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88–931 PDF 2003

S. Hrg. 108–151

JUVENILE DIABETES: EXAMINING THE PERSONAL

TOLL ON FAMILIES, FINANCIAL COSTS TO

THE FEDERAL HEALTH CARE SYSTEM, AND

RESEARCH PROGRESS TOWARD A CURE

HEARING

BEFORE THE

COMMITTEE ON 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

JUNE 24, 2003

Printed for the use of the Committee on Governmental Affairs

(

(II)

COMMITTEE ON GOVERNMENTAL AFFAIRS 

SUSAN M. COLLINS, Maine, Chairman 

TED STEVENS, Alaska 

GEORGE V. VOINOVICH, Ohio 

NORM COLEMAN, Minnesota 

ARLEN SPECTER, Pennsylvania 

ROBERT F. BENNETT, Utah 

PETER G. FITZGERALD, Illinois 

JOHN E. SUNUNU, New Hampshire 

RICHARD C. SHELBY, Alabama 

JOSEPH I. LIEBERMAN, Connecticut 

CARL LEVIN, Michigan 

DANIEL K. AKAKA, Hawaii 

RICHARD J. DURBIN, Illinois 

THOMAS R. CARPER, Delaware 

MARK DAYTON, Minnesota 

FRANK LAUTENBERG, New Jersey 

MARK PRYOR, Arkansas 

MICHAEL D. BOPP, Staff Director and Counsel 

PRISCILLA HOBSON HANLEY, Professional Staff Member 

JOYCE A. RECHTSCHAFFEN, Minority Staff Director and Counsel 

JASON M. YANUSSI, Minority Professional Staff Member 

AMY B. NEWHOUSE, Chief Clerk 

(III)

C O N T E N T S 

Opening statements: Page 

Senator Collins ................................................................................................. 1

Senator Pryor .................................................................................................... 3

Senator Lautenberg .......................................................................................... 4

Senator Bennett ................................................................................................ 5

Senator Specter ................................................................................................. 13

Senator Durbin ................................................................................................. 13

Senator Coleman .............................................................................................. 24

Senator Fitzgerald ............................................................................................ 25

Prepared statement: 

Senator Lieberman ........................................................................................... 41

WITNESSES 

TUESDAY, JUNE 24, 2003

Hon. E. Benjamin Nelson, a U.S. Senator from the State of Nebraska .............. 6

Mary Tyler Moore, International Chairman, Juvenile Diabetes Research 

Foundation (JDRF) .............................................................................................. 7

Katie Halasz, Delegate, age 16, JDRF Children’s Congress, Wells, Maine ........ 17

Colleen Rea, on behalf of her son, Dylan Rea, Delegate, age 4, JDRF Children’s Congress, Stamford, Connecticut ............................................................. 18

Sophia Cygnarowicz, Delegate, age 7, JDRF Children’s Congress, Columbia, 

Illinois ................................................................................................................... 19

Eric Bonness, Delegate, age 18, JDRF Children’s Congress, Omaha, Nebraska .................................................................................................................... 20

Alex Bonness, Delegate, age 15, JDRF Children’s Congress, Omaha, Nebraska .................................................................................................................... 21

LaNiece Evans-Scott, Delegate, age 10, JDRF Children’s Congress, Backlick, 

Ohio ....................................................................................................................... 22

Allen M. Spiegel, M.D., Director, National Institute of Diabetes and Digestive 

and Kidney Diseases, National Institutes of Health ......................................... 28

Bernhard J. Hering, M.D., Associate Professor of Surgery, Director of Islet 

Transplantation, University of Minnesota, Minneapolis, MN .......................... 30

Anne Seidel, Islet Cell Transplant Recipient, Dallas, Texas ............................... 33

ALPHABETICAL LIST OF WITNESSES

Bonness, Alex: 

Testimony .......................................................................................................... 21

Prepared statement .......................................................................................... 56

Bonness, Eric: 

Testimony .......................................................................................................... 20

Prepared statement .......................................................................................... 54

Cygnarowicz, Sophia: 

Testimony .......................................................................................................... 19

Prepared statement .......................................................................................... 52

Evans-Scott, LaNiece: 

Testimony .......................................................................................................... 22

Prepared statement .......................................................................................... 58

Halasz, Katie: 

Testimony .......................................................................................................... 17

Prepared statement .......................................................................................... 48

Page

IV

Hering, Bernhard J., M.D.: 

Testimony .......................................................................................................... 30

Prepared statement .......................................................................................... 66

Moore, Mary Tyler: 

Testimony .......................................................................................................... 7

Prepared statement .......................................................................................... 42

Nelson, Hon. E. Benjamin: 

Testimony .......................................................................................................... 6

Rea, Colleen: 

Testimony .......................................................................................................... 18

Prepared statement .......................................................................................... 50

Seidel, Anne: 

Testimony .......................................................................................................... 33

Prepared statement .......................................................................................... 77

Spiegel, Allen M., M.D.: 

Testimony .......................................................................................................... 28

Prepared statement .......................................................................................... 60

APPENDIX

Prepared statement from Alessio Fasano, M.D., Director, Center for Celiac 

Research, University of Maryland, Karoly Horvath, M.D./Ph.D., Co-Medical 

Director Center for Celiac Research, University of Maryland, Carlo Catassi, 

M.D., M.P.H., Co-Medical Director Center for Celiac Research, University 

of Maryland, Stefano Guandalini, M.D., Director, Celiac Disease Program, 

University of Chicago, and Peter H.R. Green, M.D., Director, Celiac Disease 

Center, Columbia University with an attachment ............................................ 79

(1)

JUVENILE DIABETES: EXAMINING THE PERSONAL TOLL ON FAMILIES, FINANCIAL 

COSTS TO THE FEDERAL HEALTH CARE 

SYSTEM, AND RESEARCH PROGRESS TOWARD A CURE 

TUESDAY, JUNE 24, 2003

U.S. SENATE, COMMITTEE ON GOVERNMENTAL AFFAIRS, Washington, DC. 

The Committee met, pursuant to notice, at 10:05 a.m., in room 

SH–216, Hart Senate Office Building, Hon. Susan M. Collins, 

Chairman of the Committee, presiding. 

Present: Senators Collins, Coleman, Specter, Bennett, Fitzgerald, 

Durbin, Lautenberg, and Pryor. 

Also Present: Senator Nelson. 

OPENING STATEMENT OF CHAIRMAN COLLINS 

Chairman COLLINS. The Committee will come to order. 

Good morning. Good morning particularly to all the children who 

have joined us from around the country today. We are so glad to 

have you here. 

As one of the co-Chairs of the Juvenile Diabetes Research Foundation’s 2003 Children’s Congress, I am very pleased this morning 

to hold this hearing to examine the devastating impact that juvenile diabetes has had on American children and their families. In 

addition to hearing about the personal toll that this disease imposes, we will also take a look at the tremendous economic costs 

to our Federal health programs of caring for people with diabetes. 

And, finally, we will discuss the promising breakthroughs in juvenile diabetes research that holds such hope for a cure. Particularly, 

we will examine pancreatic islet cell transplantation. 

The work that I have done in the Senate on behalf of the 17 million Americans with diabetes has been truly rewarding. It has been 

a privilege to work with the families, with the Juvenile Diabetes 

Research Foundation, whose commitment to finding a cure for this 

serious disease is truly inspiring. I want to welcome our distinguished witnesses today, but especially the 188 delegates to the 

Children’s Congress. They have traveled to Washington from every 

State in the Union to tell us what it is like to have diabetes, just 

how serious the disease is, and how important it is that we fund 

the research necessary to find a cure. 

I particularly want to welcome the delegate from my home State 

of Maine, 16-year-old Katie Halasz of Wells. Katie will be testifying 

2

on our second panel this morning, and I am looking forward to her 

testimony. 

As the founder and the co-Chair of the Senate Diabetes Caucus, 

I have learned a great deal about this disease and the difficulties 

and heartbreak that it causes for so many American families as 

they await a cure. Diabetes is a devastating, lifelong condition that 

affects people of every race, every age, and every nationality. It is 

the leading cause of kidney failure, blindness in adults, and amputations not related to injury. 

A study released by the American Diabetes Association earlier 

this year estimates that diabetes cost the Nation $132 billion in 

health care costs last year and that health spending for people with 

diabetes is almost double what it would be if they did not have diabetes. 

When I met with Katie yesterday, she gave me a nice photograph 

album telling about her family and her battle with diabetes. And 

I was amazed when she showed me this picture of just 1 month’s 

supply of the medical devices and syringes and insulin that she 

needs to keep healthy. And she told me that it costs her family 

$2,000 a month for those supplies. That really hit home to me, the 

cost of treating people with diabetes and keeping children like 

Katie healthy. 

The statistics are truly overwhelming, but what really prompted 

me to begin working on this issue was meeting more and more people like our delegates and their families today whose lives have 

been forever changed by diabetes. And that is why I want to say 

to all the children, it is so important that you traveled here to 

Washington today to tell your personal stories. You put the human 

faces on all of these statistics. You are more effective than any 

adult lobbyist could ever be, with the exception of, of course, Mary 

Tyler Moore. [Laughter.] 

You help us focus on what Congress can do to better understand 

and ultimately conquer this terrible disease. And I know that the 

burden of diabetes is particularly heavy for children and young 

adults with type 1 or juvenile diabetes. Juvenile diabetes is the second most common chronic disease affecting children. Moreover, it 

is a disease that you never outgrow. 

In individuals with juvenile diabetes, the body’s immune system 

attacks the pancreas and destroys the islet cells that produce insulin. While the discovery of insulin was a landmark breakthrough 

in the treatment of people with diabetes, it unfortunately is not a 

cure. And people with juvenile diabetes face the constant threat of 

developing life-threatening complications as well as a dramatic reduction in their quality of life. 

But thankfully, there is good news for people with diabetes. We 

have seen some tremendous breakthroughs in recent years in diabetes research, and I am convinced that diabetes is a disease that 

can be cured and will be cured. 

[Applause.] 

All of us have been encouraged by the development of the Edmonton Protocol, an experimental treatment developed at the University of Alberta involving the transplantation of insulin-producing pancreatic islet cells. This protocol has been hailed as the 

3

most important advance in diabetes research since the discovery of 

insulin in 1921. 

Of the 257 patients who have been treated, all have seen a reversal of their life-disabling hypoglycemia and 80 percent have maintained normal glucose levels without insulin shots for more than a 

year. Amazingly, many of the transplant recipients have even reported a reversal in some of their complications, such as improved 

vision and less pain from neuropathy. 

Earlier this year, I joined my colleague from Washington State, 

Senator Patty Murray, as well as my colleague and co-Chair of the 

Senate Diabetes Caucus, Senator Breaux, in introducing the Pancreatic Islet Cell Transplantation Act of 2003. This will help to advance the significant research that holds the promise of a cure for 

more than 1 million Americans with juvenile diabetes. We now 

have 39 Senate cosponsors, and you can help me get even more cosponsors in your visits to Hill offices today. 

Before turning to my colleagues for their opening statements, I 

want to welcome Representative Diana DeGette of Colorado, who 

I believe is here today with her daughter. Diana serves as the coChair, along with George Nethercutt, of the House Diabetes Caucus, and it was the House Diabetes Caucus that motivated Senator 

Breaux and myself to establish the Senate Diabetes Caucus. So I 

want to welcome the Congresswoman and her daughter, Frannie, 

who is a delegate to the Children’s Congress, to the Committee 

hearing today. 

Again, it is wonderful to have all the children here today. I know 

that your slogan is ‘‘Promise to Remember Me.’’ I want to tell you 

that when I see your faces, I know all of us do promise to remember you and to fight for the research funding that will produce a 

cure. 

I would now like to call on my colleague, Senator Pryor, for any 

opening remarks that he might have, and thank you for joining us 

today. 

OPENING STATEMENT OF SENATOR PRYOR 

Senator PRYOR. Thank you, Madam Chairman. 

I want everybody in this room to know what a great national 

leader we have here for your cause. She is doing great work. Fantastic. 

[Applause.] 

I know that the Chairman and I share the sense that this is 

what being in the Senate is all about: Trying to help people out 

there around this country every day face their unique challenges. 

And certainly juvenile diabetes is one of those, and our thoughts 

and our prayers are with you. 

One thing that I want you to know is that we on this Committee 

are very sensitive to your needs and very attentive to what you 

need. And, in fact, as the Chairman set this meeting up, she wants 

to talk about examining the personal toll on families; she wants to 

talk about financial costs to the Federal health care system; and 

she wants to talk about research progress toward a cure. And I tell 

you, she wants to continue her great leadership on this, and she 

is doing a fantastic job. And I just want to welcome everyone here 

to the Senate and to this Committee. And I want to ask the chilVerDate 0ct 09 2002 13:17 Oct 29, 2003 Jkt 088991 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 C:\DOCS\88931.TXT SAFFAIRS PsN: PHOGAN
4

dren: Has this been a good experience for you so far in Washington? Has this been good? Good. 

Well, I hope it is. And it is meaningful and it is important, and 

you all are making a real difference for people that have juvenile 

diabetes all over this country. 

Now, the last thing I need to say before I step aside here is: Who 

is here from Arkansas? That is what I need to know. All right. 

Good. Great. Well, listen, maybe we will get to visit afterwards. 

But thank you for coming to Washington. Your cause is very important. Mary Tyler Moore, thank you for being here. It is always 

an honor to see you, and thank you for your leadership on this. You 

do a great job to bring awareness to this and show great courage 

on this. 

Thank you very much. 

[Applause.] 

Chairman COLLINS. Thank you, Senator Pryor. 

Senator Lautenberg, it is a pleasure to welcome you here this 

morning as well. 

OPENING STATEMENT OF SENATOR LAUTENBERG 

Senator LAUTENBERG. Thank you very much, Madam Chairman, 

and I commend you for holding this hearing today on juvenile diabetes, and I welcome Mary Tyler Moore. We have seen you in so 

many places, but we never get tired of seeing you, and we are particularly pleased to have you here today with this group. 

As the children I am sure know, when they look at me, they see 

a grandfather. Right? OK. Well, I have nine grandchildren, and the 

oldest is 9 and the youngest is 2 months. And I love them dearly, 

and I am always looking for some reassurance about how they feel 

and how they are doing. 

And when I look at you, I feel similarly a love and affection for 

you, and I want you to be healthy, and I want to do whatever we 

can to make sure of that. And our Chairman, Susan Collins from 

Maine, deserves a vote of thanks for the courage that she has displayed, and she and Senator Murray from the State of Washington 

have put together a program to try and get more money to fight 

this disease, to fight juvenile diabetes, to see if we cannot find, if 

not a cure, some significant relief in the process. And it is shocking 

to learn that as many as a million Americans suffer from this devastating disease, and roughly 35 children will be diagnosed with juvenile diabetes each and every day. 

The incidence of diabetes, type 1 and type 2, is on the rise with 

enormous consequences for our society. We talk about the cost, but 

the cost, no matter how many billions, is insignificant compared to 

the discomfort and the danger, the risk that children have when 

they get diabetes. And that is what we are about. That is what we 

are talking about here today. And that is why we are so glad to 

see each and every one of you. 

Madam Chairman, I ask that my full statement be put in the 

record, and I would close with this: That those here, the young people who are going to tell us their story, lend encouragement for our 

government to spend more on research and try to find out what 

causes it and what we can do about it. If I would pick one of the 

wonderful assets, the values of this job of ours, it is that we can 

5

sometimes do absolutely the right thing and try to help people who 

have contracted a disease or who are sick. Now we want to do what 

we can to make sure that we reduce that possibility as much as 

possible. 

And so we send our love and encouragement to all of you, and 

we thank you for being here and for telling us how it is that you 

live your lives. It might help us get more courage and more energy 

about finding enough money to help you. Thank you very much. 

[Applause.] 

Chairman COLLINS. Thank you, Senator. Your full statement will 

be placed in the record. 

[The prepared statement of Senator Lautenberg follows:]

PREPARED STATEMENT OF SENATOR LAUTENBERG 

Madam Chairman, I commend you for holding today’s hearing on Juvenile Diabetes. As many as 1 million Americans suffer from this devastating disease; roughly 

35 children will be diagnosed with Juvenile diabetes each and every day. 

The incidence of Diabetes—type 1 and type 2—is on the rise, with enormous consequences for our society. Diabetes already accounts for more than $132 billion in 

health care costs each year. That number will continue to rise until we can stem 

the tide of new cases and find better treatments. 

I commend Senators Collins and Murray for introducing S. 518, a bill to promote 

pancreatic islet transplants so that the procedure can become standard therapy covered by insurance. Clearly, there is good reason for the people who suffer from Juvenile Diabetes and their families to have hope. 

I would make one observation: This year, Congress is completing the 5-year mission to double funding for the National Institutes of Health (NIH). I was an enthusiastic supporter of that mission before I took my ‘‘sabbatical’’ from the Senate and 

am happy to support it now that I am back. 

The research community has called for an 8–10 percent increase in NIH’s budget 

for next year. But the President just wants a2.7 percent increase—that’s barely 

enough to cover inflation. 

I don’t know how we can tell the witnesses gathered here for this hearing that 

we will have to slow down research. 

But we will have to slow down research. Why? Because the President’s tax cuts 

are causing the budget deficit to explode. 

What NIH, the National Institute for Diabetes and Digestive and Kidney Diseases 

(NIDDK), the National Cancer Institute, and similar groups do is a pretty good example of tax dollars at work finding new treatments, cures, and preventions for all 

types of illnesses and diseases. But we are told that it’s more important to cut taxes. 

President Kennedy said, ‘‘To govern is to choose.’’ I think we ought to choose to 

invest in the research that will help our witnesses live longer and better lives. 

I want to welcome our witnesses, especially Mary Tyler Moore, who needs no introduction, and the brave boys and girls who are going to share their stories about 

what it is like to have Juvenile Diabetes. Thank you, Madam Chairman.

Chairman COLLINS. Senator Bennett, a pleasure to welcome you 

today. 

OPENING STATEMENT OF SENATOR BENNETT 

Senator BENNETT. Thank you very much, Madam Chairman. 

I recall a hearing in this same room with Connie Mack in the 

chair as we began the determination on the part of the Congress 

to double the amount of funding for NIH over a 5-year period. And 

I was part of that effort. There were some in my party who, after 

we had done it for the first year, then the second year said to us, 

‘‘Well, why do we continue to give NIH double-digit increases? Look 

how well they did last year, and we have got serious budget problems. Let’s cut it back to a single-digit increase this year. Look how 

well they have done.’’

6

And we said no, we have to continue on the pattern of doubledigit increases for NIH if we are going to get to the goal of doubling 

medical research over a 5-year period. 

I am happy to say we stayed the course that was set in the hearing in this room under Senator Mack. And we did, in fact, double 

the amount of money going to medical research over that 5-year period. 

So it is appropriate, Madam Chairman, that you are carrying on 

in that tradition that Senator Mack set by now addressing the 

question of the appropriate amount of research focused particularly 

on diabetes. I am happy to report that in the State of Utah, if I 

might get parochial—but that is what we do around here, we have 

at the University of Utah some of the finest research on the issue 

of diabetes going on anywhere in the country. It is tied to the genealogical information that the Church of Jesus Christ of Latter Day 

Saints maintains in Utah, because diabetes has been determined to 

have genetic ties. There is more information in the genealogical library that the church maintains than anyplace else in the world. 

So the people at the University of Utah, some of them have said 

to me, ‘‘I could go anywhere, I have the credentials that I would 

be hired by any research institution anywhere in the world, and I 

have chosen to come to Utah because of the genealogical information that is available, and the leg up that this gives us as we deal 

with diabetes.’’

I have a particular interest in it. My grandfather died of diabetes. So I appreciate very much the leadership that you are showing 

with respect to this hearing. 

[Applause.] 

Chairman COLLINS. Thank you very much, Senator. 

We are also pleased to have with us this morning as an honorary 

member of the Committee for the day Senator Ben Nelson of Nebraska. He is going to be introducing two of our delegates today 

who will be testifying, but I also want to give him the opportunity 

if he would like to make any opening comments. 

OPENING STATEMENT OF HON. E. BENJAMIN NELSON, A U.S. 

SENATOR FROM THE STATE OF NEBRASKA 

Senator NELSON. Well, thank you very much, Madam Chairman, 

and it truly is an honor to be here today under these circumstances, recognizing the importance of the work that is about 

to be done and the work that will have to be done in the future. 

It is my pleasure to be able to introduce the Bonness family on 

the second panel, and so I will have more comments at that time. 

But thank you very much for convening this hearing. The cause is 

important, and the work is equally important. 

Thank you very much. 

[Applause.] 

Chairman COLLINS. Thank you, Senator. 

Our first witness this morning is Mary Tyler Moore. I have a 

feeling that she needs very little introduction. Most Americans 

know her well from her work, her distinguished career on both television and in films and on the stage. But she also plays a very 

special role for everyone in this room because of her remarkably effective advocacy on behalf of individuals with juvenile diabetes. 

7

1The prepared statement of Ms. Moore appears in the Appendix on page 42. 

Ms. Moore serves as the International Chairman of the Juvenile 

Diabetes Research Foundation, and it has been my great pleasure 

to work very closely with her during the last few years. Together, 

we have worked to almost triple funding for diabetes research since 

1996. I know that is making a big difference. It would not have 

been possible without the effective advocacy of Mary Tyler Moore 

and the JDRF. 

So it is a great pleasure to welcome you back to testify today, 

and please proceed with your statement. Welcome. 

[Applause.] 

TESTIMONY OF MARY TYLER MOORE,1 INTERNATIONAL 

CHAIRMAN, JUVENILE DIABETES RESEARCH FOUNDATION 

(JDRF) 

Ms. MOORE. Thank you. Thank you all for that wonderful welcome. Good morning. Before I begin my formal remarks, Senator 

Collins, I would like to personally thank you for your leadership 

and all your efforts on behalf of people with diabetes throughout 

our country, including conducting these hearings and co-Chairing 

with Senator Breaux the Senate Diabetes Caucus. With your continued support, I know we will together find a cure. 

Now, please let me offer the following testimony: 

Chairman Collins and Committee Members and all, I am here 

today as International Chairman of the Juvenile Diabetes Research 

Foundation. I wish I could say that I am happy to be here. But 

meaning no disrespect, I am definitely not. You see, I have had juvenile diabetes for more than 35 years now, and I am tired of it. 

I sincerely wish that I did not have to come back, year after year, 

to seek your help. And I do. I have to for myself, for everyone with 

diabetes, and most especially for the beautiful and courageous children who are here with me today. 

Be certain, at JDRF we have never been more dedicated to finding a cure for diabetes and its complications, and the evidence suggests that we are truly close. Much of the progress that has led us 

to what we hope and believe are the final stages of our fight 

against diabetes is the result of your support and effort. We greatly 

appreciate the good partnership we have always had with Congress 

and every administration since our founding. We are deeply grateful for the extraordinary support you showed last year in passing 

the Special Juvenile Diabetes Program. But as you can see, I am 

here again. Despite all our accomplishments together, we must face 

the fact that there are still significant hurdles that we need to 

overcome to take the last necessary steps along our path to a cure. 

Senators some of you have already met many of the 200 children, 

the delegates to JDRF’s Third Children’s Congress who are here in 

Washington this week. And you will be hearing from some and 

meeting others. You will do that later today. They are passionate 

and eloquent spokespeople for the need for a cure. But don’t be 

misled by their drive, their energy, and their unwavering commitment. They—and I—struggle every minute of every day to do what 

happens naturally for people who don’t have diabetes—that is, to 

achieve a balance between what I eat, the energy I expend, the 

8

amount of insulin I inject. For most of you, blood sugar balance is 

automatic, as automatic as breathing. But for people with juvenile 

diabetes, like me, it requires vigilance 24 hours a day, 7 days a 

week, 365 days a year. 

Each of these children and I need to be a mathematician, a physician, a personal trainer, and a dietitian all rolled into one. We 

need to be constantly factoring and adjusting, making frequent finger sticks to check blood sugar levels, and giving ourselves multiple 

daily insulin injections just to stay alive. Not to live life to its fullest, mind you; just to stay alive. And it isn’t easy. Even with the 

greatest of care and the closest of personal scrutiny, like many children and adults with juvenile diabetes, I find I am often unable to 

achieve good balance. My blood sugars can go dangerously low or 

frighteningly high. Yes, dangerous and frightening, because serious 

lows can lead to seizures, coma, and death. And high blood sugars 

can, over time, result in disabling and life-shortening complications. 

Some of you may already know the startling toll diabetes takes. 

For example, diabetes causes over 40 percent of kidney failures in 

our country that require dialysis or transplantation. It is responsible for more than half of amputations not associated with trauma. 

It is the leading cause of blindness in adults—the leading cause. 

Moreover, I have seen studies that say that virtually everyone with 

juvenile diabetes shows evidence of heart disease by age 40—and, 

further, that the pre-menopausal women with juvenile diabetes 

have a more than 30 times greater risk of death from heart attack. 

Beyond the incomprehensible personal costs, consider the economic burden that our country must bear as a result of this disease. Diabetes costs this Nation over $130 billion every year. This 

includes one out of every four Medicare dollars spent. Taken altogether, it should be crystal clear why it is urgent that we find a 

cure and find it as soon as possible. 

Chairman Collins, you and your colleagues from both sides of the 

aisle have always welcomed us warmly during the past Children’s 

Congresses. In our prior meetings, you have promised to remember 

us when making decisions about funding for juvenile diabetes research. Today, we are happy to acknowledge to all who might listen 

that you are indeed keeping your promise. And we thank you, not 

just as your constituents, but also as your partners in a shared 

mission to find a cure. 

JDRF is working closely with the NIDDK and its Director, Dr. 

Allen Spiegel. Our joint task is to ensure that the dollars provided 

by the Special Juvenile Diabetes Program are used to fund projects 

that otherwise could not be done. And we are confident that these 

projects will focus on what is needed to rapidly acquire missioncritical knowledge, provide essential research resources, and speed 

the application of advances for the benefit of people with juvenile 

diabetes. 

Madam Chairman, Senators, it is vital to remember that because 

children and adults with juvenile diabetes and their families never 

get a rest from their disease, we never rest in our efforts to find 

and deliver a cure. And because JDRF is a global cure enterprise, 

we are always looking beyond the horizon to anticipate what must 

be done next to achieve our ultimate goal—a world without juvenile 

9

diabetes. Our approach has consistently focused on what is next. 

And let me give you an example, looking at our four steps we have 

taken to get to the point where we are today in islet transplantation. 

Step one: In the mid-1990’s, JDRF created a map of all that is 

known about diabetes and identified the knowledge gaps and obstacles to progress along the various paths to a cure. We use this continuously updated map to guide us in efforts to push scientific 

advances from the laboratory bench to the patient’s bedside. 

Step two: This research mapping made it clear that islet cell 

transplantation was a potential cure. So we are invested in creating a global network of research centers to prepare and distribute 

human islets for basic and clinical research. 

Step three: As it became clear that research centers throughout 

the world were now able to test islet cell transplantation, JDRF 

substantially boosted our investments in research to find a way to 

transplant these islets without the need for toxic immunosuppressive drugs. 

Step four: In 2000, when Dr. James Shapiro’s group in Edmonton 

reported the first major critical success in islet transplantation, 

JDRF jumped to overcome the next obstacle confronting transplant 

research, and that is the inadequate supply of islets. So to create 

an unlimited supply of islet cells for transplantation, we are leading a global effort to support stem cell research. This is particularly 

necessary because each year, there are fewer than 2,000 cadaver 

pancreases donated. Yet well over 1 million Americans with juvenile diabetes could potentially benefit from islet cell transplantation. 

Overall, we have made terrific progress. But we do continue to 

look into the future and ask ourselves, ‘‘What is next?’’ And here 

is what we believe must be next, to speed a cure for diabetes. 

First, we need policies and regulations that encourage organ donations and promote the retrieval of additional human pancreases. 

As I said, supply is a major obstacle to making islet transplantation a cure for all those with diabetes who might benefit. I am 

grateful for the real leadership and vision that you have shown by 

introducing the Pancreatic Islet Cell Transplantation Act of 2003. 

This bill, which JDRF supports, will provide regulatory incentives 

for organ procurement organizations to retrieve additional pancreases. It will also test, within Medicare, insurance coverage for 

islet transplants for people with juvenile diabetes and kidney failure. I am hopeful that Congress will pass the legislation this year, 

and we are eager to work with you in achieving this goal. 

Second, we need to work with the Senate and the President to 

do things necessary to speed progress in stem cell research and to 

provide ample opportunity for this research to accomplish our 

shared goal: Finding ways to relieve the suffering of millions of 

Americans. Even with increased organ procurement, we will ultimately still face a critical shortage of islet cells for transplantation. 

To meet this demand, I believe we need to ensure that the United 

States can take its proper place in the world as a leader in stem 

cell research and the development of human stem cell-derived 

therapies, including the creation of human islets for transplantation. 

10

But, Madam Chairman, right now, due to the restrictions of the 

current administration policy, this is just not happening. I know 

the President worked hard to find a balance in his policy. He clearly recognized the great potential of stem cell-derived therapies to 

reduce pain and suffering of millions of people with many diseases, 

including juvenile diabetes. And in my heart, I know that he intended to make it easier, not more difficult, to create therapies to 

treat human disease. But now, nearly 2 years after his August 9, 

2001, decision, researchers tell us that the progress being made in 

stem cell research is not as far along as it could be. The number 

of cell lines everyone had hoped for—there were supposed to be 

more than 60—turns out to be closer to 10. Of these lines, only a 

few are widely available for research. Perhaps more important, of 

those approved lines, none can be used to develop human therapies. That is right—none. The problem is that each of those cell 

lines were established using mouse feeder cells, and the threat of 

contamination makes them unsuitable for human therapies. 

Further, because of the current circumstances, the best and 

brightest of young researchers in the United States are shying 

away from the field of human stem cell research. So not only do 

we have an insufficient number of cell lines to conduct the necessary research, we have a potentially more devastating deficiency 

of brain power. 

Again, I am confident this was not the outcome the President intended. His staff, Secretary Thompson, and Dr. Zerhouni are all 

doing what they can within the current constraints. And we are 

pleased to be working closely with them. But at the end of the day, 

without some change, we may not be able to achieve our shared 

goals: Finding cures for juvenile diabetes and other disabling diseases as soon as possible. 

Third, we need to continue to invest in developing methods to replace human islets without immunosuppression. Just 3 years after 

the reported success of the Edmonton Protocol, more than 250 people have undergone islet transplantation and no longer need insulin injections to survive. But the procedure is not yet safe for children and most people with diabetes. So we must sharpen our research to focus on transplantation without toxic immunosuppression, as well as redoubling our efforts to prevent diabetes 

and reverse or prevent its devastating complications. 

Finally, because we want a cure for everyone with juvenile diabetes, including the children here today, we need to establish a 

framework for research oversight which ensures that the needed 

clinical studies are safe for the participation of children. 

Madam Chairman, diabetes is an all-too-personal time bomb 

which can go off today, tomorrow, next year, or 10 years from now. 

A time bomb that affects millions, including me and the children 

here today. It needs to be defused. But to find a cure for diabetes 

and its complications, and then make these cures available to everyone who might benefit, will require that we remain vigilant in 

our purpose and continuously committed to asking, answering, and 

acting upon the ‘‘What next?’’ question. 

So what is next for you? Please listen to the children this morning, who will tell you how they struggle with juvenile diabetes. 

Learn about how they bravely face its daily challenges—challenges 

11

that no 15-year-old or 8-year-old or 2-year-old should have to endure. Feel their longing to know a day without diabetes and live 

the normal, carefree life of a child. Listen to the researchers as 

they highlight the progress made to date and the exciting opportunities we can now realize because of JDRF and NIH leadership and 

the extraordinary investment Congress has made in medical research. And hear firsthand from an islet transplant recipient about 

how spectacularly her life has changed since her procedure and 

how she will not rest until her young son, who also suffers from 

juvenile diabetes, can be cured. 

Finally, please join me in making a personal promise to remember what we have learned today. Ask ourselves: What must we do 

next? And then commit together to do what we must to find a cure. 

Thank you once again for all you have done and for the opportunity to speak with you this morning. 

[Applause.] 

I cannot tell you how touched I am by that reception. Thank you. 

Chairman COLLINS. Well, thank you for your testimony. I think 

every member of this panel joins everyone in this room in remarking on your eloquence in telling your own personal story as well as 

your advocacy. Your willingness to share your personal story as 

well as your leadership at the Juvenile Diabetes Research Foundation makes a real difference. It inspires each and every one of us. 

As you spoke, I could not help but remember the first time I met 

a family whose son had diabetes from my home State of Maine, 

and the little 10-year-old boy looked up at me, and he said, ‘‘I just 

wish that I could take one day off from my diabetes.’’ And that is 

when I knew that I had to get involved. So thank you for presenting your story. 

I am going to limit questions on this round so that we can hear 

from the children, so let me just ask you one question. 

Two years ago, you came to Congress to testify at the Children’s 

Congress. Are you more hopeful today as a result of the investment 

in research and the medical advances that we have seen that we 

are on the verge of providing a cure and better treatment for people with diabetes? 

Ms. MOORE. Senator Collins, I most definitely am more enthusiastic and stronger in my belief that a cure is, figuratively, around 

the corner. It cannot come soon enough for all of us, I know that, 

but especially because of the promise of stem cell research. I think 

that is the big hope. I think that it will make a huge difference to 

the people who suffer from all kinds of diseases. And won’t it be 

lovely to have all that money that we don’t have to spend taking 

care of people with horrible illnesses and can spend it on things 

that make us a better, healthier, happier Nation. 

Chairman COLLINS. Thank you. 

[Applause.] 

Senator Pryor. 

Senator PRYOR. Thank you. I know that you are more encouraged 

today than you have ever been, but what do you see as the largest 

obstacle to finding a cure today? 

Ms. MOORE. I think any roadblock that is thrown in the way of 

the good scientists who are working to find the cure. I think fear 

is a major obstacle. And from good guidance sometimes we recogVerDate 0ct 09 2002 13:17 Oct 29, 2003 Jkt 088991 PO 00000 Frm 00015 Fmt 6633 Sfmt 6601 C:\DOCS\88931.TXT SAFFAIRS PsN: PHOGAN
12

nize fear and have to put it in its place and take the chance and 

move forward. 

Senator PRYOR. Are you comfortable with the funding levels that 

NIH and others are providing for the research going on right now? 

Ms. MOORE. We are very grateful for all the advances made possible by the government and by private donors who have done 

whatever they can to bring this to the attention of government and 

the people. 

Senator PRYOR. I am not as familiar with the islet cell transplantation like the Chairman is here. Do I understand that there are 

some people who are very good candidates for that and others that 

maybe are not so good? Could you educate me on that very briefly? 

Ms. MOORE. Well, mostly it is children who are not good candidates for it right now. That may change, but in all, the overwhelming lack of islet cells is the major problem. There are over 

a million people who could benefit from a pancreatic islet cell 

transplant, but they cannot because there are not enough of them. 

There just are not enough, and it costs too much. It is approximately $100,000 per operation. And the immunosuppressants that 

one must take in order to receive and make functioning the islet 

cells are a tough thing to live with. Very tough. 

Senator PRYOR. Right. Thank you again for being here today. 

Ms. MOORE. Thank you. 

Chairman COLLINS. Thank you, Senator. Senator Bennett. 

Senator BENNETT. Thank you, Madam Chairman. I have nothing 

to add. 

Chairman COLLINS. Thank you. Senator Lautenberg. 

Senator LAUTENBERG. Thank you, Madam Chairman, for holding 

this hearing. We can sense from the reaction of people here whose 

lives are affected by juvenile diabetes a sense of interest and encouragement and even gratitude for what has happened. We thank 

Mary Tyler Moore for her eloquent statement and for information 

that frankly those of us—and I include myself in this—who have 

been spared contact, direct contact with juvenile diabetes fail at 

times to understand the impact of this disease. When you talk 

about a child in a lifetime having 50,000 injections prospectively, 

it is a painful prospect. And if we could wave a magic wand, we 

certainly would do it. 

I would ask you this, Ms. Moore: What do you think we can do 

on a relatively immediate basis to speed up the process for the development of islet and other technologies that we know something 

about? 

Ms. MOORE. I think continue to fund the research, just get in 

back of us 100 percent, support stem cell research in particular. 

Senator LAUTENBERG. How about the expansion of stem cell 

availability? Would that make a big difference, do you think? 

Ms. MOORE. The expense of stem cell——

Senator LAUTENBERG. Expanse. 

Ms. MOORE. Expanse. It is possible. It is there to be done. But 

we need the permission from our President to advance, to do the 

things that they are doing in other countries. 

Senator LAUTENBERG. That would give a lot of encouragement to 

people, wouldn’t it? 

Ms. MOORE. It certainly would. 

13

Senator LAUTENBERG. Thank you very much. 

Ms. MOORE. Thank you. 

[Applause.] 

Chairman COLLINS. Senator Specter. 

OPENING STATEMENT OF SENATOR SPECTER 

Senator SPECTER. Thank you very much, Madam Chairman, and 

thank you for convening this hearing. And thank you, Ms. Moore, 

for your leadership for many years on this important subject. You 

have appeared in this room on a number of occasions testifying before the Subcommittee on Labor, Health and Human Services, and 

Education. And as a result of your efforts and the efforts of others, 

the funding in the National Institutes of Health has been raised for 

the National Institutes on Diabetes and Digestive and Kidney Diseases to $1.633 billion, and the total diabetes funding is at $845 

million. That is as a result of the increases on NIH funding from 

$12 billion to $27.5 billion in the past several years. 

The issue of fear which you commented on and the question 

raised by Senator Lautenberg on stem cell research is a very important one, and the reality is that the hands of the scientists are 

being tied or at least efforts are being made to tie their hands, and 

there is a lot of concern and a lack of initiative in the scientific 

community because of legislation passed by the House of Representatives which criminalizes research on stem cells, which some 

people have characterized as ‘‘therapeutic cloning.’’

That is a term which raises a lot of emotion, erroneously. We are 

all against human cloning. But when you talk about therapeutic 

cloning, it is really not true. The essential medical procedure is 

that an egg is donated, the core is taken out, and then if a woman, 

for example, has Parkinson’s or Alzheimer’s or juvenile diabetes, a 

skin sampling is taken, placed in the core. It is kept in a laboratory 

dish, and those stem cells then are consistent to be used for that 

patient. 

The entity dies within 14 days so there is nothing cloning about 

it at all. 

Ms. MOORE. Right. 

Senator SPECTER. And I believe that it is important to use every 

opportunity to acquaint Americans that about 128 million are suffering from one of these maladies which might be curable by additional stem cell research. And juvenile diabetes is among them. 

So thank you for all that you have done, and I thank all of you 

for coming to this proceeding today, especially the children, and 

there are many others on Capitol Hill who are dedicated to scientific research additional funding and to finding a cure for juvenile diabetes and other dreaded maladies. 

Thank you, Madam Chairman. 

Ms. MOORE. Senator, we thank you. 

[Applause.] 

Chairman COLLINS. Senator Durbin. 

OPENING STATEMENT OF SENATOR DURBIN 

Senator DURBIN. Thank you very much, Madam Chairman, and 

thank you, Mary Tyler Moore, for what you have done and for your 

leadership, and thanks to all of your young supporters here who 

14

are starting to move a little bit here. They want the Senators to 

get moving with the questions. 

I want to refer to one aspect of this. Another one of my ‘‘sheroes’’ 

in life is a lady named Connie Payton from Chicago, whose late 

husband, Walter Payton, really made a plea toward the end of his 

life for organ donation. And she has continued in that fine work, 

and we have engaged the National Football League to make this 

part of their public service. And we have focused on Thanksgiving, 

the great national holiday, to encourage families when they come 

together to spend just a few moments with one another and let 

other members of the family know if you want to be an organ 

donor. 

It seems to be one of the major obstacles for organ donation, that 

the family members don’t know what you feel in your heart about 

organ donation. And as I read these amazing statistics which you 

have brought to us about how—and, in fact, you need really two 

donors, do you not? 

Ms. MOORE. Yes. 

Senator DURBIN. For the pancreata that is necessary for this new 

approach. It really dramatizes the enormous demand and need for 

organ donors in our country as part of this effort. 

And if the Chairman will give me a moment here, I would just 

like to do a little show of hands here, and the children are exempt 

from this vote. They are used to raising their hands in classrooms. 

But this is for all of the adults in the room, Senators and staff and 

audience. How many people in this room have communicated to 

members of their family that they would be organ donors or have 

signed a organ donation card? Good. This is an audience that is not 

typical of America because you understand this. And I hope that 

this hearing, among other things, spreads the word across America. 

We need more organ donors for so many good reasons and for these 

children. And I hope, Madam Chairman, that is a message that we 

send from this hearing as well. 

Thank you very much. 

[Applause.] 

Ms. MOORE. Thank you so much, Senator. 

Chairman COLLINS. I want to thank you very much for testifying 

today. Senator Nelson is going to start off with the introduction of 

our next panel when I bring them up here. Thank you so much, 

Ms. Moore, for all that you are doing. Because of your eloquent testimony and your leadership and advocacy year after year, we have 

been able to make a real difference in funding research for diabetes. And I know we are going to continue our great partnership, so 

thank you so much for being here today. 

Ms. MOORE. Thank you, Madam Chairman. 

[Applause.] 

Chairman COLLINS. I would now like to call forward the children’s panel. Our second panel of witnesses this morning consists 

of children who know firsthand the burden of living with diabetes. 

Our witnesses on this panel are Colleen Rea of Stamford, Connecticut, accompanied by her son, Dylan; Sophia Cygnarowicz of 

Columbia, Illinois, whom Senator Durbin may wish to introduce; 

Katie Halasz of Wells, Maine; Eric and Alex Bonness of Omaha, 

Nebraska; and LaNiece Evans-Scott of Backlick, Ohio. And we are 

15

just delighted to have those children with us. They are all delegates to the Children’s Congress, and we are going to start by having Senator Nelson introduce the Bonness children. 

Senator NELSON. Well, thank you very much, Madam Chairman. 

It really is an honor for me to be here today to introduce some fellow Nebraskans. I would like to thank you, Madam Chairman, for 

not only this opportunity but for your leadership. It is very clear 

that your commitment is making progress possible, and we all 

thank you very much. I know all the families who have been 

touched by this disease appreciate what you are doing, and we 

hope that as a result of this hearing today we will be able to advance the efforts toward a cure. 

I would like to start off this morning, before I introduce the two 

delegates, by introducing a gentleman who is well known in Nebraska, not simply as a former football player, all-American at Nebraska, and an NFL player, coached by one of our colleagues in the 

House, former coach but now Representative Tom Osborne, but a 

person who has taken this cause not only seriously but to the far 

reaches of our country to make sure that we are all aware. He has 

advanced the recognition of this disease. He has advanced the efforts to make sure that we are all working every way that we can 

to help this cause. 

Today, he joins us as the Chair-dad of the Children’s Congress, 

and I could list all the accomplishments on the gridiron and in the 

courtroom as a lawyer. But I just simply want to say to Eric 

Bonness, thank you very much, and please be recognized this 

morning. 

[Applause.] 

He is joined by a very able partner. Dr. Bonness, it is good to 

have you here as well. 

[Applause.] 

As we all turn our attention to the two young representatives, 

the two young delegates here, I think that I can speak on behalf 

of their parents and all of us who would say that with all the recognition and all the accomplishments of their parents, their parents and we all hope that they will be able to exceed those accomplishments in their lives ahead. I speak, of course, today of Alex 

and Eric Bonness. They are two of our Nebraska delegates and two 

of Nebraska’s finest young people. Both are extraordinary young 

men. They were diagnosed with type 1 juvenile diabetes before they 

entered their teens. Eric was diagnosed when he was 10, and Alex, 

although he is the younger brother, he is the elder when it comes 

to living with his disease because he was diagnosed when he was 

only 4. 

But for every day since those fateful days that they were diagnosed, these two have measured their blood sugar, taken medication, and, in general, have had to monitor their health in ways that 

most adults could not imagine, certainly with the level of care that 

few could match. But they, like so many others like them, have 

done this day in and day out because they simply have to. 

I will let them fill you in on what this entails for them, but I am 

sure my words could never match theirs. I do want to say, though, 

that the kind of courage that they have shown from the time they 

were young children in dealing with this disease has to be an inspiVerDate 0ct 09 2002 13:17 Oct 29, 2003 Jkt 088991 PO 00000 Frm 00019 Fmt 6633 Sfmt 6601 C:\DOCS\88931.TXT SAFFAIRS PsN: PHOGAN
16

ration for all of us, and it has to be encouragement for all of us 

to do everything that we can, as adults, as Members of the Congress, and as human beings. 

That inspiration should lead us to work with the Juvenile Diabetes Research Foundation in finding a cure for diabetes so that Alex 

and Eric and all the young people in this room and all the young 

people out there who live with this disease every day will not have 

to live with it any longer. That is what our hope is all about today. 

That is what our dedication must bring. And I only hope that these 

young men who come to us today, who have had to learn words like 

‘‘glaucoma,’’ ‘‘retinal scans,’’ and ‘‘diagnostics,’’ when they should 

have only had to learn about their favorite action figures or video 

games, they have met the challenges of juvenile diabetes, and we 

need to join them in the challenge of finding a cure. 

So it is an honor for me today to host Eric and Alex and their 

family, as well as Nebraska’s other two delegates who are in town 

but will not be testifying, Megan Stewart and Alyxandria Harter. 

It is my pleasure to present Eric and Alex Bonness. 

[Applause.] 

Chairman COLLINS. Senator Durbin. 

Senator DURBIN. Thank you very much, Madam Chairman. 

There are a number of Illinois children delegates here, and if they 

would either raise their hand or stand up, and I am going to introduce Sophia at the end here: Sean Bottorff from St. Charles, there 

he is; Alexandra Case of Chicago; Kevin Covarrubias of Maryville; 

Devan D’Silva, Arlington Heights; Michael Johnson of Evanston; 

and Abigail Wolter of Alton. Thank you. 

And the person I would like to especially introduce has just successfully completed the first grade. She is here today from Columbia, Illinois. Sophia Cygnarowicz is here to tell us a little about her 

experience with juvenile diabetes. She said she would like to know 

what life is like without diabetes, and she would like to eat SnoCones whenever she wants. [Laughter.] 

We are looking forward to her testimony. Thank you, Madam 

Chairman. 

[Applause.] 

Chairman COLLINS. Thank you. Senator Lautenberg. 

Senator LAUTENBERG. Thank you, Madam Chairman. I want to 

call attention to the wonderful young people who have come from 

New Jersey. They don’t have as long a trip geographically as some 

of the others, but their trip to getting here is the same perilous 

journey. And we want to say hello, and I will ask the same thing, 

that a hand be raised for Jessica Barszcz—Jessica, are you here? 

Yes, OK. Welcome. Kyle Gertner. Emily Greatrex. Is Emily here? 

Oh, a beautiful child from New Jersey. Lindsey Rosenthal. Hi, 

Lindsey. And Carey Towell. Carey, hi. Well, we are happy to see 

these youngsters and tell them that we are going to work hard to 

see that life gets better for them and their friends as well. 

Thank you. 

Chairman COLLINS. Thank you. 

We are going to start with Katie Halasz today because she is 

from my home State and I am the Chairman. [Laughter.] 

I got to meet Katie and her Mom yesterday in my office, and she 

gave me a photograph album illustrating what it has been like for 

17

1The prepared statement of Ms. Halasz appears in the Appendix on page 48. 

her since she was diagnosed. She is 16 years old. She is from Wells, 

Maine. This photograph album is just wonderful. It tells about 

what she felt. It shows what she has to do each day to monitor her 

blood and to give herself insulin. It was very helpful, and I really 

treasure it. 

So, Katie, please begin. Bring the mike up close to you so we can 

hear you. Thank you. 

TESTIMONY OF KATIE HALASZ,1 DELEGATE, AGE 16, JDRF 

CHILDREN’S CONGRESS, WELLS, MAINE 

Ms. HALASZ. Unlike Dylan and Sophia, I do know what it is like 

to live without diabetes. I dream of another day without diabetes. 

My name is Katie Halasz. I am 16 years old and from Wells, 

Maine. I want to tell you how my life changed on June 12, 1999, 

at 11 p.m. when I was diagnosed with juvenile diabetes. 

At first, I did not know what diabetes was. The doctor told me 

I would have to take insulin shots the rest of my life. I did not 

think that diabetes would change my life that much, but, boy, was 

I wrong. I have to test my blood sugar and take shots all the time. 

It affects everything I do, even being part of the color guard for the 

school band is a challenge. My blood sugars often go high and result in ketones, which is poison in my body, and it can be really 

dangerous. When you get ketones, you cannot do any exercise. It 

is very hard on my team and on me when I cannot march. 

School is a lot harder when you have diabetes. My school does 

not allow me to test my blood in the classroom. My classes are on 

the third floor, and the nurse’s office is on the first floor. When I 

feel low, I have to walk down three flights of stairs, and this is very 

dangerous. Some of my teachers think that I leave the classroom 

just to get out of class. Do they think I enjoy sticking a needle in 

my finger? When my blood sugars are high, I cannot concentrate 

on my work and my vision gets blurred. My teachers do not understand. Some of them even think it is my fault that my sugars go 

high because they think that I eat things like candy bars. They do 

not understand that my sugars can go up for no apparent reason. 

Educating my teachers has been my biggest challenge since being 

diagnosed with diabetes. 

Having diabetes complicates more than just school. Last year I 

had a cyst underneath my arm. It became infected. I went to see 

a surgeon once a month to have the area opened so it could be 

drained. My sugars were always high because of the infection, and 

the area would not heal because of the high sugars. Finally, I had 

to have surgery to remove the cyst. The doctors had to remove half 

the tissue from my underarm. 

Senator Collins and Members of this Committee, we are here 

today to ask for your help in finding a cure for juvenile diabetes. 

Each of us wants to be able to go to school, play in the band or 

on sports teams, without worrying about going into a coma because 

of low blood sugars. Each of us wants to grow up without the daily 

stress of trying to treat this horrible disease and the fear of complications. We will do our part to educate policymakers about diaVerDate 0ct 09 2002 13:17 Oct 29, 2003 Jkt 088991 PO 00000 Frm 00021 Fmt 6633 Sfmt 6601 C:\DOCS\88931.TXT SAFFAIRS PsN: PHOGAN
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1The prepared statement of Ms. Rea appears in the Appendix on page 50. 

betes and raise money to support research. But we need you to be 

our partner in this effort. We cannot do it alone. 

Senator Collins, I am glad and grateful you are my Senator. You 

have shown incredible dedication and leadership in our common 

quest for a cure. Thank you from the bottom of my heart. 

[Applause.] 

Chairman COLLINS. Thank you, Katie. You did a great job. 

We are now going to hear from Dylan Rea, but we are actually 

going to hear from his mother, Colleen, since Dylan is age 4. So, 

Colleen, would you please proceed? 

TESTIMONY OF COLLEEN REA, ON BEHALF OF HER SON, 

DYLAN REA,1 DELEGATE, AGE 4, JDRF CHILDREN’S CONGRESS, STAMFORD, CONNECTICUT 

Ms. REA. Good morning. My name is Colleen Rea, and I am from 

Stamford, Connecticut, and it is an honor to appear before you 

today with my 4-year-old son Dylan. Dylan and I are here today, 

along with all of these children, to tell you why finding a cure for 

juvenile diabetes is so important. You see, I know all too well about 

the devastation of diabetes. Diabetes has followed me and haunted 

me my entire life for three generations of my family. 

When I was a child, I found glass syringes in my house and was 

told that my grandfather, who died before I was born, had diabetes. 

When I was a young woman, my mother called and asked me to 

meet her at a hospital emergency room. My mother was being admitted for the first time because of her diabetes. When I saw her, 

she was scared. Within 10 years and many hospital stays and operations later, I was told that my mother was dying. It took only 10 

years for diabetes to kill my mother. 

When my son Dylan was diagnosed with type 1 diabetes, or juvenile diabetes, at the age of 14 months old—less than 2 years after 

my mother had died—I was devastated. It was almost more than 

I could bear. I knew what diabetes had done to my grandfather, 

and I had seen what diabetes did to my mother. 

We are very diligent in trying to care for Dylan’s diabetes. But 

controlling blood sugar levels in a toddler is impossible because 

there are so many variables. There are always times when Dylan’s 

blood sugar is dangerously high or frighteningly low, sometimes in 

the same day. He wears an insulin pump 24 hours a day, and we 

check his blood sugar at least eight times a day. And there are precious few people who are able to babysit him. My husband and I 

must be available 24 hours a day, 7 days a week. Diabetes never 

takes a break, and neither can we. We are Dylan’s pancreas. 

While we are concerned about Dylan’s physical health, we also 

worry about his emotional health. Dylan may grow up to live a long 

life, have a great and fulfilling career, and a wife and children of 

his own someday. But we know that in our hearts, despite our best 

efforts, he may be denied all of that. Either way, he has this day 

and this childhood, and I want it to be wonderful. 

We walk a tightrope in caring for Dylan, to help our child feel 

love and joy when we continually assault his body with needles and 

lancets. We give our child hope and faith in the face of fear and 

19

1The prepared statement of Miss Cygnarowicz appears in the Appendix on page 52. 

disease. We tell Dylan he is healthy but needs medicine every day, 

all day, to survive. 

I know that a cure is possible and within our reach. I hope that 

it will be found soon so that Dylan and all of these children will 

live a long and fulfilling life. This is my greatest wish and why we 

are here today to ask for your help and support in our quest for 

a cure. 

Say thank you. 

Master REA. Thank you. 

[Laughter/applause.] 

Chairman COLLINS. Good job, Dylan. That was great. 

Thank you very much, Colleen, for your very moving testimony. 

We are in the middle of two roll call votes, so I am going to have 

Sophia testify, and then we are going to have a 15-minute recess 

before we come back and hear from Eric and Alex and LaNiece. 

Sorry about that. We cannot control the schedule. 

Sophia, could you give your statement to us? 

TESTIMONY OF SOPHIA CYGNAROWICZ,1 DELEGATE, AGE 7, 

JDRF CHILDREN’S CONGRESS, COLUMBIA, ILLINOIS 

Miss CYGNAROWICZ. Hi. My name is Sophia, and like my friend 

Dylan, I don’t know what life is like to have a day without diabetes. I am 7 years old. I have had diabetes since I was one. 

I have taken 4,380 shots of insulin and have pricked my finger 

over 13,000 times to test my blood sugar. I don’t like it. It hurts. 

It is so hard to keep my blood sugar in a good range. No matter 

how hard I try, I still go low and high. 

Low blood sugars make me very tired and cranky. I need to eat 

but a lot of times I don’t want to. Sometimes I wake up in the middle of the night because I go low. My Mom and Dad will feed me 

and test my blood sugar to make sure I will be OK before I go back 

to sleep. 

I just finished first grade. It is hard going to school when you 

have diabetes. We did cooking projects and had lots of parties. I 

watched all the other kids eat cookies and cake. I couldn’t eat 

them, and that wasn’t fair. When I feel low at school, I can’t think 

well. My teacher gives me sugar tablets, and I walk down to the 

nurse’s office to do a blood sugar test. A friend comes with me to 

make sure I get there OK. Then I have juice and crackers. It takes 

me a while before I get better. I don’t like to miss class. 

Summer is lots of fun, but not when I go out and can’t stay outside and play with my friends. I have to eat at the same time every 

day so my blood sugar won’t go too low. I have to eat even when 

I am not hungry. 

I don’t know what life is like without diabetes, but I sure would 

like to find out. Finding a cure is important to me because I won’t 

have to take shots or do blood tests. Most of all, I could eat a SnoCone whenever I wanted to. My friends in this room and I aren’t 

asking for much. We just want a life without diabetes. 

[Applause.] 

20

2The prepared statement of Mr. Eric Bonness appears in the Appendix on page 54. 

Chairman COLLINS. Thank you, Sophia. You did a wonderful job 

talking to us and helping us understand what it has been like for 

you to live with diabetes, so thank you for a great job. 

We are now going to have to recess for 15 minutes, and then we 

will come back and hear from the three remaining children. Thank 

you. 

[Applause.] 

[Recess.] 

Chairman COLLINS. The hearing will come to order. 

I am very pleased now to recognize Eric Bonness for his testimony. Eric and his brother Alex are going to be testifying next. 

And then we will hear from LaNiece Evans-Scott, who has been 

very patient at the end of the table. So, Eric, would you please give 

your testimony. 

TESTIMONY OF ERIC BONNESS,2 DELEGATE, AGE 18, JDRF 

CHILDREN’S CONGRESS, OMAHA, NEBRASKA 

Mr. ERIC BONNESS. Having diabetes is not something you struggle with alone. It affects your whole family. If you have diabetes, 

it affects everything you do. If you also have a brother with diabetes, it affects everything—times two. Our family has twice as many 

blood glucose kits and twice as many insulin pumps, more than 

$10,000 worth. We do twice as many blood sugar checks and 

change catheters twice as often. We have twice as many blood 

sugar highs and lows. We have twice the costs—economic, physical, 

and emotional. 

My name is Eric Bonness. I am 18 years old and from Omaha, 

Nebraska. I was diagnosed with type 1 diabetes when I was 10, 3 

years after doctors diagnosed my little brother, Alex, with diabetes. 

I did not have to go to the doctor’s office to be told I had diabetes. 

I found out one morning in my bedroom after I had been up all 

night going to the bathroom and guzzling water. Just before dawn, 

I opened my eyes as my parents sat down on my bed holding my 

little brother’s blood glucose meter. For 3 years I had seen the 

fear—and the tears—in the eyes of my little brother as he endured 

thousands of finger pokes and insulin shots. I knew I was about 

to get my first finger poke to test my blood sugar. I was terrified. 

I had always been afraid for Alex. Now I was afraid for me. The 

doctors said there was only a small chance I would ever get diabetes. Suddenly, statistics did not matter. 

My mom poked my finger. Then my parents and I watched in silence as the seconds ticked down on the blood glucose meter to reveal my blood sugar. The numbers seems to explode off the screen 

at me—495. I asked my mom if I had diabetes, but I already knew 

the answer. 

Like any brother, Alex can be a real pain. [Laughter.] 

But he has always helped me with the pain of diabetes. When 

I was first diagnosed, Alex would get candy for me when I had a 

low blood sugar. He also taught me how to give myself insulin 

shots to bring down high blood sugars. Now that we are older, we 

still help each other recover from insulin reactions. We give each 

21

1The prepared statement of Mr. Alex Bonness appears in the Appendix on page 56. 

other test strips when one of us runs out. We even borrow the other’s insulin pump when ours stops working. 

It is scary enough to have diabetes myself. But it is even worse 

to watch my little brother suffer with diabetes. Alex sometimes has 

a low blood sugar and migraine headache at the same time. He becomes semiconscious, incoherent, and unable to help himself. I 

watch my parents struggle as they try to raise his blood sugar before he slips into a coma. We are lucky my mom is a doctor. Other 

families would have to go to the hospital. During these episodes, 

my parents give Alex an emergency IV or shot of glucagon to raise 

his blood sugar level. It is horrible to see diabetes make my brother 

so vulnerable. If diabetes is doing this to him now, even with the 

best available medical care, what is diabetes going to be doing to 

him in the future? 

I am not going to wait to find out. I start college next year and 

I plan to go on to medical school. We have to find a cure, and soon. 

Diabetes is not going to kill my brother, and it is not going to kill 

me. 

We need your vote to keep our hope alive. Thank you. 

[Applause.] 

Chairman COLLINS. Thank you very much. Eric, you should see 

your parents’ faces right now. They are so proud of you, and we all 

are. Thank you for your testimony. 

Alex, now you get to take your revenge on your brother for that 

‘‘pain’’ comment, right? 

TESTIMONY OF ALEX BONNESS,1 DELEGATE, AGE 15, JDRF 

CHILDREN’S CONGRESS, OMAHA, NEBRASKA 

Mr. ALEX BONNESS. My name is Alex Bonness. I am 15 years old 

and Eric’s younger brother. I was diagnosed with type 1 diabetes 

when I was 4 years old. I don’t remember the day I found out I 

had diabetes, but I do remember being really scared of the finger 

pokes and shots. When I was diagnosed, no one on either side of 

my family had type 1 diabetes, so living with it was a real big 

shock to us. I remember feeling lost, confused, and alone. Some 

nights I would throw tantrums and cry when it was time to go to 

bed. I never talked about why I did it. My parents thought it was 

because of the monster in my closet. Boy, were they wrong. I was 

afraid of a monster all right, but it was not in my closet. It was 

diabetes. 

When I was 7, I felt like I was saved. That is when Eric was also 

diagnosed with diabetes. I know it sounds terrible to say I felt like 

I was saved because my brother was diagnosed with diabetes. How 

could such a bad thing become good? I was sad Eric had to go 

through so much pain, but somehow I no longer felt alone. When 

Eric reached out to me, I made sure I was there for him. Don’t get 

me wrong. Eric can be a real pain. [Laughter.] 

But it was important for me to be there for him. 

As Eric and I have grown up together, we have always told each 

other we can beat diabetes. I know we can. But as I get older, my 

fears grow, too. When Eric hit his teenage growth spurt, I watched 

22

1The prepared statement of Miss Evans-Scott appears in the Appendix on page 58. 

his uncontrollable blood sugars skyrocket to high levels because of 

his changing hormones. It scared me to death. I worried about him. 

Now I am hitting my teenage growth spurt, and I worry about 

me. I have cried myself to sleep. I have also cried with my mom 

about what scares me most, like complications such as blindness 

and having my legs amputated. Mom always tries to comfort me. 

But she and I both know that complications could occur at any 

time. 

For example, I have to go to the eye doctor every year. At my 

recent eye appointment, I sat on pins and needles with every word 

my eye doctor said. She saw no signs of complications—yet. On the 

way home, I thought about what I would have said and done if she 

had seen blood vessels in my retina starting to deteriorate. 

I am not a little kid anymore. And I know my brother can’t save 

me from going blind. But I know research can. And you can make 

that happen. 

Thank you. 

[Applause.] 

Chairman COLLINS. Thank you. 

Eric and Alex, thank you so much for your testimony. I cannot 

imagine how hard it must be to have one child with diabetes. To 

have two must be so difficult. But I am so glad you have each other 

and that you can help each other. 

LaNiece, you have been very patient today, and I am looking forward to hearing what you have to tell us. So it is your turn now. 

TESTIMONY OF LANIECE EVANS-SCOTT,1 DELEGATE, AGE 10, 

JDRF CHILDREN’S CONGRESS, BACKLICK, OHIO 

Miss EVANS-SCOTT. Many of the kids here today, like my friend 

Alex, worry about getting complications from juvenile diabetes 

when they get older. I am here to tell you that some of us, like me, 

already have serious complications from juvenile diabetes. I am 

LaNiece Evans-Scott from Backlick, Ohio. I am 10 years old, and 

I have battled juvenile diabetes my entire life. 

I was diagnosed with juvenile diabetes after going into a coma 

when I was only 16 months old. I spent the first 5 years of my life 

in and out of hospitals. My mom had to learn how to give me shots 

and take care of me. She has not been able to work because she 

has to take care of me all the time. She drives me 5 hours to see 

a special doctor who helps me care for my diabetes. 

I already have problems with my kidneys, and I take medicine 

every day so that my kidneys won’t fail. I worry about what will 

happen to my kidneys and what other complications I will face as 

I get older if a cure is not found soon. I am also blind in one eye, 

not from diabetes, but I worry about what my diabetes will do to 

my other eye. 

I have a lot of trouble in school because the teachers send me 

home when my blood sugar levels are bad. I am not bad. I am good. 

It is the diabetes that is bad. I do the best I can, but I am only 

a kid and diabetes is a horrible disease. I have fallen behind in 

school because I miss so many classes. I like school, and I also like 

bowling. I have a lot of friends, and I am on the bowling team. 

23

I used to be shy about having juvenile diabetes, but I have 

learned that I must tell my story to important people like you so 

you know how serious diabetes is and why a cure is important. I 

want a cure so that I can be like my friends and go to sleepovers 

and birthday parties. I want a cure so I can go to school every day 

without worrying about being sent home. I want a cure so my mom 

won’t worry so much about me and can go back to work. 

I don’t have time to wait. Please promise to remember me. Please 

promise to remember us. Thank you. 

[Applause.] 

Chairman COLLINS. Thank you, LaNiece. You did a great job 

helping us better understand what having diabetes has been like 

for you. 

I understand that each of you, in fact, all of the delegates in this 

room to the Children’s Congress were selected from more than 800 

applicants on the basis of a special letter that you wrote on why 

getting a cure for diabetes is important to you. So I want to congratulate not only those children who testified, but every single 

child who is here today, because you won the right to come to 

Washington to help us better understand what having diabetes is 

like and why we need to work really hard for a cure. So congratulations to each of the children here today. 

[Applause.] 

Now, I am just going to ask you a couple of questions. LaNiece, 

we will start with you. What is the hardest thing about having diabetes for you? 

Miss EVANS-SCOTT. Taking shots. 

Chairman COLLINS. Taking the shots. How about you, Alex? 

Mr. ALEX BONNESS. I would say putting in catheters, and I guess 

living with it every day, not being able to do what other kids do. 

Chairman COLLINS. Eric, how about you? 

Mr. ERIC BONNESS. I would have to say that no matter how careful you think you are, how much care you are taking with your diabetes, your sugars are always off. There is always something that—

you can never have total control, which means you are going to end 

up having complications. So just the fear of not being able to fully 

be in control of this disease is probably the most scary thing. 

Chairman COLLINS. Katie, what is the hardest thing for you? 

Ms. HALASZ. I think taking shots and testing my blood all the 

time. 

Chairman COLLINS. Sophia, how about you? 

Miss CYGNAROWICZ. Taking shots and doing blood tests. 

Chairman COLLINS. And doing the blood tests. 

And, Colleen, I have a little different question for you. These 

other children, with the exception perhaps of Sophia, are old 

enough that they can monitor their blood sugar so that they know 

when they are getting into trouble to some extent, although we 

have learned it is hard when you reach your teenage years. How 

do you determine when Dylan may need your help since obviously 

he is so young he cannot report to you other than through the blood 

test? 

Ms. REA. Well, his eyes. His eyes tell a lot. And if he is very 

high, he gets very aggressive with other children and with myself. 

If he is very low, he gets sleepy. And if he is tired during the day, 

24

which he doesn’t normally nap, but we do a lot of glucose testing, 

especially when he was first diagnosed and could not even speak. 

He was 14 months old. I have tested up to 18 times in 1 day. 

Chairman COLLINS. Oh, wow. That has got to be so hard. 

I am going to turn to my colleagues for questions, and then I am 

going to have one final question for you. Senator Lautenberg. 

Senator LAUTENBERG. Madam Chairman, my questions were already answered by the stunning presentation made by these young 

people, and when I say ‘‘stunning,’’ I am not talking about—they 

are all good-looking, but that is not the stunning part. The stunning part is the realization about how much more difficult life is 

when juvenile diabetes is present. 

I have got to say for everybody here that we are so fortunate to 

have Susan Collins, the Senator that she is and Chairman of this 

Committee—by the way, ‘‘Chairman’’ doesn’t go with female, but 

we know what we mean when we say ‘‘Chairman.’’ She is the 

Chairman, and she is so motivated by her experiences with people 

who have had juvenile diabetes. And I feel similarly because when 

I look at you, all of you, I see my own grandchildren and what I 

wish for them in the years ahead. But we are lucky that we have 

Susan Collins here because she is on the Republican side of the 

ledger, I am on the Democratic side of the ledger, and the two of 

us are determined—we talked privately outside—to do whatever we 

can, and I know I include my other colleagues here as well, do 

whatever we can to move this process along, to make life just a little bit easier for all of you. And we hope that one day you will come 

here and visit and say, ‘‘What a past I have had, but I have passed 

it,’’ and we thank you all. 

[Applause.] 

Chairman COLLINS. Thank you, Senator, for your support and 

your kind comments. 

Senator Coleman. 

OPENING STATEMENT OF SENATOR COLEMAN 

Senator COLEMAN. Thank you, Chairman Collins, and I join my 

colleague, Senator Lautenberg, in applauding the Chairman for her 

tremendous leadership, and not just because she has a great heart, 

but she gets things done. And I am very hopeful. As we listened 

to these small voices, by the way, these are little voices, but they 

are very loud. They are very loud, and what you are saying, the 

witnesses, by the presence of the other kids is echoing very loudly 

in these halls. So you really are making a difference. And, Chairman, I thank you for putting this together and for your leadership. 

I want to say to LaNiece, you are very good. And folks in this 

room, the parents have got to be very proud. It is hard to sit up 

here in front of U.S. Senators and present testimony, and the parents should be very proud. 

Eric, let me ask you, how do you describe to your pals, how do 

you describe juvenile diabetes to kids, to your buddies? 

Mr. ERIC BONNESS. I just say the only people that really understand the disease are the people who are my close friends, because 

in order to really understand the disease, you have to be around 

it all day. So, actually, my close friends understand it when they 

see—just by watching me test my sugar, seeing what I do with the 

25

various readings that I get of my blood sugar. As far as other kids, 

they think when I wear my insulin pump that I have a pager or 

stuff like that. 

So I can explain it to people, but in order to get a full understanding of the disease, you pretty much have to live around it. 

Senator COLEMAN. Alex, the same question. 

Mr. ALEX BONNESS. Yes, I agree. I think the awareness of it is 

very hard to get out for people to understand really what it is. 

Senator COLEMAN. Do you take the time to talk to them a little 

about it? 

Mr. ALEX BONNESS. Yes, I try to, because I get jokes about when 

my blood sugar is low, we are eating candy during the day. And 

kids have actually said to me, ‘‘Wow, I wish I had diabetes.’’ It is 

kind of weird to hear them say that because they don’t really understand how terrible it is. 

Senator COLEMAN. LaNiece, the same question to you. How do 

you tell your friends? What do you say to them, and how do they 

react? 

Miss EVANS-SCOTT. Some people think the same thing he just 

said. They just want diabetes because I get to eat in class. And at 

the beginning of the school year, me and my mom always go to the 

class that I am in and explain it to them. Some people don’t understand it, though. 

Senator COLEMAN. Katie? 

Ms. HALASZ. I am actually really lucky because my friends help 

me take care of the disease. They make sure I always have food 

with me. They make me test my blood all the time and help me 

take my shots and stuff. So I am very fortunate with that. 

Senator COLEMAN. Sophia, do you talk to your friends at all 

about this? And what do you tell them, and what do they say? 

Miss CYGNAROWICZ. I do not really know. 

Senator COLEMAN. OK. That is OK. 

Colleen, in terms of other parents, do you have conversations and 

do they get it? 

Ms. REA. Oh, they get it. I talk to every person who will stand 

still long enough. 

[Laughter/applause.] 

Senator COLEMAN. Thank you, Madam Chairman. 

Chairman COLLINS. Thank you. 

Senator Fitzgerald, your constituent, Sophia, has been great in 

helping us understand the disease. 

OPENING STATEMENT OF SENATOR FITZGERALD 

Senator FITZGERALD. Well, thank you, Senator Collins. And, Sophia, I want to welcome you here. I know where you are from in 

Illinois. You are from Columbia, and I was there not too long ago. 

I want to welcome you for coming all this way, and I want to welcome the other Illinois constituents who are here. I know Senator 

Durbin introduced them earlier. 

And all of you kids, too, I was very impressed with your statements, and you should be very proud of the good work that you are 

doing helping to spread awareness of the difficulties associated 

with diabetes. 

26

Now, Senator Coleman asked you about what the other kids were 

thinking, and I am just wondering. You did not quite get into this, 

but are any kids at school maybe mean to you or do they make fun 

of your diabetes? Does that happen to any of you? LaNiece, are 

some of the kids mean? 

Miss EVANS-SCOTT. Sometimes. 

Senator FITZGERALD. What do you say to them if they are mean? 

Miss EVANS-SCOTT. I don’t really say anything to them. 

Senator FITZGERALD. Alex? 

Mr. ALEX BONNESS. It is not really a disease that is—it is not 

physical. You cannot see it. You couldn’t look at me and tell that 

I have diabetes. So I don’t really get much trouble from friends. 

Senator FITZGERALD. Did you when you were younger, maybe in 

second or third grade? 

Mr. ALEX BONNESS. Sometimes people joke around about it, bullies just trying to be mean, called me a diabetic and stuff. I mean, 

it is rough, but you cannot do anything about it. So you have got 

to move on. 

Senator FITZGERALD. Katie, are the kids pretty understanding? 

Ms. HALASZ. Some of them are. I know that the parents, they 

don’t really want me to go over to their houses because they don’t 

want to take the responsibility. But I don’t—other than that, they 

are fine with it. 

Senator FITZGERALD. Now, if you were to stay at somebody’s 

house overnight, you would have to be checking your blood sugar, 

and the parents of your friend might be worried about liability having you stay overnight. 

Ms. HALASZ. Yes. 

Senator FITZGERALD. How about the rest of you on the panel, are 

you able to stay overnight at your friends’ houses? 

Mr. ALEX BONNESS. Pumps help, but I have actually had—my 

brother talked about the migraine headaches, and at a sleepover I 

did have one one time. So people kind of get worried about it sometimes. I definitely don’t do as many sleepovers as a lot of my 

friends do. 

Senator FITZGERALD. The others of you, have you ever slept over 

at a friend’s house? 

Miss CYGNAROWICZ. Yes. 

Senator FITZGERALD. Sophie, have you slept over at a friend’s 

house? 

Miss CYGNAROWICZ. Yes. 

Senator FITZGERALD. And do you check your own blood sugar? 

Miss CYGNAROWICZ. Yes. 

Senator FITZGERALD. You do. OK. 

Do all of you have to wake up in the middle of the night to check 

your blood sugar, or are you able to sleep through the night? 

Mr. ALEX BONNESS. I am lucky enough that my parents actually 

wake up every night and check our blood sugars while we are 

sleeping. 

Senator FITZGERALD. Is that the same with all of you? 

Ms. HALASZ. I know when I am high or low, we have to wake 

up every couple hours to make sure we are coming down or keep 

going up. But, yes, there are a lot of nights that we have to check 

our blood in the middle of the night. 

27

Senator FITZGERALD. How many times does your blood sugar 

have to be checked during the night? 

Ms. HALASZ. Anywhere from two to three. 

Senator FITZGERALD. Two to three times every night. 

Mr. ALEX BONNESS. If you are either high or low before you go 

to bed. In most cases, you are usually good so you only check like 

one time. But in some cases, yes, two or three times. 

Senator FITZGERALD. And do your parents get up and check that? 

Mr. ALEX BONNESS. Yes. 

Miss EVANS-SCOTT. Yes. 

Senator FITZGERALD. For all of you, and do you sleep right 

through it? 

Mr. ALEX BONNESS. Well, mostly. 

Senator FITZGERALD. OK. Well, Colleen, you are the one who has 

to wake up then and check the blood sugar. It is a real burden on 

the parents, isn’t it? 

Ms. REA. Well, I go to bed late, and I test him before I go to bed. 

And if his numbers are good, because he has the insulin pump and 

he doesn’t take a lot of insulin compared to these other children 

yet, I can sometimes sleep through the night. Occasionally I get to 

sleep through the night. 

Senator FITZGERALD. Thank you so much for being here. We will 

all be working together to try hopefully someday years hence not 

to have these hearings in Washington because I am hopeful that 

someday we will arrive at a cure or some satisfactory solution that 

makes it easier to live life with diabetes. But thank you all very 

much for what you have done to bring awareness to people around 

our country on this issue. You are making a great contribution and 

leaving a significant mark on this country at a very early age. 

So thank you all very much. 

[Applause.] 

Chairman COLLINS. I told you I was going to do one more question, but I changed my mind in view of the hour. You are the best 

panel of witnesses I have ever seen, so thank you so much. 

[Applause.] 

And I know I speak on behalf of every Senator who has been 

here today when I do promise to remember you. Thank you for 

being here. 

[Applause.] 

We are now going to move to our final panel, but before we do, 

the JDRF has asked me to announce that if any of the children are 

feeling as if your blood sugar is low right now, there is food right 

outside the hearing room if you need a snack. So you can feel free 

to go get it if you think you need a snack. 

We are now going to call forth our final panel. Our final panel 

of the day will testify about some of the promising breakthroughs 

that have been made in juvenile diabetes research as well as future 

opportunities for research. They will tell us about the work that is 

being done in pancreatic islet cell transplantation, which has been 

hailed as the most important advance in diabetes research since 

the discovery of insulin. 

Dr. Allen Spiegel is the Director of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes 

of Health. 

28

1The prepared statement of Dr. Spiegel appears in the Appendix on page 60. 

Dr. Bernhard Hering is an Associate Professor of Surgery and 

Director of Islet Transplantation at the University of Minnesota. 

And Anne Seidel of Dallas, Texas, is an actual islet cell transplant recipient, and I am so eager to hear your story. 

I want to turn to Senator Coleman, because there is a distinguished witness from Minnesota here, for any additional comments 

that he might have. 

Senator COLEMAN. Thank you, Chairman Collins, and I would 

just like to do a very brief introduction for Dr. Hering from Minnesota. 

Minnesota has established itself as the cluster for medical research and technology, and in addition to making big contributions 

to the State’s economy, this activity also has important benefits to 

our Nation’s health. I was pleased to form a Medical Technology 

Caucus with Senator Biden, again, bipartisan. This is not a partisan issue. The health of our kids and our families are not partisan issues. It is Democrats and Republicans coming together. 

I am proud to note that a large part of this activity has always 

centered around the University of Minnesota, particularly in dealing with the issue of islet transplantation in our transplant facility. 

And Dr. Hering is one of the leaders in islet transplantation. 

Again, as has been noted, this technology represents a major source 

of hope for diabetics, their families, and their friends. I share Senator Fitzgerald’s hope and passion that very quickly we move forward with a cure. But the reality is that some of the advances that 

Dr. Hering is involved with are very important, and I appreciate, 

Madam Chairman, your inviting him here today to discuss the current status of this technology and the steps we next need to take. 

I am proud to be a cosponsor with Chairman Collins on S. 518, 

the Pancreatic Islet Cell Transplantation Act. Voices are being 

heard, and we will work hard to make sure that we make progress 

in this area. 

Thank you, Madam Chairman. 

Chairman COLLINS. Thank you very much, Senator Coleman. 

Dr. Spiegel, we will proceed with you. 

TESTIMONY OF ALLEN M. SPIEGEL, M.D.,1 DIRECTOR, NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES, NATIONAL INSTITUTES OF HEALTH 

Dr. SPIEGEL. Thank you. Chairman Collins, Senator Coleman, 

delegates to the JDRF Children’s Congress, family members, and 

guests, I appreciate the opportunity to testify at this hearing on 

type 1 diabetes. Nothing I could say would be more eloquent than 

the testimony you just heard from Mary Tyler Moore, from the children and teens who told their stories, nor the testimony you will 

hear from Anne Seidel, an islet transplant recipient. Nonetheless, 

I have much to tell you about what NIH support has accomplished 

to date and how we plan to seize the exciting opportunities before 

us in type 1 diabetes research. 

All this is detailed in a thick report on the special statutory funding program for type 1 diabetes, released yesterday by Secretary 

Thompson. The full report, as well as a slimmed-down executive 

29

summary, are available in hard copy and on the NIDDK website. 

This morning I will just offer a few examples and highlights. 

First, though, on behalf of NIH, I would like to thank you and 

the other Members of Congress for your support of the NIH and of 

the special statutory funding program which has significantly augmented our regularly appropriated funds for diabetes research. 

The special program has enabled the formation of unique, productive collaborations involving multiple institutes at NIH and the 

Centers for Disease Control, and has brought new researchers from 

multiple disciplines together to accelerate research on type 1 diabetes. 

I would also like to acknowledge the JDRF for its vigorous support of type 1 diabetes research. The JDRF is an invaluable collaborator as the NIH continues to define specific research goals and 

needs in type 1 diabetes. The JDRF indeed has partnered with 

NIH in diabetes initiatives and has brought its international scope 

to bear in combating diabetes since this disease knows no geographic boundaries. When the special funding program was increased from $30 mil- lion to $100 million per year in fiscal year 2001 and extended to 

2003, we formulated an ambitious research plan with input from 

expert scientists and key advocacy groups such as the JDRF. Our 

type 1 diabetes research plan has six broad goals: To identify the 

genetic and environmental causes; to prevent or reverse the disease; to prevent or reduce hypoglycemia, the low blood sugar you 

heard so much about; to prevent or reduce complications; to attract 

new talent to type 1 diabetes research; and last, but certainly not 

least, to find a cure. 

In the 2 years since I last testified before you, significant 

progress has been made in all these areas as reflected in just five 

examples. 

First, basic research on diabetes complications has shown that a 

vitamin derivative can prevent complications in animal models and 

has led to clinical trials of a drug to prevent blindness. Second, a 

network of pediatric centers called ‘‘DirecNet’’ has been created 

with the special funds to test new technology made by two different 

companies for continuous, non-invasive glucose monitoring so we 

can develop alternatives to the multiple finger sticks we heard 

about from the kids this morning and that Senator Fitzgerald 

asked about. Third, a biotechnology drug, a monoclonal antibody, 

has shown promise in reversing recent onset type 1 diabetes and 

will be tested in a larger clinical trial supported by the special 

funds. Fourth, investigators have reported success in converting 

adult stem cells—and both mouse and human embryonic stem 

cells—into insulin-producing cells. Fifth, the Immune Tolerance 

Network, with support from the special funding program, is completing a multi-center trial of the Edmonton Protocol for islet transplantation first reported in the year 2000. An interim report released just 3 weeks ago indicated that several centers are capable 

of rendering greater than 60 percent of their islet transplant recipients insulin independent. 

You will hear in much greater detail about islet transplantation 

from one of the pioneers to my left, supported by NIH, Dr. Bernhard Hering. Let me say that NIH is vigorously addressing the two 

30

1The prepared statement of Dr. Hering appears in the Appendix on page 66. 

major scientific hurdles we must clear to make islet transplantation a true cure: Developing an inexhaustible supply of insulinproducing cells, and achieving immune tolerance, a state of acceptance of a transplant that no longer requires taking potentially toxic 

and costly immunosuppressive drugs lifelong. 

For the former hurdle, the Beta Cell Biology Consortium, created 

with the special funds, is intensively studying all aspects of islet 

development so we can learn how to grow sufficient amounts for 

treatment. A significant portion of the special funds, recently augmented—with your leadership—by the Congress from $100 million 

to $150 million per year and extended from 2004 to 2008, will be 

devoted to research needed to make islet transplantation a widely 

available reality. We will also be focusing attention on so-called 

translational research that converts basic science advances into 

practical diagnostic tests, treatments, and preventive measures. 

I am grateful for this opportunity to give you some examples of 

the progress and plans being made in type 1 diabetes research, 

particularly with the assistance of the special statutory funding 

program. We are living in a new and exciting era of scientific research that, with its rapid advancement and immense opportunities, is unprecedented. We intend to take full advantage of the new 

technologies and information that have emerged in this new era to 

realize greater progress in diabetes research. 

We continue to be inspired by the dedicated efforts of patients 

and their families and by organizations such as the Juvenile Diabetes Research Foundation. We remain steadfast in our fight against 

diabetes, helping kids such as Katie Halasz right now with efforts 

such as our guide for school personnel, ‘‘Helping the Student with 

Diabetes Succeed,’’ while ever focused on the ultimate goal—finding 

a cure. 

We must help all the children in this room who represent the 

children with type 1 diabetes in this entire country. They are the 

reason for all of our efforts. Thank you. 

[Applause.] 

Chairman COLLINS. Dr. Hering. 

TESTIMONY OF BERNHARD J. HERING, M.D.,1 ASSOCIATE PROFESSOR OF SURGERY, DIRECTOR OF ISLET TRANSPLANTATION, UNIVERSITY OF MINNESOTA, MINNEAPOLIS, MINNESOTA 

Dr. HERING. Chairman Collins and Senator Coleman, my name 

is Bernhard Hering, and I am addressing you today on behalf of 

my physician-scientist colleagues. Our ability to transform the 

landscape of juvenile diabetes in this country in the next decade 

depends heavily on the Federal Government’s efforts. Chairman 

Collins, I want to applaud your efforts and those of the more than 

30 Senators who have cosponsored your legislation entitled ‘‘The 

Pancreatic Islet Cell Transplantation Act of 2003.’’ I believe that, 

if passed, this bill will empower clinical researchers to expedite the 

translation of islet transplant research into unsurpassed, innovative treatments for individuals with juvenile diabetes and accelVerDate 0ct 09 2002 13:17 Oct 29, 2003 Jkt 088991 PO 00000 Frm 00034 Fmt 6633 Sfmt 6601 C:\DOCS\88931.TXT SAFFAIRS PsN: PHOGAN
31

erate the integration of such treatments into health care delivery 

systems. 

Although the research community has experimented with islet 

cell transplants for decades, they are now at last becoming a practical, successful, superior, and distinct therapy for patients with 

juvenile diabetes. This disease continues to be challenging, with 

significant morbidity and mortality. Diabetes is a devastating burden to patients and their families, especially when acute complications are frequent and chronic complications are advanced. In the 

previous panel, you heard about the daily challenges people face in 

living with juvenile diabetes from the most effective messengers—

children who suffer each and every day with this disease. 

Please allow me now to illustrate how islet transplants are unsurpassed in their potential to transform the lives of people with 

difficult-to-control juvenile diabetes. Lorna is a 35-year-old mother 

of two boys who developed diabetes at age 9. She completely lost 

her ability to sense low blood sugar levels, also referred to as hypoglycemia. Brain function is severely compromised during episodes 

of hypoglycemia, leading to confusion, distorted perception of surroundings, dizziness, odd behavior, seizure, coma, and possibly 

death. Lorna became incapacitated by weekly episodes of severe 

hypoglycemia, requiring the help of a third person and often paramedics. As a result, Lorna lost her driver’s license, was laid off at 

work, was divorced, and was denied the right to see her boys. 

In August 2000, Lorna was admitted to the General Clinical Research Center at the University of Minnesota for an islet transplant under a protocol supported by the Juvenile Diabetes Research Foundation and the NIH. She was taken to a radiology 

suite, where a local anesthetic was given and a catheter was placed 

through her skin into the portal vein of her liver. Islets isolated 

from a cadaver donor pancreas were resuspended in buffer, transferred to a transfusion bag, and infused over 20 minutes through 

the catheter into her portal vein. Infused islets were carried by her 

blood to smaller branches of the portal vein, where they lodged, 

engrafted, and resumed tightly controlled secretion of insulin in response to her blood sugar levels. The catheter was then removed, 

and she was discharged to go home 2 days later. 

Lorna’s blood sugar levels returned to normal. She was able to 

completely discontinue insulin injections 1 month after her islet 

transplant. Since her transplant, she has not experienced a single 

episode of severe hypoglycemia. She learned to love life again, rediscovered her ability to make contributions to our world, regained 

control over her destiny, received her driver’s license back, found 

a new job, married the paramedic who had repeatedly saved her 

life——

[Laughter/applause.] 

Dr. HERING [continuing]. While she was diabetic, closed on a new 

home, and was granted authorization to take care of her boys 

again, all in the first year after her transplant. Now, almost 3 

years later, Lorna continues to be insulin independent and diabetes 

free. She takes immunosuppressive medications to prevent rejection of her transplanted islets. She has not experienced any severe 

adverse events. You will hear another remarkable success story 

from Anne Seidel following my testimony. Equally impressive sucVerDate 0ct 09 2002 13:17 Oct 29, 2003 Jkt 088991 PO 00000 Frm 00035 Fmt 6633 Sfmt 6601 C:\DOCS\88931.TXT SAFFAIRS PsN: PHOGAN
32

cess stories have been reported by a few other centers in the 

United States, including the University of Miami, Baylor College in 

Houston, and the University of Pennsylvania, to name the most active and successful of centers. 

For patients like Lorna, insulin is survival, but an islet transplant is return to life. Islet transplants are now a clinical reality, 

not just a topic for investigational research. 

Let us now assume for just one moment that your 35-year-old 

daughter suffers from juvenile diabetes complicated by recurrent 

episodes of severe hypoglycemia, that she meets all accepted medical criteria for an islet transplant, that she has good health insurance, and that she wants to proceed with an islet transplant. Will 

she be able to undergo an islet transplant? 

Most likely no. There is a severe shortage of donor organs for 

islet transplants. Funding in the area of clinical translation of islet 

transplantation has not kept pace with the science, and regulations 

must be changed to provide incentives for additional procurement 

of donor organs for islet transplantation and research. And insurance coverage of islet transplantation is currently not available, 

thereby largely restricting them to patients meeting the very stringent eligibility criteria of research protocols. 

This disconnect between the promise of basic science versus the 

delivery of better health in the United States is of significant concern. Islet transplants for the treatment of diabetes are being covered by several provinces in Canada, where a landmark pilot clinical trial called the Edmonton Protocol was performed in 2000. The 

steadfast commitment to basic biomedical research in the United 

States has provided the basis for today’s high success rate in reversing diabetes in human patients. It has also provided an unprecedented supply of information for further breakthroughs in clinical 

islet transplants. Yet islet transplants remain largely unavailable 

3 years after the demonstration of proof of principle. Failure to use 

available science is costly and harmful. It leads to overuse of inferior care. In contrast to Canada, we fail to deliver the best care we 

could for patients with difficult-to-control diabetes. Health insurance companies should be on board but are not. 

Both my learned opinion and my best bet are that one-third of 

the gifted children with juvenile diabetes with us today in this 

room will develop devastating, destructive, or deadly diabetes complications before they are 50 years old—unless we enhance our preclinical and clinical research agenda markedly in the next 2 years 

in order to realize a sizable effect within 10 years. The potential 

short- to mid-term impact of islet transplants on patients with juvenile diabetes prone to develop devastating complications is 

unmatched by any other treatment modality. The Pancreatic Islet 

Cell Transplantation Act of 2003 would help overcome the fragmentation and underfunding of today’s clinical islet transplant 

infrastructure and remove major translational blocks in the implementation of islet transplants. More specifically, it would be instrumental in maximizing donor pancreas utilization, in documenting 

the benefits of islet transplants, in shortening the time to FDA approval of transplants of human islets, and, finally, in developing an 

unlimited supply of tissue for transplantation such as xenogeneic 

islets from animals or stem cell-derived islets. 

33

1The prepared statement of Ms. Seidel appears in the Appendix on page 77. 

In closing, I believe the Pancreatic Islet Cell Transplantation Act 

of 2003, if passed, will greatly enhance the islet transplant 

translational infrastructure and help it to operate much more efficiently. It will raise needed awareness, create additional momentum, send a very strong signal to all major stakeholders in health 

care delivery, and facilitate the expedient delivery of today’s 

science and technology for the benefit of thousands of patients afflicted with juvenile diabetes. The bill will also help prepare the 

field to respond nimbly to the extraordinary advances that surely 

will emerge from stem cell biology and other high-impact, cellbased technologies of the future. Thus, this legislation will have 

implications well beyond its primary objectives. 

As I look around the room at all these children who are here 

today to take an active role in finding a cure for juvenile diabetes, 

I know that the scientific community and Congress must match 

their passion and dedication. This will not be an easy task, but 

progress in science has been truly remarkable and emerging opportunities are even more extraordinary. Removing translation blocks 

will allow our patients to benefit from scientific breakthroughs. 

We were able to put a man on the moon more than 30 years ago 

because we wanted it, because President Kennedy declared it possible. I know we could cure diabetes if we declared it possible. 

Madam Chairman, Senator Coleman, thank you from the bottom 

of my pancreas. 

[Laughter/applause.] 

Chairman COLLINS. Thank you for your testimony. Ms. Seidel. 

TESTIMONY OF ANNE SEIDEL,1 ISLET CELL TRANSPLANT 

RECIPIENT, DALLAS, TEXAS 

Ms. SEIDEL. Senator Collins and Members of the Committee, 

thank you for the opportunity to appear before you today as an example of a true success story resulting from the public-private partnership between the Juvenile Diabetes Research Foundation and 

the Federal Government in supporting medical research and the 

National Institutes of Health. I am Anne Seidel, proud mother of 

Charlie, 6, and Lacey, 5. I have been an active JDRF volunteer for 

5 years in Dallas and nationally. 

I was diagnosed with juvenile diabetes 35 years ago, at age 6. My 

son Charlie, now 6, was diagnosed 5 years ago. I cannot describe 

to you the anguish I experienced when he was diagnosed with juvenile diabetes. As a mother, your focus in life is caring for and protecting your children, but I could not protect him from this disease 

that was ravaging my body for over 30 years at that point. 

While I focused all of my energy on caring for Charlie when he 

was diagnosed, diabetes was taking an enormous toll on my body. 

Over the years of living with diabetes, I have won the battle of 

near blindness and kept going. I have had nerve damage in my feet 

and partial paralysis of my stomach and kept going. My blood sugars would jump from being at a level of 16—so low that I was in 

danger of becoming unconscious—to a level of 600—which is so 

high that I could slip into a coma—in the course of 2 hours and 

then back down and back up again. This roller coaster defined 

34

many of my days. Most days, feeling nauseated and exhausted, I 

had to keep going. 

But the complication of my diabetes that prevented me from 

keeping going was when I lost my ability to feel my low blood sugars. Instead of being able to sense this and quickly take some sugar 

and rectify the situation, my blood sugar often kept dropping until 

I was unconscious, blacked out, totaling my car, or so confused that 

I did not know who I was, who my children were, and oftentimes 

not sure whose diabetes I was taking care of. I came very close several times to accidentally giving Charlie insulin that he didn’t 

need, and the result of that could have meant his death. 

About 4 years ago, I began watching—with more than a passing 

interest—the advancement of pancreatic islet cell transplantation. 

Upon investigation, the state of my diabetes matched the criteria 

for participating in these clinical trials. When deciding to participate in the trials, I had to come to terms with the fact that the 

procedure was not available for children, and because of the immunosuppressive drugs, this was not available for many. As a 

mother, your instincts are to take care of your children first. And 

after lots of introspection, I had to become OK with having the procedure because I thought in an airplane the parent must put the 

oxygen mask on themselves first so they can save their child, and 

I had to do the same with my diabetes. 

After speaking with every center in the world that was conducting islet transplants, I was screened at several places and I 

chose to be on one list. Because of the severe shortage of 

pancreases in the United States and with my rare blood type, I 

spent over 2 years on the waiting list, hoping for the call. Every 

day that passed, I worried that my diabetes would worsen and that 

while I waited I might be prevented from receiving a transplant because of ensuing complications. I decided to increase my chances 

for a transplant and listed at three additional centers. 

I received my transplant on February 5 and my second on April 

9 of this year. Most current protocols involve two pancreases, two 

transplants to receive the appropriate number of islet cells. I was 

called to come to the Methodist Hospital in Houston, and the insulin-producing islet cells were extracted from a donor pancreas, put 

into an IV bag. And while this was being done, I changed into my 

gown and went into the radiology suite where the radiologist fed 

a small needle into my liver and dripped the cells into me. I was 

in the surgery suite for only about 20 minutes and was conscious 

throughout the procedure. Back in the recovery room, I looked 

down at my side and I said the surgeon, ‘‘You mean you just saved 

my life and all I have to show for it is this Band-aid?’’ Thirty hours 

after the transplant, I was home. 

Since my transplant, I no longer need to take insulin. To give 

you a sense of how dramatically this has changed my life, in the 

35 years I had juvenile diabetes, I have taken 255,500 units of insulin and have pricked my fingers 56,210 times. For the first 12 

years of my diabetes, I tested my urine 21,900 times. People have 

asked me to describe how I feel after the transplant, and the best 

analogy I can think of is that I felt like I had not bathed in 35 

years and somebody finally washed me off. 

35

An amazing result of the transplant is that many of the complications that plagued my days before are now gone. The nausea, 

exhaustion, confusion, unconsciousness, foot pain, and a large helping of fear are now gone. Having clear thoughts, energy, not feeling 

fearful of endangering myself or my children has been nothing less 

than utopia. Diabetes doesn’t define me anymore. I truly have received the gift of a lifetime. 

As one of the approximately 250 people worldwide whose life has 

been changed through an islet transplant, I thank you from the 

bottom of my heart. Your commitment to the NIH, coupled with 

JDRF’s commitment, has truly saved my life. But there is no time 

to sit back and congratulate ourselves because there are many 

more who cannot take advantage of this procedure. And I will not 

rest or be truly happy until Charlie and these kids and all my 

friends with type 1 can be cured like myself. They deserve no less. 

Call me demanding, but I do not like being one of so few. 

It may sound strange, but diabetes has given me many opportunities in my lifetime, one of which is the privilege of being here and 

talking to you. I want to thank you publicly and JDRF for saving 

my life. A cure is within our grasp. Together, our efforts and funds 

must make this happen sooner than later. Thank you. 

[Applause.] 

Chairman COLLINS. Ms. Seidel, thank you so much for sharing 

your miraculous story with us. I think your story gives hope to 

every person in this room. And I, too, look forward to the day when 

there are no shortages, when insurance and Medicare cover this 

procedure—in fact, I am looking at introducing an amendment to 

have a demonstration project under Medicare to pay for the procedure. And we need to get my legislation passed to overcome some 

of the other barriers that Dr. Hering also outlined for us. 

You have made the process sound relatively easy. But you do 

have to take immunosuppressive drugs, don’t you? 

Ms. SEIDEL. Yes. 

Chairman COLLINS. Have you had any negative reaction to those 

or are you generally doing as well as you seem to be doing? 

Ms. SEIDEL. I am doing really well. I have had very few complications from the drugs. I have experienced mouth sores, which are 

common side effects of the immunosuppressants, but to me, any 

bump in the road has been a very small price to pay for what I 

have received. 

Chairman COLLINS. It really is wonderful. I have followed this 

procedure for the last couple of years and read a lot about it, but 

you are the first recipient whom I have had the honor to meet. It 

is just fabulous to hear your story today. 

Ms. SEIDEL. Thank you for helping make it possible. 

Chairman COLLINS. Thank you. 

Dr. Hering, can you help us understand better why this procedure is not appropriate for most children right now? 

Dr. HERING. At this point in time, we have to limit this procedure to a very small subgroup of patients in whom the benefits outweigh the risks associated with the use of immunosuppressive 

medication. And I think it would not be appropriate to consider 

islet transplantation at this point in time for the treatment of children because complications are possibly very harmful. 

36

But progress has been made recently in our ability to prevent rejection, and as Dr. Spiegel pointed out, major research networks 

have been established recently to evaluate emerging breakthrough 

technologies in this direction. 

The limiting factor has been to move the wonderful progress that 

has been made from the mouse level to the point that it can be 

safely evaluated in people. So we need to make this translational 

step and need to provide compelling evidence obtained in nonhuman primate studies that would justify testing in people. If we 

could do this and if we could really reduce the time it takes to take 

these steps, we could clearly capitalize on all the breakthroughs 

that have been reported recently. 

Chairman COLLINS. Thank you for the research that you are 

doing. 

Dr. Spiegel, thank you for giving us the broader overview of all 

of the promising developments in research. Every time you appear 

before me, I always put you on the spot, and I always feel bad 

about it, but I am going to do it again this year. That is, we have 

heard from Dr. Hering and we have heard from the Juvenile Diabetes Research Foundation that the legislation that I have introduced 

to try to remove some of the barriers to the procurement of more 

pancreases and to otherwise encourage the development of more 

procedures to facilitate the kind of transplant that has made such 

a difference to Ms. Seidel. I have introduced the Pancreatic Islet 

Cell Translantation Act and would really like to have the support 

of NIH. Can we count on the support of NIH for my legislation? 

Dr. SPIEGEL. Given what a strong supporter you have been of 

type 1 diabetes research and of the NIH, I, of course, would like 

to say yes, so I hesitate to really inject this note in this wonderful 

hearing. You know, though, very well that in my position I really 

can’t comment on pending legislation. 

What I will say is I am happy to address any aspect of the 

science associated with this, and I would say that this is clearly 

being very carefully evaluated in the Department and elsewhere. 

We are obviously very motivated by the advances Dr. Hering has 

talked about, and we are trying with a collaborative islet transplant registry in a variety of ways to meet these goals. But I really 

can’t comment further. 

Chairman COLLINS. Well, I thought I would try. 

Dr. Spiegel, in addition to the very promising developments with 

islet transplantation, what do you view as the single other most 

promising therapy on the horizon for juvenile diabetes? 

Dr. SPIEGEL. Just sticking with the issue of a cure, we have the 

wonderful opportunity with the resources you have put at our disposal to explore at least two other alternative strategies, and these 

need to be explored in parallel. One is an artificial pancreas. Many 

of the kids you have seen—and heard from—have these pumps, 

and these are an improvement in terms of insulin delivery. If we 

could hook those up with a continuous sugar-monitoring device 

that is non-invasive—and these are being studied in this collaborative trial that I mentioned—we might have what is called a 

closed-loop system. 

Again, such an artificial pancreas would never mimic perfectly 

what we see with the actual islets, but it would be pretty close and 

37

could be pretty good. And if it were miniaturized, it could make a 

huge difference. So that is being pushed, and that is really an example also of public-private partnership, basic research done by 

NIH-supported investigators, including the small business setaside—which we support, as you know—which is then picked up by 

industry. Two major companies are advancing this technology. 

They claim they are close, but we have to see the evidence. 

The other issue is a complicated issue that Dr. Hering referred 

to—xenotransplantation, the idea, for example, of pig islets. People 

have taken pig insulin for years, and it works very well. It works 

just as well in many respects as human insulin. So, why can’t we 

just use pig islets? There are issues about viruses that are present 

and, of course, transplant rejection. 

There, too, we are supporting research. I want to make a point 

here with regard to both the immune tolerance we heard about and 

xenotransplantation. As important as this is for type 1 diabetes, it 

transcends one disease. It is important for all transplantation. 

There is a shortage of all these organs in terms of kidney and liver, 

etc. So this is very important research. 

Knock-out technology, so-called, has created pigs that lack the 

sugar that causes hyper-acute rejection. And that is a step in the 

direction of making this a reality. 

Chairman COLLINS. Thank you. Senator Coleman. 

Senator COLEMAN. Thank you, Madam Chairman. 

I was mentioning the Minnesota connection. First, I want to 

thank Mary Tyler Moore for her leadership, and I would be remiss 

in not mentioning the Minnesota connection there because she 

lived and worked there for many years. So we are very proud. But 

thank you for your strong voice here. 

Another Minnesota connection are folks from Medtronic, and I 

don’t want to pick out one company, but there is some great work 

going on in the biotechnology side. 

Dr. Spiegel, let me ask you first, you just touched briefly upon 

stem cell, and, in fact, another area where the University of Minnesota is doing some breakthrough work on adult stem cells. Give 

me your best sense of how far down the road, if you can do that, 

we are from using stem cell research to make any significant advances here, either for adult or for juvenile diabetes? 

Dr. SPIEGEL. Thank you, Senator Coleman. I will focus my remarks exclusively on stem cells as applied to diabetes, particularly 

type 1 diabetes. 

Indeed, at the University of Minnesota, is a colleague of Dr. 

Hering’s, Dr. Catherine Verfaille. She just addressed our National 

Advisory Council, and she is a member of our Beta Cell Biology 

Consortium. She is doing extraordinary work on what are called 

multi-potent adult progenitor cells. While she hasn’t yet had definitive success in turning these into insulin-producing cells, they have 

been turned into liver cells and other relevant cells, and we are 

looking for further developments. 

There have been reports of adult bone marrow-type stem cells in 

mouse models curing diabetes. At the same time, there have been 

substantial advances, as I said in my testimony, both in terms of 

turning mouse embryonic and human embryonic stem cells into insulin-producing cells. They don’t produce as much insulin as we 

38

would want. They are not perfect in terms of being like the real 

beta cells in the islets. But this is a very important step in the 

right direction that we are supporting heavily within the guidelines 

of the President’s decision of August 9, 2001. We at NIH are totally 

committed to making this not only an acceptable but a priority 

area of research. And that is the message that I and Dr. James 

Battey, who heads the NIH Stem Cell Task Force, are putting out 

across the country to encourage our investigators. 

Senator COLEMAN. I am familiar with Catherine’s work and 

working with some technology companies to do the next step, and 

translate the research into a reality. Is the FDA process of looking 

at that stuff, is that set up in a way to allow us to move quickly 

enough to take advantage of some of these research opportunities? 

Dr. SPIEGEL. To answer this would really be beyond my purview, 

so I hesitate to do so. What I would say is that the company, 

Athersys, which you are referring to, is one that has had an opportunity to present to the Stem Cell Task Force. We are really interested in public-private partnerships under Dr. Zerhouni’s leadership. He has been creating a vision for the future of NIH called a 

roadmap, and there are many aspects of that vision which we discussed at a retreat last Friday that are relevant to this audience: 

Re-engineering the clinical research enterprise, facilitating harmonization with the NIH and the FDA, and public-private partnerships. These are very relevant themes. 

Senator COLEMAN. Thank you very much. 

Ms. Seidel, just one question. How were you chosen? You said in 

your testimony you fit the criteria, but how did you take advantage 

of or get picked for this opportunity? 

Ms. SEIDEL. When the criteria was outlined by most of the centers that were doing it, Minnesota being one, the criteria included 

patients that were healthy otherwise, having primarily one complication which is asymptomatic, low blood sugars, meaning low 

blood sugars that you cannot feel to the point where that can paralyze your life from being normal in any way. And that was something that I suffered from. Otherwise, I was healthy. 

Dr. Hering can tell us more, but, really, the patients that were 

being selected were patients that could then be quickly rendered 

free of those low blood sugars once they were transplanted, but 

whose bodies could withstand the transplantation and the immunosuppressive drugs. 

Senator COLEMAN. What was your biggest fear when you decided 

to take advantage of the islet transplant? 

Ms. SEIDEL. How long it was going to take. That was my biggest 

fear. I knew that we had a severe shortage of organs in the United 

States, and with a rare blood type, I hoped that my complications 

of diabetes didn’t worsen while I waited. 

Senator COLEMAN. How long after the surgery did you first get 

the sense that, wow, something has changed? 

Ms. SEIDEL. Almost immediately. I felt better within a couple 

hours of the anesthesia wearing off. 

Senator COLEMAN. Dr. Hering, how many potential patients like 

Ms. Seidel do you kind of wade through before you get to choose? 

Which has to be, by the way, a pretty daunting feeling about making those kinds of choices. I would hate to be in that position. But 

39

what is your universe? And then ultimately how large is the patient group that benefits from this opportunity? 

Dr. HERING. Thank you, Senator Coleman, for your question. 

When we announced our program, within a matter of a few weeks 

we received 2,500 applications, and it was the first challenge how 

to deal with those applications and how to be able to get back to 

patients and explain in sufficient detail why we can do it or why 

we cannot do it. 

First and foremost, we have to protect the safety of participants. 

We have a long list of 40 exclusion criteria. We need to continue 

considering those criteria very seriously to protect the safety of participants. 

I believe that of those 2,500 that contacted us initially, only 30 

to 40 were identified as eligible candidates. If you ask the question 

how many patients in the United States at this point in time would 

meet criteria like Anne Seidel, I think you are talking about at 

least 5 percent of our population that has been diagnosed with type 

1 diabetes. So you are talking about 50,000 people at this point in 

time. 

When I look at the field of islet transplantation and cell replacement therapies today, what we do is we show the feasibility of cells 

to reverse diabetes. This is a completely new area in diabetes therapy that has not been available before. Everybody who wants to see 

can see what the implications are and future technologies are waiting to be implemented. Thus, what we do today is just a first step. 

We show the feasibility of all therapy, a technology that is fundamentally new and different. I think we need to keep the momentum going. Of particular importance is that we maximize donor 

pancreas utilization. We are not facing a true shortage. We are facing logistical problems. Within 1 year we could procure 2,000 additional donor pancreases. These organs are available, but are currently not recovered. I think your bill clearly addresses this point 

very directly. This example indicates that it is not only science that 

is limiting our ability to deliver the new technology of all therapy. 

We really have to identify non-scientific roadblocks and address 

these problems. 

Senator COLEMAN. Thank you, Doctor. I again want to applaud 

both of you for your work and also what you are doing today to 

help us, I think simply better educate some folks so that in the end 

we can pass Chairman Collins’ legislation and make a real difference in a lot of lives. So thank you very much. 

Thank you, Madam Chairman. 

Chairman COLLINS. Thank you, Senator. 

I want to thank our panel for your expert testimony today. It was 

fascinating and a fitting conclusion to what has been a very moving 

experience for me in chairing this hearing. Thank you all so much 

for being with us. 

I want to thank all of the witnesses who appeared today, and 

most of all, I want to thank the children because they are the ones 

who really motivate all of us to work harder in the search for the 

cure. 

I also want to pay tribute to Mary Tyler Moore. You could not 

have a better adult spokesperson for this cause. 

40

And I want to thank the Juvenile Diabetes Research Foundation. 

They have worked so hard to put this Children’s Congress together. 

I am very proud to have been the co-Chair this year, and it has 

been a real privilege to work with a group of people who are so caring and so committed. Together, I am positive that we are making 

a difference every day. Thank you for being here. 

The hearing record will remain open for 15 days for the submission of some additional questions that we ran out of time for and 

any statements. Thank you very much. 

This hearing is adjourned. 

[Applause.] 

[Whereupon, at 1:02 p.m., the Committee was adjourned.] 

(41)

A P P E N D I X 

PREPARED STATEMENT OF SENATOR LIEBERMAN 

Thank you, Madam Chairman for calling this hearing today so that we can focus 

on a disease that affects the daily lives of up to a million children and their parents 

across the country and on an organization—the Juvenile Diabetes Research Foundation—that deserves enormous credit for its global leadership in working to find a 

cure for this misunderstood disease. 

It’s such a pleasure to have this group of young, lively representatives here today 

who are all doing their part to raise awareness about the importance of juvenile diabetes research. Three of these young lobbyists are from my home State of Connecticut. If you’ll indulge me for a moment, Madam Chairman, they are Matt Ruby, 

a 17-year-old from Avon, Amanda Updyke, a 14-year-old from East Lyme, and 

Dylan Rae, from my home town of Stamford, who will join his mom and dad in testifying today. Dylan, I know I’m a little late, but I understand you had a big day over 

the weekend, so, on behalf of my colleagues here today, I want to wish you a belated 

but hearty Happy Fourth Birthday. 

As you all know too well, Type 1 diabetes affects anywhere from 500,000 to 1 million Americans, most of them children and young adults. In act, the risk of developing Type 1 diabetes is higher than the risk of developing virtually any other severe, chronic childhood disease. That’s why the search for a cure is so important. 

What most people don’t realize is that insulin is not a cure. Type 1 diabetes needs 

constant attention and is often difficult to manage. And because of the threat of 

complications, it can reduce the quality of life and shorten the life span of those who 

suffer from it. 

Diabetes is also one of the most expensive diseases to treat. Finding a cure not 

only would improve the lives of these young people with us today, it would save taxpayers millions of dollars in Medicare, Medicaid and State Children’s Health Insurance Program expenses. 

That’s why I have proposed an American Center for Cures, an institute dedicated 

to finding the next generation of medicines that will enable this generation of Americans to live healthier, stronger, and longer lives. We must take some of the miraculous developments that are occurring in laboratories around American today—the 

Human Genome Project, stem cell research, all sorts of other pharmaceutical breakthroughs—and focus them in one place with the goal of curing some of the chronic 

diseases—including diabetes—that plague 100 million Americans and cost $750 billion a year to treat. 

We can do this, but we can only do it with an investment of public money, attractions for private money, and a center to make this a real goal. The experts I talk 

to say that with research we are within reach of cures for a variety of diseases including diabetes, Alzheimers, Parkinson’s, cancer and AIDS, if we really work at it. 

In the meantime, we must lend our strong support to Chairman Collins’ bill, the 

Pancreatic Islet Cell Transplantation Act, which I am pleased to co-sponsor. Among 

other things, this bill directs the Secretary of Health and Human Services to study 

and assess the value of a promising new therapy—pancreatic islet cell transplantation—whereby healthy pancreatic cells are injected into diabetics who’s own 

pancreases have failed. It is a simple procedure, very similar to a blood transfusion, 

and the early results have given a lot of people hope. 

When all is said and done, what we need is national leadership on this issue, national leadership to commit resources and marshal our resolve to cure this disease. 

This is America. In America we don’t just manage problems; we solve them. That’s 

what our country is all about. All of you have committed to a goal of curing diabetes. 

Today, I join you in that commitment—to banish diabetes from our lives and the 

lives of our loved ones forever. 

Thank you, Madam Chairman.

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