make another suggestion,
that if we had a film of Mrs. Sweeney's presentation, just as
she did it, I think it would be a wonderful tool in educating
our colleagues about the toll of diabetes and the pain and the
anguish that families are going through. Thank you, Mrs.
Sweeny, and your family and Aidan, for your testimony. Aidan,
in his silence, did more to let us know what life is about than
anything else, and all of you, thank you for your testimony and
your help.
Thank you, Madam Chairman.
Mrs. Sweeney. Thank you, Senator.
Chairman Collins. Thank you, Senator.
Mr. Dudley, I want to echo the praise that Senator Coburn
gave you for your leadership, and that includes your
establishing the summer camp for children who have diabetes.
You had mentioned--and certainly Mrs. Sweeney's testimony
confirms--that so many parents never get a full night's sleep
once their child is diagnosed with diabetes, and your camp
gives them a bit of a respite.
But I think another huge benefit of your camp is it brings
children who all have the same problem together so that they do
not feel that they have got to go to the bathroom and hide when
they are having their blood sugar checked.
Could you talk about that aspect?
Mr. Dudley. Sure, absolutely. When I started the camp 11
years ago, part of it was to help kids with diabetes be able to
play sports and believe that they could achieve whatever it is
they wanted to achieve. And at that time--it has gotten better,
but some doctors were not even encouraging kids to be active.
And now we know that exercise is so important for diabetes. And
so I was really trying to help kids be able to do sports while
having diabetes.
The bigger impact in my mind, which I did not realize when
I first started, was not only helping kids have that dream that
they can achieve whatever it is they want to achieve, but also
it is so important to that age group--my camp is for boys and
girls ages 10 through 17--to not feel alone or different. As
the camper whose letter I read said, he is the only kid in his
town or school that has diabetes, and so often these kids feel
so isolated and so alone that it means so much for them to come
to a camp where not only everybody has diabetes, but they all
love basketball, and they have so much in common. And these
kids stay in touch with each other all throughout the year, and
I think it really gives them hope just to see that they are not
out there alone, that there are a lot of kids walking in the
same shoes. I underestimated how valuable that was when I first
started the camp, and it has been a tremendous blessing to just
help them in their outlook on life.
Chairman Collins. That is great.
Mr. Donald, you mentioned that you had very encouraging
results from the clinical trials at Yale that JDRF is
financing. From your perspective, what are the biggest barriers
that we face in getting these new technologies to the market,
assuming the clinical trials continue to be so positive? Are
the obstacles primarily regulatory or scientific or a matter of
getting insurers to reimburse for that technology? What are the
biggest barriers?
Mr. Donald. There are a number of barriers, regulatory
first. When you deal with a mathematical algorithm which will
connect the continuous glucose sensor to the insulin pump and
basically be an artificial pancreas, there are issues because
they cover so many different aspects of regulatory approval.
Getting all of the various regulatory groups within the FDA to
define what it will take for them to be comfortable to approve
this entire system for use is a challenge.
Now, it is something that FDA is proactive on. They are
working proactively with us and our volunteers, and obviously
with the medical profession as well and NIH and others, to
define for safety reasons as well as efficacy how we are going
to define that, what are the important measures and metrics so
we can assure we can get this in the market quickly.
Then you have access issues. Let's assume this closed loop
actually works, which it will eventually. Now you have the
issue of access for patients, which probably will be a staged
type of thing. We will have some challenges with little guys,
like Aidan, versus big guys, like Chris, just to get the timing
right and to make certain that we process through all that
properly.
But then there is the insurance coverage. There is the cost
associated with that. And then, lastly, there is the medical
professionals themselves getting them up to speed, the
practitioners who are going to recommend these systems for
people.
In the meantime, it is all very positive. The glucose
sensors themselves, as we mentioned, and as you can see from
the charts,\1\ offer a huge advance in terms of reducing the
possibility of complications. They do not eliminate
complications, but they reduce them. And just the fact we are
engaged in this activity collectively, all of us together, is
making a huge positive impact on the quality of life for those
who suffer from the disease.
---------------------------------------------------------------------------
\1\ The charts referred to appear in the Appendix on page 41 and 42
respectively.
---------------------------------------------------------------------------
Chairman Collins. Thank you.
Mr. Donald. Thank you, Senator.
Chairman Collins. Senator Coburn.
Senator Coburn. Mr. Donald, what can we do to streamline
that once you get there?
Mr. Donald. I think there are many things we can do to
streamline it. First of all--and I do have to acknowledge the
FDA, in particular, has been very proactive in organizing under
interim Director von Eschenbach to make certain that they have
defined things well enough so there is no delay as the
technology advances. So that has been very positive.
The second thing we can do is to continue to invest in the
research, and we do need more research dollars. I also agree
with you, Senator, that we need more education dollars, and we
need more general knowledge dollars. We need more of
everything, and there is a fixed pie at some point. But we
definitely need dollars, more research dollars, so that we can
get larger sample bases, find ways to accelerate the research,
and we need some new technologies. One thing that would be a
huge advance in diabetes research are biomarkers or imaging
technology. Today we cannot image the disease. We cannot image
the pancreas and the beta cells. Those would be huge advances.
We are going to do some things to accelerate the number of
people engaged in developing the mathematical algorithms so we
can get more people engaged. And as you know, JDRF is the
largest charitable funder of diabetes research in the world. We
have given over $1 billion over the last 30 years, and we did
$123 million last year, we will do $140 million this year. And
we are looking for ways to leverage the dollars we spend and
that NIH spends and the private companies spend to get more
people engaged in developing these algorithms faster and more
accurately.
Then from the insurance provider standpoint, having the
economic data to demonstrate that by reducing these
complications you are actually reducing medical costs will be
an important metric for them to have so they can go ahead and
include these devices as something that they cover.
So those would be some examples, Senator.
Senator Coburn. I note that when I first came to Congress
in 1995, between now and then diabetes research has increased
250 percent to over $1 billion a year. The thing that concerns
me--and the Chairman will get a tickle out of this--is that
there are limited dollars, and actually the American people do
not know really how severe that is going to be.
We need help from groups like the JDRF to get on the
bandwagon and help us get rid of the $200 billion waste that is
there now (so we can put the dollars where they will do some
good) and take the conflicts of interest out of Congress. If
JDRF, in their lobbying, would lobby just as hard to get rid of
the $200 billion worth of waste, fraud, and abuse we have in
discretionary programs, we would not have trouble spending
another $10 billion or $15 billion a year at NIH, and a good
portion of that on diabetes.
We hear the asking--``We need more money''--but we never
hear the pressure to help us get rid of these terrible
conflicts and this terrible waste that we have. I would just
hope that when you lobby us, you will say, ``Cut some of these
programs out that are not benefiting the country.'' Cut some of
these earmarks like building $2 million garages for museums
that have $50 million in the bank--$2 million could go a long
way on a contact lens measuring the aqueous humor in the eye.
We do not have that kind of debate. My hope is that we will get
everybody engaged as the finances get tighter so that we really
pay attention. We ought to spend the first dollar on the most
important thing to this country, and then it ought to decrease
in terms of priorities rather than doing what the politicians
want to benefit the politicians and not the country.
So my message to you is that I hear you on wanting to send
more money to NIH. Help me and the Chairman get rid of the
waste and fraud so that we will not continue to waste money and
dollars that could make a difference in Aidan's life because we
are doing something politically expedient rather than the right
thing for our country.
Mr. Donald. Well, I assure you, Senator, families like the
Sweeneys and all the families that are in the JDRF family, and
as you know, there are thousands, tens of thousands of them,
the constituencies all across this country of you all--resonate
with the message that we need to spend on the most important
things.
Senator Coburn. Just one last comment, and I have to go.
Mrs. Sweeney, I want to tell you as a doctor--I remember as a
resident at Oklahoma Children's Hospital staying up all night
with kids just like your Aidan, pumping insulin into them,
checking their sugars, keeping their fluids right, measuring
their arterial blood gases, the same thing you went through
doing that. And I also know that the youngest child I have ever
diagnosed with diabetes was 9 months old, and there is not just
a difficulty with you. It also is a difficulty for the
pediatricians. This is a tough thing for them to do as they see
you struggle with it, and they know you are eventually going to
get to the level that you need to get to care for your child
and the disease. But, I would praise the health care
professionals in this country that are doing this because they
are not only treating the disease and the child, they have to
treat the family. And the recognition of that should go out--
the kudos, especially to the pediatric endocrinologists in this
country that do such a fantastic job with this in terms of
supporting it. And my hope is in the future that they do not
have a job. That is my hope.
And I will just end thanking the Chairman again for having
the hearing. I know nobody from the HELP Committee was against
us having this hearing, much like many of my Subcommittee's
hearings. I want to thank you for doing it. I think it is a
subject well worth our discussion and time. Thank you.
Chairman Collins. Thank you, Senator. Senator Lautenberg.
Senator Lautenberg. One of the things that you will learn
in your visits here is that occasionally we have differences of
opinion with one another. My distinguished colleague, Dr.
Coburn, and I sometimes disagree on budgets and things of that
nature, surprising as that may be. And so there is money that
we spend sometimes foolishly. Our budget numbers stagger the
imagination. You folks have got one tough war in front of you.
Fight that war. In my view, you are going to have to depend on
us, all of us, to do the right thing. And when we touch things
like children's diseases, diabetes, AIDS, or asthma--we make a
difference.
So we are not wasting money--we are doing all kinds of
things, and we are spending a lot of money on another war, not
the one that you are engaged in here, but there is another one
that you read about every day when sometimes hundreds of
people, American and otherwise, die each day as a result of
violence. So maybe we can save money there, or maybe we can
save some money in tax write-offs for companies or maybe tax
cuts for wealthy individuals, just to keep a balance.
But I would ask the Sweeneys, was there any history,
anything genetic that would lead to Aidan's illness?
Mrs. Sweeney. No. We both do not have any diabetes on both
sides of our families, so we were completely shocked with this
diagnosis.
Senator Lautenberg. Is there evidence that there is
sometimes a genetic line that comes from families where
diabetes has been discovered?
Dr. Rodgers. The answer to the question is yes, but that is
really the minority of cases.
Senator Lautenberg. I see.
Dr. Rodgers. People do inherit the susceptibility gene that
I mentioned, but not everyone with that susceptibility gene--
and there are quite likely to be other genes--will go on to
develop diabetes, type 1 diabetes. Undoubtedly it has something
to do with the environmental factors and their exposure, for
example, and that is precisely the type of thing that we are
trying to quantitate and get a better handle on.
Senator Lautenberg. Is there a program that is recommended
to lessen the likelihood of a genetic transfer, a propensity
for diabetes?
Dr. Rodgers. No. At the moment, until we really have a
better handle on what these susceptibility genes are and how
they interact with environmental exposures, it is going to be
very difficult for us to make an informed decision.
If it turns out, for example, that one of these
environmental factors is a virus, within the context of someone
who is very susceptible, then immunizing him or her against
that virus would be a very cost-effective way of preventing
diabetes. But, again, those studies really need to be completed
through their fruition before we are able to be able to say
something definitive about that.
Senator Lautenberg. If the artificial pancreas is
developed, is that implanted into the patient or is it an
external device?
Dr. Rodgers. At the moment, the manufacturers and those
developing the technologies are actually looking at both
external devices as well as implantable devices. Both of these
have pros and cons associated with them. In the implantable
devices, at least the early ones that are in development, they
can be implanted, but over time the body develops a reaction to
them, and that reaction can interfere with the efficiency with
which these devices can both sense the glucose level, on the
one hand, and deliver the insulin, on the other hand. So people
are looking to see whether there is a way to interfere with
that process.
The other devices, the external devices, also have their
limitations. They do not measure glucose directly. The current
ones measure glucose that gets into what is called the
interstitial space, and there is a lag period. Part of these
algorithms that Mr. Donald has described, which is really
critically important to finally closing this loop, is to have
mathematical ways of predicting what is happening in real time
based upon what you are able to measure with these optical and
other electrochemical sensors. That is really a critical
limitation of all of these devices.
Senator Lautenberg. Once again, thanks, each one of you,
for your contribution here today. It is very important. We have
great respect for what you do and urge you to carry on. And,
Mrs. Sweeney, we are going to keep on working on this, and I am
sure that one day you will see a product that can make Aidan's
life easier and help him live longer. We promise you that.
Mrs. Sweeney. Thank you very much. And on another note,
Aidan has asthma as well, so I do feel for your grandchild.
Senator Lautenberg. How come he is so beautiful?
[Laughter.]
I think it is parental contribution, husband and wife. You
look like you have come from Central Casting. [Laughter.]
Thank you very much.
Chairman Collins. It is the good Maine air. [Laughter.]
Senator Lautenberg. I believe that, by the way.
Chairman Collins. Thank you, Senator. I know you care
deeply about this issue. We have worked together on juvenile
diabetes projects in the past, and I know we will continue to
do so.
I want to thank all of our witnesses for being here today
and sharing your personal stories, your expertise, and your
unique perspectives. I was hoping we could end before Aidan had
to go for a walk because I was going to encourage him to wave
at the cameras because he loves to wave hello and good-bye. He
is an adorable little boy.
I want to end this hearing on a more upbeat note because it
is hard to hear what you have been through, Mrs. Sweeney, and
what you have been through, Mr. Dudley. But I also am
optimistic. I believe that there are promising new technologies
on the horizon that are going to make such a difference in the
care of children and adults living with diabetes that will ease
the burden somewhat on their families, that will reduce the
likelihood of the serious complications that we know can
otherwise occur. And the support that the Juvenile Diabetes
Research Foundation has given to families with diabetes is just
tremendous, not to mention your extraordinary financial
contributions. And I am very happy to have been your partner in
helping people be more aware of juvenile diabetes and of
diabetes in general.
The NIH is such an essential partner in this fight in
providing the funding for the basic research that then the
private sector and JDRF can build on. So I want to end this
hearing on a note of hope and optimism. Every time--Aidan's
waving in the back there, so I am going to wave, too. Thank
you, Aidan, for being here today. You were great, and you are a
very brave little boy, and we are really happy to have you
here. So thank you.
He is a good waver. [Laughter.]
So I leave this hearing with a renewed, stronger than ever
commitment to the cause, and working together, I am confident
that we can make a difference. We have already made a
difference. In the time since I founded the Diabetes Caucus in
1997, we have, I think, tripled the funding for diabetes
research. That makes a difference. And I am convinced that this
is something where money does make a difference. Research is
expensive, and I just want to assure you of my personal
commitment--and I know it is shared by Senator Lautenberg, by
Senator Coburn, by Senator Coleman, and so many others on this
Committee--to providing the resources that are needed. It is
the least we can do to support you as you go forth and fight
for people with this devastating disease.
I also want to recognize Priscilla Hanley on my staff, who
has worked on this issue for 10 years as my health policy
adviser. It was to Priscilla that I first said, ``Why isn't
there a Diabetes Caucus in the Senate?'' She said, ``Well,
there has always been one in the House, but never in the
Senate.'' And I said, ``Well, Priscilla, it looks like we are
going to have to start one.'' And we did, back in 1997, and I
am very proud of that because I think it has made and is making
a difference.
So thank you for being here today. The hearing record will
remain open for 15 days for additional materials. And to the
Sweeney family in particular, I cannot thank you enough for
sharing your personal story. It really makes a difference as we
advocate for increased funding, better technology, and better
reimbursement policies. So thank you for being here.
Mrs. Sweeney. Thank you, Senator Collins. It was an honor
to be here today.
Chairman Collins. Thank you. This hearing is now adjourned.
[Whereupon, at 11:39 a.m., the Committee was adjourned.]
A P P E N D I X
----------
PREPARED STATEMENT OF SENATOR LIEBERMAN
Chairman Collins, I would like to take a moment to thank you and
your distinguished panel for taking the time to focus your expertise
and the Nation's attention on the scourge of diabetes and the promise
of new treatments for the disease. Every one of us here in this room
knows someone with diabetes and we have taken up the fight against the
disease and its frightening complications on their behalf.
The facts are compelling. Diabetes is a major risk factor for heart
disease and stroke. It is the No. 1 cause of new blindness between the
ages of 20-74 and responsible for 60 percent of none traumatic
amputations. It is the leading cause of end stage renal disease
responsible for over 44 percent of new cases.
But, it's more than the facts. The reality of diabetes in the lives
of millions of children, adults, and elderly is equally compelling. Who
here knows what it is like to prick your fingers four times a day until
they bleed in order to check the body's sugar? Who here knows what it
is like to administer insulin to the body four times a day with a
needle usually stuck right here in the abdomen? And if you get it wrong
and the insulin dose is too low, you feel sluggish. Or if the dose is
too high you get the shakes. You may even seize. Who knows what it is
like to consciously play the role of a vital organ in the body--in this
case the pancreas? This is an awesome responsibility and it
simultaneously amazes me and saddens me that so many Americans must do
this day after day, year after year, simply to survive.
But this hearing is as much about prioritization, resolve, and team
work as it is about new technologies that will prevent the
complications of the chronically high blood sugar levels, which is the
problem in diabetes. The Juvenile Diabetes Research Foundation (JDRF)
right now is building upon the dollars invested by the National
Institute of Diabetes and Digestive and Kidney Diseases' (NIDDK) to
bring together people from industry, the basic science community, those
affected by diabetes, and other stakeholders to tackle the problem of
how to measure body sugar and respond to it with insulin in real time
in the form of a small, convenient, you-don't-even-have-to-think-about-
it machine. In effect, they are trying to create an artificial
pancreas!
Without JDRF's initiatives those in the scientific community and in
industry tend to work in silos. In the Congress, it is cubicles. New
ideas only go as far as the individual or organization can and want to
take them. This works for easy problems. But for complex problems like
diabetes and technology to control diabetes this requires simultaneous
knowledge of biology, physiology, medicine, math, computer programming,
engineering, immunology, pharmacology, endocrinology, and law. Which
individual or organization possesses all of this? How do you build a
fast dependable car if you are only an expert in ignition systems? Or
how do you get access to a better car if the car companies in your town
only sell slow ones?
The answer is getting smart people from across disciplines and
sectors to work together to solve important problems. JDRF is doing
this. And I propose this in my American Center for Cures legislation--a
$5 billion proposal introduced by Senator Cochran (R-Miss.) and myself
last year. CURES establishes a new center in the NIH to develop new
diagnostics, treatments, and even cures to our country's most important
diseases as well as diseases poised for research promise. CURES does
this by leveraging large amounts of money to encourage research
collaboration that tackles diseases like diabetes once and for all.
CURES addresses research and developmental barriers such as reluctance
by the research community to take risks, information hoarding and
industry involvement too late in the research process. It simplifies
and funds large clinical trials and strengthens support of small
innovative businesses critical to the innovation process.
I am excited and encouraged by what you at NIDDK, JDRF, and our
universities are undertaking with families and those affected by
diabetes to push innovation even faster. We in Congress are with you.
We will help you with legislation like CURES that complements your
work. I look forward to hearing your ideas today and promise to work
with you in whatever way I can. Thank you.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
<all>