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77–918 2013

THE BATTLE AGAINST DIABETES: PROGRESS 

MADE; CHALLENGES UNMET 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

JULY 1, 2010 

Serial No. 111–141 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 


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SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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C O N T E N T S 

Page 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 1 

Hon. John Shimkus, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 3 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 3 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 5 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 6 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 6 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 8 

Hon. Ed Whitfield, a Representative in Congress from the Commonwealth 

of Kentucky, opening statement ......................................................................... 9 

Hon. Lois Capps, a Representative in Congress from the State of California, 

opening statement ................................................................................................ 10 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 10 

Hon. Donna M. Christensen, a Representative in Congress from the Virgin 

Islands, opening statement ................................................................................. 11 

Hon. Zachary T. Space, a Representative in Congress from the State of 

Ohio, prepared statement .................................................................................... 14 

Hon. Betty Sutton, a Representative in Congress from the State of Ohio, 

opening statement ................................................................................................ 17 

Hon. Janice D. Schakowsky, a Representative in Congress from the State 

of Illinois, opening statement .............................................................................. 17 

Hon. Tammy Baldwin, a Representative in Congress from the State of Wisconsin, opening statement ................................................................................... 18 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, prepared statement .................................................................................. 107 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 108 

Hon. Kathy Castor, a Representative in Congress from the State of Florida, 

prepared statement .............................................................................................. 111 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 113 

Hon. John Sullivan, a Representative in Congress from the State of Oklahoma, prepared statement ................................................................................... 117 

WITNESSES

Ann Albright, Ph.D., R.D., Director, Division of Diabetes Translation, Centers 

for Disease Control and Prevention .................................................................... 19 

Prepared statement .......................................................................................... 22 

Answers to submitted questions ...................................................................... 146 

Judith Fradkin, M.D., Director, Division of Diabetes, Endocrinology and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney 

Diseases, National Institutes of Health ............................................................. 39 

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

Answers to submitted questions ...................................................................... 158 


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VI 

Buford Rolin, Vice Chairman and Nashville Area Representative, National 

Indian Health Board; and Chairman, Poarch Band of Creek Indians ............ 68 

Prepared statement .......................................................................................... 71 

Answers to submitted questions ...................................................................... 174 

Robert A. Goldstein, M.D., Ph.D., Senior Vice President, Scientific Affairs, 

Juvenile Diabetes Research Foundation ............................................................ 76 

Prepared statement .......................................................................................... 78 

Answers to submitted questions ...................................................................... 175 

Robert R. Henry, M.D., President-Elect, Medicine and Science, American Diabetes Association, Professor of Medicine, University of California Department of Medicine; and Chief, Section of Endocrinology, Metabolism and 

Diabetes, VA Medical Center in San Diego ....................................................... 87 

Prepared statement .......................................................................................... 89 

Answers to submitted questions ...................................................................... 180 

SUBMITTED MATERIAL

DeGette documents for the record .......................................................................... 119 


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THE BATTLE AGAINST DIABETES: PROGRESS 

MADE; CHALLENGES UNMET 

THURSDAY, JULY 1, 2010 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:05 a.m., in Room 

2123 of the Rayburn House Office Building, Hon. Frank Pallone, 

Jr. [Chairman of the Subcommittee] presiding. 

Members present: Representatives Pallone, Dingell, Engel, 

Green, DeGette, Capps, Schakowsky, Baldwin, Barrow, 

Christensen, Castor, Space, Sutton, Waxman (ex officio), Shimkus, 

Whitfield, Burgess, Blackburn, and Gingrey. 

Staff present: Karen Nelson, Deputy Committee Staff Director 

for Health; Sarah Despres, Counsel; Purvee Kempf, Counsel; Emily 

Gibbons, Professional Staff Member; Katie Campbell, Professional 

Staff Member; Stephen Cha, Professional Staff Member; Virgil Miller, Professional Staff Member; Anne Morris, Professional Staff 

Member; Alvin Banks, Special Assistant; Allison Corr, Special Assistant; Karen Lightfoot, Communications Director, Senior Policy 

Advisor; Lindsay Vidal, Special Assistant; Clay Alspach, Minority 

Counsel, Health; and Ryan Long, Minority Chief Counsel, Health. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. The meeting of the Health Subcommittee is called 

to order. 

Today we are having a hearing on our collective battle against 

diabetes, the progress we have made so and the challenges that remain. Over 30 years ago, Congress passed the National Diabetes 

Research and Education Act, the first significant legislation directed at coordinating and expanding the government’s research 

and prevention efforts related to diabetes. While we have made tremendous progress in understanding and treating diabetes, it remains a significant public health epidemic. It is staggering to realize that over 23 million Americans have some form of diabetes 

today, and the number is growing. Even more troubling is that 57 

million Americans are at serious risk for developing type 2 diabetes 

including women with gestational diabetes. 

Until recently, kids were rarely diagnosed with anything but 

Type 1 diabetes, and the increasing rate of childhood obesity is 

changing the face of diabetes though, and certainly not for the betVerDate Mar 14 2013 01:02 Mar 20, 2013 Jkt 077918 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 E:\HR\OC\A918.XXX A918

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ter. And as we will hear today from our esteemed panels, diabetes 

is a leading cause of heart disease, stroke, blindness and kidney 

failure. 

As is often the case, diabetes disproportionately affects racial and 

ethnic minorities. American Indians have the highest prevalence of 

diabetes, nearly four times those of white Americans, with Hispanics and African-Americans close behind. 

Moreover, there is a clear economic cost. It has been estimated 

that over $220 billion in medical expenses in 2007 can be attributed to diabetes. 

These are serious problems which need aggressive and innovative action. Today we are going to hear from two of our government 

witnesses from the National Institute of Diabetes and Digestive 

and Kidney Diseases, located at NIH, and the Centers for Disease 

Control. Both will speak to their agencies’ roles in doing landmark 

research and surveillance work related to diabetes, and how this 

information has been translated into more effective prevention and 

treatment strategies, including the development of key therapies 

and technologies. I should add that NIDDK has recently celebrated 

its 60th anniversary conducting and supporting biomedical research to improve health care across the nation. NIDDK leads the 

Nation’s federal commitment in research, education and health information dissemination with respect to diabetes, and supports investigators who continue to make strides in research toward understanding, preventing and treating type 1 diabetes, type 2 diabetes 

and gestational diabetes. It is for these reasons that the ranking 

member, Congressman Shimkus, and I recently introduced a resolution honoring the NIDDK for its outstanding work. 

Now, on our second panel, comprised of leaders from the American Diabetes Association, the Juvenile Diabetes Research Foundation and National Indian Health Board, will also be able to shed 

light on the partnerships they have with government and in the 

community to maximize technology, translating to improved health 

outcomes. Lessons learned from innovative research such as that 

funded by the Special Diabetes Program, have informed our efforts 

to address the epidemic today and will continue to do in the future. 

I have to mention my home State and say that innovative, exciting 

and collaborative work on diabetes research is taking place across 

the country in public-private partnerships, and I am proud that 

New Jersey’s life sciences industry continues to play a strong role 

in contributing to our ability to address the epidemic today and will 

do so in the future. 

Before I turn it over to Mr. Shimkus—she is here. I wanted to 

mention that there were many members who asked for this hearing 

but the most persistent one was certainly the gentlewoman from 

Colorado, Ms. DeGette, but I know that many members have asked 

that we have this hearing today. Also, my Native American friends 

have been asking that we have this for some time because of the 

high incidence of diabetes in American Indian populations. 

So with that, I will turn it over to Mr. Shimkus. 


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OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Mr. SHIMKUS. Thank you, Mr. Chairman. I do want to recognize 

Diana DeGette, also, Ed Whitfield and Freddy Upton and Zach 

Space, and Diana is a rabid supporter and well known for her hard 

and diligent work, so there is a story we tell only to ourselves 

about our first term when we sat together way up front and they 

moved us, so—they moved me. 

Let me just welcome folks here, and as a member of the very 

large Diabetes Caucus and the work from all the whole community 

to help educate us, to educate, really, children and parents and 

that whole plethora, it is a success story. Obviously we would like 

to have the final success which would be, you know, cure and that 

is the research and that is the disease management and that is 

what we should be focusing on. 

We will continue to express concerns about spending and the 

debt because budgetarily it will affect our ability to get money for 

research and development. If we continue to spend more and more 

money on interest on the debt, then the discretionary money and 

the accounts that we have to do NIH, do CDC, to do all the things 

that we need to do gets limited. In fact, USA Today in their article 

the federal debt will represent 62 percent of the Nation’s economy 

by the end of this year, the highest percentage since just after 

World War II, and that is according to the CBO. 

So when we raise issues about the new health care law, when we 

raise issues about spending and dollars, we are putting ourselves 

in a bad position to really focus on the things we want to do and 

set priorities interest payments will start consuming that. So as we 

make those cases, we do that with the best intention. 

This hearing is a result of a letter that was sent by Diana and 

her colleagues. We have sent other letters on the law that we hope 

will be well received too, whether it is the CMS actuary or of concern now are high-risk pools which were promised in the new 

health care law which some States can’t fully fund and operate or 

the States that have turned it over to the federal government because they are not going to manage it themselves, we have no idea 

what we are going to do, and those are promises we made as a Nation with the passage of the law and the signing by the President. 

So we have to figure out how we can keep our promises. 

So I have a lot more I would want to say but I know time is 

short, and I will yield back my time and thank the chairman for 

letting me use his big chair. 

Mr. PALLONE. Thank you, Mr. Shimkus. 

Next is the gentlewoman from Colorado, Ms. DeGette. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you so much, Mr. Chairman, and thanks 

to Mr. Shimkus for his I think allegedly kind words. 

I really want to thank Mr. Space and Mr. Whitfield and Mr. 

Upton for requesting this hearing with me, and I also want to 

thank Mr. Green and all the rest of the members of this committee 

because we all share a collective commitment to addressing the 


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issues of diabetes. The 250-member Congressional Diabetes Caucus 

is the largest caucus in Congress, and we strive hard to keep it 

that way. The reason is because diabetes is the fastest growing epidemic in this country and it affects everybody, young and old. 

Twenty-four million people have diabetes in this country. Fiftyseven million people, which is a quarter of all American adults, 

have pre-diabetes. So one of our tasks as well as giving quality care 

and management to the people who already have one of the various 

forms of diabetes is to try to get these other people back from the 

brink, and this is something that is difficult because most of those 

people don’t even know that they are pre-diabetic. 

Have we made progress? Yes, we have made some. We know that 

effective patient self-management of an individual’s own diabetes is 

arguably the most crucial part of an overall care regimen and there 

is now a substantial body of evidence that diabetes self-management training is effective but only if the patient has access to it. 

We also know that medical nutrition therapy can have a significant 

impact on preventing pre-diabetes from becoming full-blown diabetes. 

One issue that I have been increasingly concerned about and I 

have talked to a lot of folks about this is access to technology because as the mother of a 16-year-old with type 1 diabetes, I see the 

wonderful care advances that she has access to but these advances 

are very, very expensive. She now has a continuous glucose monitor, and the sensors that she puts in once or twice a week each 

cost $80 before insurance. So I say to myself and the members of 

the Diabetes Caucus, how can we make those wonderful advances 

in care and technology available to every diabetic, not just those 

who are fortunate enough to have parents with good health care 

coverage. We also know that disparities in minority populations are 

too prevalent but we haven’t done enough research to figure out 

how to mitigate the disparities in prevention, access and treatment 

for these populations. 

So we have made progress but when the incidence of diabetes in 

the United States continues to rise unabated, it is clear that diabetes has become as described in this week’s Lancet a public health 

humiliation for our Nation. The Diabetes Caucus is unwaveringly 

committed to tackle these challenges that are still unmet and to remove this humiliation. We will continue to press forward on all of 

the priorities including making our hard-fought efforts to include 

certified diabetes educators as Medicare providers, to classify podiatrists as physicians under Medicaid, and many, many other priorities. The caucus is going to host a briefing on July 12th to address the growing epidemic of pre-diabetes so we can start thinking 

about ways to pull those 57 million people back from the brink. 

For pre-diabetes, type 1 diabetes to type 2, to gestational diabetes and even malnutrition diabetes, this condition comes at us in 

different forms but the urgency mandates that we continue to work 

tirelessly to tackle the issue, and Mr. Shimkus is right. It is a 

health issue and also a cost issue because if we don’t start putting 

the research into this issue now, it is going to overwhelm our 

health care system, as my two young girls become adults. 

So I want to thank the witnesses on both panels for coming 

today. This testimony really helps us set our course as we move 


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forward the rest of this year and into the next year to set our policy 

as a caucus but also as a Health Subcommittee, and with that, I 

yield back. 

Mr. PALLONE. Thank you. 

Ms. Blackburn. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Mrs. BLACKBURN. Mr. Chairman, I do thank you for calling the 

hearing, and I want to welcome Mr. Buford Rolin, who is chairman 

of the Poarch Band of Creek Indians and the national area representative for the National Indian Health Board and say a special 

welcome to him for coming in today and to all of our witnesses. We 

thank you for coming in today and to all of our witnesses, we thank 

you for attending, we thank you for the preparation that you put 

into the hearings as you come to us. 

Diabetes presents serious financial burdens and cost patients in Tennessee more than $3 billion in 2007. I had the pleasure of meeting the Gould family from Middle, Tennessee, last year during the 

JDRF fly-in. Four of eight children in their family suffer from type 

1 diabetes. It is impossible to imagine the financial and emotional 

toll that this disease takes on each and every day for that family. 

With the sixth highest rate of diabetes in the Nation, this is a very 

important issue to our State of Tennessee. 

According to the JDRF, over 10 percent of Tennessee’s population 

is diabetic. In an annual obesity report released Monday by the 

Robert Wood Johnson Foundation, Tennessee was ranked the second most obese State in the country. A direct link between diabetes 

and obesity exists. We all are aware of that, and it appears that 

Tennessee is on their way to a diabetes epidemic. Due to the prevalence of this disease, the research, treatment and prevention efforts 

are a significant focus for our Tennessee medical researchers. In 

fiscal year 2009, NIH—and we thank you—granted over $17 million for research in Tennessee. The American Diabetes Association 

has eight active research grants in the State. Most are focused on 

type 2 diabetes. Vanderbilt University Medical Center’s Eskin Diabetes Clinic is in the midst of 10 clinical trials to develop treatments and learn more about the disease. And finally in my district, 

we have two wonderful JDRF chapters. They are working actively 

to support those with type 1 diabetes and the organization who has 

given more than, get this, $55 million to Tennessee researchers. 

They are doing great work. 

So for all of our agencies that are in the room, we thank you for 

the working that you are putting in, and these volunteers with associations are doing an incredible job in our State. So I join my colleagues in saying this is an area we want to heighten awareness. 

We want to be more proficient in our education efforts and we hope 

that we provide the proper support for the researchers who are trying to find a cure, a treatment and disease management programs 

for this disease. 

I thank you, and I yield back. 

Mr. PALLONE. Thank you, Ms. Blackburn. I am told we are OK 

now with the mics, so we will see. 


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Next is our chairman, Mr. Waxman. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you, Chairman Pallone, for convening today’s hearing. 

The term ‘‘diabetes’’ describes a host of related health conditions 

that are familiar to us, and the facts are staggering. More than 20 

million Americans have diabetes, almost 60 million more at risk for 

diabetes, the leading cause of blindness and kidney failure. People 

with diabetes are at least twice as likely to die of heart disease or 

have a stroke, and diabetes is the seventh leading cause of death. 

It affects all age groups, both sexes and every race and ethnicity. 

However, older Americans and certain racial and ethnic groups are 

several times more likely to have diabetes than others. That is why 

I am glad that we are taking the opportunity to learn about landmark research accomplishments, ongoing efforts to translate what 

we know works into practice and research questions we have yet 

to answer. 

Research has shown genetic causes, effective prevention for type 

2 diabetes and ways to delay and prevent complications. NIDDK, 

CDC and other agencies within the Department are working to ensure that our government has a coordinated effort to advance diabetes research and improve the health of those affected by this condition. 

Still, there is work to be done. We must continue our efforts to 

prevent women with gestational diabetes from developing type 2 diabetes later in life. We are not yet able to prevent type 2 diabetes 

nor have we perfected the link between the continuous monitoring 

of blood glucose and the administration of insulin, the so-called artificial pancreas. And just this week, two new studies on the drug 

Avandia underscore the need to better understand and better treat 

type 2 diabetes. 

Underpinning all of this is the importance of a broad public 

health approach to this disease. We need sustained investments in 

research. We need people who have information to be emphasizing 

the point that diabetes is 24 hours, 7 days a week. That is why we 

support what health providers, families, and what is going on 

workplaces to maximize each person’s health and well-being. 

I want to thank the witnesses for appearing before us today and 

I look forward to hearing their testimony. With that, Mr. Chairman, I yield back my time. 

Mr. PALLONE. Thank you, Chairman Waxman. 

Next is the gentleman from Georgia, Mr. Gingrey. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Thank you, Mr. Chairman. 

The World Health Organization has found that more than 150 

million people suffer from diabetes and it is estimated that this 

number will actually double by the year 2025. For at least the last 

20 years, diabetes rates in North America have been increasing 

substantially with about 18.2 million Americans living with the 


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disease in 2002. Of those, roughly 90 percent have type 2 diabetes, 

which costs the United States as much as $132 billion a year. 

These statistics are a stark reminder of the impact the disease has 

on our Nation but also reminds us that the onset of diabetes for 

some Americans can be prevented. 

A majority of the patients with type 2 diabetes are obese, the 

connection being that chronic obesity leads to increased insulin resistance that can then develop into diabetes. Obesity in many 

forms is a gateway from which diabetes, heart disease and other 

chronic conditions can strike American patients. Therefore, as we 

look at the federal response to diabetes, I would suggest that we 

also consider the root cause of obesity, reassessing the food stamp 

program so that healthy foods are encouraged, ensuring access to 

local parks and recreational programs and promoting employer 

wellness programs, all the things that the federal government can 

and should do to encourage healthy lifestyles. 

We should also ensure that Americans with chronic diseases 

have access to quality health care. Unfortunately, President 

Obama’s health care reform bill will make it hard for many Americans with chronic diseases to find care when in need. As many of 

you know, the preexisting condition insurance plan passed as part 

of President Obama’s health care bill, Patient Protection Affordable 

Care Act of 2010, will begin accepting applications in many States 

today. However, according to an AP article that ran just yesterday, 

and I quote, ‘‘Premiums will be a stretch for many and the $5 billion that Congress allocated to the program through 2013 could run 

out well before that.’’ The Congressional Budget Office in a report 

released last week supported this finding when stating that the 

program’s funding will not be sufficient to cover the cost of all applicants. 

Mr. Chairman, Ranking Member Shimkus has repeatedly called 

for hearings on the new health care law because it is deeply flawed 

and certainly can and I think will hurt our country. Since the day 

the bill was enacted, we have been reminded how this bill fails everyday Americans, companies filing billion-lawsuits with the SEC, 

the Department of Labor reporting that half of all workers will actually lose the health plan that they have today, and many Americans with chronic illnesses will be offered health insurance that 

they just simply cannot afford. Mr. Chairman, I would urge this 

committee to act and hold hearings on the problems in the bill, 

President Obama’s health care law. 

That being said, however, Mr. Chairman, I really do want to single out and commend Congresswoman DeGette for her efforts in 

addressing the incidence of diabetes in this country. She represents 

and is I think chairperson of the largest caucus in Congress today 

with over 250 members. Her leadership in this area is laudable and 

worthy of recognition by this committee and by myself, a practicing 

physician before I got this job. 

And with that, Mr. Chairman, I yield back. 

Mr. PALLONE. Thank you, Mr. Gingrey. 

Next is our chairman emeritus, Mr. Dingell. 


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OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. DINGELL. Mr. Chairman, I thank you for your courtesy and 

I commend you for this hearing. 

First, I wish to recognize the many members of this committee 

who have continued to beat the drum on this disease, and I thank 

them for their leadership. 

It is safe to say that we have a diabetes epidemic on our hands. 

More than 24 million Americans are afflicted with the disease. 

That is more than twice the number of people with diabetes in 

1997. In my home State of Michigan, more than 680,000 people, 8.6 

percent of our population, struggle with the disease daily. In addition to the major health complications caused by diabetes, the economic toll of the disease is considerable. Diabetes costs the U.S. 

economy $174 billion every year. One-third of every Medicare dollar is spent on people with diseases and already stretched State 

Medicaid programs are confronted with the growing costs of diabetes care. 

Since the passage of the National Diabetes Research and Education Act in 1974, the federal government has worked to coordinate diabetes activities amongst the various responsible agencies. 

Most notably, the work of the Centers for Disease Control and Prevention and the National Institutes of Health have tossed a tremendous amount on the causes of this disease and ways to control 

and prevent it. Because of our surveillance, education and treatment activities, individuals today with diabetes live longer and 

healthier lives than people were diagnosed with the condition in 

prior decades. However, the rate of new cases of diabetes continues 

to increase. As a result, the gains in control and treatment are 

being overtaken and submerged by the increase in the number of 

people acquiring the condition. 

The recently enacted health reform law will address the many 

abuses employed by insurance companies to discriminate against 

those with diabetes, and I am extremely proud of that fact. Additionally, the new law provides access to the necessary tools to manage and prevent diabetes and its complications including the creation of a National Diabetes Prevention Program, a national report 

card on diabetes to be updated every 2 years, and State grants to 

provide healthy lifestyle incentives for Medicare beneficiaries. Now, 

these steps will go a long way in our fight against diabetes but 

more can and should be done. We must ensure our approach is consistent with current science and with understanding the disease. 

Our approach needs to be comprehensive and it must ensure that 

all we do and that we do all we can to prevent the onset of the disease to ensure the diagnosis of the disease is conducted in the most 

efficient and accurate manner, and to ensure that our people have 

the best methods available to control the disease and ensure that 

diabetics have the best treatment and medications available to prevent complications. These efforts we make in defeating diabetes 

will have an enormous impact on the health of our Nation. 

Thank you again, Mr. Chairman. I yield back the balance of my 

time. 

Mr. PALLONE. Thank you, Chairman Dingell. 


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Let me now—they just called three suspension votes but I would 

like to take one more speaker and then we will recess and come 

back, which should be about half an hour or so. And next on my 

list is the gentleman from Kentucky, Mr. Whitfield. 

OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY 

Mr. WHITFIELD. Thank you very much, and I certainly want to 

thank the witnesses for being here today. We appreciate very much 

the commitment that you have made to help us find a cure for this 

disease and to reduce the number of people that unfortunately 

have it, and I also hope that those in the audience are not disillusioned that Republicans and Democrats are so joined together on 

this issue. 

I do want to thank Diana DeGette and Henry Waxman and 

Frank Pallone as well as John Shimkus, Joe Barton, Fred Upton, 

Zach Space and all of those who are involved and interested in this 

issue. 

Two months ago, I was down in my district and I met with the 

parents and six teenagers who all had diabetes, and we frequently, 

those of us who are layman, think that what you eat and your 

weight is the determining factor of whether or not you have diabetes but when you talk to these young teenagers, all of whom are 

very thin, very energetic, all of them have diabetes, and then you 

realize what they go through every single day with the testing that 

they do, with the monitoring that they do, watching the foods that 

they eat, the emergency runs to the hospital they make and the impact it is going to have on their entire life, it does bring home very 

clearly the impact that this disease has. Other speakers have 

talked about the statistics and the costs and the impact on the 

number of people in our country, and so I think this hearing is very 

important. I certainly want to thank Diana DeGette for sort of 

leading the charge. I know that all of our physicians on this panel, 

Dr. Gingrey and our friend from Texas, Dr. Burgess, have particular interest as well. 

So we look forward to your testimony to help guide us as we 

move forward, and I also want to point out that while the federal 

government is spending a lot of money on research, we also have 

some private companies that are spending a lot of money on research, and one that I would like to particularly mention is Novo 

Nordisk, which happens to be a company in Denmark but they 

have 4,000 employees in the United States, and the U.S. federal 

government is the only entity that is spending more money on research on diabetes than is Novo Nordisk, so I want to thank them 

and their leadership team for their commitment to this disease as 

well 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Whitfield. 

We have time for one more before we break, so I am going to ask 

our vice chair, Ms. Capps, to do an opening statement. 


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OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mrs. CAPPS. Thank you, Chairman Pallone, for holding this hearing, and it gives me an opportunity to thank my suitemate here, 

my colleague, Diana DeGette, as well, for bringing us all together 

around this issue, and on behalf of the entire diabetes community 

because as I was just mentioning to her, this is a very well-organized group with juvenile diabetes and make visits to their Members of Congress regularly, and I want to applaud them for doing 

that. 

It really has an impact on us. I look forward to an update today 

from our esteemed witnesses on the progress of diabetes research. 

After all, despite all the promising discoveries over the past several 

decades, there still is no cure, no surefire way to prevent the development of diabetes, especially type 1. As many of my colleagues 

know, I was a school nurse for many years, and if there is one disease that is sure to make a student a frequent visitor into the 

nurse’s office at school is diabetes, so I certainly became very familiar with the maintenance of type 1 diabetes and I have been hopeful that by now we would have something in place but there are 

many promising things on the horizon which is exciting to know 

about or what we are going to learn today. 

The sad truth, however, as my colleagues have indicated, is that 

children don’t suffer today just from type 1 diabetes. There is such 

an increase now in the incidence of type 2 diabetes. I know there 

are definite steps to prevent the onset of type 2 we can take in our 

communities such as increased physical activity and better nutrition but we need also to be creative in how we get the message out 

to at-risk populations, especially minority ones, and design programs targeted for those populations. I think particularly of programs in my district such as St. John’s Latino Health Diabetes 

League, an initiative in Oxnard, California, which is tailored educational programming to at-risk communities. But they can only do 

this with the right type of evidence-based research being conducted 

at the institutions represented here today. 

So I am especially curious today to learn more about how you are 

working to equip our local communities with the tools that they 

need to address diabetes prevention and management. I look forward to hearing from our witnesses about the exciting work you 

are doing now and how Congress can better work with you and 

help you achieve our shared goal of finding a cure. 

I yield back. 

Mr. PALLONE. Thank you, Ms. Capps. 

So we will now take a recess for the three votes. The committee 

stands in recess. 

[Recess.] 

Mr. PALLONE. The committee hearing will reconvene, and we will 

begin with the gentleman from Texas, Mr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Well, I thank the chairman for yielding. 

The hearing this morning focuses on an important public health 

issue, obviously a significant impact on our Nation and a crippling 


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effect on our budgets, and we have already heard statistics from a 

number of members this morning so I won’t repeat those, only to 

mention that in my home State of Texas over 1–1/2 million people 

over the age of 18 have diabetes, and in our State, it is the sixth 

leading cause of death. 

Two bills which I would like this committee to consider to move 

expeditiously and mark up, of course, we have already heard about 

H.R. 3668, Representative DeGette, would reauthorize the special 

diabetes programs for type 1 diabetes. This program was started 

back in the 1990s under the guidance of then-Speaker Newt Gingrich, and he continues, as do I, to support the innovative work of 

this program. In fact, there have been some rather dramatic things 

that have come out of this program including auto transplantation 

of beta cells from people who have had a dramatic disruption of the 

pancreas. 

Now, I also have a bill with Eliot Engel, the Gestational Diabetes 

Act of 2009. Having practiced as an OB/GYN for over 25 years, I 

am clearly well aware of the problems of untreated gestational diabetes affecting over 200,000 pregnancies a year, over 7 percent of 

the pregnancies in this country, and they can have significant impact on both the mother and child because they are at significant 

risk of developing type 2 diabetes, and mothers are almost three 

times more likely to have a recurrence of gestational diabetes in future pregnancies. As with other diabetes trends, the rates of gestational diabetes are higher among women of African American, Hispanic, Asian and Native American descent. H.R. 5354 creates a research advisory committee headed by the CDC to expand monitoring including coordinating efforts to help mothers avoid contracting type 2 diabetes. 

So I would urge members of the committee to cosponsor this legislation. It does just so happen that I have a signup sheet for anyone interested in cosponsoring this bill, and I Mr. Engel and I 

would be happy to take that to the floor to save you the trouble. 

While we hear about the increase of obesity in the United States 

that has raised the prevalence of diabetes generally, we also need 

to hear about the impact of genetics, ethnicity and maternal age, 

particularly in the case of gestational diabetes, and focus our research on how diabetes cost can be reduced through better lifestyle 

choices. With the correlation between obesity and lower income levels and diabetes, this committee really needs to stress being involved in encouraging proper nutritional choices for our populations 

that we serve under Medicare, which is under our jurisdiction. 

So I thank you, Mr. Chairman. I will unbelievably yield back the 

balance of my time. 

Mr. PALLONE. I am supposed to take notice, I guess, right? All 

right. Thank you. 

Next is the gentlewoman from the Virgin Islands, Ms. 

Christensen. 

OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 

REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman, and Ranking 

Member Stupak for holding this hearing today to discuss the yet 


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unmet challenges facing us regarding diabetes, and thank you also 

to Diana DeGette for her leadership on this issue. 

I would like to welcome our witnesses today on both panels and 

recognize in addition the 60th anniversary of the National Institute 

of Diabetes and Digestive and Kidney Disease and wish you many 

more years of leadership and conducting and supporting biomedical 

research. 

I too also want to thank Novo Nordisk for their work on diabetes 

both in the lab and in communities like mine, which has a prevalence of diabetes that is far higher than the national average. 

Diabetes is a disease that strikes at every age level and every racial and ethnic group in America, and while it does still disproportionately affect the elderly, the fact remains that its prevalence is 

growing among all groups. In addition to the nearly 24 million people currently living with diabetes, there are 57 million estimated 

to have pre-diabetes, putting them at increased risk for developing 

diabetes and complications therefrom. Particularly disturbing to me 

is the increase in type 2 diabetes in children and the racial and 

ethnic differences in prevalence of diagnosed diabetes. When nearly 

12 percent of non-Hispanic blacks, more than 10 percent of Hispanics and an unacceptable 16.5 percent of Native Americans and 

Alaska Natives have been diagnosed with diabetes compared to 6.6 

percent in non-Hispanic whites and 7.5 percent in Asian Americans, it is undeniable that aggressive action must be taken to address these disparities. It is also alarming that the prevalence of 

a disease which 100 years ago was unknown to them affects now 

Native Americans and Alaska Natives at a rate that is more than 

twice that of their white counterparts. 

It is because of these disturbing facts that I am especially 

pleased to see that Mr. Buford Rolin is present from the National 

Indian Health Board. Although the diversity that exists among Native Americans, Alaska Native populations must be recognized. 

Your presence here is certainly a step in the right direction, and 

giving these populations a voice on this issue and ensuring that the 

diversity that exists on every American health issue is not overlooked or forgotten. 

It has been over 35 years since the Interagency Committee to Coordinate Diabetes was set up at HHS, and while advances have 

been made, in that time diabetes has exploded, especially in the 

South, and racial and ethnic minorities and type 2 in children, so 

I look forward to exploring today what is going to change forward 

so we can reverse this really terrible trend that we are seeing in 

our country. 

Mr. GINGREY. Will the gentlelady yield to me before she yields 

back just for a friendly purpose? 

Mrs. CHRISTENSEN. Certainly. 

Mr. GINGREY. I thank the gentlewoman. 

Earlier a member on our side of the aisle recognized a couple of 

physicians on the committee and on the subcommittee, and he 

failed to mention Dr. Christensen, who has come to this Congress 

from the Virgin Islands, having practiced family medicine there for 

many years, and she knows of what she speaks, so I just wanted 

to recognize that fact. 

Mrs. CHRISTENSEN. Thank you for that. I yield back. Thanks. 


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Mr. PALLONE. I thank the gentlewoman. 

Next is the gentleman from Ohio, Mr. Space. 

Mr. SPACE. Mr. Chairman, I will enter my opening statement 

into the record on the condition that I will be allotted time for my 

questioning. 

Mr. PALLONE. Absolutely. That is how we work. 

Mr. SPACE. I would like to thank you, however, for calling this 

very important hearing, and my gratitude should also go out to 

Diana DeGette for her leadership and to Ed Whitfield and Fred 

Upton for joining me in the request for this hearing. 

[The prepared statement of Mr. Space follows:] 


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OPENING STATEMENT: "THE BATTLE AGAINST DIABETES: 

PROGRESS MADE, CHALLENGES UNMET" 

July 1,2010 

Thank you, Mr. Chairman, for holding this hearing. I am most grateful for 

your attention to an issue so important to me. 

I want to thank Rep. DeGette, the co-chair of the Diabetes Caucus, and 

Reps. Upton and Whitfield for joining me in requesting this hearing. It is 

refreshing to see bipartisan attention to an issue that so strongly affects our 

nation. 

During the III th Congress, this Committee has taken on a number of critical 

issues. Energy, health care, food safety, chemical security - the list goes on 

and on. 

Yet, I have not looked forward to a hearing with such anticipation and such 

excitement as I have this one. 

That is because diabetes - just one, simple disease - is rapidly becoming one 

of the biggest threats to our nation's health care system and, more 

importantly, our nation's health. 

We have all seen the statistics -

• 26 million Americans have diabetes, a number that is certain to 

continue to skyrocket 

• As the ADA points out in its testimony, diabetes is costing our nation 

$218 billion/year in health care costs and lost productivity. 

• Most astounding - that number boils down to more than half a billion 

dollars per day. 

But let's stop for a second and put that in perspective - this week the House 

is scheduled to vote on dedicating $33 billion to the wars in Afghanistan and 

Iraq. 

In 2009 total, we spent $148.2 billion on the two wars (according to CRS). 

Look at the differential! $218 billion to fight one disease, $148 billion to 

fight two wars. 
15 


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These figures are war-like. We are at war with diabetes. 

Today, this Subcommittee will have the opportunity to learn about how we 

the United States Congress and the Federal Government are addressing 

this ever-growing crisis. 

Advances in medical technology and our understanding of diabetes have 

radically improved the quality and length of life for people it afflicts. 

A prime example of such advances would be an insulin pump. The pump 

has helped countless Americans suffering from diabetes take control of their 

own lives by providing a more precise mechanism to track insulin intake, as 

well as a convenient medium to do so. 

Innovations like the pump have helped to grow the expected life span of 

those afflicted with diabetes, as scientific research continues to provide 

progressively more detailed information about how diabetes affects the 

body. 

But I fear that success will breed complacency. While these advances are 

certainly cause for cheer, they are not cause for an end in our pursuit for a 

better life for every American with diabetes. 

As a moderate Congressman who seeks to find the center on the issues we 

tackle, I am well versed in the practice of pragmatism. 

Yet, on the issue of medical research, I believe that we cannot fear to dream. 

We cannot afford to be bound by the restraints of the pessimists - we must 

strive to achieve that which seems unachievable. 

We must work to find a cure. 

Imagine a world where anyone afflicted with diabetes can be treated and 

cured. A world where the issue is not how best to manage the disease, but 

how quickly it can be expelled from the body. 

I believe that we can achieve this goal, with the commitment of this body. 

Congress must also begin thinking about diabetes in a comprehensive 

fashion. While I commend the work of many of my colleagues in advancing 

critical bills that make a difference in the lives of diabetics every day, how 

long has it been since we examined the full scope of how we treat diabetes? 
16 


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From public health initiatives of the public, prevention, early diagnosis to 

treatments, there are many questions to ask. 

As many of you know, this battle is a personal one for me. My son Nick 

was diagnosed with Type 1 diabetes (or juvenile diabetes) just over a decade 

ago. 

Any parent who has received the news of their child's illness understands 

what I felt the day he received his diagnosis - panic, fear, and hopelessness. 

Nick has been the beneficiary of innovations like an insulin pump that help 

him to track his disease more carefully than he could have 50 years ago. 

However, my family still worries for his future. Even with all the advances 

we have now, Nick still faces an uncertain road, as do the tens of thousands 

of type 1 diabetics across the country. 

In closing, I'd like to again offer my thanks to Chairman Pallone for hosting 

this hearing. I yield back the balance of my time. 
17 

Mr. PALLONE. OK. Next is the gentlewoman from Ohio, Ms. Sutton. 

OPENING STATEMENT OF HON. BETTY SUTTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF OHIO 

Ms. SUTTON. Thank you, Mr. Chairman, and I too appreciate you 

holding this hearing today. This is an incredibly important to have. 

I, like so many members of the subcommittee, care deeply about diabetes and I am a member of Ms. DeGette’s Congressional Diabetes 

Caucus, and I thank her very much for her tremendous leadership. 

Yesterday a young woman from northeast Ohio, Selena Williams, 

came into my office. Selena is a 15-year-old and was diagnosed 2 

years ago with type 2 diabetes. As you can imagine, and as some 

of you in this room have experienced personally, this was an incredibly scary time for Selena and her parents. She was very lucky 

to be able to participate in a treatment program at Rainbow Babies 

and Children’s Hospital, which is home to a center for excellent for 

childhood diabetes, activity and nutrition, and through Rainbow 

Babies Selena and her family joined a program called the TODAY 

program, which stands for Treatment Options for Type 2 Diabetes 

in Adolescents and Youth. The TODAY program’s goal is to study 

the best ways to treat type 2 diabetes in children, and in the 

TODAY program Selena and her family learned the basic skills 

that she would need as a diabetic—how to test her blood on a home 

meter, give insulin shots and manage high and low blood sugars. 

And she also learned through home visits with a certified diabetes 

nurse how to make lifestyle changes to help her and her entire 

family be healthier such as how to read food labels, manage portions and stay active. And through the TODAY program, Selena 

has improved her health and she recently did something that she 

said she never thought she would do. She tried out for the freshman basketball team, and I am proud to report that she made it. 

Sadly, there are millions of children like Selena but not all children 

have the same treatment opportunities or educational programs 

that Selena has had but all of those children have great potential, 

and the fact that they don’t have that opportunity is heartbreaking. 

So I look forward to hearing about the progress that has been 

made in the battle against diabetes and about the work that still 

needs to be done and what we can do to help. 

Thank you, and I yield back. 

Mr. PALLONE. Thank you. 

Next is the gentlewoman from Illinois, Ms. Schakowsky. 

OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. 

You know, if for no other reason, we should as policymakers and 

as taxpayers pay very close attention to diabetes. According to a 

Mathematica report by Drs. Marsha Gold and Ronette Briefel, diabetes costs the government, just the government cost, $80 billion 

a year in medical costs. That is Medicare and Medicaid, and I am 

sure veterans health care, etc. The CDC’s testimony reports that 

national costs for 2007 exceeded $218 billion. That includes private 


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insurance. So if we were to really target diabetes in terms of research, in terms of the kinds of public education programs that 

Congresswoman Sutton talked about in controlling this disease, we 

would also be able to save billions of dollars and change lives forever. 

Diabetes is really a very cruel disease that affects 23.6 million 

Americans. It is cruel to young children who have to draw blood 

every day, monitor their sugar and their diet, which is a good thing 

for all children but in the ways that diabetic children have to do, 

it is really difficult, and to millions of adults who develop diabetes 

later in life particularly for type 2 where there really are lifestyle 

kinds of changes that can be made. We need to invest in public 

health programs, and for all the rest of diabetes type 1 and also 

type 2, we need to invest in research. 

So I want to thank Congresswoman DeGette, who has been a 

champion throughout her career here and even earlier on addressing this important disease, important in so many ways, and a disease that we can in so many ways effectively address. So let us do 

it. I yield back. 

Mr. PALLONE. Thank you. 

And next is the gentlewoman from Wisconsin, Ms. Baldwin. 

OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF WISCONSIN 

Ms. BALDWIN. Thank you, Mr. Chairman and Ranking Member 

Shimkus for calling this hearing today, and I too want to echo my 

colleagues’ comments of gratitude for the leadership of my friend 

Diana DeGette on this issue. 

I also want to welcome all the witnesses that we have today. We 

are very much looking forward to hearing your testimony. 

Diabetes clearly has a sweeping impact on our society, and in 

that vein I would like to share the story today of a very brave family making a tremendous difference in my district and across the 

State of Wisconsin. The Wickmans are just like many other American families. They love the outdoors, they love to take road trips 

on weekends, and they would do anything for their children. Yet 

this family has really been ravaged by diabetes. Grandpa Rick has 

type 2 diabetes and just had to have his foot amputated recently. 

Their daughter, Stella, just 4 years old, has type 1 diabetes and 

has to have her finger pricked dozens of times each day to make 

sure that her blood sugar level is at a safe level. This disease infiltrates every waking moment of their lives. You know, the 

Wickmans discovered that Stella was sick on a family trip to the 

upper peninsula of Michigan after a midnight ambulance ride and 

an admission to a pediatric ICU. Since that day they really could 

have sat back and bemoaned their fate but instead they have really 

thrown themselves into helping Stella and the many children like 

her across the country by championing the Juvenile Diabetes Research Foundation of Western Wisconsin. They also carry the torch 

of another Wisconsin hero, Jesse Alswager. Jesse traveled extensively in his young life educating others about diabetes. He even 

testified before a panel here in Congress in support of stem cell reVerDate Mar 14 2013 01:02 Mar 20, 2013 Jkt 077918 PO 00000 Frm 00024 Fmt 6633 Sfmt 6633 E:\HR\OC\A918.XXX A918

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search. Jesse died due to complications of juvenile diabetes in February of this year at age 13 but his legacy clearly lives on. 

In my hometown at the University of Wisconsin, the progress towards better treatment is real. An FDA-approved clinical trial is 

currently underway for the use of adult stem cells in the treatment 

of type 1 diabetes. This study is cosponsored jointly by Osiris 

Therapeutics and the Juvenile Diabetes Research Foundation. Researchers are specifically targeting newly diagnosed type 1 diabetes 

patients who still have some functioning beta cells left. An infusion 

of targeted stem cell therapy could stop the immune destruction 

and preserve individuals’ remaining ability to make insulin. 

Perhaps the most exciting news for both the Wickmans and researchers in the district that I represent is the passage of the comprehensive health care reform legislation earlier this year. This 

year, the bill bans insurers from citing preexisting conditions as a 

reason to refuse to insure children in America and to ensure that 

a child like Stella will never be without health care coverage, and 

this year that piece of legislation invests $126 million through the 

new prevention and public health fund to help create the necessary 

infrastructure to prevent, detect and manage chronic diseases like 

diabetes. Clearly, much work remains to be done. 

So as we work to implement this legislation, we must remember 

the toll that diabetes takes on our families and on our health care 

system but we must also work to improve and expand existing federal programs that are making a difference today, and I am glad 

that our witnesses are here to help inform that process. 

Thank you, Mr. Chairman, and thank you again to our witnesses. 

Mr. PALLONE. Thank you, and I think that concludes our members’ opening statements. We will now move to our witnesses. Let 

me introduce, well, first welcome you both and introduce the two 

of you. On my left is Dr. Judith Fradkin, who is director of the Division of Diabetes, Endocrinology and Metabolic Diseases at the 

National Institute of Diabetes and Digestive and Kidney Diseases 

at the National Institutes of Health. Fradkin—did I pronounce that 

properly? OK. And then is Ann Albright, who is director of the Division of Diabetes Translation of the Centers for Disease Control 

and Prevention, and thank you both for being here. I think you 

know the drill, 5-minute speeches, and then if you want to submit 

additional written comments, you can, and I will start with Dr. 

Albright. 

STATEMENTS OF ANN ALBRIGHT, PH.D., R.D., DIRECTOR, DIVISION OF DIABETES TRANSLATION, CENTERS FOR DISEASE 

CONTROL AND PREVENTION; AND JUDITH FRADKIN, M.D., 

DIRECTOR, DIVISION OF DIABETES, ENDOCRINOLOGY AND 

METABOLIC DISEASES, NATIONAL INSTITUTE OF DIABETES 

AND DIGESTIVE AND KIDNEY DISEASES, NATIONAL INSTITUTES OF HEALTH 

STATEMENT OF ANN ALBRIGHT 

Ms. ALBRIGHT. Mr. Chairman, Mr. Shimkus and distinguished 

members of the subcommittee, thank you for the opportunity to 

participate in the hearing. I am Dr. Ann Albright. I am the director 


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of the diabetes division at CDC. I am trained as an exercise scientist and nutritionist but I also live with type 1 diabetes for 42 

years. 

The diabetes division at CDC translates the science of diabetes 

into practical strategies to control and prevent diabetes in the U.S. 

population and I will be describing some of our work in surveillance to define and monitor diabetes, the reduction of the risk factors, the prevention of type 2 diabetes, and management of this disease. 

The ability to identify the magnitude of a problem through ongoing surveillance is a foundation of CDC’s work. CDC developed and 

maintains the National Diabetes Surveillance System. It is the 

world’s first system for monitoring diabetes. It relies on national 

and State-based household telephone and hospital-based surveys, 

vital statistics to monitor trends in diabetes. In the last 2 years, 

CDC has developed a methodology to estimate levels of diabetes 

and obesity at the county level, providing policymakers and communities with new information to guide programming and resource 

allocation. 

CDC in collaboration with NIH has also initiated the largest 

major surveillance system to quantify and track type 1 and type 2 

diabetes in those under 20 years of ago called Search for Diabetes 

in Youth. Among other things, Search allows us to clarify the degree to which type 2 diabetes is affecting youth of different racial 

and ethnic backgrounds. 

Findings from our national surveillance system document several 

increases or successes in the public health response to diabetes 

over the past decade but have also revealed areas of major concern 

and continuing threats to the public’s health. Rates of blood glucose 

being out of control, amputations and end-stage renal disease 

among adults have declined. However, considerable variation and 

disparities in diabetes care and outcomes remain. 

CDC does work to impact and improve outcomes for women with 

and at risk for gestational diabetes. In collaboration with the National Association of Chronic Disease Directors and the Agency for 

Health Care Research and Quality, we have established a fiveState collaboration to identify, catalog and validate routinely collected data about gestational diabetes, identify gaps and documenting prevalence and determine implications for care. 

Our greatest concern, though, is the continued increase in the 

rate of new cases of diabetes. This is evident in virtually all segments of society. This continued increase in the rate of development of new cases is unfortunately negating many of the successes 

that clinical and public health efforts have achieved in reducing the 

rates of complications. The continued increase in diabetes incidence 

calls for a comprehensive implementation of a diabetes prevention 

strategy. 

So CDC is engaged in risk-reduction efforts on multiple levels including focus on obesity for the general population but the diabetes 

division focuses on those at highest risk for diabetes, so there are 

very complementary efforts, and in fact we have focused much of 

our work in the Native American community, helping many members achieve vouchers for nutritious foods, particularly fruits and 

vegetables, and the use of those vouchers have been in excess of 


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50 percent, so a very tangible, concrete example of a way to reduce 

those risk factors. 

Based on the findings of the NIH-led diabetes prevention program clinical trial, CDC is now actually translating those findings 

into practice. We are able to do this with our partners. At the top 

of the leading role is the YMCA of USA and United Health Group, 

and we are able to offer this for about $250 to $300 a person. This 

is the first time ever that a private health insurer has joined forces 

with a national community-based organization not deliver this 

work, and we are focusing on training the workforce, on recognizing those programs for quality assurance, for actually investing 

in delivery of the programs, and for health marketing so people 

know where to go and how to get those programs. 

We are also preventing complications of diabetes, and we have 

research trials that we have been doing, the Triad study. We are 

taking those findings and we are working with our State-based diabetes prevention and control programs to actually put those into 

practice and change what health care systems are actually delivering as a result of that study. 

I want to just close with two new projects that we have going on 

that are exciting, and one is the national program to eliminate diabetes-related disparities in vulnerable populations. We will now be 

funding six organizations that will focus on reducing the mortality 

and premature mortality and morbidity, and we will be helping 

this by helping these communities to organize, plan and implement 

effective strategies. And finally, we will also be initiating a new 

platform of research studies to examine the impact of populationtargeted policies emanating from health systems, business and 

community organizations and the government. 

So several steps have been taken to stem the diabetes epidemic. 

Work in risk factor reduction must continue so fewer people develop pre-diabetes. The programs and policies for obesity prevention and control are critical. There is a critical need for effective 

programs that prevent people with pre-diabetes from developing a 

disease and the first steps have been taken in the form of the National Diabetes Prevention Program. The complications of diabetes 

have a very high cost in terms of dollars and human suffering, and 

while improvements have been made, much work remains to be 

done, especially in those vulnerable populations. Thank you. 

[The prepared statement of Ms. Albright follows:] 


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Testimony before the 

Subcommittee on Health 

Committee on Energy and Commerce 

United States House of Representatives 

The Battle Against Diabetes: Progress Made, 

Challenges Unmet 

Statement of 

Ann Albright, PhD, RD 

Director, Division of Diabetes Translation 

National Center for Chronic Disease Prevention and Health 

Promotion 

Centers for Disease Control and Prevention 

U.S. Department of Health and Human Services 

For Release on Delivery 

Expected at 10:00 a.m. 

Thursday, July 1,2010 
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Introduction 

Mr. Chairman, Mr. Shimkus, and distinguished members of the Subcommittee, thank you 

for the opportunity to participate in this hearing. I am Dr. Ann Albright, Director ofthe 

Division of Diabetes Translation at the Centers for Disease Control and Prevention (CDC), an 

agency of the Department of Health and Human Services (HHS). CDC's Diabetes Program 

translates the science of diabetes into practical strategies to control and prevent diabetes in the 

U.S. population and implements these strategies through leadership, research, programs, and 

policy. Our work stretches from surveillance and reduction of diabetes risk factors, to prevention 

of diabetes, to management and surveillance of diabetes and complications in those who already 

have the disease. Today, I will describe how we accomplish this work, and how our work 

complements that of our sister divisions and agencies. 

Background 

Diabetes is a group of diseases marked by high blood glucose (sugar) resulting from a 

shortage of insulin, a decreased ability to use insulin, or both. When diabetes is not controlled, 

glucose and fats remain in the blood and damage vital organs. Diabetes is the leading cause of 

new cases of blindness, kidney failure, and non-traumatic lower-extremity amputations among 

adults. Women of childbearing age with diabetes and who become pregnant are at increased risk 

of having babies with major birth defects, a major cause of infant mortality and life-long 

disabilities. In addition, children born to women with diabetes are at increased risk for 

developing diabetes as adolescents or adults. Adults being treated for diabetes are just as likely 

to have a heart attack or stroke or die from cardiovascular causes as people who have had a prior 

heart attack, and are twice as likely to die following a heart attack as people without diabetes. 

[I] 

Medical costs associated with diabetes are substantial. Total national cost associated 

with diabetes in 2007 exceeded $218 billion. Pre-diabetes (a condition in which blood sugar is 

elevated but has not reached the levels that would result in a diagnosis of diabetes) costs $433 

annually per person (medical costs only); undiagnosed diabetes, $2,864; type 2 diabetes, $9,677; 

and type 1 diabetes, $14,856. Gestational diabetes cost per case averaged $3,514 in 2007 -

$3,305 in higher pregnancy cost and $209 additional cost during the newborn's first year oflife. 

[2] Diabetes was the seventh leading cause of death listed on U.S. death certificates in 2007. [3] 

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Diabetes has changed from a public health concern to a widespread epidemic. Data from CDC's 

2003 - 2006 National Health and Nutrition Examination Survey (NHANES) reveal that nearly 24 

million Americans now have diabetes [4], as compared to 10.2 million in 1997. [5] One in three 

children born in 2000 are at risk of developing diabetes during their lifetime. [6] 

Diabetes can be in the form of type 1 (shortage of insulin), type 2 (decreased ability to 

use insulin), or gestational diabetes (GDM) (diabetes first diagnosed during pregnancy). Type I 

diabetes usually is first diagnosed in children and young adults, although it can occur at any age. 

Type 1 diabetes, an autoimmune disease that is not currently preventable, accounts for 5 percent 

of diabetes cases. [6] People with diabetes diagnosed before the age of20 years have a life 

expectancy that is 15 to 27 years shorter than people without diabetes. [7J Until recently, 

diabetes diagnosed in children and adolescents was almost entirely considered to be type l. 

However, while still rare, type 2 diabetes in youth is increasingly occurring in those under 20 

years of age, particularly minority youth, probably due to obesity in youth. Type 2 diabetes is 

also increasing among women of childbearing age. 

Type 2 diabetes accounts for 90 to 95 percent of diabetes cases. [6] Data from the 2004 -

2006 National Health Interview Survey (NHIS) for people 20 years and older indicate that 6.6 

percent of non-Hispanic whites, 7.5 percent of Asian Americans, lOA percent of Hispanics, and 

11.8 percent of non-Hispanic blacks had diagnosed diabetes. [8] Risk factors associated with 

type 2 diabetes include increasing age, family history of diabetes, history of gestational diabetes, 

race, and ethnicity. These are risk factors that we cannot change. Type 2 diabetes is closely 

linked to obesity and physical inactivity. These risk factors can be changed. The vast majority 

of cases of diabetes in the U.S. today are preventable. 

Gestational diabetes is of concern because of potential consequences for both the mother 

and the baby. For the mother, this includes an increased risk for high blood pressure and 

eclampsia, a condition that causes seizures. For the baby, potential consequences include, 

increased birth weight, increased risk for birth trauma, and low blood sugar. Gestational diabetes 

affects 3 to 7 percent of all pregnancies in the United States. [9] An estimated 40 to 60 percent 

of women with gestational diabetes will develop type 2 diabetes within ten years. [I OJ Because 

women with type 2 diabetes are at increased risk for having babies with birth defects, women 

with a history of gestational diabetes should receive targeted intervention strategies to prevent 

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type 2 diabetes before they become pregnant, during pregnancy, postpartum and between 

pregnancies. 

Defining and Monitoring Diabetes 

The ability to identify the magnitude of a problem through ongoing surveillance is a 

foundation of CDC's work. CDC developed and maintains the National Diabetes Surveillance 

System, the world's first system for monitoring diabetes. It relies on national and state-based 

household, telephone, and hospital-based surveys, and vital statistics to monitor trends in 

diabetes, its risk factors, levels of care, and complications. In collaboration with the National 

Institutes of Health (NIH), CDC has also initiated the largest major surveillance system to 

quantify and track the diabetes burden in those under 20 years of age, the SEARCH for Diabetes 

in Youth study. This study provides population-based information on the underlying factors, 

trends, impact, and levels of care provided to American youth who develop either type I or type 

2 diabetes. Among other things, SEARCH allows us to clarify the degree to which type 2 

diabetes is affecting youth of different racial and ethnic backgrounds. 

CDC uses its surveillance data to understand the diabetes epidemic, identify vulnerable 

at-risk populations, set prevention objectives for the nation, and monitor success of our programs 

over time, all at the national level. The system also provides essential data on the levels of 

behavioral risk factors, preventive care practices, and prevalence (percent of the popUlation who 

has diabetes) and incidence (fraction of the population that develops a new case of diabetes in 

any given year) at the state level. It uses a variety of mechanisms, such as fact sheets, 

publications, and the internet, to provide data on diabetes to a variety of audiences, including 

policymakers, professional organizations, and state health departments. In the last two years, 

CDC has developed a methodology to estimate levels of diabetes and obesity at the county level, 

providing policy makers and communities with new information to guide program planning and 

resource allocation. 

Findings from the National Diabetes Surveillance System document several successes in 

the public health response to diabetes over the past decade but have also revealed areas of major 

concern and continuing threats to the public's health. Rates of blood glucose being out of 

control and cardiovascular disease risk factors, as well as incidence of amputations, end stage 

renal disease, and deaths dueto high blood sugar among the adult U.S. population with 

diagnosed diabetes, have all declined. These findings suggest that people with diabetes live 

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longer, healthier lives than people who were diagnosed with the condition in prior decades. 

However, these improvements hide considerable variation and disparities in diabetes care and 

outcomes across the country. For example, CDC's recently published county level estimates of 

diabetes and obesity indicate that wide sections of the Southeast, Appalachia, and some tribal 

lands in the West and Northern Plains have the nation's highest rates of obesity and diabetes. 

[11 J In many counties in those regions, rates of diagnosed diabetes exceed 10 percent and 

obesity reaches more than 30 percent. [11 J Concerning disparities also persist in the levels of 

risk for complications. For example, African Americans have notably increased risk of high 

blood pressure, diabetes-related kidney disease, and diabetes itself. In addition, people of lower 

education and income have higher risk for diabetes and numerous complications. [12J 

Various factors influence low levels of testing and post partum care for women with a 

history of GDM (e.g., gaps in surveillance system, lack of awareness about GDM and future risk 

for type 2 diabetes, health system infrastructure challenges). Through strategic collaborations, 

research and education, CDC works to impact and improve outcomes for women at risk for and 

with GDM. In collaboration with the National Association of Chronic Disease Directors' 

Women's Health Council and the Agency for Healthcare Research and Quality, we are working 

to conduct a GDM validation project to: 1) establish a 5-state collaboration to identify, 

catalogue, and validate routinely collected data about GDM; 2) identify gaps in quality ofGDM 

prevalence data; and 3) determine implications for care. 

Our greatest concern is the continued increase in the rate of new cases of diabetes. This 

is evident in virtually all segments of society, regardless of age, race/ethnicity, and gender. This 

continued increase in the rate of development of new cases is unfortunately negating many of the 

successes that clinical and public health efforts have achieved in reducing rates of complications 

among people with diabetes. The continued increase in diabetes incidence calls for two major 

efforts in public health., First, the trends indicate a need for improved surveillance at regional, 

state, and local levels to improve the ability of programs to put resources where they can be most 

effective; second, these findings indicate a need fOf. comprehensive implementation of a multitiered diabetes prevention strategy. 

Reducing Risk Factors for Type 2 Diabetes 

CDC is engaged in risk reduction efforts on multiple levels, including a focus on obesity, 

nutrition, and physical activity for the general population. CDC is actively working with the 

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First Lady on the Let's Move! initiative, providing scientific expertise in the areas of healthy 

eating and physical activity, and communication support to the campaign's public service 

advertising efforts. Additionally, CDC, in collaboration with HHS, is implementing the 

Communities Putting Prevention to Work (CPPW) program as part of the American Recovery 

and Reinvestment Act. Through CPPW, CDC is funding communities, states, and territories to 

advance nutrition, physical activity, and obesity-related policy and environmental strategies with 

the goal of stabilizing or beginning to decrease adult and youth overweight/obesity, thus 

reversing long term trends of obesity and related chronic diseases. 

CDC's Division of Diabetes Translation focuses on obesity, nutrition, and physical 

activity in those with or at risk for diabetes. American Indians and Alaska Natives are at 

extremely high risk for diabetes. [13] Aboutl6 percent of American Indians and Alaska natives 

have diabetes. [l3] CDC focuses on American Indians with its Native Diabetes Wellness 

Program. The Native Diabetes Wellness Program works with 17 American Indian and Alaska 

Native communities to improve access to local, fresh produce, including traditional foods like 

squash and berries. For many people living on reservations, grocery stores can be dozens of 

miles away. These efforts focus on preserving and renewing cultural identity. For example, 

CDC is providing funds to the Standing Rock Nation, bordering North and South Dakota, in 

partnership with the U.S. Department of Agriculture, to offer fresh-produce vouchers that the 

elderly can use at local farmers markets. Redemption rates for these vouchers are more than 50 

percent. [14] 

Preventing Diabetes 

Several research studies, including the NIH-led U.S. Diabetes Prevention Program, have 

demonstrated that a structured lifestyle program, which results in a modest weight loss of 5 to 7 

percent while encouraging a healthy diet and increasing physical activity, can reduce risk for 

type 2 diabetes by 58 percent in those at high risk for diabetes or who have pre-diabetes. Based 

on the findings of the Diabetes Prevention Program clinical trial and subsequent NIH-supported 

studies that have translated these research findings into real world settings, CDC and our partners 

are implementing the National Diabetes Prevention Program. This program focuses on 

delivering the proven intervention in group settings for a cost of about $250 to $300 per person 

per year. The National Diabetes Prevention Program takes a four-pronged approach: training the 

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workforce, a recognition program for quality assurance, funding sites to deliver the intervention, 

and health marketing to increase the program's utilization. 

In partnership with Emory University, CDC established the Diabetes Training and 

Technical Assistance Center which is developing a Diabetes Prevention Program Master Trainer 

Curriculum to educate master trainers who train lifestyle coaches. The lifestyle coaches will 

deliver the evidence-based structured lifestyle intervention in group settings across the country. 

This systematic training will help build a workforce that can sustain the National Diabetes 

Prevention Program and prevent or delay type 2 diabetes in high-risk individuals. 

The recognition program sets recognition standards for diabetes prevention programs, 

monitors recognized diabetes prevention programs, and maintains a national registry of 

recognized diabetes prevention programs and a master trainer directory. The recognition process 

assures the quality and fidelity of the National Diabetes Prevention Program and provides a 

registry to track and report data, performance, and outcomes of the National Diabetes Prevention 

Program for quality assurance, monitoring, and reporting purposes. 

The National Diabetes Prevention Program is currently offered in select communities 

across the country. CDC convened public and private partners, including the YMCA-USA, 

UnitedHealth Group, University of Pittsburgh, and Indiana University to ensure successful 

uptake, referral, and delivery of the National Diabetes Prevention Program. In the first phase, 

CDC is funding ten YMCA sites, and UnitedHealth Group is funding six YMCA sites to deliver 

the lifestyle program. This program will be systematically rolled out, scalable, and sustainable. 

In future phases, other organizations will also deliver the intervention as they become CDCrecognized. Sustainability is particularly important. UnitedHealth Group will cover the cost of 

participation for its beneficiaries. This represents the first time private insurance, in this case 

UnitedHealth Group, has entered into a partnership to cover prevention of diabetes to a 

community-based national organization. Work is under way to bring on additional organizations 

and third party payers to fund the intervention. 

A CDC-NIH collaboration, the National Diabetes Education Program's 2008 Survey of 

the Public's Knowledge Attitudes, and Practices Related to Diabetes, revealed significant gaps 

between perceived and actual risks. For example, only 29 percent of the people at high risk for 

diabetes understood their risk for the disease, and only about a third of people with pre-diabetes 

understood that they were at risk for diabetes. NHANES data from 2005 - 2006 show that 30 

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percent of U.S. adults 20 years or older had pre-diabetes. Only 7 percent of those determined by 

the medical exam portion of this survey to have pre-diabetes reported that they had been told that 

they had the condition, and 48 percent of adults with pre-diabetes reported a test for diabetes or 

high blood sugar in the past three years. [15] These numbers clearly indicate the need for 

education, both for people at risk for diabetes and for clinicians. A CDC-led strategic marketing 

effort will focus on increasing the understanding of diabetes among people at risk for diabetes, 

such as women with a history ofGDM, and referring clinicians. 

Diabetes Management 

CDC is active in preventing complications among people who already have diabetes. 

Control of A 1 c (a measure of average blood sugar over the last three months), blood pressure, 

cholesterol, and smoking cessation are crucial, and are emphasized in all our efforts. 

The CDC-led Translating Research into Action for Diabetes project is a ten-year, sixcenter study of managed care and diabetes quality of care. The Translating Research into Action 

for Diabetes project was created to determine the key factors in managed care systems and 

patients that influence the progression and outcomes of diabetes care. The ultimate goal is to 

provide practical information on how to better implement effective treatment in managed care 

settings. The Translating Research into Action for Diabetes project has taught us that, among 

other things, greater out-of-pocket costs are associated with lower rates of both eye exams and 

blood sugar monitoring and that physician' reimbursement by salary or capitation is associated 

with better care than fee for service. [16] We, along with the CDC-funded state and territorialbased Diabetes Prevention and Control Programs, are using these findings to advance our work 

in improving the health care delivery system. For example, the Utah Diabetes Prevention and 

Control Program has partnered with nine major health care plans to improve diabetes care for 

state residents. Together, these partners developed initiatives to improve the quality and 

performance of important aspects of diabetes care. The health care plans that participated in the 

initiatives worked together to increase patient and provider awareness of key clinical targets and 

indicators for diabetes; increase systems-based support for the delivery of diabetes care and the 

measurement, tracking, and reporting of key health indicators; and implement patient 

reminder/call back systems that focus on key health indicators and medication adherence. 

Between 2004 and 2009, all diabetes quality of care measures improved as a result of the 

partnership efforts. These outcomes included increase in average blood glucose control (A 1 c 

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<7%) from 23 percent (baseline) to 43 percent; increase in lipid control from 18 percent 

(baseline) to 45 percent; increase in eye examination rates from 42 percent (baseline) to 64 

percent; and increase in screening to assess kidney function from 33 percent to 69 percent. [16] 

In addition, we have a special focus on vulnerable populations. For example, the Florida 

Diabetes Prevention and Control Program, in collaboration with Florida's Office of Minority 

Health, administers the Closing the Gap project in eight disease areas, including diabetes. 

Community-based organizations provide diabetes self management education, wellness 

education, community health worker services, and/or assist faith-based agencies with health 

ministry capacity building. This program has reached over 12,000 persons with diabetes. Results 

achieved include reductions in body mass index, lowering of Ale, and an increase in such 

preventive care services as foot exams, eye exams, and receipt of flu shots. [14] 

Chronic kidney disease is the ninth leading cause of death in the United States, and 

diabetes accounts for nearly half of all new cases of people requiring dialysis or a kidney 

transplant. People with diabetes are at substantial risk for diabetic retinopathy, cataracts, and 

glaucoma, all of which can cause blindness. CDC's Congressionally-mandated Vision Health 

and Chronic Kidney Disease Initiatives develop partnerships with federal and non-federal 

organizations to establish new surveillance systems and integrate them with public health, 

effectiveness, and economic studies. These initiatives help prioritize interventions that reduce or 

prevent the development or progression of these complications. 

Future Work 

We are continuing to explore new frontiers of diabetes prevention and control. We have 

two new projects that will begin by September 30, 2010. In the National Program to Eliminate 

Diabetes-Related Disparities in Vulnerable Populations, CDC will fund six organizations to 

reduce morbidity, premature mortality, and eliminate health disparities associated with diabetes. 

This will be achieved by mobilizing community partners and assisting them to effectively plan, 

develop, implement, and evaluate community-based interventions to reduce the risk factors that 

influence the disproportionate burden of diabetes that vulnerable populations bear. 

Beginning in 20 I 0, CDC will initiate a new platform of research studies to examine the 

impact of population-targeted policies emanating from health systems, business and community 

organizations, and govemments. The impetus behind this work is that many innovative public 

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health policies are initiated every year, but the true impact of these initiatives can only be fully 

assessed with further study. 

Conclusion 

People with diabetes now live longer than in the past. Improved awareness of diabetes 

has contributed to improved diagnosis. These factors, combined with our aging population, 

means that the percentage of the population with diagnosed diabetes will rise over the coming 

years. As recognized in Healthy People 2020 goals, reducing new cases of diabetes (incidence) 

requires an increased focus, while at the same time we continue to make advances in improving 

the health outcomes for those with diabetes. 

Several steps must be taken to stem the diabetes epidemic. Work in risk factor reduction 

must continue so that fewer people develop pre-diabetes. The programs and policies for obesity 

prevention and control, both in the general population and those at risk for diabetes, are central to 

this effort. There is a critical need for effective programs that prevent people at high risk for 

diabetes from developing the disease. The first steps have been taken, in the form of the 

National Diabetes Prevention Program. The complications of diabetes have a very high cost, 

both in dollars and human suffering. While improvements have been made, much work remains 

to be done, especially in vulnerable populations. 

The increasing number of new cases of diabetes demands an urgent response. CDC will 

continue to increase the reach of the National Diabetes Prevention Program by increasing the 

number of master trainers and lifestyle coaches who can implement the National Diabetes 

Prevention Program as resources permit and by managing the recognition program to assure 

quality and effectiveness. We will work with other organizations to expand the delivery and 

reimbursement for the National Diabetes Prevention Program. 

Thank you for your attention. I will now take your questions. 

References 

[11 Diabetes Patients Requiring Glucose-Lowering Therapy and Nondiabetics With a Prior Myocardial Infarction 

Carry the Same Cardiovascular Risk. Tina Ken Schramm et a!. Circulation. 2008;117:1945-1954.) 

[2J M. Dall et a!. The Economic Burden Of Diabetes Timothy M. Dall et a!. Health Affairs, 29, no. 2 (2010): 

297-30 

[3J National Vital Statistics: Deaths: Final Data for 2007, http://www.cdc.gov/nchs/datalnvsr/nvsr58/nvsr58 19.pdf 

[4J National Health and Nutrition Examination Survey 2003-2006, National Center for Health Statistics, Centers for 

Disease Control and Prevention. Available at http://www.cdc.gov/nchs/nhanes.htm 

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[5] Harris et a!. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. 

The Third National Health and Nutrition Examination Survey, 1988-1994. Harris et a!. Diabetes Care April 1998 

vol. 21 no. 4518-524 

[6] Lifetime Risk for Diabetes Mellitus in the United States. K. M. Venkat Narayan, et a!. Journal of the 

American Medical Association. 2003;290:1884-1890. 

[7] SEARCH for Diabetes in Youth Fact Sheet. http://www.searchfordiabetes.orglpublic/provider/protocol.cfin 

[8] 2004-2006 National Health Interview Survey (NHIS), National Center for Health Statistics, Centers for Disease 

Control and Prevention. Available at http://www.cdc.Rov/nchs/nhis.htm. 

[9] Gestational Diabetes Mellitus - Time to Treat. Michael F. Greene and Caren G. S 

Solomon. New England Journal of Medicine. Volume 352:2544-2546. 2005. 

[I 0] Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic 

review. Diabetes Care. 2002;25(10):1862-1868. 

[II] Estimated County-Level Prevalence of Diabetes and Obesity --- United States, 2007. E W Gregg et al. 

MMWR 58(45);1259-1263. 2009. 

[12) J. M. Robbins et al. Socioeconomic status and type 2 diabetes in African American and non-Hispanic white 

women and men: Evidence from the Third National Health and Nutrition Examination Survey. Am J Public Health. 

2001; 91(1): 76-83. 

[13] Patricia M. Barnes et al. Health Characteristics of the American Indian or Alaska Native Adult Population: 

United States,. 2004--2008 National Health Statistics Report 20, 2010. 

[14] Internal Program Progress Report, 2010. 

[IS) Linda S. Geiss et aI. American Journal of Preventive Medicine, Volume 38, Issue 4 2010 

[16] TRIAD study group. Health systems, patients factors, and quality of care for diabetes: a synthesis of findings 

from the TRIAD study. Diabetes Care. 2010 Apr;33(4):940-7. 

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Dialwtl'" i~ a dis,'dse in which dw body has a <'!lOn<'gc ofinslllin, 

a dccrea~(:'d ability til usc insulin, 01" hoth, Imulin h:1 hnrtl.1(ltl(' 

,tJnlt, had prcdiabdC's in 2.00:- I\'opk \-\'ith ,hi, H'lldillnr\ 

h:l\T In innl',lscd fbk of dcwtoping type 2 di,llwre:h hClr< 

djsc:t~<.'_ :md stroke 

Diabetes Is Common, Disabling, and Deadly 

~ In 200 " about 1,6 million nc\y os\'~ of dbbett's \-vcr, .. 

diagnosed in people «get! 20 yeMs or older. 

~ Afrkan American, I {ispanic, American Indi:m, and 

/\b~b Native adults arc twke as likely ,~\ ,vhite adult" 

to h:\vc diahctc~. 

Diabetes Is CosIly 
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DIABETES 

SUq;ESSES AND OPPORTUNITIES FOR POPULATION-BASED 

PREIENTION AND CONTROL 2010 

Utah: A Health Plan Partnership Helps 

Improve Diabetes Care Measures 

'The Utah [)P(:P partnered with nine nujor health GIfe plans 

(six commercial and thn:c 1vkdkald) 

phy~!ci~11lS and the rnainrity of people \ccking dLllwlcS care, 

regardless of rheir im,llft'd 

IhCSt' ildtiariws cn.:nuraged pwvidcf\ to ,ldopt Llt<1h\ Diahetes 

Rccommcnd;tti(ln~, collen data nn a uniftHnl set of 

AU media, :nvarencS5, 

tion of the p,lrt!1crship to determine whether these dhlf[" were 

imp;j( ling provider carl' practice and patit'nt health outcomes< 

In 2008, {he npcp invited the Utah Heart Disease and Stroke 

Texas: Creating a Diabetes Self-Management 

Pilot Project for Medicaid Recipients 

In -lexas, about 1.8 million 

and ,m csdm,lt{:d 460,040 have 

()rkX.Hl~ with diabetes. Ho"'w~vcr, it is 

who receive bendlts J.nd h:nT diaheles afe receiving adequate 

sdt,tn,,,,,,,cmcnt tralning to control their di<;case and pn:vetlt 
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'The Texas DPCP w·orked with statisticians at the Texas Health 

ivkJicaid, with the option for follow-up education. 

~lhe ·It:xa~ I)P(:P and partner organizations will monitor the 

proj{'Ct, and information lcJ.rned from 1 he 

fi.llure dl<Jr(:' to mak(' the sen·ice ,w,libb1c 

rccipirnts with dbncn::s in T(.'xas. 

Kentucky: Forming a Partnership 

to Improve Work Site Wellness 

rJ.ctor~, 

its Lexingtoll, 

in ,l!) anmnl 

showed that 

·Ihcse condition" rcsulted in health-related ahsence) from ·work 

and increAsed employer health care COH~. To address this 

problem, the comp,lll)' plannl'd to bunch an on~ilc wcl!ncss 

program. 

Educational sessions wcre 

all three work shifts. °ll-ane 

to participatc 

program 

St.tff at the Kentucky DPCP also helped Trant: connect • 

A new advisory hoard wirh 

Tranc officials noted several 

location, and the company 

the model at its other 
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.. Bat pressure control reduces the risk for heart disease and s. among people with diabetes by 330/0---50%. It reduces 

the risk for eye. kidney, and nerve dise.ases by about 3j%. 

Important Achievements, But More to Do 

elhere are encouraging outcom('s to in the effon to 

control the epidemic of diabetes. 

living longer. "{he tOll,)Wlng '"SO 

.. The 

that 

(Des Response 

throup;h public health 

and programs 

l)ivhion of Diabetes Translation 

tl.owing activities [0 achieve rhis goa!: 

health surveillance to monitor the burden of 

States. 

Ii 

1111 

New Cases of Diagnosed Diabetes in People 

Aged 20 Years or Older, by Age Group, 

United States, 2007 

1,000,000 

20-39 40-59 ?!60 

Age Group (Years) 

Source: 2004-2006 Nationa! Health Interview Survey estimates 

projected to year 2007 

.. Hospit;)!bltions among people with diabetes. 

.. Cardiovascular disease death rates among people 

with lliabetes. 

impairments among people 

• ~rhe rate of new' cases of kidney railurc among people 

\yith diabetes. 

.. Conducting research that helps communities dtliver findings 

in c1inic,t! and public hl'alth practice. 

maintaining dfecrive state~based diabetes 

control programs. 
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Defining the Diabetes Burden 

CDC's National 

Translating Research and Conducting 

New Research 

CDC translates research f-indings from scientific studies and 

dinical rrials for use by healrh 

• Translating Research Into Action for Diabetes (TRIAD). 

A national. multicenter study, TRIAD aim~ to provide 

practical information Oil 

treatments and provide benet care 

in managed care setting.'. in till.:: 

• Primary Prevention for People Most at Risk. Bui!ding on 

information learned from projects that translate research 

who have a 

Developing Programs in States 

and U.S. Territories 

evidence-hased NHional 

CDC assistant..- for diabetes 

(DPCPs) in al! ')0 ~tate~, the 

'Ihese programs implement public health strategies such as 

• Preventing diabcres among people ar highest ri~k 

• Adopring diabetes care guiddine~ in health 

delivery settings. 

• Involving communitic.'. in diabetes control activities. 

Providing Education and Sharing Expertise 

'lhe National Diaben.:s Educarion (NDEP) and th~> 

arc two programs 

"Ihe NDEE jointly 

led hv ox: and of Health, deve.' and 

disseminare.'. educariona! infurmation on the prevenrion 

COtHroj of diabetes af\-txted by diabttes, health 

care proft:ssionak 

'lhe NDEP',<; educational resources and tools are available online 

"lhc NDWP focusc~ on American Indian/Alaska Native and 

to schools, libraries, and other 

orgalliLations. For mme information on the books, go to 

http://,y\\,v.cdc.govJdiahctes/pubs/eagle.htm. 

For more information, please contact the Centers for Disease Control and Prevention 

National Center for Chronic Disease Prevention and Health Promotion • 4770 Buford Highway NE, Mail Stop K·10, Atlanta, GA 30341·3717 

Telephone: 800·CnC·INFO (232.4636) • TTY: 888·232·6348 

Ewmail: cddnfo(d'cdc.gov • Web: http://www.cdc.gov/diabetes 
39 

Mr. PALLONE. Thank you, Dr. Albright. 

Dr. Fradkin. 

STATEMENT OF JUDITH FRADKIN 

Dr. FRADKIN. Thank you, Mr. Chairman and members of the subcommittee, and I also want to thank you for your congratulations 

on our 60th anniversary and particularly to thank Congresswoman 

DeGette and Mr. Space and Mr. Green, who actually participated 

in our celebratory breakfast, and Ms. DeGette in particular made 

some remarkably inspiring remarks at that event, and I want to 

thank her. I am also very pleased to testify with Dr. Albright, because our two agencies work so effectively together on multiple efforts to combat diabetes including our National Diabetes Education 

Program which is co-led by the two agencies. 

On behalf of NIDDK and the NIH, I am pleased to report that 

we are vigorously pursuing research on diabetes and its complications and today I would like to tell you about some of NIH-supported research including research supported by the special statutory program for type 1 diabetes research, which is administered 

by NIDDK and has resulted in many scientific advances that are 

improving the health and quality of life of people with diabetes. A 

parallel funding stream for a special diabetes program for Indians 

is administered by the Indian Health Service and has led to substantial improvements in diabetes care in American Indians. 

Mr. Chairman, the need to pursue research on prevention, treatment and cure of diabetes is greater than ever because the rates 

of several types of diabetes are rising. The good news is that we 

have made tremendous progress in recent years which has led to 

improvements in survival and quality of life for people with diabetes. For example, now thanks to continuous glucose monitoring 

technology, some parents of young children with type 1 diabetes 

can sleep through the night without having to rise repeatedly to 

check their child’s blood glucose level. The device measures glucose 

every several minutes and sounds an alarm if the levels are too 

high or too low, a technological peace of mind allowing parents to 

sleep more soundly. 

Because genetic and antibody tests can predict with great accuracy which children will develop type 1 diabetes, we can now test 

prevention strategies and are doing so. To find new approaches to 

prevention, we launched the TEDDY study. TEDDY researchers 

screened over 400,000 newborns to find 8,000 who had genes that 

put them for particularly high risk of type 1 diabetes. Those children are now enrolled in the study and are being followed until age 

15 with a goal of identifying environmental triggers of type 1 diabetes. For example, if we could find an infectious trigger, we must develop a vaccine to prevent the disease. To date, the number of children who have developed autoimmunity in type 1 diabetes are exactly as predicted in the study, showcasing the tremendous power 

of these predictive tests. 

We can prevent or delay the development of type 1 diabetes in 

people at high risk for the disease as demonstrated by the NIDDKled landmark diabetes prevention program clinical trial that Dr. 

Albright mentioned. A modest amount of weight loss through diet 

changes and moderate exercise substantially reduced the occurVerDate Mar 14 2013 01:02 Mar 20, 2013 Jkt 077918 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 E:\HR\OC\A918.XXX A918

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40 

rence of type 2 diabetes at 3 years and now in the most recent report at 10 years after enrollment in the trial. This intervention 

worked in all the ethnic and racial groups studied in both men and 

women and in women with a history of gestational diabetes. 

Building on this success, NIDDK supports research to translate 

these results to people who can benefit from them. For example, 

just this week NIDDK-supported scientists announced exciting results from research in which community health workers effectively 

delivered a group-based lifestyle intervention to people at high risk 

for type 2 diabetes. At 1 year, the participants lost as much weight 

as was observed in the diabetes prevention program, suggesting 

that this approach may be a low-cost way to reach Americans. 

Another NIDDK-supported pilot study is already having a farreaching impact. Researchers successfully utilized local YMCAs to 

deliver a lower-cost group-based DPP lifestyle intervention, and Dr. 

Albright has provided information about how the CDC is building 

on the results of this NIDDK-supported research to improve the 

public health by implementing a National Diabetes Prevention Program. 

Diabetes during pregnancy brings risks to mother and child. Because of the NIH-supported hyperglycemia and adverse pregnancy 

outcome study, we now have precise information on what blood glucose levels should be during pregnancy to avoid complications near 

birth. 

These are just a few examples of how far we have come in recent 

years through vigorous supported research toward increasing 

knowledge about diabetes and improving the health of people with 

diabetes. However, much work remains to be done to curb the diabetes epidemic. For example, it is critical to move beyond continuous glucose monitoring technology and link glucose monitoring to 

insulin delivery to create the so-called artificial pancreas. This 

technology could help patients achieve blood glucose control that 

has been shown to reduce complications and also alleviate the burden of self-care. Now that we have thousands of samples collected 

through the TEDDY study, it is vital to use new and emerging 

technology to analyze those samples and identify an environmental 

trigger of type 1 diabetes. Building on the success of the many new 

available therapies for type 2 diabetes, comparative effectiveness 

research can help inform doctors’ decisions about what medications 

to prescribe for their patients and when. 

Loss of the insulin-producing beta cells underlies both type 1 and 

type 2 diabetes. Research through NIDDK’s beta cell biology consortium may develop new approaches to treatment by providing insights on how to reprogram cells to become insulin-producing cells, 

stimulate beta cell replication or replace lost beta cell function with 

cells derived from stem cells. Complementing these efforts, clinical 

research can provide information on how best to preserve beta cell 

function in people newly diagnosed with type 1 or type 2 diabetes. 

Perhaps most important to combating the diabetes epidemic is 

reversing the trend of both type 1 and type 2 diabetes occurring at 

younger ages because earlier disease onset means earlier development of complications and premature mortality. For women, earlier 

development of diabetes also endangers her offspring. The intrauterine environment plays an important role not only in problems 


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41 

at the time of birth but also in the future development of diabetes 

and obesity, a finding observed among the Pima Indians in Arizona. Thus, it is critical to pursue research to break the vicious 

cycle of ever-growing rates of diabetes by preventing or mitigating 

the effects of diabetes and obesity during the childbearing years 

and pregnancy. 

Implementing research findings into clinical practice has led to 

reductions in rates of heart disease, kidney failure and blindness 

in people with diabetes. By building on recent advances in diabetes 

research, we are poised to realize even greater improvements in 

health and quality of life for people with diabetes. We have come 

far but we must go farther. 

Thank you, Mr. Chairman, for your leadership in calling this 

hearing to focus attention on the problem and for your continued 

support of NIH research. 

[The prepared statement of Dr. Fradkin follows:] 


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Testimony 

Before the 

Subcommittee on Health 

Committee on Energy and Commerce 

United States House of Representatives 

Testimony for hearing entitled, 

"The Battle Against Diabetes: Progress Made; 

Challenges U nmet" 

Statement of 

Judith E. Fradkin, M.D. 

Director, Division of Diabetes, Endocrinology, and Metabolic 

Diseases 

National Institute of Diabetes and Digestive and 

Kidney Diseases 

National Institutes of Health 

U.S. Department of Health and Htlman Services 

For Release on" Delivery 

Expected at 10:00 a.m. 

July 1, 2010 
43 


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Mr. Chainnan and Members of the Committee: I am Judith Fradkin, Director of the 

Division of Diabetes, Endocrinology, and Metabolic Diseases of the National Institute of 

Diabetes and Digestive and Kidney Diseases (NIDDK). Our Institute has primary responsibility 

for diabetes research at the National Institutes of Health (NIH), an agency of the U.S. 

Department of Health and Human Services (HHS). 

On behalf of the NIDDK and the other Institutes and Centers of the NIH, I am pleased to 

report that we are vigorously pursuing research on diabetes and its complications. Through 

collaborative and coordinated research, we are gaining important insights into the molecular 

mechanisms underlying disease, identifying and testing promising therapies to prevent and treat 

the disease and its complications, and striving for a cure. In these efforts, we are fortunate to 

often partner with other HHS agencies, such as the Centers for Disease Control and Prevention 

(CDC) and the Indian Health Service (IHS), and other non-federal diabetes organizations. 

ADVANCES FROM DIABETES RESEARCH 

This year marks the NIDDK's 60th anniversary of conducting and supporting research to 

combat debilitating diseases within its mission, including diabetes. Diabetes is characterized by 

the body's inability to produce andlor respond appropriately to insulin, a honnone that is 

necessary for the body to absorb and use glucose, or sugar, as a cellular fuel. The most common 

fonns of the disease are type 1 diabetes, in which the body loses its ability to produce insulin; 

and type 2 diabetes, which is due to a combination of insulin'resistance and insufficient insulin 

production. Women can also develop gestational diabetes, a risk factor for type 2 diabetes, 

during pregnancy. Rarer forms of diabetes also exist. 

To appreciate the tremendous progress that has been achieved in recent decades, we can 

look back at how diabetes was treated in 1950, at the inception of the Institute. Sixty years ago, 

patierlts monitored their blood glucose levels with urine tests, which recognized high but not 

dangerously low glucose levels and reflected hours-old, not current, glucose levels. People with 

type 1 diabetes relied on painful injectious of animal-derived insulin. People with type 2 

diabetes had few treatment options: injections of iusulin or drugs that stimulated insulin release 

from the beta cells of the pancreas. Both of these therapies had associated risks. No proven 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Unmet" 

House Energy arid Commerce Subcommittee on Health 

July 1, 2010 

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strategies existed to prevent disease complications, such as blindness, heart disease, kidney 

disease, and nerve damage. 

Insights gained from NIDDK and NIH-supported research over the past 60 years have 

contributed to a knowledge base leading to improvements in survival and quality of life for 

people with diabetes. Doctors now use simple blood tests to diagnose diabetes and to assess 

long-term blood glucose control. People at high risk for type 2 diabetes can prevent or delay 

disease onset by losing a modest amount of weight through dietary changes and moderate 

exercise. People with type 1 diabetes can reduce their risk for complications by intensively 

controlling blood glucose levels. Doctors can prescribe new claases of oral drugs and 

combinations of drugs to tryat people with type 2 diabetes. Patients can use new technologies, 

such as insulin pumps and continuous glucose monitors, to manage their diabetes. As a result of 

these past accomplishments, people with diabetes are living longer and healthier lives than ever 

before. I am pleased to provide you with a few specific examples of how NIH-supported 

research has contributed to these tremendous improvements in the health and quality of life of 

people with diabetes. 

RESULTS OF MAJOR CLINICAL TRIALS AND TRANSLATING THOSE RESULTS TO 

IMPROVE PUBLIC HEALTH 

One approach to combat the diabetes Ypidemic in the U.S. is to prevent the disease. A 

landmark clinical trial studying type 2 diabetes prevention ~as spearheaded by the NIDDK. The 

Diabetes Prevention Program (DPP) clinical trial showed that people with pre-diabetes-defin'ed 

as having blood glucose levels that are higher than normal but not yet high enough to be 

diagnosed as diabetes-can dramatically reduce their risk of developing type 2 diabetes through 

lifestyle changes that achieve modest weight loss or through treatment with the drug metfonnin, 

although the metformin intervention was much less effective than the lifestyle intervention.l The , 

interventions worked in all ethnic and racial groups studied, in both men and women, and in 

women with a history of gestational diabetes. Research now shows that, after a 10-year period 01 

following DPP participants, the interventions result in long-term benefits: people still had a 

I Knowler we, et aI. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metfonnin. N Engl J Med 

346:393-403,2002. 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Unmet" 

House Energy and Commerce Subcommittee on Healtb 

July I, 2010 

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lower risk of developing type 2 diabetes and those who made lifestyle changes also had reduced 

cardiovascular risk despite taking fewer drugs to control their heart disease risk factors.2 

Building on these critically"important results, the NIDDK supports research to translate 

DPP findings to improve public health and benefit the approximately 57 million Americans with 

pre-diabetes.3 One successful research effort utilizes local YMCAs for delivering a group-based 

DPP lifestyle intervention. A pilot study showed that this group-based approach reduces costs to 

deliver the intervention, while achieving similar levels of weight loss in participants;4 a larger 

trial is ongoing. The impressive findings of this pilot study serve as the basis for a new 

partuership established earlier this year among the UnitedHealth Group, the National YMCA, 

and the CDC to offer a diabetes prevention program in sixteen U.S. cities, with plans for a 

national rollout over the next couple of years. 

Another way that the DPP results are being translated to the public and health care 

providers is through the National Diabetes Education Program (NDEP), which is a partuership 

between the NIDDK and the CDC. The NDEP developed the "Small Steps. Big Rewards. 

Prevent Type 2 Diabetes" education campaign to disseminate the DPP results. The NIDDK and 

its collaborators remain dedicated to building on the tremendous successes to date in order to 

take advantage of new and emerging opportunities to expand type 2 diabetes prevention efforts. 

Another NIDDK-Ied clinical trial has changed the face of type 1 diabetes management. 

The Diabetes Control and Complications Trial (DCCT), and its follow-on, the Epidemiology of 

Diabetes Interventions and Complications (EDIC) study, cOl!clusively demonstrated that early 

and intensive blood glucose control prevented or delayed the debilitating complications of type I 

diabetes involving the heart, eyes, kidneys, and nerves.5 These impressive findings have 

revolutionized the management of type 1 diabetes, as physicians now recommend that people 

control their disease as early and intensively as possible. Intensive treatment is being translated 

2 Diabetes Prevention Program Research Group, et al. lO-year follow-up of diabetes incidence and weight loss in the Diabetes 

Prevention Program Outcomes Study. Lancet 374:1677-86, 2Q09. 

3 CDC. National diabetes fact sheet: general infonnation and national estimates on diabetes in the United States, 2007. Atlanta, 

GA: U.S. Department of Health and Human Services, CDC, 2008. 

• Ackennann RT, et al. Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. Am J Prev 

~. 35: 357-63,2008. 

The Diabetes Control and Complications Trial Research Group. The effeet of intensive treatment of diabetes on the 

development and progression oflong-term complications in insulin-<iependent diabetes mellitus. N Engl] MOO 329: 971-986, 

1993; Nathan OM, Geary PA, Backlund N, et al. Diabetes Control and Complications Trial!Epidemiology of Diabetes 

Interventions and Complications (DCCTIEDIC) Study Research Group. Intensive diabetes treabnent and cardiovascular disease 

in type I diabetes mellitus. N Engl ] Med 353: 2643-2653, 2005. 

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House Energy and Commerce Subcommittee on Health 

July I, 2010 

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into improved health, as researchers recently reported that the outlook for people with 

longstanding type 1 diabetes has greatly improved in the past 20 years.6 

The NIDDK-supported United Kingdom Prospective Diabetes Study showed that people 

with type 2 diabetes also benefit from improved glucose control early in the course of the diseasl 

with respect to reducing rates of disease complications? However, in people with long standing 

type2 diabetes who also are at high risk for heart disease, more intensive blood glucose control 

than is currently recommended by treatment guidelines can be dangerous, as demonstrated in the 

ACCORD clinical trial, which is led by the National Heart, Lung, and Blood Institute.8 The trial 

found that lowering blood pressure to normal levels did not significantly reduce the risk of 

cardiovascular events overall, although it may reduce the risk .of stroke. In the lipid trial, 

combination therapy of a statin and a fibrate appeared t.o be safe, but did n.ot lower the risk of 

heart attack, stroke, or death from heart disease more than statins al.one. The ACCORD findings 

indicate that people who have longstanding type 2 diabetes and are at high risk f.or a 

cardiovascular event and are well controlled as per current recommendations d.o not need t.o be 

treated more intensively to reduce heart attacks, str.okes, and .other cardiovascular events. Thus, 

the patients can be spared fr.om unnecessary additional medicati.ons. These key results from type 

2 diabetes clinical trials suggest that, rather than a .one-size-fits-all approach, recommendati.ons 

f.or treating people with type 2 diabetes can be personalized. 

Further insights into the management .of type 2 diabetes are expected to emerge fr.om the 

NIDDK-Ied Lo.ok AHEAD (Acti.on f.or Health in Diabetes) cJinical trial, which is examining the 

heaith effects .of a lifestyle interventi.on desigued t.o achieve and maintain weight l.oSS over the 

I.ong term in over 5,000 overweight and obese adults with type 2 diabetes. Encouraging results 

are already emerging. After following participants for 1 year, researchers f.ound that people in 

the intensive lifestyle arm sh.owed impr.oved diabetes, blood pressure, and lipid control, with 

6 DCCfIEDlC Research Group, et al. Mooem-day clinical course of type I diabetes mellitus after 30 years' dU!"tion: the diabetes 

control and complications trialfepidemiology of diabetes interventions and complications and Pittsburgh epidemiology of 

diabetes complications experience (1983-2005). Arch Intem Med 169: 1307-I 6, 2009. 

1 Holman RR, et al. IO-year follow.up of intensive glucose control in type 2 diabetes. N Engl J Me!! 359:1577·89, 2008. 

B Action to Control Cardiovascular Risk in Diabetes Study Group, et aI. Effects of intensive glucose lowering in type 2 diabetes. 

N Engl J Med 358: 2545-49, 2009; ACCORD Study Group, et al. Effects of intensive blood-pressure control in type 2 diabetes 

mellitus. N Engl J Moo 362:1575·85, 2010; ACCORD Study Group, et ,I. Effects of combination lipid therapy in type 2 diabetes 

mellitus. N Eng!] Med 362: 1563-74,2010. 

Testimony for hearing entitled, ''The Battle Against Diabetes: Progress Made; Challenges Urunet" 

House Energy and Commerce Subcommittee on Health 

July I, 2010 

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reduced medication use and costs.9 After 4 years, researchers observed a sustained effect of the 

lifestyle intervention on weight loss, as well as improved glucose control with reduced 

medication use. IO Participants continue to be followed to assess longer-term outcomes. These 

are just a few examples of the NllI-supported clinical trials that have provided unprecedented 

insights into diabefes prevention and management. 

DISPROPORTIONATE IMPACT ON MINORITY POPULATIONS 

Type 2 diabetes occurs more frequently among racial and ethnic minority groups in the 

U.S., including American Indians, African Americans, Hispanic/Latino Americans, and 

AsiansIPacific Islanders. 11 Because of this disparity, the NllI has included large numbers of 

minority participants in its type 2 diabetes studies. For example, nearly half of the DPP 

participants were from minority groups, and the interventions worked in all groups. Those 

results are being translated in culturally appropriate ways through the NDEP and other 

translational research efforts. 

Type 2 diabetes is an emerging health problem in youth, particularly minority youth, 

being driven by the obesity epidemic. The NllI and its partners are tackling this issue on many 

fronts. For example, just this week, researchers announced results from the NIDDK-led 

HEALTHY clinical trial, which examined whether a middle-school based'intervention could 

lower risk factors for type 2 diabetes. The study was conducted in schools with a high 

emollment of minority children and youth from low-income families. The intervention was 

found to lower the obesity rate in students at highest risk for type 2 diabetes-those who started 

out overweight or obese in sixth grade. However, schools that implemented the program did not 

differ from comparison schools in the study's primary outcome--the prevalence of overweight 

and obesity combined-which had declined by 4 percent in both the intervention and control 

schools by the end of the 3-year study.12 These results are important for informing future school- , based efforts to reduce overweight and obesity in children. 

9 Redmon JB, et at Effect of the look AHEAD study intetVf2ltion on medication use and related cost to treat cardiovascular 

disease risk factors in individuals with type 2 diabetes. Diabetes Care 33: 1153-8,2010. 

'0 The Look AHEAD Study: Design of the Lifestyle IntetVention and Four-Year Weight Losses, Presented at the American 

Diabetes Association 69" Scientific Sessions, June 2009. Publication in press, Archives Int Medicine. 

II CDC, National diabetes fact sheer. general information and national estimates on diabetes in the United States, 2007, Atlanta, 

GA: US, Department of Health and Human Services, CDC, 2008. 

12 Presented al the American Diabetes Association 71/' Annual Sessions, June 201 0, 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Unroef' 

House Energy and Commerce Subcommittee on Health 

July I, 2010 

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Another school-based effort is the Diabetes Education in Tribal Schools (DETS) Project, 

on which NIDDK and IHS partner. The DETS Project is aK·12 curriculum focused on 

increasing American Indian/Alaska Native students' understanding of health, diabetes, and 

maintaining life in balance; understanding and application of scientific and community 

knowledge; and interest in science and health professions. The NIDDK is currently building on 

the success of the DETS Project to develop a K-12 curriculum for African American and 

Hispanic students. 

For children who already have type 2 diabetes, the NIDDK supports the Treatment 

Options for Type 2 Diabetes in Adolescents and Youth (TODAy) clinical trial at centers around 

the country to test three different treatment regimens. A large percentage of children who are 

enrolled in this study are from minority groups disproportionately burdened with type 2 diabetes. 

Through TODAY and other studies, the NIDDK hopes to ameliorate type 2 diabetes and its 

complications in this most vulnerable population. 

Gestational diabetes mellitus (GDM) also disproportionately affects minority groups. 

Although this form of diabetes generally goes away after the baby is born, it leaves both mother 

and child at increased risk for developing type 2 diabetes. Important insights about GDM have 

emerged frOm the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, which is led 

by NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development 

(NICHD). The HAPO study showed that the higher a pregnant woman's blood glucose is, the 

higher her risk of pregnancy complications-whether or not,her blood glucose reached the level 

at which GDM was diagnosed at the time of the study.13 The effect is significant enough that a 

recent panel of experts has recommended changing the diagnostic criteria for GDM to be less 

stringent, such that under the proposed new guidelines, the prevalence ofGDM will more than 

double. 14 The good news is that the DPP showed that a healthy diet and exercise can help 

prevent later type 2 diabetes in women who have had GDM. For this reason, the NDEP, in , 

collaboration with the NIH Office of Research on Women's Health, recently expanded its 

" HAPO Study Cooperative Research Group, et aI. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med 358: 1991-

2002,2008. 

14 International Association of Diabetes and Pregnancy Study Groups Consensus Panel. International association of diabetes and 

pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care 33: 

676-82,2010. 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Urunet" 

House Energy and Commerce Subcommittee on Health 

July I, 2010 

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educational campaign for women with a history of GDM to raise awareness of the health risks 

for these women and their offspring. 

CURRENT RESEARCH 

The NIDDK and other NIH Institutes and Centers are supporting a wide range of diabetes 

research efforts that are having a far reaching impact. For example, the NIH supports research to 

improve diabetes treatment strategies, to help patients achieve blood glucose control associated 

with reduced rates of complications and to reduce the burden of diabetes self-care. NIHsupported research contributed to the development of continuous glucose monitoring 

technologies, which reveal dynamic changes in blood glucose levels by assessing glucose levels 

hundreds of times per day and displaying trends. The NIH is committed to capitalizing on this 

technology and supports research on "artificial pancreas" technology to "close the loop" and link 

insulin delivery to continuous glucose measurements. This technology has the potential to 

benefit people with both fonns of diabetes. 

The NIDDK also supports research on cell replacement therapy for people with diabetes, 

which could potentially restore the body's ability to produce sufficient levels of insulin and 

properly control blood glucose levels. The NIDDK-Ied Beta Cell Biology Consortium is making 

significant progress in understanding beta cell biology and development toward the goal of 

generating unlimited supplies of beta cells in the laboratory for transplantation, or promoting 

growth of new beta cells in the pancreas. Because impaired function of the beta cell is central to 

both type 1 and type 2 diabetes, this research can infonn treatment strategies for people with 

both fonns of the disease. 

Although the DPP identified effective strategies to prevent or delay type 2 diabetes, 

disease prevention remains a major goal of type 1 diabetes research. The NIDDK-Ied Type 1 

Diabetes TrialNet is tackling this goal by conducting prevention trials, including a trial testing , 

whether oral insulin could prevent the disease in people who have high levels of antibodies to 

insulin (a pre-clinical marker of disease). TrialNet plans to launch a second prevention trial with 

an agent proven to slow beta cell loss in new onset type I diabetes. An NICHD-led clinical trial, 

called TRIGR (Trial to Reduce the Incidence of Type I Diabetes in the Genetically at Risk), is 

determining whether weaning newborns at risk for type 1 'diabetes to extensively-hydrolyzed 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Unrue!" 

House Energy and Commerce Subcommittee on Health 

July 1. 2010 

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formula, as compared to standard cow's milk formula, will reduce the risk of developing type 1 

diabetes. 

Diabetes has a strong genetic basis that is modified by environmental factors. The last 

few years have seen unprecedented discoveries in diabetes genetics research. Recent research 

has identified over 40 genes or genetic regions associated with type 1 diabetes,ls and 38 

associated with type 2 diabetes. 16 The NIDDK is now supporting research to pinpoint the exact 

genes involved and to understand their function in health and disease. New insights about the 

genetic underpinnings of diabetes can inform new strategies for prevention or treatment, and 

even on a personalized or customized basis. 

With respect to environmental factors, The Environmental Determinants of Diabetes in 

the Young (TEDDY) study has recently completed recruitment of over 8,000 newborns at high 

genetic risk for type I diabetes and is now following them to age 15 to identify environmental 

triggers of disease. Identification of a dietary or infectious cause of type 1 diabetes could have 

an enormously positive impact on public health through a diet change or vaccine for disease 

prevention, for example. Importantly, TEDDY may also contribute to understanding the 

development of celiac disease, which is an autoimmune disease primarily affeCting the 

gastrointestinal tract. Some genes confer susceptibility to both celiac disease and type I 

diabetes, and many people have both diseases. Thus, TEDDY may benefit not only people with, 

or at-risk for, type 1 diabetes, but also people with celiac disease and other autoimmune diseases. 

New insights about diabetes in youth are stemming f!om the SEARCH for Diabetes in 

Youth study, which is' supported by CDC and NIDDK. SEARCH is defining the incidence and 

prevalence of diabetes in youth, which is important for informing public health efforts. Because 

of SEARCH, for the first time we now can estimate how many children in the U.S. have 

diabetes, and we will be able to see how the rates are changing over time. This knowledge could 

help , to explain the findings from HEALTHY showing that overweight and obesity rates se~ed 

to fall in both the intervention and control schools; SEARCH could help us determine if this 

trend is also being seen on a broader level. 

IS Barrett Ie, et aI. Genome-wide associ~tion study and meta-analysis find that over 40 loci affect risk of type 1 diabetes. Nature 

Genetics 41: 703-707, 2009. 

16 Personal communication; unpublished data. 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Unrnet" 

House Energy and Commerce Subcommittee on Health 

July I, 2010 

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Another high impact program conducted jointly by NnI and CDC is improving 

standardization of hemoglobin Al c (HbAlc), which is a measurement that provides infonnation 

on a person's average blood glucose levels for the past 2-3 months. TIlls program has been 

important for translation of the good glucose control proven so beneficial in DCCT and other 

trials nationwide. I am pleased to testify today with Dr. Ann Albright, Director of the CDC 

Division of Diabetes Translation, because our agencies work so effectively together on efforts to 

combat diabetes, such as on this standardization program, the SEARCH study, the NDEP, and 

several other efforts. 

COORDINATING RESEARCH ACROSS THE GOVERNMENT 

Diabetes research is effectively coordinated throughout the government toward a 

common goal of improving health. One important venue for coordination is the statutory 

Diabetes Mellitus Interagency Coordinating Committee (DMICC), which is chaired by the 

NIDDKand includes other components ofNnI and other HHS and federal agencies that support 

diabetes-related activities. The DMICC facilitates cooperation, communication, and 

collaboration on diabetes among these goveinment entities. DMICC meetings help members 

identify emerging issues and opportunities and develop ways in which different govemment 

components can work together and build upon each other's expertise and resources. This 

approach heips ensure that federal diabetes activities are coordinated and not duplicated, and also 

stimulates collaborations. 

ThepMICC, with leadership by the NIDDK, has undertaken a diabetes research strategic 

planning process to help guide the federal investment in diabetes research. The draft Plan is 

currently posted on the NIDDK website and is expected to be finalized later this summer. The 

Plan was developed as a coIJaborative effort across federal agencies and with input from the 

external research and patient advocacy communities. The Plan will guide the NnI, other federal , agencies, and the investigative and lay communities in our pursuit of a common goal of 

conquering diabetes. 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Unmet" 

House Energylmd Commerce Subcommittee on Health 

July I, 2010 

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FUTURE DIRECTIONS FOR RESEARCH 

As the NIDDK reflects on the past 60 years of supporting and conducting research on 

diabetes, it is clear that the scientific progress achieved during that time period has been 

remarkable. People with the disease are living longer and healthier lives than they did a few 

short decades ago. However, diabetes still places an enormous personal and economic toll on 

our country, s~ it is critically important to continue the pursuit of research to make further 

improvements in patients' health and quality oflife. 

For example, it is critical to link glucose monitoring to insulin delivery to create an 

artificial pancreas, which can help people with diabetes achieve blood glucose control associated 

with reduced complications, as welJ as alleviate the everyday burden of self-care. Now that we 

are collecting thousands of samples through the TEDDY study, researchers can use new and 

emerging technologies to analyze those samples and identify an environmental trigger of type 1 

diabetes. We must break the link between diabetes and its complications, and prevent the 

disproportionate burden that heart disease places on people with the disease. With the 

availability of many new medicines for type 2 diabetes, comparative effectiveness research can 

help inform doctor's decisions about what medicines to prescribe for their patients at different 

stages of disease to achieve the best health outcomes. Research can identify new strategies to 

help people maintain weight loss that is needed to prevent or delay development of type 2 

diabetes. 

Vital to these and other research efforts is the continued vigorous support of basic, preclinical, and clinical research, including research to address disparities in minority populations 

disproportionately burdened by diabetes. We will also continue to develop educational materials 

to disseminate new research findings to patients, their families, and health care providers. 

Strategic planning, including the new Diabetes Research Strategic Plan, will continue to guide , future research directions. The NIH will remain steadfast in our goal to support and conduct 

research that can continue to improve the health of people with and at risk for diabetes. 

In closing, thank you Mr. Chairman and members of the Committee for the opportunity 

to share with you a few highlights of NIH-supported diabetes research efforts. I am pleased to 

answer any questions you may have. 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Urunet" 

House Energy and Commerce Subcommittee on Health 

July J, 2010 

Page ]0 
53 


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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and Digestive and Kidney Diseases 

Biographical Sketch 

Judith E. Fradkin, M.D. 

Dr. Judith E. Fradkin became the Director of the Division of Diabetes, Endocrinology, 

and Metabolic Diseases (DEMD) at the National Institute of Diabetes and Digestive and Kidney 

Diseases (NIDDK) of the National Institutes of Health (NIH) in 2000. She had previously 

served as the Deputy Director of the Division, Chief of the Endocrinology and Metabolic 

Diseases Programs Branch, Acting Chief of the Diabetes Research Programs Branch, and 

Director of the Cystic Fibrosis Research Program within the Division. 

Dr. Fradkin graduated magna cum laude from Harvard College, received her medical 

degree from the University of California at San Francisco, and completed her internship and 

residency in internal medicine at Harvard's Beth Israel Hospital in Boston. She came to NIDDK 

as a clinical associate in 1979 after an endocrinology fellowship at Yale University. Dr. Fradkin 

is board-certified in Internal Medicine and in Endocrinology and Metabolism. 

In her 3 I-year career at NIDDK, Dr, Fradkin has created or directed a diverse array of 

high-impact clinical and basic research programs, including multi-centered clinical trials to 

evaluate new approaches to prevent and treat diabetes and its complications, scientific consortia 

to define the genetic and environmental triggers of diabetes, and diabetes research centers. She is 

responsible for a major series of diabetes initiatives focused on beta cell development and 

function, improved glucose control through development of continuous glucose monitors and an 

artificial pancreas, and research on obesity, insulin action, and animal models of diabetes. 

Under Dr. Fradkin's leadership ofDEMD, major new clinical research networks have 

been created to conduct trials for prevention or delay of progression of type 1 diabetes, 

prev~ntion of development of risk factors for type 2 diabetes in children, and comparison of 

treatment approaches to type 2 diabetes in children, and the landmark Diabetes Prevention 

Program clinical trial was successfully completed. 

Dr. Fradkin serves as Chair of the Diabetes Mellitus Interagency Coordinating 

Committee, which is charged with facilitating collaboration on diabetes among Federal entities. 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Unmet" 

House Energy and Commerce Subcommittee on Health 

July 1, 2010 

Page 11 
54 


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She also serves the on the Executive Committee providing leadership for the National Diabetes 

Education Program. 

In addition to her oversight of major biomedical research programs, she has served as an 

endocrinology consultant at the National Naval Medical Center in Bethesda, Maryland, since 

1984. 

The recipient of numerous NIH and Public Health Service awards, Dr. Fradkin is also the 

2003 recipient ofthe American Medical Association's Dr. Nathan Davis Award for outstanding 

public service in the advancement of public health. 

Testimony for hearing entitled, "The Battle Against Diabetes: Progress Made; Challenges Unmet" 

House Energy and Commerce Subcommittee on Health 

July I, 2010 

Page 12 
55 

Mr. PALLONE. Thank you, Dr. Fradkin. 

Now we are going to have questions now from the members of 

the subcommittee, and I will start with myself for 5 minutes. 

As you both know, the Diabetes Mellitus Interagency Coordinating Committee is in the midst of finalizing a diabetes research 

strategic plan. It is the first comprehensive research plan to be released in several years. I understand it is going to describe the future direction for 10 major diabetes research areas, and Dr. 

Fradkin, if I could start with you, can you briefly summarize the 

major focus areas of this report, and then I was going to ask Dr. 

Albright, she identifies the increasing rate of new diabetes cases as 

an area of great concern for CDC, so how do you think that plan 

will help stem the diabetes epidemic? I will start with Dr. Fradkin. 

Dr. FRADKIN. Thank you. So NIDDK is pleased to chair the 

DMICC, which includes participation from CDC and multiple agencies across HHS and throughout the government and really serves 

as a very effective organization to bring us together to share information and develop plans. So we have developed with the help of 

over 100 external researchers chapters focusing on each of 11 critical opportunities, and these range from very basic areas such as 

autoimmunity and the beta cell function that I was telling you 

about to needs with regard to comparative effectiveness research 

and translational research to build translation from clinical research into translational research, and we have identified a number of opportunities for important clinical trials that we would like 

to undertaken if funds are available as well as some key opportunities utilizing new genomics, proteomics technologies to try to elucidate the basis of diabetes so that we can develop new strategies for 

prevention and cure. 

Mr. PALLONE. All right. Thanks. 

Dr. Albright, as I mentioned, how is this new plan going to stem 

the diabetes epidemic looking at the rate of new diabetes cases? 

Ms. ALBRIGHT. There certainly is continued research that needs 

to be done in developing ways to reduce the onset of diabetes in 

those that have pre-diabetes and reducing the risk factors so people 

don’t even into the world of pre-diabetes. So particularly the trend. 

There will be certainly chapters in this plan that will help with 

those more basic biologic mechanistic work, which is critical, but 

importantly, this plan also includes a chapter on translational research and that is an area that CDC and NIH and others share. 

We both have a role to play in the translation of the basic science 

into practice. So there will be questions and guidance in that chapter for how to identify those areas that are real world in which you 

take what we learn in a laboratory or in a contained setting and 

now you have got to take it out to the real world. So it important 

that we have studies that allow us to make those transitions, and 

then certainly from CDC’s perspective, we then take that information and try to scale it and sustain it and be sure that there is a 

much broader research. Otherwise the discoveries that we made 

end up with a very limited reach, and that is not effective for the 

investment in research. We need to be sure that we get it out to 

as many people as we possibly can. 

Mr. PALLONE. All right. Dr. Albright, let me ask you this. You 

talked about, you know, trying to promote fresh vegetables, fresh 


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fruit, that type of thing. I actually am still the vice chair of the Native American Caucus and I have taken an interest in diabetes as 

it pertains to Native Americans in particular, and also in urban 

areas, and I have always felt that the biggest problem is not having access to fresh fruits and vegetables. I remember when I went 

to the Tahona Odem reservation years ago, they were a desert people that relied on just, you know, nuts and fruits and things they 

gathered in the desert, and all of a sudden they are eating processed cheese and tacos and all this kind of stuff, and I know that 

they have made an effort there to try to go back to some of the subsistence agriculture, but it is often difficult for people. Like I take 

my kids to McDonald’s. One day I was at McDonald’s, and McDonald’s is now starting to offer salads and fruits and different things 

that are better, but if you stand there for a half an hour, nobody 

orders any of that. They still order the burgers and everything. So 

how do you promote this effectively? And also, are there alternatives? Like some people have suggested that maybe use dietary 

supplements, vitamins, because if people aren’t going to eat the 

fresh fruits and vegetables, there is some other way to supplement 

their diet through vitamins or whatever, I don’t know. It just seems 

like even though there are a lot of people out there trying to promote the fresh fruits and everything that we continue to lose the 

battle, not just amongst Native Americans but just in general. I 

mean, it is sort of a comment, but if you could just—how do we get 

there and are there alternatives like supplements that could be 

used instead? 

Ms. ALBRIGHT. I think that some of the things that we are trying 

that have an evidence basis behind them, and that is first important, that what we do try has an evidence basis behind it. I think 

part of the challenge is that we haven’t been able to implement 

these on a large enough scale to have the kind of impact. We do 

have to change the culture and change the environment so that the 

healthier choice is the easier choice for people, and that can have 

to do with pricing strategies and other kinds of things that make 

it easier, so it is availability both from a geographic—you don’t 

have to hike 10 miles to get an orange and you can reach right 

next to you and get a 52-ounce soda. So we have really got to make 

access to those things easier. That can be supported by policies and 

by pricing, other sorts of things that may help with that. So it is 

going to require a culture change. 

As far as supplements, they may have a role to play if people are 

not getting adequate nutrition but really our major challenge is 

that people are overconsuming calories. So we do have to consider 

ways to reduce caloric consumption and that is what is resulting 

in the obesity epidemic and increase the physical activity opportunities which again is another situation where people need to have 

safer places to be physically active and know what they can do to 

improve their health. So while there certainly may be a role for 

supplements and vitamins and minerals, as a dietician I often recommend that people are taking those but they are not a replacement or an answer for reducing caloric intake and increasing physical activity. 

Mr. PALLONE. Thank you very much. 

Mr. Shimkus. 


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Mr. SHIMKUS. Thank you, Mr. Chairman. I have to continue my 

role as the burr underneath the saddle of the majority and the 

loyal opposition sometimes, but I need to stand up for McDonald’s 

and understand the market. If they are not making any profit off 

those salads, they just wouldn’t be selling them. 

Mr. PALLONE. But they don’t sell that many. 

Mr. SHIMKUS. They must be selling enough to keep it on the 

menu board. My son used to get the apples over the fries but now 

he is older, he is moving to the fries now. But that is a real issue. 

They wouldn’t—they are marketing and they are selling, and if 

they weren’t—you know, they are doing it for the bottom line, but 

it is an educational aspect, so when parents are taking their kids 

in, you know, the parents can also choose healthy. They can set the 

example for the kids. But I just wanted to put that aside there. And I also want to put down, the first of the health law’s $569 million in tax increases starts today with the $2.7 billion tax on 

tanning services, so I just got a little blurb on that and wanted to 

put that on the record. We can celebrate. 

Now, this is more in line with your visit here, and I do appreciate it, and it is a little technical so I have got to read some of 

this. You all, CDC and NIH through this section shows the positive 

benefits of lifestyle intervention, diet and physical exercise to individuals with type 2 diabetes, plus it has been known that diet 

plays a major role in treatment and management of type 1 diabetes, and we were talking about that. In fact, insulin’s effectiveness 

requires diet interventions to manage diabetes and slow the progression of diabetes comorbidities, primarily cardiovascular, kidney 

and eye complications, again something that you were just referring to, Mr. Chairman. So this is a question directing about the 

registered dieticians who provide medical nutrition therapy which 

for a decade since the Benefits Improvement Protection Act, BIPA, 

as a lot of us like to say, passed has been a Medicare Part B-covered intervention for diabetes chronic kidney disease. Under the 

health care law, the Affordable Care Act, states that copayment 

and deductible fees are waived for prevention and interventions 

recommended by the U.S. Preventive Services Task Force with a 

grade A or B. CMS recently released proposed rules for section 

4104 of the medical nutrition therapy, was given a grade B. So the 

U.S. preventive Services Task Force recommends intensive behavioral diet counseling for cardiovascular and other diet-related 

chronic diseases. Does CDC believe diet interventions for cardiovascular risk factors such as high blood pressure and high cholesterol for pre-diabetes and other diet-related chronic diseases should 

be included with diabetes and chronic kidney disease in Medicare 

Part B medical nutrition therapy? I know it is a lot. I had to read 

it. And if this is too big and voluminous, you know, if you could 

respond in writing or get back to us, unless you know the answer. 

Ms. ALBRIGHT. Sir, I can’t speak to the specific official position 

of our agency. What I would offer, though, is to think about those 

services that you are describing which are education and counseling. Those are important services. They will have limited impact 

if they are not undergirded and supported by other interventions 

that focus on making the opportunities for people easier to get to 

so the advice they get from their dietician, and I advise patients 


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as a dietician, they have to go home to their settings, and if those 

do not support easier opportunities to get those healthy foods and 

to participate in physical activity, it makes it more difficult to implement the advice that they are being given by their registered dietician whether it is for hypertension or for diabetes. So there are 

other opportunities to help support that education and counseling 

so it can actually have the best impact it could possibly have. But 

it does need to be supported by these other options and other sorts 

of things that allow people to make that choice, the healthy choice, 

much easier for them to make. 

Mr. SHIMKUS. And if I may, has the Common Fund, which was 

established in the NIH reauthorization law, been used to coordinate diabetes research across NIH? Dr. Fradkin, do you know? 

Dr. FRADKIN. So the Common Fund is actually focused on things 

that are of broad interest and are not disease specific with the idea 

that it is, for example, developing new technologies that will be applied to diabetes. But over half of the institutes, in fact, a great 

majority of the institutes and centers at NIH do participate in the 

Diabetes Mellitus Interagency Coordinating Committee which is 

the major coordinating function. Could I just speak to your previous question briefly also? 

Mr. SHIMKUS. Oh, yes, if the chairman will allow. 

Dr. FRADKIN. The study that I just mentioned that was just reported actually 2 days ago on a more cost-effective way to deliver 

the diabetes prevention program intervention, it provided people 

with three sessions with a dietician and then all the rest of the sessions were with low-cost community caseworkers, and they found 

a very dramatic reduction in weight. So that is an example of the 

kind of study that we support, you know, which does provide evidence for the value of dieticians. And if I could just make one additional comment? When the U.S. Preventive Services Task Force 

gives something a relatively low grade, that could be because it 

doesn’t work, but often it is because it simply hasn’t been studied. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Shimkus. 

Next is the gentlewoman from Colorado, Ms. DeGette. 

Ms. DEGETTE. Thank you. 

Dr. Fradkin, my first questions nicely piggyback on Mr. 

Shimkus’s question because one of the big concerns of the Diabetes 

Caucus for a long time has been the disparities between minority 

populations like African Americans, Latinos and American Indians 

and Alaska Natives and Anglos, and we are not really sure why 

those disparities exist other than a combination of factors of health 

access, community, environment, genetics, so I am wondering if you 

can talk a little bit more about any ongoing research by NIH to address the cause of the disparities because until we find out the 

cause, we can’t really address how to deal with it. 

Dr. FRADKIN. So first of all, we make a big effort to include minorities in all of our clinical research and in fact to over-represent 

minorities because they are disproportionately affected by diabetes, 

and in a study such as the diabetes prevention program, the interventions worked just as well in minority participants as in non-minority participants, but we do see some differences. So, for example, there has been research recently, for example, suggested that 


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African Americans may have higher hemoglobin A1C values at the 

same level of glucose values. 

Ms. DEGETTE. Right. 

Dr. FRADKIN. We need more research to look at that, but if that 

is the case, what it means is that they aren’t necessarily getting 

worse glucose control but it is the measure of the glucose control 

that could potentially—— 

Ms. DEGETTE. Right, which means you are going to have different therapies for those groups. And then we have some groups 

like the Pima Indians we were talking about earlier where they 

have a huge percentage of their populations with type 2 diabetes 

and it could be that not necessarily those groups, dietary habits or 

exercise habits are that much worse than a comparable other population but that there is some kind of genetic propensity or something else that we could use. Is that right? 

Dr. FRADKIN. Absolutely, and so most of the studies that have up 

to now been done in terms of genetics of type 2 diabetes have 

looked at Caucasian largely European populations and the NIDDK 

just established a very major genetics consortium to look specifically at genes for type 2 diabetes in high-risk minorities. 

Ms. DEGETTE. And just for the commercial portion of my questioning, we have this minority disparities legislation which has attempted to deal with this exact issue, and Dr. Christensen has 

been a huge help and some of the other caucuses, Mr. Chairman, 

so we should really look at that bill too as we move along. 

I want to ask you, Dr. Albright, very briefly about this new report that came out from the Robert Wood Johnson Foundation this 

week. Unfortunately, it is called F is for Fat and it says that the 

intensity, the rate of obesity continues to increase in 2010, particularly in the Hispanic and African American subpopulations, and 

this is despite all of CDC’S public health campaigns to improve diet 

choices and activities and everything else. I am wondering what 

CDC’s strategy is to try to reverse this trend. I know CDC has been 

working assiduously on it but it just seems every time we get one 

of these reports, it is worse and worse. My State of Colorado is almost always the vast State but that doesn’t mean it is good because it just means that the rate of obesity is lower than other 

places. It doesn’t mean people aren’t obese. I am wondering if you 

can talk about how we can ramp up our efforts to reverse these 

trends. 

Ms. ALBRIGHT. It is certainly a significant issue and one that is 

going to require a multi-pronged approach. I think that is one of 

the things we all have to remember is that there isn’t a simple single answer for this, it is multifactorial. Other divisions within CDC 

and other agencies in the federal government are certainly tackling 

and taking on obesity, particularly working on childhood obesity so 

starting early in life and trying to change those habits early in life. 

They are also working on things related to adult obesity prevention 

and treatment issues. Much of the focus is turning toward policies 

and changing the built environment that will help with that. There 

will need to be some time in order to determine the impact of those 

broader changes in policy that should have a much bigger impact 

on a larger segment of the population. 


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Ms. DEGETTE. Thank you. One last question for you, Dr. 

Fradkin. Going back to the special diabetes funding that we are 

trying to get reauthorized, what benefits, if any, does the multiyear 

funding stream in that program provide to the ability to fund the 

most promising research in the field and how important is that 

multiyear funding aspect of the special diabetes program? 

Dr. FRADKIN. Let me give you an example of one thing that we 

did with the special funding that absolutely required multiyear 

funding. We created a program for career development, research 

career development for researchers studying childhood diabetes so 

we gave funds to the institutions that had very, very strong programs in pediatric diabetes research which enabled them to recruit 

in promising new investigators with the promise of 5 years of career support, and I can tell you that some of the people supported 

through that program have already made tremendous contributions 

so, for example, at Yale one of the investigators who was supported 

through that program has already got NIH funding and is working 

on trying to close the loop, and in fact three out of four of the people supported at Yale are now junior faculty there. We had to stop 

that program because we don’t have 5 years of funding remaining 

and so as a result we couldn’t offer people 5 years of career development support. That is just a specific kind of an example but I 

think it kind of gives the favor of why it is important, and many 

of things that we are doing like TEDDY where we have to follow 

kids until they are 15 just clearly require a sustained stream of 

funding. 

Ms. DEGETTE. Thank you very much. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. 

The gentleman from Georgia, Mr. Gingrey. 

Mr. GINGREY. Thank you, Mr. Chairman. 

Dr. Fradkin, you responded to one of my colleagues just a few 

minutes ago, and this is not an exact quote but you essentially said 

when the United States Preventative Services Task Force gives 

something a low grade, it often means that it hasn’t been well studied. I would like to ask your opinion in regard to the low grade that 

they, the U.S. Preventive Services Task Force, gave regarding 

screening mammography for women in their 40s to either prevent 

or early detection of breast cancer. Do you have any thought on 

that? 

Dr. FRADKIN. I really have not followed screening mammography 

closely. That is not in my area. 

Mr. GINGREY. But you are a medical doctor. 

Dr. FRADKIN. So, you know, I think probably the grade that concerns us in particular relates to their grade on screening for identifying people with diabetes and with pre-diabetes where the quality 

of evidence that it would require for them to recommend supporting that would require many, many years because simply identifying people with diabetes or pre-diabetes doesn’t rise to the status that they require to find something effective. You have to actually—— 

Mr. GINGREY. Well, let me pull back just for a second and then 

I will let you continue, because the reason I ask you that, I do have 

some real serious concerns, because you know that in the Patient 


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Protection and Affordable Care Act of 2010, sometimes referred to 

as Obamacare, that this task force will begin pretty darn soon to 

not just recommend but to mandate, and I think it is really important that we take a very, very close at that. But let me go ahead 

and shift to the area in which you are now involved of course. 

With some 57 million Americans estimated today to have pre-diabetes, strategies to prevent or delay the progression to type 2 diabetes are critical to stemming the burden of diabetes on patients 

and our health care system. Do you think the existing guidelines 

sufficiently address the needs of patients with pre-diabetes or is it 

more important or more attention needed to ensure these patients 

have access to the most appropriate treatment options? My concern 

being that, you know, we know a lot of people have pre-diabetes. 

You gave a figure, an astoundingly large figure, but are we doing 

enough to really prevent them from progressing to full-blown type 

2 diabetes? 

Dr. FRADKIN. So I think this is where the kind of joint effort that 

Dr. Albright and I have been talking about is particularly important. We at NIH are doing research to try to figure out how to most 

cost-effectively prevent diabetes in those patients. We have a very 

strong program looking at multiple different ways to achieve prevention and specifically looking at culturally sensitive approaches, 

looking at what works best in particular populations and then CDC 

and actually it is wonderful to see even private payers, you know, 

building on the results of our research to try then to create public 

health programs that give people access to the things that the research has shown was effective. But clearly our research shows 

that about 90 percent of people with pre-diabetes don’t even know 

that they have pre-diabetes and most of them are not taking effective steps to try to reduce their risk. 

Mr. GINGREY. Thank you, Dr. Fradkin. 

Dr. Albright, again, regarding that, and you mentioned the vast 

majority of cases in the United States today are preventable and 

certainly these many people with pre-diabetes. What are the top 

things that can be done to prevent these cases from progressing? 

Ms. ALBRIGHT. At this point the evidence that we have suggests 

really scaling up and making this National Diabetes Prevention 

Program widely available to people. We are now offering it. CDC 

is providing funding to 11 sites. United Health Group is providing 

it to six. They have agreed to take over coverage of their beneficiaries so it is a very good public-private model. We will get the 

ball rolling in some of these locations and the private insurer can 

take over and continue to reimburse as time goes on, and so that 

is a nice combination. But we do need to get to more places and 

get to more locations, particularly harder to reach places. We need 

more entities that can deliver this in addition to the YMCA USA, 

who is outstanding, and other additional third-party payers. So we 

have got the beginning infrastructure there and it is time now for 

us to expand that infrastructure and allow it to reach across the 

country. 

Mr. GINGREY. Thank you, Dr. Albright, Dr. Fradkin, and I will 

yield back. Thank you both. 

Mr. PALLONE. Thank you, Mr. Gingrey. 


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Next is the gentlewoman from the Virgin Islands, Ms. 

Christensen. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman, and I want to 

thank you both for your testimony and your answers thus far. 

Dr. Albright, you mentioned working with five States and six organizations. Do they have a good mix of the population, a good population mix? 

Ms. ALBRIGHT. Yes, they—— 

Mrs. CHRISTENSEN. I don’t know if you had mentioned what 

States they are or—— 

Ms. ALBRIGHT. Yes. We can’t publicly announce them yet because 

the reviews have just been done, but we work to pay special attention to that. We first look for the best applicants. Certainly that is 

number one. But we are working and always seek to assure a wide 

representation of States and more territories and Pacific jurisdictions as well. We do provide funding to all of the U.S.-affiliated territories, so we are eager to have them involved as well. 

Mrs. CHRISTENSEN. I just wanted to make sure that there was 

diversity represented in those States and organizations. 

Ms. ALBRIGHT. Yes. 

Mrs. CHRISTENSEN. Both of you have talked about the importance of the social and economic determinants of health, and certainly that is some of the reason why we haven’t been able to make 

the impact in the African American, Native American, Hispanic 

communities. I have been supporting having an executive order 

similar to the one that President Clinton had issued back in 1998, 

I guess, around environmental justice requiring that all agencies of 

government, all departments do health impact assessments on 

their policies and programs and actually go beyond that to try to 

address some of the social and economic environmental issues 

through their policies. Is that something that you could support? 

Because it seems as thought we are not going to make any progress 

as long as people live in food deserts, have, you know, all of the 

social and economic and environmental barriers to improving their 

health. 

Ms. ALBRIGHT. I can certainly say that CDC’s focus is growing 

in that area under the leadership of our agency director, Dr. Tom 

Frieden. We certainly are focused on policies and environmental 

changes that will support that, and really one of the themes that 

CDC is really seeking help in all policies. It is going to take—because it is so multifactorial of a problem, we do have to consider 

and evaluate the kinds of things that we are doing to try to make 

inroads in these very broad areas in our society but it is critical 

that we do investigate them and find solutions within these multiple areas. 

Dr. FRADKIN. Maybe I could just speak to one specific investigation that we have done in this regard that we actually just reported 

the results on this past week, and that was a huge study in which 

we looked at the environment in 42 middle schools focusing on the 

schools that predominantly serve minority and low-income students. Fifty percent were Hispanic, over 20 percent were African 

American. Most of them were on free or reduced lunch. And we 

looked in those schools at changing the food services, increasing 

physical activity, and also promoting behavioral change, and we got 


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some positive results. We didn’t get everywhere we wanted to be 

but we saw reductions in obesity in the kids who started overweight or obese, which was half the kids in these schools were 

overweight or obese, and those children had reduced obesity as a 

result of this intervention, decreased waist circumference, decreased levels of insulin. So some positive impacts on risk factors 

for type 2 diabetes, and this is the kind of societal intervention that 

I think, you know, NIH likes to do research to test and then when 

we see results from studies like this, you know, then the public 

health agencies move to try to translate that. 

Mrs. CHRISTENSEN. Thank you. I yield back, Mr. Chairman. 

Mr. PALLONE. Thank you. 

Mr. Space for 8 minutes. 

Mr. SPACE. Thank you, Mr. Chairman, and thank you again for 

exhibiting your commitment to such an important issue by convening this hearing. 

Where to begin? Dr. Albright, your testimony, and actually both 

of your testimonies, I think, underline the increase that we are seeing all types of diabetes and your testimony briefly alludes to, and 

I think some of my colleagues have referenced it very specifically, 

the cost that this is visiting upon our country, and just doing a little bit of quick math, assuming that we are somewhere north of 

$200 billion a year now, which I know is probably true. I know the 

ADA’s study from a couple years ago, 2007, was at $174 billion. 

That computes to over a half a billion dollars a day that this disease is costing our society, and as Ms. Schakowsky pointed out, 

much of that is a direct governmental expenditure, and to put it 

in perspective, in 2009 we spent $148 billion on two wars in this 

country, and now we are spending upwards of $200 billion a year 

dealing with the effects of this one disease that has taken several 

different forms. Is it a safe assumption that with the increase in 

incidence of diabetes that these costs will continue to escalate? 

Ms. ALBRIGHT. Yes. That would be the short answer. 

Mr. SPACE. And much of the costs associated with diabetes consist of treating the complications of diabetes, correct? 

Ms. ALBRIGHT. They certainly are associated with the costs of 

treatment. Fortunately, as we have said, there are ways for us now 

to prevent, and we have been trying to work to get those to be delivered as cost-effectively as possible. 

Mr. SPACE. Right. So with the delivery of those preventive mechanisms and maintenance mechanisms, in the end you will mitigate 

the total cost associated with treating the complications that you 

can prevent or reduce through effective maintenance and treatment, and in the end, dollars spent today will result in a significant decrease in dollars spent tomorrow. Is that a safe statement? 

Ms. ALBRIGHT. I think there are some little parameters you have 

to put around there when you are looking at cost-effectiveness. You 

are very right, that you have to look at the time horizon and you 

have to look at the assumptions, but there certainly are opportunities for us to drive the costs down in treatment and prevention so 

that we can indeed have more productive citizens who can be contributing to the economy in successful ways, so there is certainly 

benefit to doing that. 


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Mr. SPACE. If we were to develop a cure for diabetes, and I want 

to on subsequent panels maybe talk a little bit about we might better do that, but just hypothetically if we were to develop a cure for 

diabetes, and that cure can take many different forms, it could be 

an artificial cure like the closed loop system that you have referenced or it could be a more natural cure, perhaps some day some 

embryonic stem cell research, if you have got a young person that 

develops diabetes at the age of 6 or 7 years old was diagnosed with 

type 1, the complications that that child is likely to experience as 

a result of the disease are not likely to manifest themselves for decades, correct? 

Ms. ALBRIGHT. That is right. 

Mr. SPACE. So by the that child is 40 or 50 years old, his risk 

for heart disease, blindness, stroke, kidney disease, amputation is 

much, much higher than it would be for someone who is not diabetic at that age. 

Ms. ALBRIGHT. Absolutely. 

Mr. SPACE. What I am trying to drive at here is the future costs 

of this disease, as debilitating as they are today, you know, society 

in a country that can’t afford the luxury of $200 billion a year in 

one disease, as debilitating as these costs are today, can you give 

us some projection as to where may be in 20 years or 30 years 

given the rather rapid increase in incidence of both type 1 and type 

2 diabetes in the event that we do not see a cure and we do not 

see the implementation on a wide scale of some of the measures 

that you are testifying about today with maintenance? What will 

be the implications economically to the society in 20 years if we 

continue to go the way we are going now without massive intervention and maintenance and/or cure? 

Dr. FRADKIN. Well, I think obviously the CDC is predicting that 

one in there children born today and one in two minority children 

born today will develop type 2 diabetes if we don’t intervene and 

change things, but I would like to point out that things actually— 

there are some very real improvements in terms of the prognosis 

for people with diabetes that have effects on health care costs, so 

because rates of diabetes are increasing so fast, if it weren’t for 

some of the effective things that we are doing to bring down the 

complications of diabetes, we would be seeing even greater costs 

than we are seeing today. So, for example, even though rates of 

end-stage kidney disease, which is a huge expense for Medicare, 

are going up, the actual proportion of people with diabetes who develop end-stage renal disease is falling. So if we weren’t doing 

those effective interventions as diabetes is increasing, we would be 

seeing even greater increase in the cost than we are seeing. 

Ms. ALBRIGHT. And I think this is definitely a combination of we 

are—this is—where we are seeing a greater number of people with 

diabetes, and that is because as people live longer, as we diagnose 

them earlier, as we catch them, people have undiagnosed diabetes, 

we are going to have a bigger total prevalence or total population. 

We want to drive that number down by reducing the new cases so 

that what resources we have can be delivered to effectively manage 

those people that have the disease and then hopefully over time not 

have a future of one in three and the devastating complications so 

we have got to make headway in preventing all forms of diabetes 


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and better treating diabetes because it also is where we will spend 

the cost. Yes, it does cost to take care of people with the disease, 

it does cost to prevent, but the opportunity to not have people suffer the ravages of this disease and continue to be productive members of society is a critical piece to be sure we keep in the discussion about the economics of diabetes. 

Mr. SPACE. Thank you, Doctor. Thank you, Doctor. 

I regret that I have no additional time. 

Mr. PALLONE. No, that is all right. I mean, I am glad you don’t 

because we are going to have a vote. We have three votes. I am 

going to try to get in our other two people here. 

Ms. DEGETTE. Mr. Chairman, before you recognize, can I just ask 

unanimous consent to submit a folder of different statements by 

different groups about their activities for the record? And this has 

been cleared with the minority. 

Mr. PALLONE. We will take a look at it first. 

Ms. DEGETTE. They have seen it. 

Mr. PALLONE. You have? 

Ms. DEGETTE. Yes. 

[The information appears at the conclusion of the hearing.] 

Mr. PALLONE. Without objection, so ordered, and I am going to 

try to get in Ms. Schakowsky and Mr. Engel and then we will let 

you go and we will come back after the votes for the second panel. 

I recognize the gentlewoman from Illinois. 

Ms. SCHAKOWSKY. I really—I think this is a quick question. 

There has been a lot of recent news about Avandia, the drug that 

is used to treat type 2 diabetes by increasing the body’s sensitivity 

to insulin. Two new studies released earlier this week add to the 

body of evidence about the risk of heart attack, stroke and heart 

failure among people who take these drugs and those are of course 

the very things we are trying to prevent by treating diabetes. The 

FDA is holding an advisory committee meeting in July where the 

safety of Avandia will be under review, and I think this is an appropriate action at this time. While the FDA deliberates on the 

safety and effectiveness of this drug, I wanted to ask about the underlying research and public health implications. Dr. Fradkin, in 

your professional opinion, what are the implications of the recent 

studies? And Dr. Albright, if you have anything else to add. 

Dr. FRADKIN. Well, let me just say that there are now multiple 

different classes of drugs that are available to treat type 2 diabetes 

as a result of research, and rosiglitazone, Avandia and pioglitazone 

are members of one of those classes of drugs. Most of the drugs 

have been approved based on relatively short-term studies that 

show that they are effective in reducing glucose but I think what 

we really need and what the strategic plan that the chairman referred to that the DMICC is developing is what we really need to 

head-to-head comparisons of the various drugs that are available 

for treating type 2 diabetes with longer-term time frames looking 

not simply at glucose lowering but looking at what they do over the 

course of diabetes in terms of heart disease, in terms of weight 

gain, in terms of quality of life for people, and we don’t have those 

head-to-head comparisons and so most of the data like these current studies that you are referring to are basically analyses of observational studies. They aren’t the ideal rigorous kind of research 


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that you need to answer the question, and the rigorous research is 

something that we need. 

Ms. SCHAKOWSKY. So let me ask you, Dr. Albright, then what advice would you have for people who are taking Avandia right now? 

Because it appears that not only do we have to reduce the blood 

sugar but how we do it is very important, and obviously more and 

more research and studies scientifically based studies have to be 

done. But in the meantime, what do we tell them? 

Ms. ALBRIGHT. Well, our response when we are asked, and we 

are asked these questions, is that it is critical that people have the 

discussion with their health care professional because as Dr. 

Fradkin referenced, there are other treatments. Their particular 

risks can be very carefully examined and determined. So it is important that people have a conversation with their health care provider because diabetes is a disease where you have to make lots of 

decisions and it is imperative that you have a good discussion with 

your health care provider to make those decisions for you as an individual. 

Ms. SCHAKOWSKY. Well, all of this really is a humbling reminder 

that we still have a lot to learn about diabetes and that we need 

to do that, so thank you very much. 

I yield back. 

Mr. PALLONE. Thank you. 

Mr. Engel. 

Mr. ENGEL. Thank you, Mr. Chairman. I will try to speak very 

fast. 

A hundred and thirty-five thousand women are diagnosed with 

gestational diabetes each year as well. I know that Dr. Burgess 

spoke about it. He and I have introduced the Gestational Diabetes 

Act, H.R. 5354, and we have gotten many cosponsors and I hope 

people on this subcommittee will all cosponsor it in a bipartisan 

way. And what our Act aims to do is lower the incidence of gestational diabetes and prevent women afflicted with this condition and 

their children from developing type 2 diabetes, and the legislation 

creates a research advisory committee headed by CDC to develop 

multi-site gestational diabetes research projects to enhance surveillance, provides demonstration grants to focus on reducing the incidence of gestational diabetes and expands basic clinical and public 

health research investigating gestational diabetes and current 

treatments and therapies, and I ask unanimous consent for my 

opening statement to appear in the record. 

[The information was unavailable at the time of printing.] 

Mr. PALLONE. Without objection, so ordered. 

Mr. ENGEL. Thank you, Mr. Chairman. 

Let me ask first Dr. Fradkin, and I will ask each of you one question. First of all, Doctor, congratulations on the NIH National Institute of Diabetes and Digestive Kidney Diseases 60th anniversary. 

Dr. FRADKIN. Thank you. 

Mr. ENGEL. It is because of the tremendous support of the National Institute’s research toward understanding, preventing and 

treating diabetes that we are closer than ever to better fighting 

and curing the disease, so congratulations. 

Could you tell me more, please, about the results of the hyperglycemia and adverse pregnancy outcome study? I guess it is the 


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67 

HAPO study. And do you find that expansion of basic clinical and 

public health research investigating gestational diabetes and obesity during pregnancy such as our Act would be useful to further 

develop the insights gained from the hyperglycemia and adverse 

pregnancy outcome study? 

Dr. FRADKIN. I can’t speak specifically to the Act but I can tell 

you that I think gestational diabetes is one of the most important 

problems confronting us in the area of diabetes because not only 

does it cause problems at the time of birth for both the mother and 

the child, increasing rates of cesarean section and injury to the 

child but also it puts the mother at increased risk for subsequent 

diabetes but also we have data suggesting that the intrauterine environment puts the offspring at increased risk for diabetes and obesity. So you can imagine the vicious cycle that can occur as type 

2 diabetes occurs at younger and younger ages moving toward people developing gestational diabetes or even type 2 diabetes during 

their childbearing years, then the offspring of that pregnancy not 

only has the genetic risk that it gets from the parent but also has 

the increased risk conferred by this adverse metabolic environment 

that also then increases the risk, so you can imagine sort of a vicious cycle where rates of diabetes will increase at expanding rates. 

So this is a cycle that we really need to break and I think the 

HAPO study has given us some extremely important information 

showing that adverse effects of hyperglycemia in pregnancy occur 

at much lower levels of glucose than we previously appreciated. 

Mr. ENGEL. Thank you. Very well said. 

Dr. Albright, you mentioned in your testimony that women with 

type 2 diabetes are at increased risk for having babies with birth 

defects and women with a history of gestational diabetes should receive targeted intervention strategies to prevent type 2 diabetes before they become pregnant, during pregnancy, postpartum and between. Can you please describe some of the intervention and educational outreach strategies the CDC is undertaking to increase 

awareness of gestational diabetes and the risks associated with it? 

Ms. ALBRIGHT. Yes. Briefly, we are making special effort in the 

National Diabetes Prevention Program that we mentioned earlier 

to really put recruitments efforts and raising the awareness of 

women of childbearing years and their risk if they have had for 

GDM for developing type 2 diabetes and special efforts will be 

made to really try to seek to get them involved in this program. 

They are a terrific candidate for the National Diabetes Prevention 

Program. We also as part of the National Diabetes Education Program that Dr. Fradkin and I have the honor of working on together, we are working on some more gestational diabetes education efforts. We have received some funding from HHS and NIH 

will be taking the lead in doing some comparative effectiveness 

work with our NDEP materials. So we are continuing to work together in that area. 

Mr. ENGEL. Thank you. And before I yield back, I just want to 

throw a little accolades to our counsel here to my left, Emily Gibbons. I am going to thoroughly embarrass her, but she was my 

long-term legislative director and health person, and Mr. Pallone 

stole her from me. 

Mr. PALLONE. With permission. 


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Mr. ENGEL. With permission, and she does marvelous work and 

has done the work for both of us on gestational diabetes. So now 

that I have thoroughly embarrassed you, I yield back the balance 

of my time. 

Mr. PALLONE. I will second that. 

Thank you, Mr. Engel, and thank you both of you. This was very 

helpful. We really appreciate it, and obviously something that we 

have to deal with long term, but we appreciate your testimony. 

And what we are going to do is take—we are voting now. We 

have three votes. It should take us to approximately 1:30. So if 

anybody wants to have lunch, we will reconvene at 1:30 and we 

will have our second panel. Thank you. 

The committee stands in recess. 

[Recess.] 

Mr. PALLONE. The subcommittee will reconvene, and as I promised, we will begin with our second panel. Let me introduce each 

of you. First is Chairman Buford Rolin, who is vice chairman and 

national area representative for the National Indian Health Board 

and also chairman of the Poarch Band of Creek Indians. Thank you 

for being here. Then we have Dr. Robert Goldstein, who is senior 

vice president for Scientific Affairs of the Juvenile Diabetes Research Foundation, and Dr. Robert R. Henry, who is presidentelect, Medicine and Science for the American Diabetes Association, 

professor of medicine at the University of California, Department 

of Medicine, and chief of the section of endocrinology, metabolism 

and diabetes at the VA Medical Center in San Diego. 

I need to mention to the panel that Chairman Rolin is going to 

testify and then leave because he has to catch a plane and pervious 

commitments, but he will take written questions, and the way we 

work, as I think you know, we have 5 minutes’ opening from each 

of you and then we take questions, but you can submit additional 

written statements if you like and then members may also follow 

up with some written questions as well. 

So we will start with Chairman Rolin. Nice to see you again. 

STATEMENTS OF BUFORD ROLIN, VICE CHAIRMAN AND NASHVILLE AREA REPRESENTATIVE, NATIONAL INDIAN HEALTH 

BOARD, AND CHAIRMAN, POARCH BAND OF CREEK INDIANS; 

ROBERT A. GOLDSTEIN, M.D., PH.D., SENIOR VICE PRESIDENT, SCIENTIFIC AFFAIRS, JUVENILE DIABETES RESEARCH FOUNDATION; AND ROBERT R. HENRY, M.D., PRESIDENT-ELECT, MEDICINE AND SCIENCE, AMERICAN DIABETES ASSOCIATION, PROFESSOR OF MEDICINE, UNIVERSITY 

OF CALIFORNIA DEPARTMENT OF MEDICINE, AND CHIEF, 

SECTION OF ENDOCRINOLOGY, METABOLISM AND DIABETES, VA MEDICAL CENTER IN SAN DIEGO 

STATEMENT OF BUFORD ROLIN 

Mr. ROLIN. Thank you, Mr. Chairman and members of the subcommittee. I am Buford Rolin, chairman of the Poarch Band of 

Creek Indians and vice chairman of the National Indian Health 

Board. I also serve as the co-chair of the Tribal Leaders Diabetes 

Committee and—— 


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Mr. PALLONE. I am not sure, Chairman, that your mic is on. Is 

it green? 

Mr. ROLIN. It is green. 

Mr. PALLONE. Then you have to bring it a little closer. 

Mr. ROLIN. Can you hear me? 

Mr. PALLONE. That is better. Thanks. 

Mr. ROLIN. I will just begin again. 

Good afternoon, Mr. Chairman and members of the subcommittee. I am Buford Rolin, chairman of the Poarch Band of 

Creek Indians and vice chairman of the National Indian Health 

Board. I also serve as the co-chair of the Tribal Leaders Diabetes 

Committee, and on a personal note, I have lived with diabetes for 

the last 6 years. Thank you for inviting NIHB to participate in this 

important hearing. I apologize, but I must leave early to catch a 

flight. 

Today, American Indians and Alaska Natives suffer disproportionately from diabetes. Indian adults are two times more likely to 

have diabetes compared with the non-Hispanic whites. In some 

tribal communities, more than half of the adults have been diagnosed with diabetes. Sadly, the highest rate of diabetes diagnosis 

has appeared among our young children and young adults. From 

1990 to 2009, young native people ages 25 to 34 years experienced 

a 161 percent increase in diagnosis of type 2 diabetes. In addition, 

diagnosis of diabetes rose 110 percent in our teenagers 15 to 19 

years old during the same period. 

Despite these alarming statistics, progress is being made. This 

progress would not have been possible without the Special Diabetes 

Program for Indians. Congress created the SDPI in 1997 in the 

wake of increasing public concern about the burden of diabetes in 

native communities. In 1998, the Indian Health Service established 

the Tribal Leaders Diabetes Committee to provide guidance on 

SDPI, diabetes and related chronic diseases. Today, through SDPI, 

IHS provides funding in support for diabetes prevention and treatment programs, services and activities to over 450 IHS tribal and 

urban Indian SDPI programs, and it is working. Diabetes-related 

health outcomes have improved significantly in native communities 

since the launch of SDPI. For example, there is 11 percent decrease 

in the blood sugar level A1C in Indian people who have been diagnosed with diabetes. This decrease translates to a 40 percent reduction in diabetes-related complications such as blindness, kidney 

failure, nerve disease and amputations, 16 percent in total cholesterol level and a decrease of 20 percent in bad cholesterol. Research 

has shown that lowering cholesterol levels reduces the risk of developing complications associated with diabetes such as heart attacks, stroke or heart failure, 32 percent decrease in the prevalence 

of protein in urine and a risk of kidney disease. New cases of diabetes-related dialysis in Indian people decreased 31 percent between 

1999 and 2007 while remaining relatively unchanged in other 

races. Preventing kidney failure is critical to help people with diabetes, avoid needing dialysis or kidney transplants. In addition, 

SDPI has enabled the IHS tribal and urban Indian programs to 

provide expanded screening, prevention and diabetes treatment 

services as well as to build a desperately needed infrastructure. 


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70 

The committee should also know that the outcomes of the SDPI 

and knowledge gained through these scientific-based programs 

have helped to inform and advance other IHS diabetes programs 

such as the model diabetes program established under the Indian 

Health Care Improvement Act. The 19 model diabetes programs in 

the Indian health system have made significant contributions including state-of-the-art comprehensive clinical diabetes care 

through a multidisciplinary preventive and treatment approach. 

The Special Diabetes Program for Indians has been lifesaving to 

people who have diabetes, life-changing to those who have avoided 

diabetes because of early detection and prevention efforts, and perhaps most importantly, it is helping to ensure a diabetes-free future for our children and future generations. Making real progress 

in this area and ensuring that future generations will be free of the 

burden of this disease requires federal and tribal government collaboration. We have shown it can work. Now we need to recommit 

ourselves and this hearing is a good first step. 

On behalf of the National Indian Health Board, thank you for 

this opportunity to address the subcommittee regarding this important issue. Thank you. 

[The prepared statement of Mr. Rolin follows:] 


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National Indian 

Health Board 

~ 

TESTIMONY OF BUFORD ROLIN 

CHAIRMAN, POARCH BAND OF CREEK INDIANS, 

VICE-CHAIRMAN, NATIONAL INDIAN HEALTH BOARD & 

CO-CHAIRMAN, TRIBAL DIABETES LEADERS COMMITTEE 

BEFORE THE HOUSE COMMITTEE ON ENERGY AND COMMERCE 

SUBCOMMITTEE ON HEAL TIl 

FOR TIlE HEARING ON 

THE BATTLE AGAINST DIABETES: PROGRESS MADE; CHALLENGES UNMET 

THURSDAY, JULY 1,2010, AT 10:00 A.M. 

2322 RAYBURN HOUSE OFFICE BUILDING 

Good Morning Mr. Chairman, and Members of the Subcommittee: 

I am Buford Rolin, Chairman of the Poarch Band ofCr~ek Indians and Vice-Chairman of the 

National Indian Health Board (NIHB). Thank you for inviting the NIHB to discuss the crisis of 

diabetes facing our American Indian and Alaska Native (AllAN) people. 

Established in 1972, the NIHB serves all 564 federally recognized AllAN Tribal Governments 

by advocating for the improvement of health care delivery, as well as upholding the federal 

government's trust responsibility to AlIANs. We strive to advance the level and qualiry of health 

care and the adequacy of funding for health services delivered directly by the Indian Health 

Service (IHS) or directly operated by Tribes and Tribal Organizations. Our Board Members 

represent each of the twelve IHS Areas and are generally elected at-large by their respective 

Tribal Governmental Officials within their regional area. The NIHB is the only national 

organization solely devoted to the improvement ofindian health care on the behalf of the Tribes. 

All AN people suffer disproportionally lower health status and experience higher health 

disparities. In many tribal communities, diabetes is three to five times the national average. I am 

pleased that your Committee is working to both elevate this issue in Congress and to develop and 

support policies and programs to address the problem. 

926 Pennsylv:,lIlla Avenue, SE I Washington, DC 20003 t 202·507+4070 I 202-S07A071 en I www.nihb.org 

The RI:d Fcatber" ofH(Jpt' and HC(flhVl 
72 


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Page 2 of5 

Diabetes in Indian Country 

Less than 100 years ago, diabetes was virtually unknown in Native communities. Today, AllAN 

communities suffer disproportionately high rates of type 2 diabetes. AllAN adults are 2.2 times 

more likely to have diabetes compared with non-Hispanic whites. I Furthermore, in comparison 

with 8.7% of non-Hispanic whites, 16.3% of AllAN adults have been diagnosed with diabetes? 

In some AllAN communities, more than half of the adults aged 18 and older have been 

diagnosed with diabetes, with prevalence rates reaching as high as 60%3 Adding to these 

troubling statistics is the rise of obesity and type 2 diabetes among our young people. The 

highest rate of increase has occurred among AllAN young adults aged 25-34 years, with a 161% 

increase from 1990-2009. Alarmingly, type 2 diabetes rose 110% in AllAN adolescents, 15-19 

years old. 

60 

50 

40 

30 

20 

10 

Prevalence of diagnosed diabetes among 

AlAN children and young people 

by age group, 1990-2009 

Per 1,000 

Year 

Age 

... <15 

15-19 

.. 20-24 

... 25-34 

Source: IHS Diabetes Program Statistics 

All AN people are also more likely to die from diabetes or diabetes related causes than other 

Americans. The diabetes mortality rate is nearly three times higher in the AllAN population than 

the general U.S. population (2003-2005)4. The diagnosis of diabetes also leads to diagnosis of 

other diseases, which lead to further health complications. For example, AIIANs have a 3.5 

I Indian Health Service (June 2008). Diabetes in American Indians and Alaska Natives: Facts at a Glance. 

Retrieved from bttp://www.ihs.gov/MedicaIPrograms/Diabetes/index.cfin?moduJe-resourcesFactSheets ArANs08. 'Id.· ----

3 Special Diabetes Program for Indians: Together We Fight Diabetes for our Ancestors, Our Communities and 

Future Generations citing the Indian Health Service Report to Congress, 2007. 

41ndian Health Service (January 2010). Indian Health Service Faetsheets,' Indian Health Disparities. Retrieved 

from http://info.ihs,oQvlDisparities.asp. 

/ ~~ 

~.~~~. ~"S7!Y 

926 PconsyJ\'aoi::t Avenue, SE I WashingtoJl, DC 20003 I 202-507-4070 I 202-507A071 fax I www.nihb.org 

Tht' Red Fcnthn'ofHopc ami HmJilllf 
73 


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Page 3 of5 

times higher of rate of diabetes-related kidney failure compared to the general U.S. population in 

20045 

The Special Diabetes Program for Indians 

Despite these alarming statistics, there is progress being made that, if continued, will help to 

stem the tide of diabetes in Native communities. It is difficult to highlight this progress without 

calling attention to the Special Diabetes Program for Indians (SDPI). That is because prior to the 

creation ofSDPI, there was no focused federal effort to address diabetes in tribal communities. 

Moreover, in the twelve years since SDPI began providing support to communities for diabetes 

treatment, prevention and education, data has been collected that shows real progress. 

Congress created the SDPI in 1997 in the wake of increasing public concern about the human 

and economic costs of diabetes in the U.S. and its growing prevalence among the AllAN 

population. The SDPI was implemented through consultation with Tribes to develop the 

methodology and the process for distribution ofthe funds. In 1998, the IHS formally established 

the Tribal Leaders Diabetes Committee (TLDC) to provide advice and recommendations on 

policy and issues concerning diabetes and related chronic diseases. The TLDC is comprised of 

an elected Tribal Leader from each of the 12 IHS Areas, one IHS representative and one 

representative from five national organizations, including the NIHB. Currently, I have the honor 

to serve as the Co-Chair of the TLDC along with Dr. Kelly Acton with the IHS Division of 

Diabetes Treatment and Prevention. 

The TLDC's collaborative effort with the IHS has been an important factor of the SDPT. The 

IHS recognized from the start of this program that it would have to make careful choices about 

where to invest these funds and knew these choices would best be made with input from Tribal 

leaders who serve on the TLDC. In addition, the TLDC plays a key role in ensuring that the IHS 

consults with Tribes before making decisions on diabetes treatment and prevention efforts. 

Growth and Impact of SDPT 

In the beginning, the SDPI funds provided funding to 333 non-competitive grant programs to 

IHS, Tribal, and urban Indian health programs in 35 states to begin or enhance diabetes treatment 

and prevention programs in Indian communities. The result has been the creation of innovative, 

culturally appropriate strategies that address diabetes. The Community-Directed Diabetes 

Programs continue today with 385 grant programs funded. The IHS encourages the use of the 

Indian Health Diabetes Best Practices and promotes the development of local programs based on 

local community needs and priorities. This focus on the local priorities and community centered 

has been the key to the success of the program as the local tribal community designs the program 

based on the needs oftheir community. 

In 2004, at the direction of Congress, the SDPT expanded witli the addition of two demonstration 

projects, which included 66 competitive grants. Thirty-six grantees participated in the Diabetes 

Prevention Demonstration Projects, which focused on preventing diabetes through lifestyle 

changes, such as exercise and weight loss. The remaining 30 grantees participated in the Healthy 

5 See note 1. 

926 Pcnns~'h';1!1ia Avenue, SE I vVashington, DC 20003 f 202-507·4070 I 202·507·407] fax I www.nihb.org 

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74 


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Page 4 of5 

Heart Demonstration project that targets Indian people who have been diagnosed with diabetes 

by treating for related cardiovascular diseases. 

Today, the IHS provides funding and support for diabetes prevention and treatment programs, 

services, and activities to over 450 IHS, Tribal and urban Indian program, serving nearly all 

federally recognized tribes. The following is a sample of some of the prevention, screening, and 

treatment services provided by the IHS, Tribal, and urban diabetes programs: 

Clinical annual examinations of the eyes, teeth, and feet to prevent diabetes-related 

complications 

Laboratory tests to assess diabetes control and complications 

Nutrition education and counseling services by registered dieticians 

Culturally appropriate diabetes education and awareness activities 

Diabetes primary prevention programs for children and families 

Community-based healthy eating programs at area schools and nursing homes 

Community physical fitness activities 

Diabetes-related health outcomes have improved significantly in All AN communities since the 

inception of the SOP!. For example: 

One of the most important improvements is an II percent decrease in the mean blood 

sugar level (AlC) of AIIANs with diagnosed diabetes, a major achievement over 12 

years. Decreases of this magnitude translate to a 40% reduction in diabetes-related 

complications such as blindness, kidney failure, nerve disease and amputations.6 

The mean total cholesterol level has decreased by 16% from 1997-2009, and mean LDL 

cholesterol ("bad" cholesterol) has been reduced 20%. Research has shown that lowering 

cholesterol levels may help reduce the chance of developing cardiovascular 

complications associated with diabetes such as heart attacks, stroke or heart failure. 

The prevalence of protein in the urine (a sign of kidney dysfunction) was reduced by 32% 

between 1997-2009.' New cases of diabetes-related dialysis in AIANs decreased 31% 

between 1999 and 2007, while remaining relatively unchanged in whites and blacks. 

Preventing kidney failure is critical to preventing people with diabetes from needing 

dialysis or kidney transplants' 

The SDPI has allowed many of the IHS, Tribal and urban programs to provide preventive and 

other basic elements of diabetes care that was not available to AI/ANs prior to the SOP!. In fact, 

it is proving to be both a successful effort and a good investment. The SDPl funding has enabled 

the IHS, Tribal, and urban Indian programs to provide expanded prevention, screening and 

treatment diabetes services. Through an increase in prevention and screening activities, the 

economic costs of treating diabetes and diabetes-related complications in Indian communities 

6 Special Diabetes Program/or Indians: Together We Fight Diabetes/or our Ancestors, Gur Communities and 

Future Generations citing Indian Health Service Report to Congress, 2007, 

7 Special Diabetes Program/or Indians: Together We Fight Diabetes for our Ancestors, Our Communities and 

Future Generations citing Indian Health Service, DDTP Fact Sheet. 

S Special Diabetes Program/or Indians: Together We Fight Diabetes for our Ancestors, Our Communities and 

• Future GeneratIOns cItmg 2009 USRDS Atlas available at http/lwv.'Wusrdsorg/atias htm 

G~~~_~~ 926I'enn,yivallJaAvenllc,SE I W"hmgton, DC 20003 I 202-507·4070 I 202-507-4071 fax I www.nihb.org 

~BJV _ 'V' 7 11Jt' Red Fcntbn of Hope l1ud Hwitn.q 
75 


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Page 5 of5 

should be lessened. However, more importantly, the SDPI funds have significantly enhanced 

diabetes care and education in All AN communities, as well as built a desperately needed 

infrastructure for diabetes programs. 

The outcomes of the SDPI have helped to advance other lHS diabetes programs such as the 

Model Diabetes Program, which was established under the Indian Health Care Improvement Act. 

The Model Diabetes Program also promotes collaborative strategies with Tribes for the 

prevention and treatment of diabetes. The J 9 Model Diabetes Programs in the Indian health 

system have made significant contributions, including state-of-the-art comprehensive, clinical 

diabetes care through a multidisciplinary preventive and treatment approach, and education and 

nutritional counseling services. 

The Future 

The vision of the TLDC is to empower AllAN people to live free of diabetes through healthy 

lifestyles while preserving cultural traditions and values. The SDPI is a vital program that is 

fulfilling this mission of the TLDC. I am proud of what the SDPI has accomplished. This 

program has been life saving to people who have diabetes, life-changing to those who have 

avoided diabetes because of early detection and prevention efforts, and perhaps most 

importantly, it is helping to ensure a diabetes-free future for our children and future generations. 

Diabetes is one of the greatest public health challenges facing Native communities as well as our 

country as a whole. Making real progress in this area and ensuring that future generations will 

be free of the burden of this disease will take the federal government and tribal governments 

working together. We have shown it can work. Now we need to recommit ourselves and this 

hearing is a good first step. 

On behalf of the National Indian Health Board, I appreciate having this opportunity to provide 

this testimony. Thank you for inviting me here and I am happy to answer your questions. 

926 Pennsylvania AvemH.,\ SE I Washington, DC 20003 I 202-507·4070 I 202-507·4071 f.n I www.nihb.org 

The Red Ferrt/;t'1' of Hope emd Henli1ilf 
76 

Mr. PALLONE. Thank you, Chairman, and thank you. I know that 

you have to leave but I do appreciate your testimony, and I want 

you to know that I speak for myself but I think I can speak for everyone in saying that you were particularly conscious of the impact 

of diabetes on the Native American community and want to help 

in any way we can to deal with this epidemic. I appreciate your 

comments. 

Dr. Goldstein. 

STATEMENT OF ROBERT A. GOLDSTEIN 

Dr. GOLDSTEIN. Chairman Pallone, Ranking Member Shimkus 

and members of the subcommittee, thank you for the opportunity 

to testify before you today. I am Robert Goldstein, senior vice president of Scientific Affairs for the Juvenile Diabetes Research Foundation. I am honored to be here today before this distinguished 

committee with my colleagues from the diabetes ct. 

JDRF is the largest charitable funder and advocate of diabetes 

research worldwide. Since our founding 40 years ago by parents of 

children with type 1 diabetes, JDRF has awarded more than $1.4 

billion to diabetes research. 

Type 1 diabetes, also known as juvenile diabetes, is an autoimmune disease for which there is no cure, at least not yet. It is 

the second most common chronic disease affecting children. It is 

growing rapidly, particularly in our youngest children. Diabetes 

overall costs our Nation more than $174 billion a year and one in 

three Medicare dollars is spent on people with the disease. But the 

good news is that we are moving faster toward a cure for type 1 

diabetes than ever before, thanks to a strong federal commitment 

to diabetes research funding as well as JDRF’s private investment. 

A key component of the federal investment is the Special Diabetes Program, which provides a critical 35 percent of NIH funding 

for type 1 diabetes research and supports the multicenter human 

clinical trials that are contributing to discovering better treatment. 

Let me highlight some of the key advances which benefit not only 

those with type 1 diabetes but those with type 2 diseases and other 

autoimmune diseases. 

Researchers have discovered ways to slow the autoimmune attack that causes type 1 diabetes. Charlotte Cunningham, a 15-yearold from Maryland, was able to produce her own insulin for 3 years 

after receiving a drug treatment called anti-CD3, and today is better able to control her blood glucose levels. Great strides have been 

made in investigating therapies to regenerate and replace insulinproducing cells. Thanks to this research, Anne Sidell Demarek of 

Texas and now California, who received an islet transplantation, no 

longer suffers from frequent low blood sugar episodes which impacted her ability to care for her young son who unfortunately also 

has type 1 diabetes. Researchers have paired continuous glucose 

monitors with insulin pumps to develop an artificial pancreas to 

help those with type 1 more easily and accurately control their 

blood glucose levels. A study recently published in the Lancet found 

an early artificial pancreas system lowered the risk of low blood 

sugar emergencies in children and teenagers while they were 

asleep. Researchers have recently found a way to reverse diabetic 

eye disease, the leading cause of adult-onset blindness. Sally CartVerDate Mar 14 2013 01:02 Mar 20, 2013 Jkt 077918 PO 00000 Frm 00082 Fmt 6633 Sfmt 6633 E:\HR\OC\A918.XXX A918

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77 

wright, a 66-year-old type 2 patient, can now drive thanks to a 

treatment combining a drug and laser treatment. 

As this progress shows, diabetes research is one of the world’s 

most effective public-private partnerships focused on curing a particular disease, yet despite tremendous advances, there is still 

much work to be done. On behalf of JDRF and the millions of families affected by diabetes, I thank the committee for its leadership 

and strong support for the Special Diabetes Program, which is a 

key element of our continued success. We deeply appreciate your 

commitment and look forward to continuing to work with you to 

cure this devastating and costly disease. 

Thank you again for holding the hearing. I will be happy to answer questions. 

[The prepared statement of Dr. Goldstein follows:] 


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TESTIMONY 

BY 

ROBERT A. GOLDSTEIN, M.D. PH.D. 

SENIOR VICE PRESIDENT, SCIENTIFIC AFFAIRS 

FORmE 

JUVENILE DIABETES RESEARCH FOUNDATION INTERNATIONAL 

AT THE HEARING ENTITLED 

THE BATTLE AGAINST DIABETES: 

PROGRESS MADE; CHALLENGES UNMET 

BEFORE mE 

HOUSE ENERGY AND COMMERCE COMMITTEE 

SUBCOMMITTEE ON HEALTH 

July 1,2010 
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Chairman Pallone, Ranking Member Shimkus and Members of the Subcommittee, thank 

you for the opportunity to testifY before you today on the state of type 1 diabetes 

research, the progress to date and the need for continued research along our path to a cure 

for this disease. I am Dr. Robert Goldstein, Senior Vice President of Scientific Affairs 

for the Juvenile Diabetes Research Foundation International (JDRF), and I am honored to 

be here today. I am also privileged to sit on the same panel with my colleagues - the 

American Diabetes Association and the National Indian Health Board - who are 

tremendous partners of JDRF's in the fight against diabetes. 

JDRF is the largest charitable funder and advocate of diabetes research worldwide. Our 

mission is to find a cure for type I diabetes and its complications through the support of 

research. Until there is a cure, JDRF is also committed to working tirelessly to develop 

better treatments to improve the lives and health of people who have type I diabetes. 

Since our founding four decades ago by parents of children with type 1 diabetes, JDRF 

has awarded more than $1.4 billion to diabetes research, including more than $100 

million last year. To fund this research, JDRF volunteers and staff do their part every day 

to raise money through walks, galas and other events in communities across the nation. 

Weare moving faster towards a cure for type 1 diabetes than ever before, thanks to the 

combination offederal diabetes research funding and JDRF's private investment, which 

is one of the world's most effective public-private partnerships focused on curing a 

particular disease. 

Diabetes: Background on a Complex, Chronic, and Demanding Disease 

About Type 1 and Type 2 Diabetes 

Type 1 diabetes, often referred to as juvenile diabetes, is an autoimmune disease that 

causes the destruction of pancreatic beta cells, the cells in the body that make the 

hormone insulin. Insulin is required for people to get energy from food; therefore, people 

with type 1 diabetes must take multiple injections of insulin each day or continually 

infuse insulin through an insulin pump in order to survive. They must also monitor their 

blood glucose levels closely with frequent blood testing throughout the day and night and 

adjust their insulin levels, food intake and amount of exercise accordingly. Even with 

the most rigorous attention, many other factors can adversely affect a person's blood 

glucose levels, including stress, hormonal changes, growth spurts, medications, illnesses, 

and fatigue. The management of this disease is a constant battle, not only for the patients 

but also for their families and loved ones - low glucose causes potentially deadly 

medicai'emergencies such as seizure and coma, while high glucose causes debilitating 

and sometimes fatal health problems such as kidney failure, blindness, nerve damage, 

amputation, heart attack, stroke and pregnancy complications. 

Typically, type I diabetes strikes in childhood, adolescence or young adulthood; 

however, it is not a disease one can outgrow. Warning signs ofthe disease include 

extreme thirst, frequent urination, drowsiness or lethargy, increased appetite, sudden 

weight loss, and vision changes. Unfortunately, diet and exercise cannot prevent the 
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onset of type 1 diabetes as is often the case with type 2 diabetes. Today, nothing can 

prevent the onset of type 1 diabetes. 

Type 2 diabetes typically affects adults, although it is an increasing public health problem 

facing"children. Injections are usually not required for people with type 2 diabetes 

because the pancreas produces insulin; the body just cannot process it effectively. 

Obesity and lack of exercise are important risk factors for type 2 diabetes. While the 

causes and management of type 1 and type 2 diabetes are different, the complications 

associated with the disease are the same. People with diabetes are two to four times more 

likely to have a heart attack or stroke than those without the disease. Diabetes is the 

leading cause of kidney disease, adult onset blindness, and non-traumatic amputations 

and is a leading cause of nerve damage. Overall, the risk of death for people with 

diabetes is about double that of people of similar age without the disease. 

Incidence of Diabetes 

Type 1 diabetes is the second most common chronic disease affecting children. Each 

year more than 15,000 children are diagnosed with diabetes in the U.S. Unfortunately, 

the number of new diagnoses of type 1 is increasing annually at an unprecedented rate. 

Historically, the diabetes research community has estimated the incidence of type 1 

diabetes to increase, on average, by 2 percent per year. Currently, however, researchers 

believe increased incidence to be as high as 4 percent each year, with incidence of the 

disease rising particularly in children under the age of four. 

In total, diabetes affects more than 24 million adults and children in the United States, 

and one out of every three Americans born in 2000 is predicted to develop some form of 

diabetes during his or her lifetime. Despite the staggering statistics of today, the outlook 

for the future is even bleaker: over the next 25 years, the number of Americans with 

diabetes is predicted to nearly double, while the cost of diabetes will almost triple. 

Economic Impact of Diabetes 

Diabetes is one of the costliest chronic diseases. In 2007, diabetes accounted for $174 

billion in costs in the U.S, and 1 in 3 Medicare dollars is spent on people with the disease. 

The nation spends $11,744 for medical care for each person with diabetes, compared to 

$2,935 on people without diabetes, as of 2007. These increased costs are attributable to 

diabetes' .role as the leading cause of kidney failure, adult blindness, and non-traumatic 

amputations, and a leading cause of nerve damage, stroke, and heart attacks. Continued 

research to better prevent, treat and cure diabetes will significantly reduce the incidence 

and economic impaCt the disease has on this country. 

Progress in Type 1 Diabetes Research 

Research offers the best hope for a cure for a patient with type 1 diabetes. In the forty 

years since JDRF's founding, we have not yet achieved a cure for this devastating 

disease, but investments in research have yielded new and improved therapies and 

treatments that now give people with type 1 diabetes greater quality of life and longer life 

expectancy. Today, people with type 1 diabetes have better tools to test and control 

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blood sugar, and significant progress has been made towards an artificial pancreas. The 

risks of complications are .now lower than ever before, and thanks to research, doctors are 

beginning to have better ways to diagnose complications, slow their progression, and 

lessen their impact. And research has put us on a pathway towards therapies to restore 

the function of insulin-producing beta cells and stop the autoimmune attack that damages 

them. Many of the advances on the horizon would benefit not only those with type 1 

diabetes but those with type 2 diabetes or other autoimmune diseases as well. 

These many advances would not have been possible without the public-private 

partnership and steadfast commitment to diabetes research by the Congress and the 

federal government. On behalf of JDRF and the millions of families affected by diabetes, 

I want to thank the committee for its leadership in advancing diabetes research. Among 

your many contributions is your leadership in the Special Diabetes Program, a 

congressionally-mandated type I diabetes research program administered by the National 

Institutes of Health (NIH). The Special Diabetes Program provides a critical 35 percent 

of NIH funding for type 1 diabetes research and dedicates funding for the innovative and 

collaborative multi-center human clinical trials that are contributing to better therapies 

and treatments for people with type 1 diabetes. This public-private partnership must 

remain strong and stable if we are to capitalize on the advances to date and achieve our 

mutual goal of a cure for people with diabetes. 

Immune Therapies: Research to Prevent Type 1 Diabetes 

To prevent type 1 diabetes, one must know how the disease develops. Current evidence 

indicates that both a genetic pre-disposition and an environmental trigger cause type I. 

Currently, by the time patients recognize the symptoms and receive a type 1 diabetes 

diagnosis, they have already suffered the devastating autoimmune attack that has 

destroyed most ofthe insulin-producing beta cells in the pancreas. 

Research funded by JDRF and NIH could vastly improve the current standard of care. 

Thanks to research, we now know of about 40 gene regions associated with type I 

diabetes and can identifY those who are genetically at risk. Long term studies are being 

conducted to identifY the environmental trigger(s) of type I diabetes. And new therapies 

are being developed and tested to help prevent the disease altogether and enable newly 

diagnosed patients to preserve remaining insulin-producing beta cells and possibly even 

regenerate new ones. Promising research results in this area include: 

• Antibody Treatment Slows Autoimmune Attack in New Onset Type 1 

Diabetes Patients: NIH-funded researchers first identified a drug - a monoclonal 

antibody named anti-CD3 - that can slow the progression of type 1 diabetes. 

Together, JDRF and NIH funded the proof-of concept clinical trial that showed 

that a short 1-2 week treatment with anti-CD3 helps patients maintain or increase 

their ability to produce insulin naturally for several years after diagnosis. Patients 

on anti-CD3 therapy use less insulin and have more stable blood glucose levels 

for an extended period oftime. 

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For example, Charlotte Cunningham from Maryland enrolled in the anti-CD3 trial 

soon after her diagnosis at the age of 10. While Charlotte now requires insulin at 

15 years old, she produced her own insulin for three years after her diagnosis -

helping her to better control her blood glucose levels and protect her from the 

complications that accompany type 1 diabetes. This success could not have been 

achieved without several Special Diabetes Program-funded programs at NIH, 

including the Immune Tolerance Network (which develops new therapies to 

treat/prevent autoimmune disease and to prevent or treat graft rejection in 

transplantation by Inducing immune tolerance) and Type 1 Diabetes TrialNet 

(which also supports studies aimed at both preventing further destruction of 

insulin-producing beta cells in those newly diagnosed with type 1 diabetes, as 

well as developing the therapies to prevent the disease altogether). 

Despite this tremendous progress, our work is not done. Pivotal phase III clinical 

trials on two different anti-CD3 drugs are now underway to further test their 

effectiveness. Continued federal support will allow for the additional research 

needed to determine how to prolong the effectiveness of the treatment, whether 

early treatment prior to disease onset can prevent diabetes or whether these 

therapies can be successful when given years after the onset of type 1 diabetes. 

• Vaccine to Prevent Type 1 Diabetes Onset: Research toward the development 

of a vaccine to reverse the immune attack that causes diabetes holds great promise 

for type I diabetes patients. NIH- and JDRF-funded researchers have 

successfully cured and prevented type 1 diabetes in mice using a vaccine made of 

nanoparticles thousands of times smaller than the size of a cell, coated with 

proteins involved in immune cell communication. Thanks to NIH funds from the 

Special Diabetes Program, researchers have shown that these particles are safe for 

use in humans. 

The NIH, JDRF and privately-funded researchers are also working on promising 

vaccine therapies to preserve beta cell function in people newly diagnosed with 

type 1 diabetes. 

Beta Cell Tberapies: Researcb to Restore Insulin Production 

Therapies to restore insulin production by beta cells in the pancreas would benefit all 

patients with type 1 diabetes and many with advanced forms of type 2. Researchers are 

focusing on replacing diseased beta cells with functioning ones from a human donor or 

from animals like pigs, as well as by changing different types of cells, such as liver cells, 

into becoming insulin-producing cells. Researchers are also investigating therapies to 

regenerate insulin producing cells either by copying existing cells or encouraging the 

pancreas to create new ones. While more work is needed to fulfill the promise of 

regenerative medicine, recent research toward that end includes: 

• Continued Progress in Islet Transplantation: Researchers continue to improve 

the efficiency of procedures for transplanting islets from human donors to people 

with difficult-to-control or "brittle" diabetes. Thanks to efforts by the NIH and 

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JDRF, islet transplantation researchers worldwide are sharing information learned 

with each new procedure, and helping to quickly disseminate this knowledge. 

• Identification of the Gene Critical to Beta Cell Development: Researchers 

have identified a gene, called Rfx6, which is required for the development of 

insulin-producing beta cells and other cell types in the pancreas. Mice lacking the 

gene failed to regenerate beta cells and most other cells in the pancreas. In 

people, deficiency ofthe gene resulted in diabetes in newborns. Research on beta 

cell development may help identify potential new treatments that could be used in 

both type I and type 2 diabetes. 

• Potential of Other Pancreas Cells to Convert into Insulin-Producing Cells: A 

JDRF-funded researcher recently found that "alpha" cells in the pancreasspecialized cells that produce glucagon, not insulin - can spontaneously convert 

into insulin-producing beta cells without genetic manipulation. This finding is 

significant, especially since the alteration of genes is a process that cannot be 

easily translated into therapies for people. More research into alpha cells would 

be particularly beneficial for people who have long struggled with diabetes and 

have few or no remaining beta cells. 

Glucose Control: Research to Advance an Artificial Pancreas 

Until there is a cure, people with diabetes will need better tools to control their blood 

glucose levels, as better control will keep people healthier and help them avoid diabetic 

complications. The federally-funded Diabetes Control and Complications Trial (DCeT), 

a clinical trial of almost 1,500 people with type 1 diabetes conducted between 1983-1993, 

demonstrated that tight control of blood glucose levels through intensive insulin therapy 

could significantly reduce or delay many diabetic complications. A follow-up study -

which was funded by the Special Diabetes Program and the results of which were 

published in The New England Journal of Medicine - found that intensive diabetes 

therapy aimed at achieving better glucose control reduced the risk of any heart disease 

event by 42 percent, and the risk of nonfatal myocardial infarction, stroke, or death from 

heart disease by 57 percent. 

Despite the clear benefits of glucose control demonstrated by these studies, far too many 

patients with diabetes cannot achieve tight glucose control with traditional diabetes tools. 

For example, a 2005 study found diabetes patients who tested their blood glucose on 

average of nine times a day - far above the national average - spent less than 30 percent 

of the day in normal glucose range (between 90-130). These patients had higher than 

acceptable blood glucose ranges (over 180) for eight hours of the day and low ranges 

(less than 90) for two hours per day. 

JDRF is working in partnership with the National Institutes of Health and private sector 

partners to accelerate the development and availability of new technologies to improve 

glucose control. These devices include the continuous glucose monitor (CGM) and the 

artificial pancreas (a closed-loop device that will consist of a continuous glucose monitor, 

an insulin pump and software to link the two) and will enable a person with diabetes to 
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maintain normal glucose levels by providing the correct amount of insulin at the 

appropriate time. Promising research includes: 

• Advancements in Glucose Monitoring Technologies: Just within the past few 

years, new glucose sensing technologies that can monitor glucose levels 

continuously have come on the market. These CGM devices are a critical part of 

an artificial pancreas system, and have been shown to improve glucose control 

when used alone. NIH funded the original glucose sensor research which was 

developed by the private sector into CGM products. The NIH DirecNet program 

then tested the products and demonstrated benefits in children. JDRF then funded 

a larger trial including children and adults with type I, whose results were 

published in The New England Journal of Medicine, which led to insurance 

coverage by major health plans. This public-private effort by NIH, JDRF and the 

private sector has enabled wide spread adoption of this beneficial technology. 

However, research has also shown there are limits to the benefits of CGM 

technology, which require the patients to respond manually to the data, 

something difficult to do continuously throughout the day and especially at night 

while sleeping. Thus, a parallel effort has been underway to accelerate the 

development of an automated artificial pancreas system. 

• Accelerating the Development of an Artificial Pancreas: Early research 

funded by JDRF at Yale had shown that, by using sophisticated software in a 

hospital setting, CGM data could be used to effectively direct insulin delivery, 

creating an early artificial pancreas system. In 2006, JDRF funded a worldwide 

consortium of diabetes researchers, mathematicians, and engineers to develop and 

test the software algorithms for a first generation artificial pancreas. This 

consortium has developed, tested, and refined algorithms needed to automatically 

deliver insulin in various situations (e.g., during overnight, meals, exercise) in 

hospital-based clinical trials, and results to date show a first generation artificial 

pancreas system can improve glucose control throughout the day and lower the 

risk of blood glucose emergencies at night. Additional r.esearch is underway to 

further hone these software algorithms so they can be used in real life situations 

and tested to ensure safety and effectiveness. In 2009, the NIH funded mUltiple 

grants to help accelerate this process which are complementary to the JDRF 

funded research and funded through the Special Diabetes Program. As a result of 

this promising research, companies have announced plans to develop and 

commercialize artificial pancreas systems, a development that holds great promise 

for those with type 1 diabetes. 

Complications Therapies: Research to Reverse Costly Diabetes Complications 

Thanks to the public-private diabetes research partnership, diabetic complications are 

declining, and people with diabetes are living longer. The introduction oflonger and 

shorter acting insulins and improved technologies - such as insulin pumps and CGMs -

are helping many patients avoid unexpected and dangerous low blood sugars. Research 

funded by JDRF and the federal government has increased our understanding of how 

diabetes causes complications, and led to the development of new drugs and treatments to 

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stop, prevent or reverse the various complications. These complications include eye 

disease, nerve damage, kidney disease, heart disease and stroke, and they place a 

tremendous economic burden on society. Some of the exciting recent advances in this 

field include: 

• Reversing Diabetic Eye Disease: Recent research has confirmed the ability to 

halt and reverse diabetic eye disease, a major complication of diabetes and the 

leading cause of adult-onset blindness. Research supported by the Special 

Diabetes Program and JDRF has shown that a treatment combining a drug and 

laser therapy is almost twice as likely to improve vision in peop'le who have 

diabetic macular edema as laser therapy alone (50% vs. 28%). Improved vision 

was defined as being able to read two lines better on the eye chart, an 

improvement that could be the difference between being able to see well enough 

to drive, or hold ajob - or not. The result of this research brings us one step 

closer to a new and much-needed treatment for diabetic eye disease, the first in 

almost 25 years. 

• New Gene Identified with Diabetic Kidney Disease: Kidney disease is a 

dev'astating complication of diabetes and develops in 40 percent of patients with 

the disease. Researchers have identified a gene, called ELMOl, that identifies 

people with type 1 diabetes who are at greater risk of developing kidney disease. 

More research is needed so that doctors can eventually identify type 1 patients 

with low, medium, and high risk for kidney disease and take steps earlier to 

mitigate the onset of kidney disease and its pr~gression. 

• Reversing and Repairing Nerve Damage: Research has shown the ability to 

reverse and repair diabetic nerve disease in the legs. People with diabetic 

neuropathy who were given a drug therapy had a significant increase in the 

number of small nerve fibers in the skin, which are responsible, for sensation and 

motor function and are lost in diabetes patients with neuropathy complications. 

Conclusion 

As JDRF looks back on the last forty years since its founding, there is much to be proud 

of in the field of type 1 diabetes research. Tremendous research advancements have 

produced a number of new therapies and technologies that are undoubtedly improving the 

lives of people with type 1 diabetes. This, progress, however, has yet to lead us to a cure 

for this devastating disease. We must redouble our efforts on both the federal level and 

in the private sector to ensure continued momentum toward our goal of a cure. 

The renewal of the Special Diabetes Program is a key element of our continued success, 

and I would like to thank Rep. Diana DeGette for introducing H.R. 3668, which would 

provide a multi-year renewal ofthe program. I would also like to thank Ranking Member 

Shimkus for his contribution to the program's success, as he was the lead sponsor of 

legislation to renew the Special Diabetes Program in 2002. Additionally, JDRF is 

grateful to the majority of the Energy and Commerce Committee for co-sponsoring the 

bill and for the tremendous support you have given patients with type I and their loved 

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ones. JDRF wholeheartedly endorses this legislation, which has currently 281 bipartisan 

cosponsors, and knows all too well the program's importance in our mutual effort to 

understand, treat and eventually cure type 1 diabetes. JDRF will keep doing its part in 

this fight, and we hope that we can count on Congress to continue funding the medical 

research that will be necessary to maximize research opportunities and capitalize on the 

federal investment made in type 1 diabetes research to date. We have come too far along 

our path to a cure to tum back now. 

Thank you again Chairman Pallone, Ranking Member Shimkus and Members of the 

Subcommittee for holding this hearing. I am happy to answer any questions you may 

have. 

8 
87 

Mr. PALLONE. Thank you, Dr. Goldstein. 

Dr. Henry. 

STATEMENT OF ROBERT R. HENRY 

Dr. HENRY. Well, thank you for the opportunity to testify today 

and to Chairman Pallone and Ranking Member Shimkus for holding this hearing. I am pleased to be here on behalf of the American 

Diabetes Association. My full written testimony has been submitted for the record, and in the 5 minutes I have, I will summarize it. 

I have just come from the American Diabetes Association’s 70th 

scientific sessions conference in Orlando, Florida, the world’s largest diabetes research meeting, where over 14,000 diabetes researchers, providers and educators gathered to hear and discuss 

the latest in diabetes research. The CDC has identified diabetes as 

a disabling, deadly epidemic that is on the rise. Between 1980 and 

2007, the prevalence of diabetes has increased by 300 percent. Its 

total cost is over $218 billion a year. 

The Association is grateful to the committee for supporting vital 

HHS diabetes programs including the NIDDK, CDC’S DDT and the 

Indian Health Service. Because of this investment, our knowledge 

of the disease has been expanded and the critical work towards 

ending this epidemic can continue. 

Our efforts have significantly changed the way diabetes is addressed in both the clinical and community settings. Since 1952, 

more than 4,000 research projects on type 1, type 2 diabetes and 

gestational diabetes has been funded by the American Diabetes Association. In 2009, the Association awarded $33.55 million in new 

research support. We strive particularly to bring research from 

bench to the bedside and swiftly into the hands of patients and 

care providers. We fund cutting-edge research. Association-funded 

work developed the first handheld blood glucose meters, a key tool 

to achieving diabetes control. Currently, our research has found a 

potential new treatment for diabetic retinopathy, a complication 

that makes diabetes the number one cause of adult-onset blindness. 

We value our partnerships with key health organizations, and I 

am pleased to point to our continued work with JDRF in the development of an artificial pancreas that holds the promise of revolutionizing diabetes management for type 1 diabetes. We are committed to developing the pipeline of diabetes researchers including 

funding younger researchers and more minority investigators to ensure the vitality of future research. We have made great progress 

but more has to be done. 

With this in mind, I want to outline several key next steps in the 

battle to stop diabetes. More attention must be paid to the pressing 

needs of special populations particularly affected by the diabetes 

epidemic including minority populations. We remain steadfast in 

our effort to support research that addresses these disparities. H.R. 

3668, sponsored by Representatives Diana DeGette and Mike Castle, helps address this issue by renewing the Special Diabetes Program. SDP programs in American Indians and American Native 

communities and SDP-funded type 1 are highly successful. The proVerDate Mar 14 2013 01:02 Mar 20, 2013 Jkt 077918 PO 00000 Frm 00093 Fmt 6633 Sfmt 6633 E:\HR\OC\A918.XXX A918

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88 

gram expires in 2011, and I urge Congress to pass this legislation 

soon so this work can continue. 

H.R. 1995, the Eliminating Disparities and Diabetes Prevention 

Access and Care Act, also seeks to address racial and ethnic health 

disparities related to diabetes. We thank Representative DeGette 

again for introducing this bill and Representative Donna 

Christensen for including it in the tri caucuses health disparities 

legislation. 

We also must increase efforts to prevent and treat gestational diabetes. Representatives Eliot Engel and Michael Burgess have 

sponsored H.R. 5354, the Gestational Diabetes Act, which aims to 

lower the incidence of gestational diabetes in order to protect mother and baby and prevent future cases of type 2 diabetes. 

Our collective fight to stop diabetes must be continued. Your 

leadership in combating this growing epidemic is absolutely essential. Thank you for your commitment to the diabetes community 

and it will be my pleasure to answer any questions you might have 

on these important issues. Thank you again. 

[The prepared statement of Dr. Henry follows:] 


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Testimony of Robert R. Henry, M.D., 

A American 

Diabetes 

• Association. Cur& • Care. Commitm&nte 

P[esident~Elect, Medicine and Science, American Diabetes Association 

Before tbe 

Subcommittee on Health 

Committee on Energy and Commerce 

United States House of Representatives 

"Tbe Battle Against Diabetes: Progress Made; Cballenges Unmet" 

Thursday, July 1 - lO:OOa.m. 
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Testimony of Robert Henry, M.D., President-Elect, Science and Medicine, American Diabetes L\ssociation 

Page 2 

Thank you for the opportunity to provide this testimony to the House Energy and Commerce 

Committee's Subcommittee on Health. I am pleased to testify on behalf of the American Diabetes 

Association (Association). I want to especially thank Chairman Pallone and Ranking Member 

Shimkus for holding the hearing. . 

I must say the Subcommittee has impeccable timing in scheduling this hearing. I have just come 

from the American Diabetes Association's 70'h Scientific Sessions conference in Orlando, Florida, 

the largest diabetes research meeting in the world. Over 14,000 diabetes researchers, providers, and 

educators gathered to hear and discuss the very latest on research related to diabetes. 

I am here today newly reenergized that outstanding studies are underway that will allow us to refine 

current prevention tools, improve the management of the disease, provide more effective care to 

individuals with diabetes, and ultimately find a cure for this devastating disease. 

We cannot afford to waste time. In the five minutes I will speak to you today, fifteen more 

Americans will be diagnosed with diabetes. While nearly 24 million Americans have diabetes today, 

that number is expected to grow to 44 million in the next 25 years if present trends continue. Every 

24 hours, 230 people with diabetes will undergo an amputation, 120 people will enter end-stage 

kidney disease programs, and 55 people will go blind from diabetes. Every single day, diabetes costs 

the United States over a half a billion dollars, yet, this is but a fraction of the costs that lie ahead 

unless we take action immediately to stop this epidemic. 

The Association is grateful to the Committee for supporting vital diabetes research, including 

scientific studies through the National Institute of Diabetes and Digestive and Kidney Diseases 

(NIDDK) at the National Institutes of Health (NIH), research translation, prevention, control and 

surveillance efforts through the Centers for Disease Control and Prevention's (CDC) Division of 

Diabetes Translation (DDT), and the development and operation of clinical and public health 

efforts to treat and prevent diabetes in American Indians and Alaskan Natives through the Indian 

Health Service (IHS), to help address diabetes. It is because of this investment that our knowledge 

of the disease has been expanded and the critical work towards ending this epidemic can continue. 

As the nation's leading non-profit health organization providing diabetes research, information and 

advocacy, the Association believes that diabetes prevention and research are critical. The 

Association was founded in 1940 and has been funding innovative research since 1952. Beginning 70 

years ago, our unit of analysis for success and our main focus has been the individual with or at risk 

for diabetes. For the Association, maintaining a public health perspective reminds us of the 

importance of the health of patients and the communities in which they live. 

In order to effectively combat the diabetes epidemic, research must be patient-centered, multilayered and translational. That is, we must take what we learn in the laboratory and make it work 

both in the clinical setting and in the communities where we live. What patients and health care 

professionals need now is a translational diabetes GPS to help navigate and if necessary, recalculate, 

the curvy, often rocky road to optimal diabetes prevention and care. With this in mind, the 

Association remains dedicated to helping researchers, health professionals and patients connect the 

dots linking evidence-based studies to improved, high quality diabetes management and prevention 

tools. 
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We stand ready to collaborate with our partners in the federal government and our sister 

organizations and foundations in the pursuit of new and better ways to address the diabetes 

epidemic. We are all truly interdependent in this endeavor, and it will take a united front to stop 

diabetes. 

I will provide the Committee with an overview of the prevalence and costs of diabetes, then discuss 

the Association's research program and the ways in which we support researchers to take novel, 

evidence-based ideas from bench to bedside. I will also highlight the partnerships we have forged 

with both the public and private sectors to foster cutting-edge diabetes studies in order to speed up 

the day that new diagnostic, prevention, and treatment tools - and ultimately a cute - will be 

available to people with, and at risk for, diabetes. 

Taking a Toll: Diabetes Prevalence and Costs. 

Nearly 24 million American adults and children (nearly 8 percent of the population) have diabetes, 

and 57 million more individuals have pre-diabetes. Of those with diabetes, almost 6 million are 

unaware they have this devastating disease. Together, this means a quarter of the U.S. population 

either has, or is at high risk for, developing diabetes. 

Diabetes is a chronic condition that impairs the body's ability to use food for ·energy. The hormone 

insulin, which is made in the pancreas, is needed for the body to change food into energy. For 

people with diabetes, either the pancreas does not create insulin, which is type 1 diabetes, or the 

body does not create enough insulin and/or the cells are resistant to insulin, which is type 2 diabetes. 

Pregnant women with gestational diabetes are unable to make and use all the insulin they need 

during pregnancy. Without enough insulin, glucose cannot leave the blood and be changed to 

energy. 

Diabetes results in too much glucose (sugar) in the blood stream. Insulin and some oral medications 

used to treat diabetes can cause blood glucose levels to become too low. Blood glucose levels that 

are either too high or too low can be dangerous in the short term. In the long term, it is high levels 

of blood glucose that cause the complications of diabetes including heart and kidney disease, 

blindness, and amputation. 

The majority of diabetes cases, 90 to 95 percent, are type 2, while type 1 diabetes accounts for five 

to ten percent of diagnosed cases. Additionally, gestational diabetes affects 135,000 American 

women each year, or 2 to 5 percent of all pregnant women. For individuals with pre-diabetes, blood 

glucose levels are higher than normal; however with lifestyle intervention, many people can prevent 

the progression to type 2 diabetes. 

Despite the many advances in diabetes research, prevention and treatment, the CDC has identified 

diabetes as a disabling, deadly epidemic that is on the rise. Between 1980 and 2007, the prevalence 

of diabetes increased by 300 percent. According to the CDC, one in three children born in the year 

2000 will develop the disease in their lifetime if the number of cases of diabetes continues to grow. 

This number is even greater among minority populations, where nearly one in two children face a 

future with diabetes. 
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Additionally, type 2 diabetes, traditionally seen in older patients, is beginning to reach a younger 

population, due to the surge in childhood obesity. An alarming 2 million adolescents (or 1 in 6 

overweight adolescents) aged 12-19 have pre-diabetes. 

The impact diabetes has on individuals and the health care system is enormous and continues to 

grow at a shocking rate. Diabetes is a leading cause of kidney disease, adult-onset blindness, lower 

limb amputations, heart disease and stroke. Gestational diabetes is associated with health problems 

for both mother and child during pregnancy and childbirth, including preeclampsia and pre term 

delivery. Since 1987, the death rate due to diabetes has increased by 45 percent. In that same period, 

the death rates for heart disease, stroke and cancer have dropped. 

In addition to the physical toll, diabetes also attacks our pocketbooks. A recent study by the Lewin 

Group found that in 2007 the total cost of diabetes in America (including both diagnosed and 

undiagnosed diabetes, pre-diabetes, and gestational diabetes) was $218 billion. That year, medical 

expenditures due to diabetes totaled $116 billion, which included $27 billion for diabetes care, $58 

billion for chronic diabetes-related complications, and $31 billion for excess general medical costs. 

Indirect costs resulting from increased absenteeism, reduced productivity, disease-related 

unemployment disability and loss of productive capacity due to early mortality totaled $58 billion. 

This is an increase of 32 percent since 2002. Thus, in just five years, the cost of diabetes increased 

by $42 billion, or $8 billion per year. Added to that is another $18 billion for costs associated with 

undiagnosed diabetes, $25 billion for pre-diabetes, and $623 million for gestational diabetes. In fact, 

approximately one out of every five health care dollars is spent caring for someone with diagnosed 

diabetes, while one in ten health care dollars is directly attributed to diabetes. Additionally, one-third 

of Medicare expenses are associated with treating diabetes and its complications. 

The American Diabetes Association Research Program 

The Association's Standards of Medical Care in Diabetes, published in our journal, Diabetes Care in 

January 2010, and, developed by leading experts in the field, are the respected standard for diabetes 

treatment and care in our country. Diabetes is a chronic illness that requires continuing medical care 

and patient-management education to prevent or delay complications. As such, our guidelines cover 

a broad range of issues, recognizing patients, clinicians, researchers, payors and other individuals 

need evidence-based standards to develop patient-centered diabetes care, treatment goals, and tools 

to evaluate and provide quality care. 

The Association brings the same comprehensive approach to our research program. Because 

diabetes care is so complex and requires that many issues, in addition to blood glucose, are 

addressed, we believe that research on diabetes must accordingly explore the full range of clinical 

and public health issues facing individuals with type 1, type 2, and gestational diabetes. 

We realize that the federal government is, and will continue to be, by far the greatest source for 

diabetes research in our countty. The goal of the Association's research program is to support the 

government's efforts by complementing and leveraging its commitment to diabetes research. We do 

this in several ways. First, we fund cutting edge research. We realize the importance of dedicating 

our public dollars to the research that has demonstrated it has the best chance of making a 

difference - that is, a bang for the taxpayer's buck. But we also know that a good idea does not 
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become a promising idea without that first infusion of funding that gets the ball rolling. Thus, the 

Association is dedicated to looking for the best cutting edge and novel research proposals to give 

them the support they need to prove their case for larger governmental funding. Second, we are 

commiited to developing the pipeline of diabetes researchers who will ultimately work On 

government-funded projects by using our funds to give a start to promising young researchers and 

developing investigators, including more minority researchers. Thus, the Association is doing all that 

it can to help foster the emerging scientists interested in pursuing cateers in diabetes research. We 

recognize that effort will require support for researchers at a number of key stages along the 

academic pipeline and we will continue to support promising scholars at the undergraduate, 

graduate, and doctorate levels, and in all stages of their professional careers, to enSure the vitality of 

future diabetes research. Third, we partner with the federal government to provide additional needed 

funds when necessary to help fully explore promising research. . 

Program Structure 

Since the research program's inception in 1952, more than 4,000 research projects have been 

funded. Last year, there were 439 ADA-funded research projects nationwide at 164 leading research 

institutions throughout the country. In 2009, the Association awarded $33.55 million in new 

research support. It is an understatement that we are extremely pleased with the quality and depth of 

the studies we have funded in the past as well as those currently being conducted. 

From the Bench to Clinicians and Communities: Translating Our Research 

The Association approaches diabetes research from the complete view of the person and the 

public's health, looking at multiple layers of the disease. When considering even basic research, we 

believe that it is just as important to provide evidenced-based treatment and management tools in 

clinical settings and in the community as it is to understand the causes and effects of the disease 

itself. 

Our efforts have been significant and measurable, and have changed the way diabetes is addressed in 

both clinical and community settings. For example, Association-funded reseatch developed the first 

hand-held blood glucose meters and established the benefits of diabetes self-management, thus 

giving patients key tools to enable them to control their futures with the disease. 

Some examples of current reseatch provide a window into the breadth and depth of our program. 

We ate excited to report that research funded by the Association has found a potential new 

treatment for diabetic retinopathy, a common complication of the eyes that makes diabetes the 

number one cause of adult onset blindness. Another project is examining the influence of gestational 

diabetes and a serious complication of pregnancy known as preeclampsia in order to provide health 

care professionals and their patients with information to protect both mother and baby. Another 

recent grant addresses overcoming batriers to diabetes management in the elderly. And research 

supported by the Association is currently underway to find ways to enhance the ability of individuals 

with diabetes to exercise in order to improve both diabetes and cardiovascular disease outcomes. 

Raising All Boats: Partnering with the Federal Government and Key Organizations 

In addition to funding private diabetes studies, we are also actively engaged in co-supported 

reseatch, providing support to select federally-funded research programs. This funding mechanism 
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Testimony of Robert Henry, M.D., President-Elect, Science and Medicine, American Diabetes Association 

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allows us to provide additional funding to expand on a basic science study or clinical trial and obtain 

even more data and important research results than would have been possible without our donation. 

For example, the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, sponsored 

by National Heart, Lung, and Blood Institute (NHLBI) and NIDDK, was the largest clinical trial of 

adults with established type 2 diabetes at risk for cardiovascular disease and sought to prevent heart 

attack, stroke, or death from cardiovascular disease using intensive glycemic, blood pressure, and 

lipid management. The Association provided support for the ACCORD-MIND study of cognitive 

function in individuals with type 2 diabetes. 

The Association is also proud to participate in TrialNet, an international network of researchers who 

are exploring ways to prevent, delay and reverse the progression of type 1 diabetes. We jointly fund 

this initiative with the NIDDK, the National Institute for Allergy and Infectious Diseases (NIAID), 

the National Institute for Child Health and Human Development (NICHD), the National Center 

for Research Resources, and the Juvenile Diabetes Research Foundation ODRF). TrialNet was 

created in response to the Healthy People 2010 report, which called for more diabetes research. 

Clinical trials are underway in eight countries including the United States to test new treatments for, 

and to document the history of, type 1 diabetes in adults and children. 

Additionally, the Association co-supported the groundbreaking Diabetes Prevention Program 

(DPP), and the long-term follow up Diabetes Prevention Program Outcomes Study (DPPOS). The 

DPP, which was conducted by the NIDDK, found modest weight loss through dietary changes and 

increased physical activity could prevent or delay the onset of type 2 diabetes by 58 percent. Work 

by DDT showed that this research could be translated into the community setting at the cost of less 

than $300 per person. Collaboration between DDT, the YMCA, and leading researchers showed 

what made sense in theory and worked in the clinic could succeed in the community. This is the 

exact model we hope for - a 'progression from basic science to clinical application to community 

implementation - with an incredible success rate. Congress has recently recognized the value of the 

DPP and DPPOS by including the Diabetes Prevention Act, which creates a National Diabetes 

Prevention Program to expand this approach, in the Patient Protection and Affordable Care Act 

(p.L. 111-148). We are pleased that the Centers for Disease Control has been authorized to move 

forward in the effort to scale up the implementation of this successful diabetes prevention 

intervention and call upon Congress to quickly fund this program so this vital work can begin. 

Finally, the Association values its partnerships with key health organizations that are also committed 

to furthering the science of diabetes prevention and treatment. I am pleased to point to our 

continued our work with JDRF in the development of an artificial pancreas that would restore 

insulin production to individuals with type 1 diabetes. We have also recently teamed with the 

American Cancer Society in the announcement of a consensus statement acknowledging 

connections between diabetes and cancer and calling for further research to study the relationship 

between the two conditions. 

Towards a Cure for Diabetes: What Is Needed to Defeat the Disease 

The Association looks forward to the day when diabetes is no longer an epidemic and, ultimately, 
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when it ceases to exist. While we collectively have made demonstrable strides in diabetes research, 

prevention and treatment, there is much more to be done. 

The Association is committed to continuing its diabetes research, public education and advocacy 

efforts. Additional studies are needed in multiple areas of diabetes research, including research into 

new drugs, insulin pumps and glucose sensors; gene therapy and stem cell research; new prevention 

trials; and population studies to help predict diabetes and better treat individuals with the disease. It 

is essential that diabetes funding at NIH, CDC, and IHS be increased to reflect the burden of the 

diabetes epidemic, both on our citizen's lives and on our nation's pocketbook. In addition, I want 

to outline several key next steps that must be met if we are to succeed in the battle to stop diabetes. 

Continued Efforts to Translate Research into Health Care Delivery 

We collectively must encourage more translational research to help put cutting edge research and the 

newest innovations into the hands of patients, providers, and the public health community as swiftly 

as possible. For example, the DPP is already encouraging further studies on patient-centered 

diabetes prevention interventions focused on lifestyle changes. According to late brea:king research 

presented at Scientific Sessions, several similar programs, including a group setting at a primary care 

practice in California and in churches in Georgia and Connecticut, have shown outstanding results. 

Other research presented at the Scientific Sessions conference involved African-Americans, a 

population that is at higher risk of developing type 2 diabetes and 3-5 times as likely as whites to 

develop End Stage Renal Disease (ESRD). This study found African Americans with diabetic 

chronic kidney disease progress faster than other races to advanced stages of kidney disease, largely 

due to poor glucose and blood pressure control and lower vitamin D levels. This information is 

critically important for patients and providers in order to maximize treatment and avoid 

complications. 

To meet the challenge of diabetes and to begin to reflect the burden it has on this country we must 

significantly increase support for diabetes research programs at the NIDDK, and research, 

prevention, and treatment programs at the DDT, and the development and operation of clinical and 

public health efforts to treat and prevent diabetes in American Indians and Alaskan Natives through 

the IHS. For example, despite its successful research, prevention, and surveillance efforts, DDT is 

allotted only a little over 80 cents per year for each American with diabetes and pre-diabetes. 

Additionally, while the DDT has consistently comprised 10.3% of CDC's overall budget from FY 

2005 to FY 2010, it has essentially been flat funded in this time period. Similarly, the NIDDK has 

received slight increases over the pas't five years, but this has not kept pace with the estimated 3.5% 

rate of biomedical inflation. The Association is dedicated to highlighting translational research, and 

stands ready to collaborate with the diabetes research community to foster these efforts, but a 

greater commitment from Congress is imperative. 

Addressing the Needs of Special Populations 

More must be done to address the pressing needs of special populations particularly affected by the 

diabetes epidemic. Diabetes disproportionately affects minority populations, including AfricanAmericans, Latino-Americans, Asian-Pacific Americans, and American Indians and American 

Natives (AlAN). The Association remains steadfast in its efforts to support research that addresses 

people of color and disparities in diabetes care in minority communities. 
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With this in mind, the Special Diabetes Program (SDP) has been particularly successful in addressing 

the prevalence of diabetes in AlAN, as well as spurring research in type 1 diabetes since 1997. The 

program has demonstrated significant increases in the availability of diabetes prevention and 

treatment services for AlANs and has shown tangible success in preventing diabetes and its 

complications in AlAN communities across the country. I join my colleagues from JDRF and the 

National Indian Health Board in applauding Representative Diana DeGette and Representative 

Mike Castle for introducing legislation to reauthorize SDP, H.R. 3668, which expires in 2011. This 

bill will reauthorize the programs for five years and expand the funding by $50 million per year. This 

increase recognizes that these programs have not seen an increase for the past six years. While the 

programs have continued to do amazing work without additional funding, we know this limits the 

reach of the research dollar and the prevention and treatment programs. I urge Congress to pass 

this important legislation so this work can continue to move forward. 

We commend Representative DeGette for introducing H.R. 1995, the Eliminating Disparities in 

Diabetes Prevention Access and Care Act (EDDPAC), which seeks to reduce racial and ethnic 

health disparities related to diabetes prevention, care and treatment. The bill importantly requires 

the NIH to expand and support new and ongoing research regarding diabetes and pre-diabetes in 

minority populations. We also applaud Rep. Donna Christensen for her work to include.EDDPAC 

in the Tri-Caucus's health disparities legislation. Again, I urge Congress to move quickly as the 

disparate impact of diabetes on minority communities stands as a high barrier to effectively stopping 

diabetes. 

Additional research is also needed to address gestational diabetes. Greater understanding is needed 

by the NIH, CDC, providers and patients on how to prevent and treat this condition. New therapies 

and interventions to detect, treat, and slow the incidence of this condition must be identified. 

That is why the Association thanks Committee members Representative Eliot Engel and 

Representative !l-1ichael Burgess for introducing H.R. 5354, Gestational Diabetes Act (GeDi), which 

aims to lower the incidence of gestational diabetes, both to protect mother and baby now and to 

prevent women afflicted with this condition and their children from developing type 2 diabetes. Our 

youngest victims of diabetes need Congress to act. 

Preparing the Next Generation of Diabetes Researchers 

The Association is doing all that it can to help foster the young scientists interested in pursuing 

careers in diabetes research. We recognize that these efforts will require support for researchers at a 

number of key stages along the academic pipeline and we will continue to support promising 

scholars at the undergraduate, graduate, doctorate levels and in all stages of their professional careers 

to ensure the vitality of future diabetes research. 

Conclusion 

The diabetes epidemic is growing at an astonishing rate. If left unaddressed - or under-addressed -

diabetes will overwhehn the health care system with tragic consequences. To change this future we 

need to increase our commitment to research and prevention in a way that reflects the burden 

diabetes poses both for us and for our children. 
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We pledge to do our part to support the young researchers, the developing investigators, and the 

cutting edge research that will continue to lead to major breakthroughs at NIH, CDC, and IHS. 

However, our fight to stop diabetes must be significantly expanded. Your leadership in combating 

this growing epidemic is essential. 

Thank you for your commitment to the diabetes community and for the opportunity. to participate 

in this important hearing. The Association is prepared to answer any questions you might have on 

these important issues. 
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Robert R. Henry, MD 

President-Elect, Medicine and Science 

American Diabetes Association 

Dr. Robert R. Henry, MD, is Professor of Medicine in the Division of Endocrinology and 

Metabolism at the University of California, San Diego. Dr. Henry is also Chief of the Section of 

Endocrinology, Metabolism & Diabetes and Director of the Center for Metabolic Research at the 

VA Medical Center in San Diego. 

He received his medical degree from the University of Manitoba Medical School, Manitoba, Canada, 

where he also completed his residency in internal medicine and fellowship in endocrinology. Dr. 

Henry has been Visiting Assistant Professor of Medicine, Diabetic Research Unit, at the University 

of Colorado Health Sciences Center; Visiting Assistant Research Endocrinologist at the University 

of California, San Diego; and Visiting Professor of Medicine at the University of Edinburgh, Royal 

Infirmary. 

He is a member of several volunteer health organizations and professional societies including the 

American Diabetes Association, American Heart Association, Endocrine Society, Royal College of 

Physicians and Surgeons of Canada, and the American Federation for Clinical Research. Dr. Henry's 

honors include awards from the American Board of Internal Medicine and the American Board of 

Endocrinology and Metabolism. He is also a Fellow of the Royal College of Physicians and Surgeons 

of Canada. Dr. Henry's primary research interests involve studies in the etiology, treatment, and 

prevention of obesity and type 2 diabetes. 

He has authored more than 200 scientific journal articles and book chapters, the most recent 

publications describing the metabolic and cardiovascular effects of novel therapies for insulin 

resistance and diabetes, as well as defects of insulin signal transduction in skeletal muscle and 

adipose tissue of type 2 diabetic subjects 
99 

Mr. PALLONE. Thank you, Dr. Henry. 

We are going to have questions from the panel, and I will start 

with myself. 

Dr. Goldstein, can you explain how the promising research you 

are doing with the NIH and the private sector on initiatives like 

the continuous glucose monitor, artificial pancreas was mentioned 

several times, how these are going to be better control diabetes and 

the disease’s associated costs and complications? Because we know 

the costs are unbelievable. One out of three Medicare dollars is 

spent on diabetes. 

Dr. GOLDSTEIN. Mr. Chairman—— 

Mr. PALLONE. And I ask Dr. Henry to comment as well. 

Dr. GOLDSTEIN. The NIH-supported DCCT study in 1993 for the 

first time demonstrated that high-quality tight control of the blood 

sugar variations resulted in improvements. Over time, those patients have now been studied for 20 years and the complication 

rates have just dropped from very large numbers to 15 and 20 percent numbers so that the reduction in complication rate from just 

exerting tight control has been enormous. With the continuous glucose monitors, we have upped the ante because patients can now 

achieve high-quality tight control with lower risk for getting blood 

sugars that are too low and with just an improvement in the overall quality of life because they don’t have to concern themselves so 

much with measuring blood sugars six, seven, eight times a day. 

So the JDRF supported a study that was published a couple of 

years ago that showed you could drive the hemoglobin A1C down 

which is directly correlated to reduction in complication rates, and 

we are in the phase now where we are working with everybody we 

can find, industry, other organizations, to implement high-quality 

tight control in as many patient populations as possible ranging 

from children, adolescents, pregnancy—we are just beginning to 

start there—and the idea is, while we are waiting for a cure, we 

want people to implement very high-quality control of their diabetes so that they will be in good enough health when the cure does 

appear. 

Mr. PALLONE. Dr. Henry, you can answer that. Also, I wanted to 

ask you a question too separately about the Association’s role as a 

government partner and how you strike a balance in addressing 

the needs of the different types of diabetes, you know, type 1, type 

2, gestational. So if you want to follow up on him and then get into 

that. 

Dr. HENRY. Well, I would say I agree with everything that Dr. 

Goldstein has stated, and clearly the goal for an artificial pancreas 

is to make it easier to be able to regulate the blood sugar within 

the normal limits and as you heard, complications are minimized 

by good glycemic control, particularly low blood sugars, hypoglycemia, which can have devastating consequences, as well as persistent high blood sugars, which leads to complications. So these 

can be minimized by feedback between understanding the blood 

glucose levels and injections of insulin. 

The other thing that we found that the DCT research, the long 

term funded by the NIDDK data showed is that there was a legacy 

effect so that controlling diabetic patients today with type 1 diabetes had effects on cardiovascular disease, beneficial effects on carVerDate Mar 14 2013 01:02 Mar 20, 2013 Jkt 077918 PO 00000 Frm 00105 Fmt 6633 Sfmt 6633 E:\HR\OC\A918.XXX A918

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diovascular disease 10 years later so that there was this shortterm—the study lasted for several years but even 10 years later 

there were significant benefits. So I think that it emphasizes that 

good control now will not only reduce the long-term consequences 

but they will have sustained benefits for many, many years. 

In terms of the second question, can I ask you to repeat that? 

Mr. PALLONE. I may forego that because I did want to ask something else. I am so interested in the issue as it affects the Native 

Americans, and Chairman Rolin left, but I just wanted to ask, he 

gave me the impression that we really were getting a handle on diabetes amongst American Indians. Is that—I mean, obviously there 

is some success but my recollection just talking to different tribes 

is that the incidence of diabetes is still on the increase and particularly amongst younger people. How do I reconcile that with what 

he said? I mean, he is not here so it is difficult but—— 

Dr. HENRY. Sure. I would be happy to. I think you are correct 

that the prevalence continues to rise in the Indian and the Native 

Alaskan population. However, we are doing a better job of taking 

control of those people so they are living longer but we are doing 

a better job of preventing the complications. 

Mr. PALLONE. So more people are still contracting diabetes but 

you are able to control it and make them live longer? 

Dr. HENRY. And many of the complications of the nerves and of 

the kidneys and the eyes, we have made substantial progress in reducing those so while there has been significant progress, as he 

states, the prevalence of the disease does continue to rise, though. 

Mr. PALLONE. Thank you very much. 

Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Dr. Goldstein, and Dr. Henry, you can chime in too, you talked 

about the islet technology and use, and I know in the early part 

of the decade there was widespread media reports on the promise 

of this, especially those with type 1 diabetes, and the hope was that 

they would be able to live without daily injections of insulin. You 

briefly mentioned one case. What is the promise of the islet use? 

Dr. GOLDSTEIN. So the pancreatic islet transplantation study you 

are referring to, which was reported from Canada in the year 2000, 

was widely heralded and adopted and NIH studied it and the initial promise probably exceeded what could be delivered, but the 

long-term promise is quite interesting. So if we prepare islets from 

a donor, a cadaveric donor pancreas, and transplant that into 

somebody who has got relatively severe disease, typically with 

what is called hypoglycemia unawareness where they don’t know 

that they are getting low blood sugars and could be prone to seizures and that sort of thing. The islet transplant actually reverses 

the hypoglycemia unawareness, even if you still have to take insulin, and for those patients who have had to continue to take insulin, the quality of their treatment has improved so much and two 

complications have begun to reverse, one in the eyes and one in the 

nerves. So it has had an important conceptual effect which we 

would call a proof of therapy that cell therapy or replacement therapy can actually work. That kind of replacement therapy requiring 

lifelong immunosuppression to prevent graft rejection is not exactly 

what we would like to give to our children, so we made improveVerDate Mar 14 2013 01:02 Mar 20, 2013 Jkt 077918 PO 00000 Frm 00106 Fmt 6633 Sfmt 6633 E:\HR\OC\A918.XXX A918

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ments on that and hopefully this will lead the way towards the 

next generation of productivity. 

Mr. SHIMKUS. Great. 

Dr. Henry, do you want to add anything to that? 

Dr. HENRY. Well, I would only say that there was a large number 

of symposia at this recent ADA meeting in Orlando which addressed islet cell rejection and techniques to prevent rejection, techniques to stimulate other cells to become islet cells and so I think 

that this is a very sort of stimulating area of research that is currently ongoing. 

Mr. SHIMKUS. Dr. Goldstein, you mentioned also in your statement, not the written but when you were talking, anti-CD3. Can 

you elaborate on that? 

Dr. GOLDSTEIN. Can I divert your attention for 30 seconds? 

Mr. SHIMKUS. It happens all the time. 

Dr. GOLDSTEIN. Dr. Burgess talked about a soldier who was injured by a blast injury and was losing his pancreas surgically to 

save his life in other ways. That pancreas went to one of the islet 

transplantation programs in Miami. They recovered the islets from 

this soldier’s damaged pancreas, sent them to Walter Reed. They 

were transplanted back, and he now has function and doesn’t have 

diabetes because of that traumatic event. That couldn’t have happened if there weren’t a facility that understood how to prepare 

those islets. 

Let me tell you about anti-CD3 in a moment, please. So type 1 

diabetes is an autoimmune disease where the immune system reacts in an abnormal way. If we could stop that autoimmune response, we presumably can stop the attack on the insulin-producing cells. Anti-CD3 is a monoclonal antibody which blocks the 

autoantibody response. If you give it to Charlotte Cunningham 

within 4 or 5 weeks of the time she got the disease and blocked 

that autoimmune response, her body stops destroying insulin-secreting cells and she keeps them functional now almost up to 4 

years. 

Mr. SHIMKUS. Great. That is good news on hopefully future uses. 

And I will just end with this. 

Dr. Goldstein, I know that the charity, JDRF, has a good ratio 

of money spent out versus overhead costs, and I was going to ask 

questions but I will just place that in the record because we do 

know that you are good stewards of the donations and I put on the 

record a family who especially since I got elected to the Congress 

has just been all over me, and they have two—their youngest boy 

is Kevin Covarubius. He has been up here for the Congress years 

ago. And what was challenging is that he as a young, young body 

was identified. Then his brother, who is older, only was identified 

in his late teens, like 18 or 19 years old, which I guess had Ryan 

appreciate what Kevin went through for all those years. So my 

hats off to the Covrarubius family for doing the work in the field, 

and I yield back, Mr. Chairman. Thank you. 

Mr. PALLONE. Thank you. 

Ms. DeGette. 

Ms. DEGETTE. Thank you, Mr. Chairman, and I want to thank 

both of you for coming and for all of the work of your organizations. 

I was getting a lot of thanks up here but really it is you and your 


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102 

partners at the federal agencies that are doing all the work and all 

of the families too. Whenever Mr. Space and Mrs. Capps and the 

chairman and I and everybody will tell you that—even Mr. Shimkus will tell you that when these families come up to the Hill to 

testify and to talk to members, it is the most powerful evidence 

that we get up here. So thank you for that. 

I want to follow up on a couple of questions. Both of you were 

talking about the islet cell transplantation work that has been 

done, and I just think it is worth noting as well as the anti-rejection issues, the other issue that we have right now with using the 

islet cells from cadavers is that the supply is—even if you could figure out the rejection issues, you would have such a low supply of 

existing islet cells that you couldn’t possibly treat the existing populations. I am wondering if either of you or both of you would like 

to comment on that. 

Dr. HENRY. Well, my comment would be that is likely to be true. 

The options of stem cells I think is really a true one, and while we 

still have to get around the rejection issue, because that has been 

sort of the thorn in the side of getting a cure, I think that stem 

cells still hold significant promise. 

Ms. DEGETTE. And that is because with the stem cells you can 

actually make new cells versus the existing research where you 

have to just collect—— 

Dr. HENRY. Right, and hopefully immune tolerant so that they 

don’t get rejected. 

Ms. DEGETTE. Right. Let me ask you along those lines, the NIH 

recent work of trying to improve new cell lines, is that sufficient 

to be doing the research that is out there right now on the stem 

cell research and what about this issue of having cell lines that 

might have the genetic predisposition towards diabetes? What is 

the status from your perspective as private organizations? 

Dr. GOLDSTEIN. There are now many approved lines for NIH 

funding. We think that is terrific. There are alternative sources for 

new lines from induced pluripotent stem cells, which are excellent 

resources, and disease-specific lines are being produced, for example, at the Harvard Stem Cell Institute with the technique of induced pluripotent stem cells and they are making the cells available for study by researchers. They include rare genetic disorders 

as well as things like type 1 diabetes. So I would say the rate-limiting event today is funding for research to take advantage of the 

available material more than we need to make even more material 

this week. 

Ms. DEGETTE. Yes, because not only did we have President 

Obama’s expansion of the embryonic stem cell research but just in 

the last few years we had discovery of the IPS cells and so now we 

need the funding to capitalize on that. 

I just have one more question for both of you, which is, a lot of 

your testimony and the previous panel’s testimony was around this 

concept of an artificial pancreas, and of course, as the parent of a 

diabetic, I follow these research developments with interest, and I 

think the closed loop system will be the next big step. How far 

away are we, though, from really developing, to being able to get 

clinical trials of the closed loop system and then to actually have 

it be widely available for folks? 


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Dr. HENRY. Well, there have been some clinical trials that are already being conducted and have shown efficacy in small numbers 

of patients. I think the difficulty right now is having sufficient 

funds to be able to do in larger populations of patients, and of 

course to research to make it more user friendly. Right now the artificial pancreases that have been studied are still bulky and large 

and they are very effective but not particularly adaptable to everyday life, and that is what we have to strive to do. But I think we 

are certainly heading in the right direction, moving quickly but 

perhaps not quickly enough. 

Ms. DEGETTE. Dr. Goldstein? 

Dr. GOLDSTEIN. The technology is a bit cumbersome at the moment. Not every teenager likes to wear it. And if we can package 

that and shrink it and make it more user friendly and get more 

widespread use, we will be able to take advantage of current technology. We need improvements. We are funding work that is going 

ahead full blazes in terms of understanding how to set an algorithm to describe exercise situation or sleeping at night situation 

with the infinite variety of details that a person might go through. 

But our notion is that to whatever extent we can automate the 

technology, we will get those tough-to-treat patient populations like 

adolescents and teenagers to use the technology, and that will 

make it better for everybody. 

Ms. DEGETTE. Thank you. 

Mr. PALLONE. I am going to try to finish, guys. You have 5 minutes each, which is fine. Because we have not only a series of votes 

but also a motion to recommit, so it will probably be at least an 

hour, so we are going to try to finish. So we will go to Ms. Capps 

next. 

Mrs. CAPPS. Thank you very much for your testimony and also 

for your patience getting through this very long day. Two questions 

for each of you, and they can be brief and we can go to Mr. Space. 

A couple for Dr. Goldstein. In your testimony, you state that type 

1 diabetes typically strikes in childhood, adolescence or young 

adulthood, then you note that the incidence has increased particularly among children under 4. I wonder if you could briefly give us 

a couple of reasons for that if they are known. 

Dr. GOLDSTEIN. I wish I could give you a couple. 

Mrs. CAPPS. Or some kind of—— 

Dr. GOLDSTEIN. I should say two things quickly. About half the 

cases come in people 20 years old and older, so type 1 diabetes is 

not strictly speaking only a disease of children. 

Mrs. CAPPS. Right. 

Dr. GOLDSTEIN. What has happened from the epidemiologic studies in the past 5 years from both Europe and the United States is 

unfortunately we are seeing it in younger and younger children in 

a more aggressive version, and since nothing much has changed in 

the genetic structure of people, the assumption is that it is related 

to something in the environment, so studies are focusing on identifying a theoretical virus that could do that, some antigen within 

your body that—— 

Mrs. CAPPS. So there is no clear path or—and therefore we need 

a lot more research in this area. 

Dr. GOLDSTEIN. We do. 


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Mrs. CAPPS. Let me move on, because you described also the disproportionate burden of type 2 and gestational diabetes on certain 

groups. I wonder if this also holds true for type 1 and can you tell 

us whether there are certain age groups beyond children under 4 

that are particularly affected by type 1 diabetes, you know, with 

ethnic, racial, whatever kind of groups that you—— 

Dr. GOLDSTEIN. Well, type 1 diabetes appears to be an equal opportunity disease, and the numbers are fairly similar across ethnic 

groups. Where it is extremely important, for example, as in, let us 

say, Los Angeles, if we would like to get the technology into certain 

areas of Los Angeles to treat ethnic groups with type 1, that is a 

tour de force because that is not easily done without an army of 

educators and third-party pay, etc. So we have some of our artificial pancreas researchers working there on that. That is the hope 

for the future. 

Mrs. CAPPS. I see. So it is going to depend on some other things. 

Maybe that will segue into questions that I have for you, Dr. 

Henry. These could have been interchanged with each of you. 

Earlier today, Dr. Albright was talking about in testimony that 

CDC is actively working with the First Lady and Let’s Move, that 

campaign to provide expertise in healthy eating and physical activity as a way to deal with diabetes, and they are also sponsoring the 

diabetes—CDC is—the diabetes prevention program Master Training Curriculum. I am particularly interested in types of prevention 

research and activities that will really work and that ties into 

areas like that they would work with particular community groups, 

and Dr. Henry, maybe you can tell us more about some efforts that 

your organization is getting behind and the advocacy community is 

working on in terms of outreach, specifically, how they are being 

tailored to meet the needs of individual communities. 

Dr. HENRY. I think one of the major ways is in the application 

of the diabetes prevention program information which was highly 

effective, as you know, a 58 percent reduction in the development 

of diabetes in individuals who are able to lead a healthy lifestyle, 

so clearly one can make big inroads in that. The task has now been 

to take it to the community level, and that has been done. The 

translational part of that program has been initiated and we are 

obviously very supportive of that and has been done for a reasonable amount of money, as you heard, in the range of $250 to $300 

per year per person, which is, I think, a reasonable amount of an 

expenditure. So I think that that is right now where our major efforts are going. But there are also many preventive efforts that are 

being directly truly at the pancreatic beta cell, which not only does 

it decline and cease in type 1 diabetes but it declines progressively 

in type 2 and is a major contributor to many of the complications 

through poor glucose control. So there is again a great deal of research focusing on preserving the beta cell, preserving and also 

treating the insulin resistance that you heard about because we 

now know that efforts directed at treating the insulin resistance, 

whether it be through lifestyle modification or through medications, prolongs the pancreas and gives it a longer period where it 

can produce sufficient insulin to maintain glucose control. 

Mrs. CAPPS. Thank you very much. 

Mr. PALLONE. Thank you. 


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Mr. Space. 

Mr. SPACE. Thank you, Mr. Chairman. 

Thank you both for being here today, and I certainly want to 

echo the remarks of my colleague, Mrs. DeGette, regarding how 

valuable the work that both your agencies do is. I have, Dr. Henry, 

for you first. Your testimony references special populations as 

being especially prone to contracting diabetes, and there has been 

some talk today about ethnic minorities and Native Americans, and 

there hasn’t been much said, however, about geographic and demographic breakdowns. My district in southeastern Ohio, it is Appalachian Ohio. It is a very poor, very rural district. Some of my 

counties have actually twice the incidence of diabetes than the national average or even the statewide average, and I would be interested in your thoughts as to whether those types of demographics, 

location or access to health care facilities or poverty, whether or 

not they have negatively influenced the diabetes incidence rate and 

whether your studies are accounting for that and what can be done 

to offset that. 

Dr. HENRY. I think that it seems unquestionable that is the case, 

and access to care is definitely one of the limiting factors because 

in many cases there is prodrome, not only obesity but different 

forms of obesity, that precede the development of at least type 2 

diabetes and individuals at risk for gestational diabetes, and certainly those populations, they need to be effectively treated and 

have access to care. Just as well, I think that healthy lifestyles are 

difficult when you are poor. It is very difficult to eat the fruits and 

vegetables that we have talked about, and I think that that also 

increases the likelihood that individuals with a genetic risk of diabetes which it clearly has a genetic component are more likely to 

develop diabetes. So I think that those are real issues that have 

to be addressed, and I think that better access to preventive technology as well as better treatment of the comorbidities will translate to a reduction in the development of diabetes. 

Mr. SPACE. Thank you. 

And Dr. Goldstein, thank you, by the way, for meeting with me 

earlier today and taking time out of your busy schedule. We have 

about 2 minutes, and if you could give us just a very brief account 

of how the NIH funding works in conjunction with foundational 

funding that comes from sources like ADA and JDRF and how it 

works in conjunction with industry sources of funding for research 

and development from biotech and pharmaceutical companies. 

Dr. GOLDSTEIN. So here is the 2-minute version. We work very 

closely with the NIH to do complementary things so we are not 

funding the same things, and I would say that most important 

piece of information is that the NIH, which has made a historically 

important investment in basic science and discovers new things, to 

develop those things, you have to pass that off as you go along. So 

initially new discoveries get in the hands of small companies. NIH 

has a modest program. JDRF has a modest program to encourage 

small companies to develop things. We like to nourish them along 

the pathway to get into proof-of-concept clinical trials, which is 

about the first place that large pharma becomes interested after 

you have already got some data. And once you have got the data 

and a phase III trial, large pharma becomes very interested. So, for 


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example, the anti-CD3 I spoke about, two large pharmaceutical 

companies are both taking that to market, and it costs lots of 

money to do that. We can’t afford to do it nor can the ADA probably. 

Early on, NIH gets us the discovery, but once you hit the small 

company level and the small biotech and the small investigators, 

the handful of people who are moving the next generation of 

science along, it is really hard to get money to do that these days. 

Venture capital has dried up, and the foundation world has said 

that is a gap we need to think about filling, how could we do it 

wisely, and that is exactly where we are focusing our more limited 

resources in a more strategic way. So we frankly pick and choose. 

We try to take something more promising and try to move it along 

to the point where it can either move or not, and that is a partnership that I would argue has served the United States of America 

very well in terms of being a model for how to do things for people, 

and at some point the big clinical translation apparatus comes into 

play and NIH has played an important role in doing that as well. 

Mr. SPACE. Thank you very much. 

Mr. PALLONE. We are going to have to end, otherwise we are 

going to miss the votes. 

I thank my colleagues and both of you for your presentations. It 

was very helpful. The way we work is, we have about 10 days to 

submit written questions and particularly since Chairman Rolin 

had to leave, I am sure there will be some, and the clerk will send 

you those and then we ask you to get back to us as quickly as possible. But again, thank you, and I know there is a lot more to be 

done on this issue but at least we had a beginning here today. 

And without objection, this meeting of the subcommittee is adjourned. 

[Whereupon, at 2:18 p.m., the Subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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Statement of the Honorable Anna G. Eshoo 

Committee on Energy and Commerce, Health Subcommittee 

Hearing on "The Battle Against Diabetes: Progress Made; Challenges Unmet" 

July 1,2010 

Mr. Chairman, thank you for holding this important hearing on the progress of diabetes in 

our country. This is a critical public health issue. 

According to the CDC, an estimated 23.6 million Arnericans-or 7.8% ofthe country's 

population-have diabetes. Another 57 million Americans have pre-diabetes. With 1.6 

million new adult cases being diagnosed each year, we simply can't afford to continue 

down this path. 

The vast majority of diabetes cases in this country are preventable. While a small 

percentage of diabetes patients are Type I diabetic (autoimmune disorder) at least 90% 

have Type II diabetes, characterized by "insulin resistance." Type II diabetes is most 

often caused by obesity, which has skyrocketed in the U.S. with no signs of slowing. 

Obesity rates in the United States are on the rise amongst every sector of the population, 

including children. 

I commend the efforts of First Lady Michelle Obama with her "Let's Move!" campaign. 

The campaign brings national awareness to the issue of childhood obesity, while 

encouraging parents, parents, schools, and kids themselves to make h~althy choices. 

Mrs. Obama spearheaded a task force which recently released a "Childhood Obesity 

Action Plan" with recommendations on how to prevent obesity. This is an excellent step 

in the right direction and I'm eager to hear from our witnesses about how we get people 

to actually/allow these recommendations. 

Addressing the obesity epidemic in our country is no easy endeavor. It requires a multipronged approach, including communities, schools, families, advertising, and personal 

choices. We've come leaps and bounds in the last century at closing the hunger gap, but 

we haven't done so with an eye toward health. The accessibility of cheap and unhealthy 

food, especially in low-income communities, without healthier alternatives, is a major 

contributing factor to the prevalence of obesity. 

I want to thank our witnesses for being here today and I look forward to learning more 

about the progress of research in the area of obesity and diabetes. 
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Statement of Congressman Gene Green 

House Committee on Energy and Commerce 

Subcommittee on Health 

"BattIe Against Diabetes: Progress and Challenges" 

July 1, 2010 

Thank you Mr., Chairman for holding this hearing today on diabetes. 

I'm interested in hearing from our witnesses on the status of research at 

the CDC, NIH, and the National Institute of Diabetes and Digestive and 

Kidney Diseases. 

I don't need to tell any of you here that diabetes is a serious, costly, and 

life-threatening chronic illness that affects more than 23 million 

Americans. 

There are three types of diabetes: Type 1 diabetes is a chronic, 

genetically determined, and debilitating disease, Type 2 diabetes, 

formerly called adult-onset or noninsulin dependent diabetes, and 

gestational diabetes that some women develop late in pregnancy. 

Diabetes is one of the most costly chronic diseases, costing the United 

States economy more than $174 billion annually in direct and indirect 

health care costs. 

On average, individuals with diabetes pay $13,000 in annual health care 

costs, compared to $2,600 for individuals without diabetes. Insulin treats 

but does not cure this potentially deadly disease or prevent the 

complications of diabetes, which include blindness, heart attack, kidney 

failure, stroke, nerve damage, and amputations. 

Diabetes is more prevalent in women than men and among certain racial 

and ethnic groups, including Native American, African American, and 

Hispanic and Latino populations. Our district, which is nearly 70% 

Hispanic, and Texas in particular have high rates of diabetes and prediabetes. 
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Approximately 1,727,000 Texans-l 0.4% of the state's populationhad diagnosed diabetes, and many of them suffer from serious diabetes 

related complications or conditions. 

The financial burden diabetes places on the health system in Texas is 

high-in 2007, the direct and indirect cost of diabetes in Texas was 

approximately $12.46 billion. 

With diabetes as widespread as it is, I don't doubt that every one of us 

knows someone with the disease, either a friend, a neighbor, or a loved 

one. So we all know how much individuals with diabetes struggle to 

control their illness. 

Their lives are dictated by a regimen of strict diets, painful blood sugar 

tests, multiple medications, and sometimes insulin, which they must rely 

on in order to survive. 

Just as troubling is that almost 6 million individuals with diabetes do not 

know they have the disease, and won't learn it until they develop one of 

its life threatening complications. 

An additional 57 million Americans suffer from a condition known as 

"pre-diabetes" that, when left untreated, will develop into diabetes. 

We need to do more to educate people about the risks of diabetes, so 

they know what to look out for. There is also more we can and should do 

to screen for and diagnose the millions of individuals with undiagnosed 

diabetes and pre-diabetes. 

Additionally, we need to ensure we continue funding research programs 

like those at CDC, NIH, the National Institute of Diabetes and Digestive 

and Kidney Diseases, and the Special Diabetes Program. 
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Promising advances have been made in determining root causes ofthe 

disease and finding a cure will depend on funded research initiatives and 

training the next generation of diabetes researchers, but Congress can do 

more to advance the research on diabetes. 

Thank you Mr. Chairman and I want to thank the witnesses for 

appearing before the committee. I yield back my time. 
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U.S. Representative Kathy Castor 

Committee on Energy and Commerce - Subcommittee on Health 

Hearing on "The Battle Against Diabetes: Progress Made; Challenges Unmet" 

July 1,2010 

• Thank you Mr. Chairman for holding this morning's hearing 

on a critical issue that every member of this subcommittee 

cares about a great deal. 

• Each of us is affected in some way by diabetes. We all have 

a family member, friend, sibling or neighbor who struggles 

with diabetes. Many of us can remember a childhood friend 

growing up that may have been insulin dependent and relied 

on blood sugar tests throughout the school day to stay 

healthy. 

• This disease affects more than 24 million adults and children 

and one of every three Americans born just 10 years ago will 

develop some form of diabetes during his or her lifetime. 

• In my home state of Florida, just over 8% of the population 

has diabetes. In 2007 alone, the direct and indirect costs of 

diabetes in Florida were more than $12 billion. 

• It is estimated that diabetes costs the U.S. economy $174 

billion annually and one third of every Medicare dollar is 

spent on diabetes. 

• I am particularly concerned about the trends in childhood 

obesity that are a head start for becoming an overweight or 

obese adult and increase the risk for type 2 diabetes later in 

life and gestational diabetes for pregnant women. 

• In Florida, more than 33 percent of children are overweight 

or obese, which is higher than the national average. As the 

numbers of children who are overweight have increased in 
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recent years, campaigns to fight childhood obesity have 

sprouted around the country. I am encouraged by the First 

Lady's decision to make the fight against childhood obesity 

her priority by creating the Let's Move initiative. 

• It is critical that we continue to fight known risk-factors for 

type 2 diabetes and some gestational diabetes cases that may 

be preventable by maintaining a healthy weight. 

• As type 1 diabetes - an autoimmune disorder different from 

the other forms of diabetes - often affects children, it is also 

important that families are able to count on school nurses and 

faculty to be aware of warning signs of the adverse effects of 

type 1 diabetes, so that problems can be detected and treated 

before tragedy strikes. 

• Just recently, in Pinellas County near my home, a young high 

school student passed away after going into a blood sugar 

"low" at school. No one at the school was able to recognize 

warning signs or detect his symptoms - he died overnight 

after slipping into a diabetic coma and never recovering. 

This student's death could have been prevented if appropriate 

education for school faculty was provided and someone was 

able to recognize his symptoms before it was too late. 

• Again, thank you Mr. Chairman for holding today's hearing. 

I look forward to hearing from our witnesses about what is 

currently underway to address some of these issues and the 

work ahead to combat diabetes. 
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The Honorable Joe Barton 

Committee on Energy & Commerce 

Subcommittee on Health 

The Battle Against Diabetes: Progress Made; Challenges Unmet 

July 1,2010 

Thank you, Mr. Chairman for holding this hearing today. In this 

country, there are an estimated 24 million people afflicted with diabetes, 

a number that is projected to double in the next twenty-five years. 

Diabetes is a lifelong disease marked by elevated levels of sugar in the 

blood. The complications can be devastating, ranging from heart 

disease, stroke, blindness, to kidney disease. 

Type one diabetes results from the body's failure to produce insulin 

-- the hormone that "unlocks" the body's cells, allowing sugar to fuel 

them. The most common form of type one diabetes is caused when the 

body's immune system attacks and destroys the insulin-producing cells 

of the pancreas. Although the common name for type one diabetes is 

juvenile diabetes, our witnesses from the Juvenile Diabetes Research 
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Foundation can attest that it is a disease individuals must manage their 

whole lives. 

Type two diabetes, sometimes known as adult-onset diabetes, 

results from the body's inability to make enough or properly use insulin. 

Type two diabetes is the most common form of diabetes and its 

prevalence is rising every year. Approximately 57 million American 

are thought to have early signs of type two diabetes. 

People at risk oftype two diabetes can take steps to avert the onset 

of the disease and mitigate the effects of it. Balanced diets and 

increased physical activity can prevent the disease or its complications. 

Those individuals with histories of diabetes in their families must be 

especially vigilant. Mr. Buyer and others on this Committee advocate 

allowing employers and health plans to provide incentives to those who 

join wellness programs. I believe such incentives could go a long way 

to reversing the current trend in the growth of type two diabetes. 

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I look forward to hearing from our witnesses on the advances in 

medical technology for diabetes treatment. Several years ago, the 

promise of islet cell transplantation led many to believe that a major 

breakthrough in diabetes was near. However, we hear little about the 

potential breakthrough now. There have also been reports about the 

development of a vaccine to prevent type one diabetes. I look forward 

to asking the witnesses whether islet cell transplants are as promising as 

once thought, and I look forward to hearing from the witnesses on when 

and if a type-one vaccine will be available. 

As promising as these new therapies are, it is unfortunate that the 

health reform bill passed by this Congress will make these therapies 

more expensive for consumers. In an April 22nd letter, the 

Administration's own actuary stated, "we anticipate that [the] fees and 

the excise tax [in the Act] would generally be passed through to health 

consumers in the form of higher drug and device prices and higher 

insurance premiums." I do not see how higher drug and device prices 

and higher insurance premiums fit the definition of reform. I am also 

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concerned that these new taxes will reduce investment in research and 

development that could yield future therapies and cures. 

I want to thank the American Diabetes Association for being here 

today. The ADA has an office in Dallas, and I have participated in 

many of their events in the Metroplex. I would also like to thank the 

Juvenile Diabetes Research Foundation for testifying. Every year JDRF 

representatives from Texas come to Washington, and they always have a 

remarkable story to tell about the research their foundation supports. 

Thank you again Mr. Chairman for holding this hearing and I yield back 

the balance of my time. 

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July 1, 2010 

Opening Statement of 

Congressman Jo1m Sullivan 

House Energy and Commerce Subcommittee on Health 

"The Battle against Diabetes: Progress Made; Challenges Umnet" 

2322 Rayburn House Office Building 

Chairman Pallone, 

Thank you for holding this important hearing on our nation's battle against Diabetes. 

Diabetes is a terrible disease that is the leading cause of kidney failure, new adult blindness and 

amputation. This disease also takes a tremendous toll on the personal lives and families of its 

victims who must often times administer life-sustaining insulin injections and strictly monitor 

their diet and physical activity of those with the condition. 

According to the Kaiser Family Foundation, my state of Oklahoma ranks sixth in the nation in 

our diabetes rate with 10% of our population afflicted. This is a public health crisis that must be 

addressed. According to the journal "Diabetes Care, " it is predicted that diabetes levels in the 

United States are likely to double in the next 25 years, resulting in 44.1 million sufferers by 

2034! It is imperative that we explore our current understanding of the causes and consequences 

of diabetes and evidence-based prevention and management strategies used to combat the 

disease. 

Being overweight is a risk factor for developing this disease, but other risk factors such as family 

history, etlmicity and age also playa role. In an era when we are faced with less time for 
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physical activity and the temptation and convenience fast food, it is important for all 

Oklahomans and Americans to take simple steps to live longer and healthier lives. By exercising 

regularly and maintaining healthy eating habits, individuals can feel better and control their diet 

and exercise, which will reduce their risk of chronic health conditions like, diabetes. 

As a member of the bipartisan Congressional Diabetes Caucus, I am an advocate for finding a 

cure and for utilizing best practices with our public health efforts to combat the disease. I look 

forward to hearing the testimony of our witnesses today on examining research advances into 

type 1, type 2 and gestational diabetes so we can better fight this terrible disease that is a leading 

cause of death and disability in our nation. 

I yield back the balance of my time 
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July I, 2010 

The Honorable Frank Pallone 

Chairman, and Commerce 

Subcommittee on Health 

House Office 

DC 20515 

The Honorable Diana DeGette 

Co-Chair, Diabetes 

Caucus 

2335 

The Honorable John Shimkus 

Ranking Member} and 

Commerce Subcommittee on Health 

2322A Rayburn House Office 

DC 20515 

The Honorable Mike Castle 

Co-Chair, Diabetes 

Caucus 

1233 Longworth HOB 

DC 20515 

Dear Chairman Member Co-Chair DeGette, 

and Co-Chair Castle: 

that the Subcommittee on Health has scheduled the 

Battle Diabetes: Made, 

Unmet:' As you Novo Nordisk is a company with 87 

years of innovation and in diabetes care, and the U.S. 

leader in insulin. We welcome the opportunity to a few issues to 

your attention. 

The timing of this hearing coincides with an editorial published in the 

medical journal Lancet which calls the explosion of diabetes in America 

health humiliation" while calling for "a strong, integrated, and 

response." We agree on the need for 

dramatic action and 1001< forward to with the committee to 

defeat this disease, 

The of 2 Diabetes in America 

With 24 mllilon Americans living with diabetes (a quarter of 

whom do not know they have the and 57 million more with 

and at risk for developing the diabetes could 

be called the most important critical public health issue 

currently facing our country. Within the last 30 years, Since 1980, the 

percentage of Americans diagnosed with diabetes has more than 

doubled. On its current course, by 2034, the number of people with 

diabetes will nearly double again to 44.1 million. 
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Diabetes is the leading cause of new cases of blindness, kidney disease 

and amputations. Research also suggests a relationship between 

diabetes and depression, Alzheimer's disease and other conditions. 

Thus, some clinicians and'public health officials are increasIngly 

referring to diabetes as a "gateway disease." 

Overail, the risk for death among people with diabetes is about twice 

that of people without diabetes of similar age. In 2006, diabetes was 

the sixth leading cause of death on U.S. death certificates. Given the 

fact that the Centers for Disease Control has estimated that diabetes is 

vastly underreported as a cause of death, in reality, diabetes is one of 

the top killers in America - and its death rate continues to rise. 

Already, diabetes is one of the most costly diseases in America. 

Factoring in the previously unidentified costs of undiagnosed diabetes, 

prediabetes, and gestational diabetes, the total diabetes-related 

costs in the United States in 2007 amounted to $218 billion. One in 

every lO health care dollars is spent .. on diabetes and its complications, 

and one in every three Medicare dollars is spent on people with 

diabetes. According to a recent study by Thorpe et al published in 

Health Affairs: "Much of the recent growth in spendIng among 

Medicare beneficiaries is attributable to rising spending on chronic 

conditions-specifically diabetes and hypertenSion, both of which rose 

considerably in treated prevalence over the past two decades." 

A report issued by HHS In November 2009, Preventing and Treating 

Diabetes in America: Health Insurance Reform and Diabetes in 

America, highlighted as a problem that "diabetes prevention and early 

treatment are under-emphasized" in the U.S. 

Nowhere is this more evident than when examining federal funding for 

diabetes. 

Inflation-adjusted, the combined federal NIH and CDC funding for 

diabetes has been decreasing since 2004, dropping from $1.009 billion 

in 2004 to $850 mHlion in 2010 based on CPI-adjusted 2003 dol/ars. 

HIV/AIDS, on the other handl received more than $4.6 billion in 

funding in 2010 (CPI-adjusted 2003 dollars), a funding level nearly 5 

times higher than diabetes-for a disease whose prevalence is less 

than l/lOth that of diabetes. The important and necessary progress 

against HIV/AIDS is proof that we can make a difference in the fight 

against a disease state when we make it a national priority. 
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Among the chronic diseases, estimated per capita federal spending on 

diabetes prevention and research lags far behind that of heart disease, 

cancer, and HIV/AIDS. Per capita spending for diabetes is $55, vs. 

$111 for heart disease, $665 for cancer, and $3,609 for HIV/AIDS. 

This disparity does not look to change soon, as the CDC budget 

request for FY 2011 for diabetes was $64.7 million, a decrease of $1.3 

million below the FY 2010 Omnibus. Indeed, diabetes funding at CDC 

- the world's premier prevention agency - has been stagnant In real 

dollars since 2004, which has meant a significant decrease in real 

spending power over this time. During this same period of prevention 

funding stagnation, the prevalence of diabetes has increased by over 

50%. 

Without a significant national investment in the prevention of diabetes 

and diabetes complications, Americans, especially those who are 

disproportionately Impacted by the disease - those in the Hispanic, 

Afrfcan American and NatIVe American communities - will continue to 

needlessly develop blindness and kidney disease, and be at far greater 

risk for amputation and early mortality from heart attack and stroke. 

The Importance of Diabetes Screening 

While every disease is important,not every disease is a pubUc health 

crisis. Diabetes Is a gateway disease that leads to many other health 

complications. Health refOrm will not be successful unless it succeeds 

at changing the way the country prevents diabetes and treats people 

who are diagnosed with diabetes. Novo Nordisk strongly supported 

the creation of the Public Health Fund and believes, if properly utilized, 

it could create a sea change In the care and treatment of diabetes and 

other chronic diseases. 

We believe that as health reform is implemented, Congress and the 

Administration should place a high priority on ensuring a new, 

aggressive approach to screening people at risk for dlabetesl along 

with prevention and treatment of diabetes. We have strong concerns 

that this priority is not yet reflected in several initiatives that should 

give more attention to diabetes. 

First, we believe that HHS, CMS and CDC must make a commitment to 

promote diabetes screening and prevention for the Medicare 

population. Efforts to date to implement the Medicare diabetes 

screening benefit the Congress passed as part of the Medicare 

Modernization Act have been minimal at best. In addition, it is 
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critically important that efforts to implement the 

Diabetes Prevention Program for the Medicare population is a clear 

government priority .~ and that it receive the funding necessary to 

make a 

The Committee may be interested to know that people 65 and older 

have the highest prevalence of diabetes and of any age 

group: of adults 65 and older have diabetes and 

46% of them are . An additional 40% of those 65 and 

older have Taken those with 

6 out of 10 Medicare 

beneficiaries qualify for the Medicare benefit because 

have diabetes risk factors. 

Diabetes tests are covered once per year for all Medicare 

beneficiaries 65 years of age and with anyone of the risk 

factors: 

tests per year are allowed for those with 

No or deductible is 

The Diabetes Prevention a 

in the intervention 

intensive individual and motivational on effective 

and behavior modification-reduced their risk of 

diabetes by 58 percent. worked 

particularly well for 60 and older, reducing their risk 

by 71 percent. Follow-up studies show or of diabetes 

with intervention can for at least 10 years. 

To address the critical need to promote diabetes and 

prevention for Medicare beneficiaries, the "Medicare Diabetes 
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A National Drive to Find the Undiagnosed" was 

created in 2006. The Medicare Diabetes is a 

coalition of more than 20 national the 

American Diabetes Association, the Healthcare Leadership and 

Novo Nor-disk, and supported by Novo Nordisk as a Changing 

Diabetes(c) initiative, These have worked with 

patient and senior and 

to promote the benefits of and 

create local models and messages that can be 

across the It works, 

For example, data available from CMS shows that the utilization rate of 

the Medicare diabetes benefit has increased by 16.2% from 

2005 to 2008, In our of the 

rate increased by 50% from 2005 to 2008! And the Columbus rate 

was more than 60% than the statewide utilization rate, 

It may interest you all to know that the Committee can take action 

today to address the diabetes in H.R. 

introduced last year the 

Diana 

Lee and 

evaluate why the of the Medicare diabetes benefit 

has been so low and create a outreach program to 

reduce the number of seniors with and 

This has been scored at zero by and we 

urge the Committee to move it as soon as The other 

of H.R. 1402 are now law thanks to the of 

and Senator . the bill's <:rrop", " , 

by as soon as possible. 

we are concerned that the current drafts of the Healthy 

2020 (HP2020) - which the federal 

official stand on what needs to be achieved in diabetes 

over the next 10 years - do not include a recommendation to 

increase of at risk for diabetes. Diabetes stands out 

among major conditions in terms of its and 

climbing mortality rates- unlike many it lacks a Healthy 

2020 around it. Other important areas of 

public health, such as HIVjAIDS, some forms of cancer, and 

cholesterol, all have speCific screening or 

for Healthy 2020. 
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Given the size and of the diabetes epidemic among the U.S. 

population, we believe there is a need to increase the proportion of at 

risk adults screened for diabetes. The inclusion of a diabetes 

in the set of HP2020 Diabetes is 

crucial to such as critical to the health of the 

nation. We have formally commented and met with tile relevant HHS 

but at this paint, we have not received a positive response. We 

would welcome the to work in concert with IIke··minded 

Members on the Committee and the Diabetes Caucus to communicate 

the of a in HP2020. 

Prediabetes and the Promise of Prevention 

Individuals with have an increased risk of heart disease 

and stroke. with 2 diabetes 

within 10 years. As noted news is that lifestyle 

interventions individual counseling and towards 

effective exercise and behavior modification have been shown to 

reduce the risk of diabetes onset. 

the Preventing Diabetes in Medicare Act and introduced by 

Diana DeGette and Mike calls 

for medical nutrition (MNT) for these 

giving them the evidence"based tool they need to reduce the risk of 

diabetes onset. We urge to pass this important as 

soon as 

However, the opportunity exists for the Obama Administration to make 

this important change on its own accord, Medicare covers 

medical nutrition therapy (MNT) nutritional diagnostic, and 

counseling services from a dietitian or nutrition 

- for beneficiaries with diabetes or renal disease who are 

referred by a doctor. However, until the enactment of the Patient 

Protection and Affordable Care Act (ACA), the Centers for Medicare & 

Medicaid Services (CMS) lacked the authority to extend the MNT 

benefit to beneficiaries with prediabetes: those most at risk of 

developing diabetes. Without nutritional counseling to promote 
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in diet, beneficiaries with lack the most potent 

tool to reverse their condition and the onset and enormous 

costs associated with treatment of diabetes. 

Now, under current law, the Secretary would be authoriied to modify 

the current coverage of MNT services such that the benefit is covered 

for both beneficiaries with diabetes or rena! disease and beneficiaries 

with Novo Nordlsk encourages the (or to 

adopt this common sense to diabetes in Medicare. 

Diabetes and 

white 

White Americans living with 

over 10 of Hispanic/Latino and 16.5 

of American Indians and Alaska Natives live with diabetes. If 

the rate of diabetes in minority communities is not ,rn,nrr\"c,r\ 

to the Centers for Disease 1 in 2 minority children 

born after 2000 will diabetes in his or her lifetime. 

At Novo we believe that everyone should have appropriate 

diabetes prevention and treatment of race or 

there are barriers that prevent racial and ethnic 

groups from taking better contra! of their health. Ther'e must be 

better interventions that are culturally sensitive and population 

better cultural training for health care 

and more career pipelines that lead doctors to work in 

high minority-populated areas. 

before the Committee, H.R. the Eliminating 

in Diabetes Prevention, Access and Care Act (EDDPAC) 

introduced by Diabetes Caucus Co-Chairs DeGette 

and which must be a high priority if we are to 

improve the rate of diabetes in minority communities. More research 

is necessary to understand the environmental and 

that make the prevalence of diabetes higher in some 

racial and ethnic groups. More effective treatment and prevention 

are necessary to better curb the onset of diabetes and 

empower those most affected to be responsible for their diet and 
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EDDPAC calls various federal agencies to action. The National 

Institutes of Health, the Centers for OlseaseControl and Prevention, 

the Health Resources and Services Administration, and other federal 

health agencies would focus on researching the disparity in diabetes, 

stimulate culturally appropriate public dialogu'e on diabetes, and . 

initiate programs to increase participation from minority health care 

professionals. 

Without adequate funding and resources, diabetes and its 

complications will continue to ravage racial and ethnic minority 

communities. Data from diabetes prevention programs show that with 

the appropriate policy changes and long-term financial Investment, 

diabetes rates will improve and lives wifl be saved. Novo Nordlsk 

remains committed advocating for appropriate legislation and 

increased federal funding to eliminate the disparity in diabetes 

prevention, detection and treatment. 

The Promise of Implementing the Diabetes Prevention Program 

The National Diabetes Prevention Program (NDPP), a provision 

included in the recently-passed ACA, is targeted at adults at high risk 

for full onset of type 2 diabetes. Such adults are often overweight or 

obese, and therefore also at high risk for hypertension and high 

cholesterol. NDPP authorizes support for community efforts to 

establish, run, monitor, and evaluate affordable programs modeled 

upon the groundbreaking clinical trial, the Diabetes Prevention 

Program (DPP). The DPP intervention is an intensive overall !lfestyle 

intervention, which although designed to be specific for people with 

prediabetes, will also positively impact other conditions, disease 

states, and outcomes. This community-based lifestyle intervention: 

*Promotes weight loss; 

"'Encourages an increase in physical activity levels; 

*Facilitates healthier eating habits; 

*Improves the risk factors for cardiovascular disease; and 

"'Improves health-related quality of life. 

As indicated earlier, the original DPP study found that individuals 

diagnosed with prediabetes that lost a moderate amount of weight (5 

to 7 percent) and engaged in regular physical activity reduced their 

chances of developing type 2 diabetes by 58 percent. The Diabetes 

Prevention Program Outcomes Study (DPPOS), a 10-year follow-up of 

the DPP, shows that prevention or delay of diabetes and its 

complications persisted through the decade. 
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A report issued by HHS in November 2009, Preventing and 

Diabetes in America: Health Insurance Reform and Diabetes in 

highlighted as a problem that "diabetes prevention and early 

treatment are in the U.S. Solutions do exist that 

can be YMCA of the in conjunction with a . 

host of has transformed the of 

primary programs for diabetes at the community level 

translating the Diabetes Prevention Program through a communitybased program, first in and soon in 17 sites across the 

with the NIH, CDC and UnitedHealth Group. Novo 

Nordisk was the first United Health 

Group to this initiative and we are actively to put 

activities our in to these efforts. We urge 

the Committee to further examine these and other successful 

models that are on the ground, making a difference 

lives. 

that this committee does not have direct 

over funding, the Committee Members can make a 

difference in the need to fund the National Diabetes 

Prevention which falls under the of this 

committee. We urge committee or to 

million from the Public Health Fund to fund the NDPP and 

these 

State and local Resources falling Short 

It is important for to conSider the impact of 

diabetes on our states and and then act to provide 

the resources necessary to battle the scope of the epidemic. Research 

conelucted last year by the National Conference of State 

(NeSL) strongly that current resources are falling far short of 

what is required to credibly the 

and address its 

the NCSL published a report entitled "Diabetes Health 

State Laws & Programs." This review found the Centers for 

Disease Control and Prevention to be the primary source of support 

from the government for state and national activities associated with 

battling and preventing diabetes. The assessment found that of the 

approximately $60 million available to fight diabetes through the CDC 

during the last fiscal year, only $28.4 miflion in was available to 
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the states and territories to battle diabetes, control the disease and 

prevent it. This represents a 4.3% decrease in funds from the prior 

fiscal year. The balance of the CDC diabetes funding was used for 

surveillance or other activities. Further impacting resources available 

to states is a new funding formula that ultimately reduced diabetes 

funding avallable last year to 40 states and government entities 

including Tennessee[ Colorado, New Jersey, Utah, Illinois, 

Pennsylvania and Arkansas. Some states experienced a 14% 

reduction in funding or more. The NCSl publication also suggests that 

the mandated state match is often not met, further limitIng state 

commitment to diabetes public health activities. 

The funding provided by CDC to states represents essentially the 

entire universe of public health resources available nationwide to 

battle diabetes. Responding to the data provided by NCSl, state and 

local legislators from across the country are requesting that Congress 

provide adequate resources to battle diabetes. Since July 2009, NCSl, 

Native American interests, the National Black Caucus of State 

legislators and others have adopted resolutions calling for new 

resources dedicated speCifically to helping people diagnosed with 

diabetes and its complications. A question for the Committee to 

consider is how seriously America can battle diabetes, diagnose the 

disease and prevent it when public health programs in communities 

across the nation have less than $28 million available, Put another 

way, does Congress believe that America can control a diabetes 

epidemic that currently impacts about 24 million Americans and their 

families, is increasing in numbers 7 - 80/0 per year{ and costs nearly 

$13,000.00 per capita with a budget for state and local diabetes 

control activities that totals less than $28 million? 

We believe it is imperative for Congress to provide funding and 

resources necessary to control diabetes as well working to prevent the 

disease, commensurate with the reach and scope of the epidemic. 

Modernizing Congressional Budget Office Scoring 

Novo Nordisk believes that our country is on the cusp of a new era in 

preventionl but such advances for people with diabetes and other 

chronic diseases will be muted if we do not update our budget laws to 

incorporate rigorous, credible disease-progression analysis into our 

official cost estimates. Official budget estimating process conducted at 

OMS and CBO tends to be narrowly focused on provider and institution 

payments, and are tied to a narrow budget window of 10 years. This 

.limits the federal government's ability to consider more fully the long-
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from certain chronic disease interventions when 

the budgetary impact of proposed legislation, or 

waivers. Within health care, and specifically chronic disease treatment 

and prevention, the federal scoring process does not make use of 

disease-based modeling to inform of federal health 

We believe this approach does not serve or the 

nation well. 

The Conclusion: It's Time to Modernize the 1974 National 

Diabetes Research and Education Act 

There is a wide-swath of diabetes-related before the 

evidence that a is needed to 

address this crisis in America. 2 

has since 1974 when last addressed this issue in a 

way the passage of the National Diabetes 

Mellitus Research and Education Act (NDMREA). we are 

2 diabetes - which constitutes 90%-950/0 of all diabetes 

in the 24 million Americans who have the disease - with most of the 

same public health programs created in when there were only 4 

million diagnosed with diabetes. 
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Thirty-six years ago, Congress took bold, comprehensive action to 

make diabetes a national priority by passing the NDMREA. Congress' 

action resulted in a long-range plan with resource recommendations to 

combat diabetes. In 1974{ no one could have envisioned the scope of 

the diabetes crisis as it exists today. We owe it to the millions of 

families who are living with diabetes everyday, and the tens of 

thousands of people who are fighting this disease on the frontlines, to 

ensure that our government's research and publlc health efforts match 

the challenge at hand. As such, Novo Nordisk strongly urges the 

Committee to act to bring the nation's diabetes infrastructure into the 

Century this year by modernizing the National Diabetes Mellitus 

Research and Education Act. 

Thank you for the opportunity to comment on this important hearing. 

We look forward to working with you on this critical issue in the days 

and months ahead. If we can be of further aSSistance, please do not 

hesitate to contact me or Christopher Porter in our Washington office 

at 202-626-4524. 

Sincf;lrely, 

Michael Mawby 

Chief Government Affairs Officer 

Novo Nordisk 
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June 30, 2010 

The Honorable Diane DeGette 

Unite<! States House of Representatives 

Washington; DC 20515 

Dear Mrs. DeGette: 

American Dietetic 

Association 

1120Conn«dcut Avenue NW 

Suite 400 

WashlngtQn, D.C. 20036 

SOOI87Hl!l77 

WVlW.e:titright.org 

RE: Energy and Commeree Subcommittee Hearing on Diabetes, July 1, 20 I 0 

On behalf of the American Dietetic Association, the largest professional organization of fuod 

and nutrition pro.iessionals, I am writing to share ADA '8 concerns and issues regarding .the lack 

of covt.."fage for interventions aimed at reversing pre-diabetes. ADA's more than 71,000 

members, most of whom are register¢<! dietitians, fhankYQu for your ongoing support to secure 

covemge for medical nutrition therapy (lvINT) for pre-diabetes. 

For almost a decade, the Centers tor Medicare & Medicaid Services has covered Medicare, Part 

B MNT outpatient services by a registered dietitian for diabetes and for chronic kidney disease 

and renal transplantation. eMs has just issued proposed rules tor Affordable Care Aet Sec. 

4104, Removal of Barriers to Preventive ServiccB in Medicare. ADA is plcased that CMS has 

awarded a grade of "B" to MNT based on U.S. Preventive Services Task Force 

recommendations. For one, this means that coinsurance/deductibles have been waived fur 

Medicare benefil..'iaries to improve al.'Cess to MNT. 

ADAremains concem¢<! cautiously optimist.ic that CMS's decision in.the proposed rules to 

designate MNT as a USPSTF "B" service, translates to includes pre.diabetes. The optimism is 

based on USPSTF's recommendation in its 2.0()3 report titled "Behavioral Counseling in 

Primary Care to Promote a Healthy Diet," the basis fur MNT's "B" grade.l The 

recommendation is more expansive, stating that USPSTF"recommcnds intensive behavioral 

dietary counselingjor ... known risk foctors for ... (tiet-related chronic disease. " 

1 Tbe USPSTF rerommcud!:i intenSIve. bebavioral dietary -<'"nunseling: fj)f adult patients with hyp:edipidcmia and otber .k:1tnwu ritk 

fadors for tardiOvllscuttlr and dle-t~reJared chronie. disea~~~ Intensive eol.JUscUng can be dcliver.oo by primary -care ctinie-ians or by 

referral to other spedalistst such u.s nutritionists (II' dietiHuns. 

Rating~ B Rmrnmmdation. 

Rmimu#e:.l1u~ USPSTF fuund good evidence !hut meditun~ to high-intensity cOlloseUng int~rvCfltiuns can produce mediwn~to .. tm;gc changes. 

in aVCl'age daily intake of oore cpmpo.nmUl. of a healthy diet {inc[udmg lHlturcltcd fat., Ilher. fiuit, Dod vegetables) among adult patirots at 

in?l'UIse4 rl&k f(w dk-1.·relatoo chronic disease. Intensive rouDs:cling intl'n'Cl)tlon.., thm have httn ~Ilmined in controlled t.rials among at-risk 

adult patictUs h.ave combint.'d nutrition educalioo with behavioral dk'tmy coonse1ing provided by a nutritionist, dietiti.an, (If ~funy train&:1 

primaf}'-care clinician (.e.g .. physiCian. nunu..; or nurse practitioner). 

!\<cc;;s<'d Joo<28. 20 I 0: bllP:!I:lt.\l'YiJ!!lt\!,w%!micj.l!lluAA§tltdW!l!!L@1Jlm 
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ADA would greatly appreciate you agreeing to confirm that CMS will act on Congress' intent to 

~pat1.d and cover MNT to help Medicare beneficiaries manage diet-related risk factors for 

chronic disease sJ,lch as hypertension, pre-diabetes, obesity and. chronic conditions such as 

cardiovascular disease. diabetes, kidney disease and others. CMS needs to clarify in the 

Medicare final rule for CY 2011 that MNT and intensive behavioral counseling provided by 

RDs are covered for these conditions recommended by USPSTF. including pre-diabetes. 

ADA lIUpportS your effurts to cover appropriate interventions for pre-diabetes. Plea.'Ie feel free 

to contact me at rnhagpr@eatright.org or (202) 175-8217. 

Best regards, 

/;?'# 'tV 9(t?~ 

Mary H. Hager. PhD, RD,. FADA 

Director, Regulatory Affairs 

C: Heather F{)ster 
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July 1, 2010 

The Honorable Frank Pallone 

Chairman, Energy and Commerce 

Subcommittee on Health 

2125 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Diana DeGette 

Co-Chair, Congressional DiabeteS caucus 

2335 Rayburn House Office Building 

Washington, DC 20515 

The Honorable John Shimkus 

Ranking Member, Energy and Commerce 

Subcommittee on Health 

2322A Rayburn House Office Building 

Washington, DC 20515 

The Honorable Mike Castle 

Co-Chair, Congressional Diabetes Caucus 

1233 Longworth HOB 

Washington, DC 20515 

Dear Chairman Pallone, Ranking Member Shimkus, and Co-chairs DeGerte and Castle, 

Diabetes, as a chronic disease affecting nearly 24 milf!on Americans and often leading to 

multiple chronic conditions or co-morbidities, is a critical public health iliStie for the nation, 

Within the last 30 years, the percentage of Americans diagnosed with diabetes has more 

than doubled, On its current course, by 2034, the number of people with diabetes will 

nearly double again to 44.1 milHon. 

Enclosed are several documents from members of the Diabetes Action Alliance 

(OM} which have been sent to various agencies and officials in our efforts to gain 

funding for the National Diabetes Prevention Programs (NDPP), as well as to 

inelude an objective focused on diabete~screening in Healthy People 2020, We 

believe these two areas are critical in the efforts to help properly manage and prevent the 

diabetes epidemic and ultimately its related conditions, 

The DAA is made up of nine diverse organizations who have come together to speak in one 

strong voice with the vision of changing how the nation perceives and approaches the 

problem of diabetes. Our current members include the American A$sOclation of Clinical 

Endocrinologists, American AssOCiation of Diabetes Educators, American Clinical Laboratory 

Association, American Diabetes Association, American Optometric Association, Medicare 

Diabetes Screening Project, Noito Nordlsk Inc, The Endocrine SOCiety, and Vision 5ervice 

Plan. 

Already, diabetes is one of the most costly diseases In .America, Direct and indirect costs for 

diabetes and prediabetes were estimated at $218 billion In 2007, The good news Is that we 

have proven interventions, such as the NDPP, that lead to therapeutic weight loss and 

reduction in diabetes risk factors, What's more, we have shown that these eVidence-based 

interventions can be offered affordably, 

We appreciate the opportunity to provide these letters and comments to yoo, If we can 

work together to change diabetes, we will at last make a significant change to the health of 

our nation. 

Sincerely, 

Diabetes Action Alliance 
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The Honorable Kathleen Sebelius 

Secretary of Health and Human Services 

U.s, of Health and Human Services 

200 Avenue S.W. 

Washington, DC 20201 

lvtarch 23, 2010 

Dear Secretary Sebeltus: 

Thank you for your during American Diabetes Month in November 

2009 and on related efforts to bring attention to the needs of those with 

diabetes, As leading organizations in the diabetes community, we write to 

a meeting with you and your team so we can discuss the 

diabetes poses to the nation and ways the federal government can 

make an impact. 

Before taking office, President Obama highlighted the need to reorient our 

health care system "towards prevention and public health" in his Pian for a 

Heaflflier America. Health reform legislation just passed would 

allocate at least $15 billion over 10 years to prevention effortswhich represents an important step toward this reorientation. 

As you consider the implementation of Administration or Congressional funds 

for disease prevention and health promotion, we you to provide 

substantial resources toward diabetes, given magnitude and the 

seriousness of the disease in the US population, and its disproportionate impact 

on minority populations. 

Every day, diabetes continues to exact a significant human and financial toll, 

Some 4,400 Americans develop diabetes each In fact, almost every 

20 seconds someone is newly diagnosed with OIclDt:~[ec;. 

Nearly 24 million Americans already have diabetes and another 57 million 

have pre-diabetes and are at risk of developing the disease. 

Within the last 30 years, since 1980, the percentage of Americans 

diagnosed with diabetes has more than doubled, On its current course, 

by 2034, the number of people with diabetes will nearly double again to 

44.1 million. 

Already, diabetes is one of the most costly diseases in America, Factoring 

in the previously unidentified costs of diabetes, preand gestational diabetes, the total diabetes-related costs in the 

United States in 2007 amounted to $218 billion. 

One in every 10 health care dollars is on diabetes and its 

and one in every three dollars is spent on people 

with diabetes. 
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According to a recent study by Thorpe et al published in Health Affairs: 

"Much of the recent growth in spending among Medicare beneficiaries is 

attributable to rising spending on chronic conditions-specifically diabetes 

and hypertenSion, both of which rose considerably in treated prevalence 

over the past two decades." 

The potential availability of funds designated for disease prevention and 

wallhess offers.i:ln unprecedented opportunity to addreS!1 diabetes, one of our 

nation's most prevalent and costly chronic diseases. DIabetes is a chronic 

condition that presents a great opportunity for targeted interventions to: save 

llves and redUce incidence of co-morbidities; reduce health care costs-and 

increase economic productivity; support prevention and well ness across the 

lifespan-from children and adolescents to adults and seniors-Clnd reduce 

geographic, raCial, and ethnic disparit1es. 

We ask that you make diabetes a priority and commit $5 billion of the 

prevention and wellness funds over 10 years to diabetes prevention 

and management. 

ReversIng the trend of rapid growth of diabetes in America is certainly being 

held out as a key metric of success for health care reform. In fact, in your 

N\?vember 2009 report, Preventing and Treating Diabetes In America; Health 

Insurance Reform and Diabetes In America, you highlight as a problem that 

"diabetes prevention and early treatment are under-emphasized" in our health 

care system. In addition, President Obama, in speaking about the need for 

health care reform, has consistently pointed out diabetes as a chroniC disease 

that requires the nation's attention; First Lady Michelle Obama spoke of the 

specter of diabetes being the future for one third of our children unless we 

change course when introducing her childhood obesity initiative; and Surgeon 

Genera! Benjamin's Vlsfon for a Healthy and Fit Nation calls out the epidemic of 

diabetes. Moreover, a recently released report from the National BusIness 

Council on Health shows that. employers have identified diabetes as a priority 

area for prevention. According to the report, "Employers are increaSingly 

seeing that it is.a bottom line issue to prevent diabetes, Identify it early, and 

treat it 'to goal' in their employee population." 

Despite all the attention being showered on the many problems assoclated with 

diabetes, the means to address this crisis are simply not In evidence. Relative 

to the impact of diabetes in America, the federal commitrnentto diabetes falls 

woefully short of what is needed. The prevention and wellness funds offer a 

significant opportunity to right this wrong. 

Without a significant national investment in the prevention of diabetes and 

diabetes complications, Americans, especially those who are disproportionately 

impacted by the disease, particularly those in the Hispanic, African-American 

and Native American communities, will continue to needlessly develop blindness 

and kidney disease, <;lnd be at far greater risk for amputation and early 

mortality from heart attack and stroke. . 
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organizations in the diabetes community, we urge that diabetes 

and evidence-based clinical and 

community-based interventions to reduce rates of diabetes and improve 

diabetes care management-be considered a top priority when the prevention 

and wellness funds are aliocated, 

Fortunately, mLich is known abmJt how to prevent type 2 diabetes, and how to 

treat type 1 and type 2 diabetes to avoid costly Already, 

significant evidence exists that clinical interventions are 

a difference. 

Therefore, we recommend the 

wellne$$ funds can be used to address 

* programs based on the 

trial, the Diabetes Prevention Program 

that individuals diagnosed with pre-diabetes who 

engage in moderate lifestyle changes can reduce their chances of 

developing type 2 diabetes by 58 percent. Research has shown that 

these positive resuits can be replicated in a community setting for far 

less cost than the DPP, Senators Franken and 

Lugar introduced that wi!! support community efforts to 

establish, run, monitor and evaluate such affordable programs. This 

language, induded in the health reform legislation signed today by 

President Obama, will go a long way in preventing type 2 diabetes at the 

community level. 

Support other effecl:ive, 

interventions such as the Asheville project, REACH, Bridges to 

Excellence, Project Dulce, Peers for Progress, and the Stanford Chronic 

Disease Self- Management Program. 

* and expand efforts for early detecl:ion through greater 

utilization of current diagnostic testing methodologies and promotion of 

already existing Medicare benefits. 

" Support the proposed HP 2020 diabetes objectives that cal! for: 1) 

increasing the proportion of adults with diabetes whose condition has 

been and 2) improving glycemic control among the population 

with diagnosed diabetes. 

Support research, treatment programs, public education 

programs, and diabetes health and nr,pv .. ,.,ti ..... , 

programs for minority populations. 

We respectfully request a meeting with you this month to discuss how we can 

work to accomplish oLir mutua! goals. We look forward to working 
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with you to improve our nation's health, beginning with changing the way we 

approach diabetes prevention and treatment. 

Sincerely, 

American Academy of Physician Assistants 

American Association of Clinical Endocrinologists 

American Association of Diabetes Educators 

American Clinical Laboratory Association 

American Diabetes Association 

American Dietetic Association 

American (\1edical 10 

American Optometric Associatlon 

Center for Health Transformation 

Diabetes Hands Foundation 

diaTribe 

Medicare Diabetes Screening Project 

National Black Nurses Association 

National Minority Quality Forum 

Novo Nordisk Inc. 

Results for Life: lab Testing - Better Health, Improved Outcomes 

Tethys Bioscience 

The Endocrine Society 

Vision Service Plan (VSP) 

Xl Health 

CC:Ann Albright, Thomas Frieden, Dora Hughes, Kaya lewis 
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Dr. Howard Koh, MD, MPH 

Assistant Secretary of Health 

U.S. Department of Health and Human Services 

200 Independence Avenue, SW 

Washington, DC 20201 

May 4, 2010 

Dear Dr. Koh: 

We are writing to express our concern that the recently released Healthy 

People 2020 diabetes objectives, which represent the federal government's 

official stand on what needs to be achieved in diabetes over the next 10 

years, do not include an objective related to screening for diabetes. We have 

formally commented and met with the relevant HHS and look forward 

to our meeting With you to directly discuss the need to indudeti1is as a key 

objective rather than just a strategy. 

In December 2009 some 20 'Organizations and companies, including the 

American Diabetes Association, American Medical Association, National Black 

Nurses Association, National Council on Agingt Novo Nordisk,a~d the 

Partnership for Prevention submitted written comments to reCommend that 

the Healthy People 2020 Diabetes objectives include an objective related to 

screening for diabetes, specifically to: "Increase the proportion of adults who 

have been tested for diabetes." In fact, among all the comments on the 16 

diabetes objectives posted to the Healthy People 2020 webSite, 

approximately 500

/0 urge the Federal Interagency Workgroup to include 

screening language. 

More recently, we met with key staff at CDC and NIH to discuss this issue 

and they agreed that it is both appropriate and timely to include screening 

language within one of the Healthy Peo'ple 2020 diabetes objectives. In fact, 

they brought proposed language before the Federal Interagency Workgroup. 

Diabetes stands out among other major chronic conditions in terms of its 

growing prevalence-and predse!y because of the lack of a Healthy People 

2020 screening objective around it. Other important areas of public 

health, such as HIV/AIDS, some forms of cancer, and cholesterol, all have 

specific screening and testing objectives proposed .for Healthy People 

2020. Given the size and impact of the diabetes epidemic on the U.S. 

population, we believe there is a need to increase the proportion of adults 

screened for diabetes, and thus merits the lnclusion of diabetes screening as 

an HP2020 Diabetes Objective, and not as a strategy contained wlthin other 

objectives. 
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In 2010" diabetes screening was clearly acknowledged in the preamble to the 

diabetes section and ih the iOlO Midcourse Review as one of the "four 

transition points" that offers an "opportunrt(y) to reduce the health and 

economic burden of diabetes." But nO$teps were taken then or since to 

include diabetes screening within Healthy People objectives. 

OVer the two decades since the inception of Healthy People, diabetes has 

relentlessly contll'1ued to exact a significant human and financial toll 

nationwide. 

Nearly ~4 million Americans already have diabetes, a quart~r of 

whom do not know they have. the disease, and another 57 

mUlion have pre-diabetes and are at risk of developing the 

disease. 

Within the last 30 years, since 1980, the percentage of Americans 

diagnosed with diabetes has more thai') doubled. On its curre!lt 

course, by 2034, the number of p~p'e with diabetes win nearly 

double again to 44.1 million. 

" The rising prevalence of diabetes is contrlbutiog to increasing numbers 

of disabling conditio!')s such as blindness, limb amputations and kidney 

disease, as well as more premature deaths. 

Already, diabetes is one ofthe most costly diseases in America. 

Factoring in the previously unidentified costs of undiagnosed diabetes, 

p~·diabetes, and gestational diabetes, the total diabetes-related 

costs in the United States in 2007 amounted to $218 billion. 

One in every 10 health care dollars is spent on diabetes and its 

complicatlom.! and one in every three Medicare dollars is spent on 

people with diabetes. 

The Healthy People 2020 website dearly states that "Healthy P~ople 2020 

will reflect aS$essments of major risks to health and well ness ... " In 

addition, during the July 10, 2009 Healthy People 2020 Planning Meeting, Dr. 

Jonathan Fielding and others talked about making Healthy People 2020 the 

cornerstone o.f prevention. 

The statistics on diabetes are compeUlng-C)nd demonstrate that it certainly 

qualifies as a major risk for the American public and therefore demands a 

better preventive response from the public health and clinical care . 

communities, One particularly potent response would be to include a 

screening objective in Healthy People 2020. Doing so could help increase 

awareness around this critical component in addressing the overall problem 

and pave the way for appropriate action by the diabetes community in 

advocating for change. 

Clinical research has conclUSively shown that early diagnosis and intervention 

in type 2 diabetes can Significantly reduce the development of long-term 

complications and mortality rates. Moreover, conclusive landmark clinical 

trials-both the Diabetes Prevention Program and the Diabetes Prevention 
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Program Outcomes Study-have demonstrated that, among people with prediabetes, type 2 diabetes can be prevented or delayed in both the short term 

and the long run through lifestyle modification. We have an evidence base of 

programs to prevent, manage and reverse diabetes. Thus, there is a 

medical, if not a moral, imperative to identify people with undiagnosed 

diabetes aod pre-diabetes. 

Some of these proposed screening and testing objectives in Healthy People 

2020 are in accordance with recommendations set forth by USPSTF, while 

others are not. Nonetheless, it is our understanding that you are looking to a 

broader evidence base for objectives proposed for HealthY People 2020, 

including CDC's Guide to Community Preventive Services, studies funded by 

anel rE;ported on by the Robert Wood Johnson Foundation, Cochrane reviewsl 

practice-based evidence, and the like. 

Lack of baseline data on diabetes screening is not a stumbling block for a 

diabetes screening objective because a national data source already exists. 

Beginning with the 2005~2006 NHANES surv·ey, and continuing on the 2007· 

2008 survey and the questionnaire for 2009-2010, there is a diabetes 

screening/testing question. 

In light of the preponderance of support and evidence-and the critical need 

to proactively address the ever growing diabetes epidemic-we urge you, the 

Secretary's Advisory Committee and the Federal Interagency Workgroup, to 

include diagnostic testing for diabetes within the objectIves proposed for 

Healthy People 2020. Thank you for your time and attention. 

Sincerely, 

American Association of Clinical Endocrinologist 

American Association of Diabetes Educators 

American Clinical Laboratory Association 

American Diabetes Association 

AmericsourceBergen Corporation 

American Optometric Association 

diatribe/Close Concerns, Inc. 

Medicare Diabetes Screening Project 

Novo Nordisk, Inc 

Obesity Action Coalition 

Results for Life - Lab Testing: Better Health, Improved Outcomes 

The Endocrine Society 

VSP Vision Care 
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Jurie 10, 2010 

The Honorable Tom Harkin 

Cl:lairm;ln 

U.5 .. Senate Appropriations Committee 

Subcommittee on labor, HH5, and Education 

131 Dirksen Senate Office Building 

Washington, DC 20520 

The Honorable Thad Cochran 

Ranking Mem.ber 

u.s. Senate Appropriations Committee 

Subcommltte.e on Labor, HHS, and Education 

The Capitol, 5-206 

Washington, DC 20510 

Dear Ch~irman Harkin and Ranking Member Cochran: 

Before taking office, President Chama highlighted the need to reorient <\uthealth care system 

"towards prevention and public healtl:l" in his Plan for iii Healthier America. The recently enacted 

Pal;ient Protection and Affordable Care Act (hereafter referred to as the Affordable Care Act or 

ACA), which contains many provisions to Increase health promotion andt.li$ease prevention in the 

U.S., represents a dr;!lrnatlc shift in this direction. We are writing to respectfully urge you to 

provide $80 million from the Prevention and Public Health Fund in ACA t9. fund the 

Franken-Lugar AmElndment; $20 mUlion to initiate the provisions authorized through 

the Catalyst to Better Diabetes C,are Act in ACA; and $10 milli!>n f~~ titiS to develop and 

Implement a public action initiative around existing Medicare Diabetes Screening 

coverage. 

Given ttle magnitude of the diabetes epidemic, this funding must not supplant current:fundlng for 

essentli;ll diabetes programs and research. 

Any solution to America's current health challenges must include what public health professionals 

call "vpstream" Interventions, which eng(jge and enable local c.ommunitles to mak;e environmental 

changes that will allow and encourage more people to five healthier lives. The good news Is that 

we have proven Interventions that lead to therapeutic weight 1055 and reduction In diabetes risk 

factors.· What's more, we have shown thClt these evidence-based Interventions can be offered 

afi'Ordably, 

To this end, Senator AI Franken (D-MN) and Senator Richard Lugar (R-IN) co-authored the 

National Diabete$ Prevention Program (NDPP), a provision included In ALA, which is targeted at 

adults at high risk for fun onset of type 2 diabetes. Such adults are often overweight or obesl!!, 

and therefore also at high risk: for hypertenSion and high cholesterol. The legislative language ·for 

NOPP authorizes support for community efforts to establish, run, monitor, and evaluate affordable 

programs modeled upon the groundbreaklng clinical tria!, the Diabetes Prevention Program (DI'P). 

The DpP Intervention is an Intensive overall lifestyle Intervention, Which although designed to be 

specific for people with pre-diabetes, will also positively Impact other conditions, disease states, 

and outcomes. This community-based lifestyle Intervention: 

Promotes weight loss; 

• Encourages an increase In phySical activity levels; 

Facilitates healthier eating habits; 
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Improves the risk factors for cardiovascular disease; and 

Improves health-related quality of life, 

The original DPP study found that individuals diagnosed with pre-diabetes who lost a moderate 

amount of weight (5 to 7 percent) and engaged in regular physical activity reduced their chances 

of developing type 2 diabetes by 58 percent. The Diabetes Prevention Program Outcomes Study 

(DI>POS), a 10-year follow-up of the DPP, shows that prevention or delay of diabetes and its 

complications persisted through the decade, 

ReCent research has shOwn that these positive clinical trial results can. be replicated 

cost effectively in a community setting at an annual per~perso.n.c:ost of less than $300. 

In fact, Senator Harkin, you characterized these programs In a press release from your office, as 

such: " ... Programs like those offered through the YMCA help rein in chronic diseases like diabetes, 

which wlll mean less health spending down the roacl." 

Already, UnitedHealth Group has announced its intent to partner with YMCAs ill Cincinnati, 

Columbus and Dayton, Ohio; IndianapoliS, Indiana; St Paul, Minnesota and Phoenix, Arizona to 

reimburse particiPants in these DPP-like programs, In a recent editorial in the New EnglancJ 

Journal of Medicine, Assistant Secretary for Health, Dr, Howard Koh, comments that the rising 

prevalence of diabetes "means that even greater attention must be paid over the next decade to 

scaling up evidence-based diabetes prevention interventions In high-risk populations," 

1. As you craft the Fiscal Year 2011 Labor, Health and HUman. Sel;'Vlces, and Education 

(LHHS) Appropriations bill, we urge that YOIl provide $80 million from the Prevention 

and Public Health Fund to fund the Franken-Lugar Amendment and support these costeffective, community-based prevention Intervention$,. Supporting this proven lifestyle 

modification intervention will not only result in healthier fives for partiCipants, but is instrumental 

in lowering the staggering economic toll that diabetes currently takes on our country, estimated 

at $218 billion each year. 

2. We also urge that you include in the LHHS Appropriations bill a total of $20 million to 

ini~iate the provisions authorized through the Catalyst to Better Diabetes. Care Act, 

under section 10407 of the Affordable Care Act. The Catalyst Act, like DPP, has the 

potential to go a long way towards your goal of reining in chronic disease and its associated 

health care spending by raising awareness about the state of diabetes care in the U,S.; the 

impact of diabetes on morbidity and mortality; and the quality of medical education around the 

disease, We specifically request: 

$10 million to HHS to work with the states and appropriate agencies to educate 

providers on the proper reporting of information on death certificates, including 

oata on diabetes. 

$5 million to HHS to prepare a National Diabetes Report Card every two years with 

aggregate health outcomes related to diabetes and pre-diabetes. 

$5 million to the Institute of Medicine to conduct a study and report to Congress 

on the impact of diabetes on medical practice In the United States and whether 

there Is an appropriate amount of diabetes medical educatfon prior to licensure, board 

certification, and board re-certlflcatlon, 

3. In addition, we ask for $10 million for HHS to develop and Implement a public: action 

initiative around the Medicare Diabetes Screening coverage The Medicare Modernization 

Act (P.L 108-173) included a new diabetes screening benefit to help Identify the thousands of 
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seniors on Medicare with undiagnosed diabetes. However, according to the Centers for Medicare 

and Medicaid Services, in 2007 only 12.2 percent of Medicare beneficiaries took advantage of this 

diabetes screening benefit. Given the new annual well ness visit and personalized prevention plan 

services provided under ACA, it is Important to ensure beneficiaries know of arid utlli.e the 

Medicare Diabetes Screening coverage. Therefore, we urge you to provide funding to 

increase awareness and utilization of this important benefit. 

In addition, Senators Harkin and Cochran, we respectfully req",est a meeting with each 

of you sometime during the next month to discuss the epidemic of diabetes i.n the U.S, 

and the asks outlined in this letter. 

Thank you for yolir consideration of our requests. Changing the way we approach diabetes 

prevention and treatment in the U.S. is another significant step toward re-orlentlng our health 

care, system, arid thereby improving our nation's health. . 

Sincerely, 

American AssOciation of Clinical Endocrinologists 

American Association of Diabetes Educators 

American Diabetes Association 

American Dietetic Assoc:latlon 

American Optometric Association 

Healtbwavs 

Novo Nordisk, IIlC. 

Obesity Action Coalition 

The Endocrine Society 

Vision Servic.e Plan (VSP) 
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~HonOreb'e Diana DeGette 

2335~aYbum HouSe Office Building 

WashingWli. DC 20015 

Dear Congresswoman DeGetle. 

July 1. 2Q1Q 

GiVen YQUT !1mIafkable commitment to lackling the diabetes epidemic, I Wailt to bring to youratlenllo1i;an 

~1l!'g1ngpn:lblem plag\ill)g developing rot:ntrles alound {he WOrld. "MainutritlolHl100ulliled dlabele$ mel!i\us~iIl a 

deVaStating fotm· Qf diabetes affecting millions of people glQIlally, YE1! virtually unknown in the WestemmedlOl,ll 

literature. Chronically malnourished individuals present in adolescen~ or early adulthood with seVere dia~, 

often fullowifjg a stressfulHfe event. These pli\tients .Ulnd to have: very poor outcomes. High bIOlld.$Ugar levelsalid 

.co~ting vitamin delfcieMies make thllll! parlicularly suscefllible to compl~tions Of diabetes. Since soJllt!e is. 

krl()WOabeut this condition and its management, mallysuch patients are labeled as type 1 diabetes andare pr~bed insuIiO. Unfortuoately, when insulin Is \'ICIUafly availaQle In these settings, taking Insulin when fOOd Is 

scarce Causes:many of these impoverished patients to die from low blood sugar. 

It Is intriguing, in the twentY-firsl century, to encOuoter a coodition as prevalent and devastating as malnull:ition 

diablilEls, yet about which so much remains to beJearned. Building on Elnstein's strength .in complex metabolle 

reSearch .studies. the Global Qiabetes Initiative Is collllbomtlng with fesearchers at the worki-rerrowned Chrlstian 

Medlo<\l College (CMC) Wltore In South India to carefully chara$rize this. cqndition. SpecificallY. knowIng . whether lheSepalients have defects in insulin secretinn, insulin sen~\tlvity, andlor fat metaboi.ism GOUld P<>!m 

towsrdsthe use.of safer, cheaparoralllgents aIid nuJrillonalapproaches. The tremendous res!la('Ch 

l\I:IRhi~tiCelion of CMC Vellare together with its poor pliliEmt poj:lll!etloh provides a unique opportunity to carefullY 

research this condition. 

Additionally, CMC Vellore has deVeloped an outsterding dlabetes educalion program that has ",Iready tralned 

health care professionals at 120 hosplt"'ls arouod India in comprehensiVe diabetes managament. Thlsvery 

s1.!OOessfuf program ine!udes a textIJook .. a series of IIVOI1<books •. and videuconferene!ng In addltOO!o highly. , 

focused training sesSions. CM(; has apiJroached Einstein Ie) perform a carefui mqnitoring l30d evaluatiOn Of this 

program. AddltiOnall:>,. the Global Diabetes Initiative has numerous contacts with inslllutions in Nepal. 

Bangll;!desh, Afghanistan. Thailand. Jordan; Kenya, Ethiopia aIld Uganda, and is in the process of parlnerlng with 

CMC to adapt their program for diverse settings beyond India. 

It has been a plessure to communicate. WIth Heather Foster In. your office, and we would be delighted 10 provide 

yeo with any additional Information and materials thet might be helpful. 

Thank you for your strong leadership in the fight against diabetes. Your efforts and energy are truly appreciated. 

Sincerely. 

Meredith Hawkins, MD 

Professor of Medicine 

Director, Global Diabetes toiliative 
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National Indian 

Health Boord 

July 1,2010 

Dear Representative DeGette: 

We nnderstimd that today the Energy and Commerce ~ubcQmmitteeoll Health is holding a 

hearing fncused on diabetes and ihe~ss bemg ma~eintuming the tide of this publi~h<:alth 

~$_ ·We aj>plaud the Committee fQtlo\lllllin..g 911 this\ltiucal ,issue and yO\Jl' leadership in 

requesting thjs 1i:earing. You have bOOll a strong champiol1ibr people with diabetes, lllld weare 

grateful for your efforts. 

As yoU moW, American Indians.and AlaskaNati1les (AlAN) ~uff.;:r in .gre;\ter numbers.from 

ml\hetes than any other U.S raciwl;lnd etl\nic group_ Atn,ongAU\NS, diabetes is fo\Jl' to e~llt 

times more coonnOll, than ill thegClleud.pollulatiOll. And~aps mOSf alarming is the fact wat 

dill~teS prevalCllCC rateS oontinue to risejnAlAN yo1it1l. . 

But real pro~ssjs bein~made, inJarge ~rt due to the SpeCial Diabetes Program fur: Indians 

(SDFI). Snl'l funding has allowed Indian health p~ and trlbal.coonn¥nities.to d~~ 

vital resources and tools to .both preveltt and treaI dlnbetes. SDPI cnirenUy funds 450 programs 

in~5 &tates, allowing local tribes and.health programs tosetpriorities tilatmeet their lleeds. 

whllthet it is preventiofitiQtivities ottreatmCllt. . 

SDP! 1i:asmcreased diabetes treatmCllt.and prevention programs fur American.Indians~ Alaska 

l'Iati1les., andhas .Oeqome olWofthe mo$!: styateglcand (lomp~sive lii~tes lteatmen~ and 

. ntry. Keyheaith indicators ~ including blood sugare<mtrol, 

eholeste . . .. .. . function ~ haw improved'among American Indians and Alaska 

Nalivel! with diabetes ellllh year since thispiQgram wall created. 

Theseare lImAllg the suct>-esses thai demonstrate thllt thjsprogram isyiclding.reaI retll~S on the 

federal investment and shouldcoutinuetQreeeive broad O<mgressional $UP~rt. SDPI is a model 

ofwltat wec<'!ll ~compljsh when the Federal and Tribal gOvetmnentS WOlle, togeth~,.Renewing 

the prograni this year will CllSllre eontinllity in the programs so that in'\lal c~itie!;<llIn .' 

cootinue to.ooi!d upon the successes achieved. Congress hasreoognized ~ importanccoftrull 

and has acted lUlder asimilartimeliIW in the past We~atly appr:eeiate the. historical SllpPort 

Congress has provided fOf this program a1id look lbrwardto working with you to secure a umlti • 

. year fCllewal this year. 

Si~ly, 

Reno Franklin, Chairman 

NIHB 

Jeff~n Keel, President 

NeAl 

Dr. Patrick Rock,President 

NCUIH 
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HENRY A. WAXMA~, CAIJFORNIA 

CHAiRMAN 

ONE I1UNDRED ELEVENTH CONGRESS 

"OUlt ot ~epttJtntatil1el!i 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RA'iBtil<N HOUSE Or-flCE BUILDING 

WASHlNGTON, DC 20515-6115 

July 21, 2010 

Ann Albright, Ph.D., R.D. 

Director, Division of Diabetes Translation 

Centers for Disease Cm1\fol and Prevention 

1600 Clifton Rol'd NE, MS K·IO 

Atlanta, OA 30333 

Dear Dr. Albright: 

JOE BARTON, TEXAS 

RANKING MEMBER 

Thank you for appearing before !he Subcommittee on Health on July 1,2010, at !he 

hearing entitled "The Battle Against :Diabetes: Progress Made; Challenges Unmet" 

PUrsuant to the Committee's Rules, attached are ,vritten questions for lhe record directed 

to you lrom certain Members of the Committee. In preparing your answers, please address your 

response to lhe Member who submitted lhe questiolllt 

Please provide your responses by Augusl4, 2010, to Earley Green, Chief Clerk, via email to E@rley.Green'ii;1l1ail.housc.gov. Please contact Earley Green or Jennifer Bercnholz at 

(202) 225-2927 if you have any questions. 

Sincerely, 

Chairman 

~.~~ Attachment 
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CDC Responses to Questious for the Reeord 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Against Diabetes: Progress Made, Challenges Unmet 

The Honorable Henry A. Waxman 

1. As your testimony states, improved diabetes surveillance is one of the most important 

initiatives in which CDC is engaged. We need to continue to understand who is affected by 

diabetes, particularly as we've seen a sizeable increase in the rate of cases. It is also 

important for us to know which groups are most impacted by this disease. 

a. Please summarize for the record the process by which CDC goes about collecting 

data on diabetes. 

A key component of CDC's diabetes surveillance activities is the National Diabetes 

Surveillance System (NDSS) as well as dissemination of data from this system such as 

the National Diabetes Fact Sheet. The NDSS is a comprehensive assembly of diabetesrelated data from national and state-based surveys like the National Health and 

Examination Survey (NHANES) and the Behavioral Risk Factor Surveillance Survey 

(BRFSS) and other data systems. For example, NHANES findings over the past decade 

have been widely disseminated in research publications and the public media. Among its 

communications are reports on 1) the increase in the United States of a major risk factor 

for developing diabetes, that is obesity; 2) change in the percentage of people in the 

United States with diabetes; and 3) how well people with diabetes are controlling their 

condition. Other data collection mechanisms obtain data on the changing pattern of 

diabetes treatment (National Health Interview Survey); diabetes hospitalizations 

(National Hospital Discharge Survey); and diabetes deaths (National Vital Statistics 

System). CDC has maintained and adapted these systems to meet the expanding diabetes 

surveillance needs. It has done this in partnership with many Federal agencies, including 

within HHS the National Institutes of Health's (NIH) National Institute of Diabetes and 

Digestive and Kidney Diseases (NIDDK) which has provided ongoing support for 

NHANES and NHIS. This broad, complex, and dynamic system has proven successful at 

monitoring trends in the magnitude of diabetes and its complications, identifying diabetes 

health service research needs, developing and monitoring national health objectives, 

detecting changes in health care practices, facilitating program planning and educational 

materials, and allocating resources. Most recently, CDC also deVeloped a methodology 

to estimate levels of diabetes and obesity at the county level, providing policy makers and 

communities with new information to guide program planning, resource allocation and 

develop long term strategies. 

b. Can you explain why CDC has selected this surveillance strategy over other available 

methods? 

Because diabetes is a complex disease affecting nearly every organ system of the body, 

the scope of diabetes surveillance is broad. No single surveyor data system can provide 

CDC with all the important data needed. Specifically, NHANES can provide laboratory 

and examination measures of a national sample of people with diabetes. The BRFSS can 

provide telephone interview information from people at a state-level. CDC's priorities 

have been to collect data that provide the most comprehensive national and state-level 
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CDC Responses to Questions for the Record 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Agaillst Diabetes: Progress Made, Challenges Ullmet 

picture possible of major health outcomes of importance, modifiable risk factors, and the 

degree to which evidence-based interventions are delivered. There is, however, 

unfortunately a gap in our ability to characterize the levels of variation in care and risk 

factors around the country. For these reasons, an important priority is to improve the 

regional and local surveillance oflevels of risk factors and care, ideally with integration 

of electronic health records. 

2. You describe the work that your agency is doing with respect to the three forms of diabetes 

that were the subject of our hearing: type I, type 2, and gestational diabetes. 

a. Given that you have finite resources to devote to diabetes research, how do you strike 

a balance in addressing the research and other public health needs of each type of 

diabetes? 

CDC works diligently to strike a balance in addressing the pressing needs of all types of 

diabetes and has strategically chosen to distribute resources where we can achieve the 

greatest impact. Type 2 diabetes accounts for 90 to 95 percent of all diagnosed cases of 

diabetes. CDC provides funding and technical assistance to state grantees to enable them 

to implement local, regional and statewide, multi-level public health approaches to 

affordable, high-quality type 2 diabetes prevention and control care and services, with 

priority on reaching high-risk and disproportionately affected populations. 

CDC has made a significant investment in translating the science from the NTDDK-Ied 

Diabetes Prevention Program (DPP) into public health practice through cost-effectiveness 

research and community interventions aimed at exploring the efficacy of communitybased lifestyle modification programs. The National Diabetes Prevention Program 

(NDPP) is CDC's current effort and is the most ambitious of its decade-long commitment 

to translating the science of type 2 diabetes prevention. The program is built on results 

from NIDDK-supported research to translate the results of the DPP. The goal of the 

program is to systematically scale the adapted cost-effective model of the DPP research 

trial for high risk persons. Through a four-pronged approach that includes training, a 

recognition program, model sites, and health marketing, CDC is partnering with public 

and private industry leaders, aimed at collectively maximizing the opportunity for 

successful outcomes. 

Though type I diabetes accounts for 5 to 10 percent of all diagnosed cases of diabetes, 

CDC is able to dedicate significant resources to research that is identifYing cases of 

diabetes in those younger than 20 years of age through the Search for Diabetes in Youth 

Study (SEARCH). SEARCH, which is also supported by the Special Diabetes Program 

and the NTDDK, is the most comprehensive study of its kind and will yield valuable 

information: I) the number of children and youth younger than 20 years of age who have 

diabetes (prevalence) and the number who develop diabetes each year (incidence); 2) an 

understanding of how type I diabetes and type 2 diabetes differ, including how they 

differ by age, sex, and race/ethnicity; 3) better understanding of the risk for acute and 

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CDC Responses to Questions for the Record 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Against Diabetes: Progress Made, Challenges UllInet 

chronic complications of diabetes in children and youth; 4) data about the different types 

of care and medical treatment that these children and youth receive; and 5) insight into 

how diabetes affects the daily lives of children and youth in the United States. 

Gestational diabetes (GDM) presents a unique case for mother and child. Approximately 

5 to 10 percent of women with gestational diabetes are found to have diabetes, 

immediately after pregnancy, usually type 2 diabetes. CDC is working with other 

organizations to 1) establish a five-state collaboration to identiJY, catalogue, and validate 

routinely collected data about GDM; 2) identiJY gaps in quality of GDM prevalence data; 

3) develop recommendations for improving data quality; and 4) determine implications 

for care for those with GDM. 

b. How will investments in research, not specifically directed at diabetes or one of the 

specific types of diabetes, benefit each form of diabetes? 

Diabetes is a very complex disorder affecting nearly every organ system of the body. As 

a result, research examining vision health, kidney, cholesterol, smoking cessation, and 

other topics will contribute to prevention or delay of diabetes and its complications. As 

examples: 

• Research conducted on hypertension prevention and control is beneficial. Individuals 

with sustained high blood pressure, treated or untreated, are at high risk for type 2 

diabetes. A CDC supported report by the Institute of Medicine outlines the need for a 

population based approach to policy interventions to address hypertension in the 

United States. If manufacturers gradually reduced the amount of sodium in processed 

and prepared foods, public consumption of sodium could be reduced to safer levels 

with little or no behavior changes needed on the part of the individual consumer. 

• Research conducted by other CDC divisions and NIH on environmental issues, 

policies, health disparities, and health behaviors provides the basis for strategies and 

potential interventions for managing, preventing, and controlling diabetes and its 

complications. Often, people with type 2 diabetes are able to lower their blood 

glucose by losing weight and increasing physical activity. 

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CDC Responses to Questions for the Record 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Against Diabetes,' Progress Made, Challenges Unmet 

The Honorable Diana DeGette 

Medical Nutrition Therapy & Diabetes Self-Management Education 

1. Dr, Albright, you are here today in your capacity as Director of DDT, however, I understand 

that you have worked extensively with both the American Association of Diabetes Educators 

and the American Dietetic Association. I have also done significant work with both of these 

groups in my role as Co-Chair of the Congressional Diabetes Caucus. Could you please 

elaborate on the role you see for both diabetes self-management therapy (DSMT) and 

medical nutrition therapy (MNT) in the quest for addressing the unmet challenges in the 

battle against diabetes? 

Medical nutrition therapy (MNT) and diabetes self management education (DSME) are central to 

improving diabetes outcomes and should be supported in medical and community-based settings 

across the United States. DSME can be delivered by a variety of health professionals including 

Registered Dietitians (RDs), pharmacists, nurses and other health professionals. RDs playa vital 

role in the delivery ofMNT and are an integral part of the diabetes care team. Community 

health workers have also been shown to be effective in supporting and reinforcing DSME and 

MNT. 

CDC uses a variety of approaches to integrate both MNT and DSME into its programs for people 

with diabetes. For example, 

• CDC works with 59 state and territorial Diabetes Prevention and Control Programs 

(DPCPs) to support efforts to increase diabetes self management education programs 

across the country, to improve nutrition, to increase physical activity, to increase smoking 

cessation, and to increase wellness for people with or at risk for diabetes. 

• The National Diabetes Education Program (NDEP), which is co-led by CDC and NIH, 

consists of more than 200 public and private organizations concerned about diabetes. 

NDEP has developed several resources in multiple languages that include information 

about making healthy food choices and increasing physical activity for people with and at 

risk for diabetes. More information can be found on the website at: 

www.yourdiabetesinfo.org. 

CDC funds 17 American Indian! Alaska Native communities, tribal organizations, and tribal 

colleges to increase access to traditional local healthy foods and physical activities for diabetes 

prevention and health promotion. CDC also developed and distributes The Eagle Books, a series 

off our children's books for Native American children and those interested in healthy living. The 

books promote diabetes education and encourage a return to traditional ways, including physical 

activity and healthy eating. For more information on CDC's activities with tribal communities, 

visit: http://www.cdc.gov/diabetes/projects-wellness.htrn 

Providers 

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CDC Responses to Questions for the Record 

Health Subcommittee ofI-Iouse Committee on Energy and Commerce Hearing 

July J, 2010 

The Battle Against Diabetes: Progress Made, Challenges Unmet 

2. I am aware that there is a group called PPOD (pharmacists, podiatrists, optometrists, and 

dentists) within CDC that actively engage in educational efforts to the public and other 

providers to help prevent drug interaction, foot ulcers and amputations, and oral and vision 

complications. How effective has that group been in helping educate providers and the 

public about prevention of the complications of diabetes? 

Often allied health professionals, such as pharmacists, podiatrists, optometrists, and dentists, are 

the first providers to see people with diabetes. They are an essential part of the important team 

care approach to treating diabetes. A 2008 Healthstyles survey of 5399 American adults found 

that approximately 40 percent of those with pre-diabetes or diabetes used pharmacists as sources 

of information about diabetes and 64 percent of both groups said they trusted recommendations 

from their loeal phannacist. As co-sponsors of the National Diabetes Education Program 

(NDEP), CDC has and NIDDK have guided the PPOD work group in creating and promoting 

materials for PPOD professionals and their patients, such as: 

• Working Together to Manage Diabetes: a Guide for Pharmacy, Podiatry, Optometry, and 

Dental Professionals and its Diabetes Medication Supplement 

• 1 can control my diabetes by working with my health care team, a poster available in 

English and Spanish for people with diabetes 

• A checklist to help eoordinate care between PPOD and other health eare professionals so 

that people with diabetes receive all of the recommended standards of eare (currently 

being piloted tested for incorporation into an electronic medical record) 

NDEP and its PPOD partners have been actively promoting these materials to all of the specialty 

organizations and their constituents. The Working Together training guide was requested by 

over 9000 professionals, is in its second printing, and currently is being updated and reformatted 

for the web and new technologies to enable NDEP to reach more PPOD professionals. NDEP is 

conducting a limited evaluation to measure the use and impact ofPPOD resources with relevant 

audiences. 

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CDC Responses to Questions for the Record 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Against Diabetes: Progress Made, Challenges Unmet 

The Honorable Zack Space 

1. Too often, I hear horror stories from health care providers in my district who receive visits 

from patients suffering from diabetes they didn't even know they had. Please discuss some of 

the efforts the CDC and NIDDK have undertaken to improve early detection efforts across 

the country. 

Evidence from the Diabetes Prevention Program (DPP) a randomized controlled clinical trial, led 

by NIDDK and supported by CDC, indicated that weight loss of 5 to 7 percent while 

encouraging a healthy diet and increased physical activity can reduce risk for type 2 diabetes by 

as much as 58 percent in those who have pre-diabetes. CDC is further translating what is known 

from this study to the public by implementing the National Diabetes Prevention Program. 

Currently, CDC is working witb the YMCA USA and United Health Group to identify those at 

risk and refer them to programs in 17 communities throughout the United States. This program 

delivers the proven intervention in group settings and is built on results ofNIDDK-supported 

research in which scientists successfully utilized local YMCAs for delivering a lower-cost, 

group-based DPP lifestyle intervention. Elements of the program include: 

• Health Marketing to inform populations at highest risk for diabetes about risk factors 

for pre-diabetes and to raise awareness among both providers and high risk populations 

of referral to and availability of diabetes prevention programs. 

• National Recognition Program for community-based lifestyle programs to ensure that 

interventions to prevent diabetes in high risk persons are of high quality and evidencebased. This initiative includes development of a national registry of CDC-recognized 

diabetes prevention programs accessible to the general public, third party payers, and 

clinicians that documents and reports the perfonnance of community-based diabetes 

prevention programs. 

• National Training and Outreach Program to develop a workforce of competent 

Lifestyle Coaches that deliver lifestyle interventions to high risk persons served by CDCrecognized programs. 

• Model Sites to establish sustainable community-clinical partnerships for the delivery of 

structured lifestyle interventions to persons at high risk for developing type 2 diabetes. 

Another collaboration between CDC and NIDDK is the National Diabetes Education Program 

(NDEP). NDEP consists of more than 200 public and private organizations concerned about 

diabetes and the health status of their members. NDEP develops and disseminates educational 

information on the prevention and control of diabetes for various target audiences. NDEP has 

developed several resources in English and Spanish for people at risk for diabetes that includes a 

risk assessment to determine individual risk for type 2 diabetes. This tool is available on the 

NDEP website at http://www.ndep.nih.gov/resources/ResourceDetail.aspx?Resld=252 

2. My Congressional District falls directly into the heart of Appalachia. We face all of the same 

ehallenges of a rural area when it comes to access to care. Some recent figures I have seen 

indicate that Appalachia has a much higher prevalence of diabetes than other areas. For 

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CDC Responses to Questions for the Record 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Against Diabetes: Progress Made, Challenges Unmet 

obvious reasons, I find this extremely troubling. I worry that public health/education efforts 

in my Congressional District may be more difficult than in some urban and suburban areas. 

Have you seen any evidence that suggests your education efforts are more effective in urban 

rather than rural settings? 

Currently, CDC does not have any evidence that suggests education efforts are more effective in 

urban than in rural settings. CDC materials are tested and adapted for targeted audiences. 

For the past 10 years, CDC has supported the Appalachian Diabetes Control and Translation 

project to prevent and control diabetes through developing coalitions in poor, rural Appalachian 

counties. These community projects help people with type 2 diabetes control their disease and 

prevent the disease in people who may be at risk for developing type 2 diabetes. 

Additionally. the CDC and NIDDK eo-led National Diabetes Education Program has recently 

developed a number of educational resources that are ideal for addressing diabetes prevention 

and control in rural areas, such as Appalachia, and will be promoting and evaluating their use in 

the next year. These include: 

• Road to Health Toolkit 

Capacity Building for Diabetes Outreach Tool Kit 

Beginning in FY2011, CDC will fund six organizations to work with diverse communities in 

Appalachia and other rural areas such as the Mississippi Delta through the National Program to 

Eliminate Diabetes-Related Disparities in Vulnerable Populations. This program will address 

both rural and urban settings and will help CDC to understand more fully the types of approaches 

that work best in these different communities or vulnerable populations. 

3. Can you share with the Subcommittee what you think are the most pressing diabetes research 

needs that must be met if we are to build on past successes, improve prevention and 

treatment and ultimately close in on a cure? 

Type 2 diabetes is a disease that results from multiple factors rooted largely in our culture and 

lifestyle. Fortunately, the evidence for prevention of diabetes and its complications is now very 

strong. Better outcomes for diabetes require the collaboration of health related sectors and nonhealth related sectors to modifY our health systems and change the characteristics of our 

communities to promote prevention of type 2 diabetes and improve treatment for all forms of 

diabetes. 

Areas of public health research that are crucial to realize these changes include: 

1. Studies that prioritize modifiable risk factors, stimulate new interventions, and examine 

the causes of disparities in diabetes risk. Such studies would help clarifY the best ways to 

reduce the race/ethnic, income, sex, and age-related disparities that remain in diabetes 

prevention and control and improve our understanding of how mechanisms and risk 

factors for disease vary across the lifespan. 

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CDC Responses to Questions for the Record 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Against Diabetes: Progress Made, Challenges Ullmet 

2. Improved local and regional diabetes surveillance tools. Better surveillance systems feed 

programmatic efforts by helping to identifY and target the popUlations at risk, but they are 

also a crucial base for research efforts because they uncover the factors that have the 

largest proportional influence on the population as a whole. New surveillance tools 

should go beyond traditional health surveys and make use of electronic health records, 

registries, and community-Ievcl information where available. 

3. Research efforts that test population-targeted policy interventions to prevent and control 

of diabetes. Although there is clear evidence that intensive lifestyle interventions can 

prevent type 2 diabetes for high risk individuals, there is a need to study policies that 

support cost-effcctive diabetes prevention and control. The diabetes problem is now 

large enough that we need to have solid evidence around not only the biological 

processes that influence diabetes risk, but also the public policy approaches for delivering 

intervention. 

4. Public health research that improves measurement and our understanding of the best 

practices to promote healthy nutrition and physical activity lifestyles. We know that 

excess caloric consumption and insufficient physical activity can result in weight gain, 

which is a major risk factor for developing diabetes. We also know that unbalanced 

nutritional intake (e.g. consuming excess saturated fats) or a sedentary lifestyle may 

increase the risk of diabetes rclated complications such as heart attacks or strokes. We 

also know that nutrition and physical activity patterns can vary considerably by 

demographic characteristics (i.e. age, sex, race, etc) in the United States. Further 

research is needed to understand if healthy nutrition and physical activity lifestyles are 

being achieved in the various popUlation subgroups, to determine approaches that are 

successful in achieving improvements, and to identifY remaining barriers to healthy 

nutrition and physical activity. 

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CDC Responses to Questions for the Record 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Against Diabetes: Progress Made, Challenges Unmet 

The Honorable Bruce Braley 

1. Currently Medicare Part D plans are required to establish medication therapy management 

(MTM) programs. Plans are required to make MTM available to targeted beneficiaries 

those with multiple chronic conditions who take multiple prescription drugs, and whose drug 

spending is likely to reach a designated amount. Congress recently took steps to strengthen 

the MTM program by codifYing into statute changes that will help in standardizing benefits. 

Unfortunately, under current law, fewer than 13% of all Medicare beneficiaries have access 

to the MTM benefit due to the eligibility requirements. 

As you know, of the 24 million Americans with diabetes, approximately 20-25% of them are 

Medicare beneficiaries. Pharmacies are often the most accessible healthcare providers and 

pharmacists can playa critical role in helping patients to manage their diabetes. Are you 

familiar with MTM and what can Congress do to better utilize trusted healthcare 

professionals like pharmacists to combat diabetes? 

CDC is aware ofMTM and supports the important role of pharmacists in helping prevent the 

complications of diabetes. A 2008 Health~tyles survey of 5399 Ameriean adults found that 

approximately 40 percent of those with pre-diabetes or diabetes used pharmacists as sources of 

information about diabetes and 64 percent of both groups said they trusted recommendations 

from their local pharmacist. 

Since 1997, through its support of the NDEP's Pharmacy, Podiatry, Optometry, and Dental work 

group, CDC and NIDDK have been promoting the role of pharmacists in the prevention and 

control of diabetes. Selected activities include: 

• Developing and promoting guidance materials for pharmacists - Working Together to 

Manage Diabetes: a Guidefor Pharmacy, Podiatry, Optometry, and Dental 

Professionals and its Diabetes Medication Supplement (currently in its 2nd printing 

and being updated) and informational brochures targeting each profession about 

diabetes prevention 

• Creating and disseminating a poster (in English and Spanish) urging people with 

diabetes to "Team up with your pharmacist" and providing steps to do this 

• Collaborating with primary and specialty healthcare professionals to develop and 

promote a checklist for the entire diabetes health care team that includes a section for 

pharmacists to record vital infonnation about medications and ensures that other 

health care providers and patients are aware of the need to consult with pharmacists 

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CDC Responses to Questions for the Record 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Against Diabetes: Progress Made, Challenges Unmet 

The Honorable Michael C. Burgess 

1. What is being done to research the correlation between gestational diabetes and the mother or 

child developing type 2 diabetes? 

The association between gestational diabetes (GDM) in the mother and risk of developing type 2 

diabetes in the offspring is not well understood. Numerous studies have addressed the risk of 

overweight, obesity, and of diabetes in offspring of women with diabetes, but these studies have 

numerous methodological limitations, including lack of inclusion ofa control group, combining 

women with chronic diabetes and women with GDM, lack of control for relevant confounders, 

and small sample size. In the NIH-led Diabetes Prevention Program (DPP) trial, women with 

impaired glucose tolerance (lOT) and a history of GDM had a higher incidence rate of diabetes 

compared with women with IGT and no history ofGDM, and a 50 percent reduction in diabetes 

risk with lifestyle or metformin therapy. Women with GDM are at increased risk for type 2 

diabetes and should receive postpartum screening and appropriate prevention referral and followup. CDC is addressing these needs by: 

• Working to identify strategies to increase postpartum screening in collaboration with Los 

Angeles County and University of Southern California Women and Children's Hospital 

by conducting a randomized trial of an intervention using a promotora to educate Latina 

women with GDM about their risk of developing diabetes and to facilitate their return for 

postpartum testing vs. usual care. 

• Collaborating with Kaiser Permanente Northwest to evaluate the effects of systems-based 

changes (including reminder systems for clinicians and reminder calls to affected 

women) on postpartum diabetes testing rates. 

• Supporting the development and evaluation of a DPP-style intervention, modified for 

postpartum women, to help develop diabetes prevention guidelines for the Massachusetts 

Department of Public Health. Funds were awarded to Brigham and Women's Hospital to 

assess, through informant interviews and focus groups, interest in participating in a 

diabetes prevention study and the preferred format. 

• Collaborating with the National Association of Chronic Disease Directors' Women's 

Health Council to conduct a GDM validation project to: 1) establish a five-state 

collaboration to identify, catalogue, and validate routinely collected data about GDM; 2) 

identify gaps in quality ofGDM prevalence data; 3) develop recommendations for 

improving data quality; and 4) determine implications for care. 

• Translating what is known from the DPP and NIDDK-supported translational research 

utilizing YMCAs to deliver a cost effective program based on the DPP to the public by 

implementing the National Diabetes Prevention Program. Currently, CDC is working 

with the YMCA USA and UnitedHealth Group to identify those at risk, including women 

with a history ofGDM, and refer them to evidenced-based programs in 17 communities 

throughout the United States. 

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CDC Responses to Questions for the Record 

Health Subcommittee of House Committee on Energy and Commerce Hearing 

July 1,2010 

The Battle Against Diabetes: Progress Made, Challenges Unmet 

2. In June, it was recently announced that HHS will spend $250M to increase the number of 

healthcare providers and strengthen the training of the primary care workforce. What steps 

are being taken to ensure appropriate diabetes-related education for these new providers? 

CDC recognizes that healthcare providers are an essential and trusted source of information for 

people with diabetes and those at risk for diabetes. The National Diabetes Education Program 

(NDEP), a collaboration between CDC and NIH, provides a wide range of up-to-date 

information and resources available to primary care and other healthcare professionals through a 

website tailored to healthcare professionals (www.bctterdiabetescare.nih.gov).This site provides 

tools to help healtheare professionals improve diabetes prevention and care in the health care 

delivery system and is updated annually. 

NDEP aetively promotes these resources through exhibits at major medical meetings, 

newsletters, conferences, webinars, and organizational websites and works with partners from all 

of the major healthcare professional organizations to educate providers. 

CDC's funded state and territorial Diabetes Prevention and Control Programs will continue to 

work with academic medical centers to teach students, residents and faculty about the planned 

care model and diabetes as part of the American Association of Medical Colleges Academic 

Chronic Care Collaborative. Training programs in primary care require trainees to learn about 

systems change such as the planned care model, especially for people with chronic conditions 

like diabetes. 

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QUESTIONS SUBMITTED FOR THE RECORD 

HEARING ENTITLED, 

"THE BATTLE AGAINST DIABETES: PROGRESS MADE, CHALLENGES UNMET" 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON ENERGY AND COMMERCE 

UNITED STATES HOUSE OF REPRESENTATIVES 

JULy 1,2010 

Questions for Judith E. Fradkin. M.D. 

Director. Division of Diabetes. Endocrinology. and Metabolic Diseases 

National Institute of Diabetes and Digestive and Kidney Diseases 

National Institutes of Health 

Department of Health and Human Services 

The Honorable Henry A. Waxman 

1. In your testimony you state that diabetes has a strong genetic basis, which is modified by a 

person's environment. You describe The Environmental Determinants of Diabetes in the 

Young (TEDDY) study, which will identify environmental triggers of type 1 diabetes among 

at-risk children. 

a. What do we already know about how the environment increases one's risk of 

developing type 2 diabetes? 

FRADKIN: Diabetes has a genetic basis that is modified by environmental factors. For type 2 

diabetes, these environmental factors include diet, physical activity, and being overweight or 

obese. The intrauterine environment during pregnancy also plays an important role in future 

development of diabetes and obesity for the child. 

b. Are there ongoing trials that will yield more information on this topic? 

FRADKIN : Yes. For example, the NIDDK's landmark Diabetes Prevention Program, or DPP, 

clinical trial showed that type 2 diabetes could be prevented or delayed in people at high risk for 

the disease if they lost a modest amount of weight by making diet changes and engaging in 

moderate exercise. The ongoing DPP Outcomes Study continues to follow participants and has 

found that benefits persist for at least 10 years. For overweight or obese adults who already have 

type 2 diabetes, the NIDDK's ongoing LookAHEAD clinical trial is examining the health effects 

of a lifestyle intervention designed to achieve and maintain weight loss over the long term. The 

results can shed light on new management strategies for adults with type 2 diabetes. 

Very recently, researchers announced the results of the NIDDK-supported HEALTHY clinical 

trial, which focused on the school environment. Scientists tested the ability of a middle-school 

based intervention to lower risk factors for type 2 diabetes. The intervention was found to lower 

the obesity rate in students at highest risk for type 2 diabetes, but the intervention schools did not 

differ from comparison schools in the prevalence of overweight and obesity combined. These 

results are important for informing future school-based efforts to reduce overweight and obesity 
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in children. The NIH is also bolstering research on the intrauterine environment to further 

understand how it contributes to future development of type 2 diabetes and obesity. Research is 

also ongoing to combat obesity and its associated health consequences, including type 2 diabetes. 

2. You describe the work that your agency is doing with respect to the three forms of diabetes 

that were the subject of our hearing: type 1, type 2, and gestational diabetes. 

a. Given that you have finite resources to devote to diabetes research, how do you strike 

a balance in addressing the research and other public health needs of each type of 

diabetes? 

FRADKIN: The NIDDK considers many factors in addressing diabetes research and public 

health needs. For example, the NIDDK not only considers the nnmber of people suffering from 

a disease, but also the associated morbidity and premature mortality. Therefore, diseases that 

often strike in childhood, such as type I diabetes, may get particular emphasis because of the 

earlier potential onset of health complications, including those that may lead to premature 

mortality. Another consideration is the impact of the disease on future generations, so research 

on gestational diabetes is particularly important because of the health implications for both 

mother and child. Along with considering these types of factors, the NIDDK continually seeks 

external input from scientists, professional organizations, patient advocates, and the public to 

help inform strategic planning for diabetes research. The federal government's statutory 

Diabetes Mellitus Interagency Coordinating Committee, which is chaired by the NIDDK, also 

plays a key role in coordination and strategic planning. For example, the Committee is now 

finalizing a new Diabetes Research Strategic Plan, for publication later this year, that highlights 

numerous scientific opportunities that will help to guide the NIH, other federal agencies, and the 

scientific community on future directions for diabetes research. 

Because different forms of diabetes share common features, research findings are often relevant 

to more than one form of the disease. For example, research on beta cell biology can benefit 

people with all three forms of diabetes. Research to mitigate overweight and obesity can help to 

reduce risk for type 2 and gestational diabetes. Research on complications benefits people with 

type 1 and type 2 diabetes who share some of the same complications. Emerging research shows 

that factors in the immune system are not just important in type I diabetes, but are also involved 

in childhood type 2 diabetes and "hybrid" forms of diabetes that have characteristics of both type 

1 and type 2. Thus, research on the immune basis of diabetes broadly benefits children with 

diabetes. 

b. How will investments in research, not specifically directed at diabetes or one of the 

specific types of diabetes, benefit each form of diabetes? 

FRADKIN: Success has already been realized in the genetics field with the identification of 

numerous genes and gene regions associated with type I or type 2 diabetes. These discoveries 

were possible because of the Human Genome Project. We also expect that diabetes research will 

benefit from several ongoing broad initiatives. One example is research supported by the NIH 

Common Fund on the Human Microbiome Project, which is identifying and characterizing the 

microorganisms found in the body. Technologies stemming from that research could be used to 

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analyze samples being collected in the TEDDY study to uncover possible environmental triggers 

oftype 1 diabetes. Another example is the Common Fund program on epigenetics, which 

involves the study of changes in the regulation of gene activity and expression that are not 

dependent on gene sequences. Research on epigenetics may provide insights into how 

intrauterine environmental factors contribute to risk of obesity and type 2 diabetes in offspring of 

gestational diabetes pregnancies. A final example is the Common Fund program to establish a 

national resource for induced pluripotent stem cells. These cells have potential for being used as 

a source to make insulin-producing beta cells for treating people with type 1 diabetes or severe 

cases of type 2 diabetes. Therefore, many of the broad initiatives supported by NIH have 

enormous potential for benefiting people with different forms of diabetes. 

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The Honorable Gene Green 

1. We have heard about the recent activities of the NIDDK regarding research in diabetes 

prevention and treatments. With the need to put research into practice to enhance quality of 

life and decrease health care costs, can you elaborate on how NIDDK engages the health 

professions community to ensure that important research findings in the area of diabetes are 

translated to the physician practice so that patients receive the benefits of this important 

research? 

FRADKIN: The Nlli and the Centers for Disease Control and Prevention co-sponsor the 

National Diabetes Education Program (NDEP) in order to translate the 

latest science, spread the word that diabetes is serious, common, costly, yet controllable and, 

for type 2, preventable. Thus, the NDEP helps to maximize the benefits ofNlli investments in 

diabetes research. In addition to a copious array of culturally tailored publications for patients, 

translated into a NDEP features a series of important resources for health 

resources include: 

l'nllCIlJles for Diabetes Care, outlines patient-centered principles for people with 

• Diabetes Numbers at a Glance gives health care providers the clinical recommendations 

to diagnose and treat diabetes and pn~-dl:abletell: 

• The Support for Behavior Change resource Ullm;!~"'Ll'VJ5Glli~illlJ[hgQYc,§llim!lQj~!1ill10 

is a searchable database of research articles, programs to 

providers help their patients with the "how-to" make and sustain 

with diabetes and make lifestyle changes for people with pre-diabetes. 

• NDEP recently created the Transitions from Pediatric to Adult Care tool to help teens, 

their families and their health care team make the transition from pediatric to adult care: 

• Working Together to Manage Diabetes: A Guide for Pharmacists, Podiatrists, 

OptoIllletrists, and Dental Professionals 

resources in the diabetes care team. 

• And to help health care professionals help their patients take steps to prevent or delay 

2 diabetes, the GAMEPLAN toolkit is available at: 

Another valuable resource for primary care providers is the Better Diabetes Care website 

Ul1~;':~.l'V~~\!,mefJ5l.ffilfllli~:g.l!!illt!l1gQ:::D, which focuses on helping health care providers assess 

deliver care to their patients with diabetes. 

The NIDDK is also working to dramatically expand access to lifesaving diabetes research in a 

way that is cost-sustainable through its Translational Research for the Prevention and Control Of 

Diabetes and Obesity program. This initiative has funded exciting research to deliver proven 

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diabetes prevention methods cheaply and efficiently by community health workers and at 

YMCAs. 

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The Honorable Diana DeGette 

Technology 

1. I read about the exciting results released this week on the STAR-3 study which demonstrated 

improved blood glucose control with glucose sensors and insulin pump therapy. Can you 

describe the results from this trial and its potential significance for diabetes management? 

FRADKIN: Yes. The goal of this industry-supported study, the Sensor-Augmented Pump 

Therapy for AIC Reduction (STAR) 3 clinical trial, was to see ifnew diabetes management 

technologies could help people with type I diabetes who had inadequate glucose control improve 

their hemoglobin Al C levels. The trial compared strategies for intensive blood glucose control 

in two groups of adults and children. One group used an insulin pump paired with a continuous 

glucose monitor, enabling users to adjust insulin doses based on glucose sensor values. The 

other group used a standard regimen of multiple daily ~ections of insulin and monitoring by 

finger sticks-an approach that has been in use since the NIH-supported Diabetes Control and 

Complications Trial (DCCT) showed that it could help reduce or delay complications. The 

STAR 3 study found that sensor/pump technology resulted in much greater improvement in Al C 

than the standard injection regimen. Most significantly, more people achieved recommended 

Al C targets with sensor/pump technology than with injection therapy, with no increase in 

hypoglycemia. It was especially encouraging that children had many fewer hypoglycemia 

episodes with the sensor/pump strategy than were seen, for example, in the DCCT. However, 

although these results are promising, this approach still does not represent a panacea A number 

of people enrolled in this and similar trials have had difficulty with the new technologies and 

consider them a burden, sometimes dropping out of studies or not using the devices consistently 

during a study. NIDDK-supported research contributed to the development of the currently 

approved continuous glucose monitoring devices, and the Institute is now working on improving 

the technology so that futnre devices will be more accurate and less burdensome. 

Disparities in Minority Populations 

2. From your perspective, are there gaps in the ongoing NIH research in terms of the disparate 

effect of diabetes? What further research do we need to initiate in order to fully address the 

problem of diabetes in every community and how can we eliminate any gaps in the current 

research? 

FRADKIN: We are making great strides in our efforts to understand and address diabetes health 

disparities. For example, the Diabetes Prevention Program showed that interventions to prevent 

or delay type 2 diabetes were effective across a racially and ethnically diverse population of 

women and men, laying the groundwork for a multicultural health campaign that has reached out 

with important diabetes prevention messages for Americans from all communities. Similarly, 

the Look AHEAD clinical trial involves a diverse population in a study of the benefits of weight 

loss in people with type 2 diabetes, Onr efforts to prevent or treat type 2 diabetes in youth, such 

as the HEALTHY study and the TODAY trial, have focused on children and adolescents from 

racial and ethnic minorities that are the hardest hit by this disease. 

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On a more fundamental level, we are closing gaps in what we know about type 2 diabetes risk 

genes outside of people of Western European descent-for example, NIDDK has collaborated 

with the National Human Genome Research Institute to establish a Multiethnic Study of Type 2 

Diabetes Genes. NIDDK-supported research also led to a recent report that the results of 

hemoglobin Al C tests may differ based on race, such that African Americans in the study had 

higher Al C values, on average, than their white counterparts when they had the same blood 

glucose values-a disparity that was most apparent among people with the highest glucose 

levels. We are exploring this surprising finding further, as it could have important implications 

for the use of A 1 C tests in issues such as diagnosing diabetes, setting glucose control targets, and 

evaluating health disparities. Finally, while disparities in access to health care have been a 

significant barrier to appropriate diabetes care, there are also factors within care systems that 

may affect diabetes outcomes for different populations. Thus, we have been collaborating with 

the Centers for Disease Control and Prevention on a study called Translating Research into 

Action for Diabetes, or TRIAD, to examine quality of diabetes care in a very diverse population 

of people enrolled in managed care systems, to identify these factors and determine if there are 

practical steps that can be taken to improve treatment processes and outcomes. These are just a 

few examples of our many current efforts to address biologic and environmental factors 

contributing to diabetes health disparities so that we may see improved health for all Americans. 

Special Diabetes Program 

3. The multi-year funding stream for diabetes research is a unique feature of the Special 

Diabetes Program. What benefits, if any, does the multi-year funding stream provide to your 

ability to fund the most promising research in the field, and how important is this factor in 

the success of the program moving forward? 

FRADKIN: Multi-year funding benefits research supported by the Special Diabetes Program. 

For example, because type 1 diabetes is a chronic disease in which outcomes develop over a long 

time period, clinical trials studying this disease require many years to complete. In particular, 

trials to prevent type 1 diabetes require substantial timeframes and screening of tens of thousands 

of people. Thus, clinical trials to prevent and treat type 1 diabetes and its complications benefit 

from multi-year funding. Another example of the benefit of multi-year funding is research to 

identify environmental triggers of type 1 diabetes. Such studies require the coordinated efforts 

of research teams capable of identifying newborns at high genetic risk for type I diabetes and 

collecting clinical data and biosamples over many years. This type of coordinated effort is now 

being done by the Special Diabetes Program-funded TEDDY study, which has enrolled over 

8,000 newborns and is following them to age 15 to identify environmental triggers of type 1 

diabetes. 

Diet & Lifestyle Changes 

4. NIDDK's Diabetes Prevention Program is widely recognized as strong evidence that Type 2 

Diabetes can be prevented or delayed with a 7 percent reduction in body weight. Its followup trial, the DPP Outcomes Study data showed that even after a 10-year period the benefits 

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oflifestyle changes yielded long-term health benefits. What will it take to let Americans 

everywhere have the chance to benefit from these same interventions? 

FRADKIN: One way to reach as many of the 57 million Americans with pre-diabetes as possible 

is to develop lower cost adaptations of the Diabetes Prevention Program lifestyle intervention 

that maintain efficacy, and to make such efforts widely available, particularly in communities 

with high rates of diabetes. The NIH is pursuing this goal through its Translational Research for 

the Prevention and Control of Diabetes and Obesity program. This initiative has funded exciting 

research to deliver proven diabetes prevention methods efficiently and at relatively low cost. 

Studies funded through this program include research to use a group-based lifestyle intervention 

delivered by professional and lower cost lay health counselors in a community setting via 

innovative expansion of an existing diabetes education program. This pilot project achieved 

excellent results, and is being expanded to a larger trial. It could be scalable to thousands of 

community care centers certified by the American Diabetes Association nationally. Another 

exciting project is testing a similar group-based approach delivered at YMCAs. Based on the 

results of this NIH-supported research, the Centers for Disease Control and Prevention (CDC) is 

implementing the National Diabetes Prevention Program to deliver this evidenced-based 

intervention. The initial phase of this implementation includes a unique partnership with the 

UnitedHealth Group, a private insurance company, and the YMCA to deliver this intervention 

cost effectively. Additionally, CDC is in discussion with other health care payers and 

community based organizations who can deliver the intervention. 

The NIH also collaborates with the Centers for Disease Control and Prevention through the 

National Diabetes Education Program to disseminate the latest science, 

spread the word that diabetes is serious, common, and costly, yet controllable and, for type 2, 

preventable. The NDEP provides culturally tailored publications for patients, translated into a 

variety and features a series for health care professionals 

5. In 2003, the U.S. Preventative Services Task Force (USPTF) recommended intensive 

behavioral dietary counseling for adult patients with hyperlipidemia and other known risk 

factors for cardiovascular and diet-related chronic disease. Intensive counseling can be 

delivered by primary care clinicians or by referral to other specialists, such as nutritionists or 

dieticians USPTF awarded a B grade for these services. In the same document, USPTF 

concluded that such counseling is likely to improve health outcomes and that benefits 

outweighed potential harms. 

It is now 2010. Is there sufficient data to recommend similar intensive counseling for 

children? Ifnot, when can we expect to have such information? 

FRADKIN: People with diabetes manage their disease every day. This is a burden and 

challenge for even the most vigilant, and especially for children. Patient education plays an 

important role in effective disease management. For example, data from the NIDDK's Diabetes 

Control and Complications Trial (DCCT) showed that the intensive therapy intervention, which 

included intensive education and counseling, benefited the adolescent type 1 diabetes 

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participants. Data are expected in 2012 from the NIDDK's TODAY clinical trial on the 

importance of intensive counseling for lifestyle change in children with type 2 diabetes. 

A need for tools to help patients manage their diabetes and achieve and sustain intensive blood 

glucose control associated with reduced rates of complications led to the development of new 

technologies such as continuous glucose monitors and insulin pumps. Enabling patients and 

providers to make optimal use of these technologies and the vast amounts of infonnation these 

tools provide, requires additional knowledge, skill, training, and motivation. Until these 

technologies are automated, people, especially children, will need significant counseling to use 

the devices and benefit from their promise. To optimize the potential impact of these 

technologies, the NIH is supporting research on behavioral aspects that may enhance or constrain 

the sustained use of these technologies toward the goal of fully automating the system and 

relieving the burden associated with their use. Results from this research could lead to improVed 

understanding of how to help people, including children, better manage their diabetes. To 

educate youth with diabetes in disease management, the National Diabetes Education Program 

(NDEP), jointly led by the NIDDK and Centers for Disease Control and Prevention, has 

developed materials specifically for children and teenagers to help them take appropriate actions 

to manage their disease for a long and healthy life. The NDEP also recently developed a Web 

site resource with materials to help teens transition from pediatric to adult health care and 

assume responsibility for and management of their own health and health care needs. 

Stem Cell Research 

6. As you know, I have been a proponent of embryonic stem cell research, which has the 

potential to unlock a cure or treatment for diabetes. Can you speak to any research the 

NIDDK is doing with stem cells? Do you know whether there is a need for diabetes-specific 

stem cell lines before research to this effect can proceed? 

FRADKIN: The NIDDK is supporting research on stem cells through the Beta Cell Biology 

Consortium (BCBC), which just began its third award cycle. BCBC investigators work 

collaboratively toward the goal of developing cell-based therapies for type 1 diabetes, including 

research on stem cells. For example, these researchers are working to generate the insulinproducing beta cells lost in type I diabetes directly from stem or progenitor cells, so that they can 

be transplanted into people with type 1 diabetes. They are also conducting research to identify 

stem cells within humans that are capable of becoming beta cells, as it may be possible to 

stimulate these cells to regenerate beta cells. BCBC scientists are also exploring ways to 

increase the numbers of beta cells in people with diabetes by reprogramming other adult cells to 

become beta cells. 

As it is not yet known which types of stem cells will lead to an effective cell-based therapy, 

research on all types of stem cells, including induced pluripotent stem cells and approved 

embryonic stem cells, is being pursued. It is critically important that research to produce beta 

cells for cell-based therapies is coupled with research on ways to control immune system 

responses. As type 1 diabetes results from an inappropriate attack by the immune system on a 

person's beta cells, it will be necessary to ensure that a similar attack does not destroy any newly 

generated beta cells. 

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The Honorable Zack Space 

1. Too often, I hear horror stories from health care providers in my district who receive 

visits from patients suffering from diabetes they weren't aware they had. Has the 

NIDDK done any research into the benefits of early detection? Or, conversely, has the 

NIDDK done any research into the cost of treating patients who failed to detect their 

diabetes early on? 

FRADKIN: N1DDK -supported research has provided us with the tools to delay or prevent type 

2 diabetes in people at risk, and to prevent or delay complications of all diabetes. Because 

diabetes is a progressive disease, earlier intervention can lead to better health outcomes. It may 

also help in terms of health care costs. Just this month, NIDDK-supported investigators 

published an analysis suggesting that screening for diabetes and pre-diabetes, combined with 

preventive management, could be cost-effective for the health care system. NIDDK has 

supported a number of efforts to facilitate diabetes detection. For example, NIDDK-supported 

research led to the use and standardization of the hemoglobin Al C marker that is used to monitor 

diabetes control. The American Diabetes Association has now recommended using the Al C test 

as a diagnostic test for diabetes and pre-diabetes in many individuals. This eliminates a barrier 

to detection due to the inconvenience of tests requiring fasting. We are also pursuing new 

biomarkers for detecting pre-diabetes, diabetes, and complications. For example, an NIDDKsupported team recently reported promising results of a pilot study that could lead to a simple 

blood enzyme test to detect pre-diabetes. However, even when it is caught early, there are still 

questions about the best way to treat and manage diabetes. Along those lines, we are currently 

planning an initiative to determine whether there are long-term benefits to early aggressive 

treatment of type 2 diabetes, which could potentially encourage efforts in early detection. 

For type 1 diabetes, relatives of type 1 diabetes patients are participating in research studies and 

can be identified early in the course of the disease when autoimmunity first develops. Through 

the Special Diabetes Program, tens of thousands of family members are being screened and their 

risk assessed. People who know they are at high risk for type 1 diabetes are less likely to present 

with life threatening ketoacidosis at disease onset. 

2. Would you agree that early detection of diabetes can be an important way to mitigate the 

suffering of the patient and minimize costs to the system? 

FRADKIN: Many health complications of diabetes start developing well before diabetes is 

diagnosed or detected, so the earlier we can detect either diabetes risk factors or its onset, the 

better chance people have to preserve their health and possibly lower health care costs. 

3. I have been working with a number of my colleagues to advance legislation that would 

improve utilization of screening benefits under Medicare and Medicaid. Would you 

agree that mechanisms that would encourage seniors to be screened early for diabetes 

would have a positive effect on their health? 

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FRADKIN; Older Americans are at high risk for diabetes, and nearly a quarter of people 60 and 

over have the disease, so screening is very important for people over 60. Older individuals are 

also at high risk for pre-diabetes and older participants had the best results with lifestyle change 

to prevent or delay type 2 diabetes in the Diabetes Prevention Program clinical trial. Because the 

same test that finds type 2 diabetes also finds pre-diabetes, testing can help identifY people who 

can benefit from prevention efforts. Diabetes presents a number of challenges to seniors, who 

often have other medical conditions that require medication or that could interfere with diabetes 

care. Thus, the NIDDK-CDC National Diabetes Education Program has developed efforts 

tailored to seniors, encouraging them to be aware of their diabetes risk and providing infonnation 

on the Medicare benefits related to diabetes. 

4. Can you talk about some of the efforts the NIDDK has undertaken to improve early 

detection efforts across the country? 

FRADKIN: Our most important efforts in this area come from the National Diabetes Education 

Program. The NDEP has developed a number of tailored publications for multiple audiences. 

The NDEP'g "Am I At Risk?" pUblieation gets at the heart of improving our ability to find 

people with diabetes and pre-diabetes, by encouraging people to consider their possible risk 

factors and get tested. Currently, the NDEP is also partnering with the NIH Office of Research 

on Women's Health on a new campaign to increase awareness of diabetes risk among women 

with a history of gestational diabetes and their children, who are at greater risk for diabetes and 

obesity in the future. 

5. As you may know, my District falls directly into the heart of Appalachia. We face all 

of the same challenges of a rural area when it comes to access to care. Some recent 

figures I have seen indicate that Appalachia has a much higher prevalence of diabetes 

than other areas. For obvious reasons, I find this extremely troubling. Can you talk 

about any efforts the NIDDK has undertaken to investigate geographic disparities in the 

prevalence of diabetes? Were significant conclusions drawn about this divide between 

rural areas and the rest of the country? 

FRADKIN: The Centers for Disease Control and Prevention (CDC) monitors trends of diabetes 

and its complications over time on a nationwide, state-wide, and county-wide level. CDC maps 

showing the number of adults with diagnosed diabetes overlap significantly with maps showing 

the number of obese adults, reaffirming the close association between obesity and type 2 

diabetes. The maps indicate that diabetes and obesity tend to be more prevalent in rural and poor 

areas. The NIDDK supports research to identifY ways to translate the results of our diabetes 

clinical trials to reach communities at risk, including rural populations. For example, researchers 

are studying telemedicine approaches to reach rural populations. 

6. I worry that public health/education efforts in my Congressional District may be more 

difficult than in some urban and suburban areas. Have you seen any evidence that 

suggests your education efforts are more effective in urban rather than rural areas? 

FRADKIN: It is more challenging to reach people who live in rural areas, so the NIH is 

specifically supporting research that can benefit rural populations. For example, the National 

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Eye Institute, with support from the Special Diabetes Program, is supporting studies to develop 

new tools and technologies that can be used to increase patient access to eye exams for detecting 

diabetic retinopathy, a complication of diabetes that can lead to blindness. A major goal of the 

research is to identify ways to reach rural populations who do not have easy access to eye 

specialists. For example, researchers are developIng cameras that can be used by non-eye 

specialists, such as primary care physicians, to take retinal images that can be sent to a remote 

processing site for interpretation and diagnosis by retinal specialists. This research could help to 

improve detection of diabetic retinopathy because patients would not necessarily have to make a 

trip to an eye specialist for an exam. 

The NIDDK also supports translational research on the prevention and control of diabetes and 

obesity, including research on telemedicine approaches to reach rural communities at particularly 

high risk of developing type i diabetes. NIH-supported research is also focused on developing 

computer-assisted programs to promote weight loss and improve management of diabetes, which 

could be utilized by people living in rural areas. The NIDDK and the Centers for Disease 

Control and Prevention also make educational materials developed by the National Diabetes 

Education Program available on the Internet, to reach as broad an audience as possible. 

7. Can you share with the Subcommittee what you think are the most pressing diabetes 

research needs that must be met if we are to build on past successes, improve 

prevention and treatment and ultimately close in on a cure? 

FRADKIN: There are many exciting scientific opportunities in diabetes research, the results of 

which could greatly improve prevention, treatment, quality-of-Iife, and potentially lead to a cure. 

These opportunities have been outlined in a new Strategic Plan to guide diabetes research that is 

being developed under the auspices of the Diabetes Mellitus Interagency Coordinating 

Committee and with leadership from NIDDK. For example, the beta cell-the cell in the 

pancreas that produces insulin-is central to all forms of diabetes. Therefore, research toward 

replenishing, replacing, or regrowing beta cells can benefit people with type 1, type 2, or 

gestational diabetes. The NIH vigorously supports research on the beta cell to enhance 

understanding of disease and help inform new cell-based therapies. The NIH also supports 

research to develop an "artificial pancreas"-a mechanical system that will couple glucose 

monitoring with insulin delivery. We know that control of glucose soon after diabetes diagnosis 

can prevent complications, but many people cannot achieve it. An artificial pancreas could have 

a tremendously positive impact on patie!lts' health and quality oflife, and alleviate an enormous 

amount of the burden of diabetes care. We now have many drug classes available to treat type 2 

diabetes, but comparative effectiveness research would help to personalize medicine so providers 

know which medication will work best in particular patients and stages of disease. 

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The Honorable Bruce Braley 

1. Currently Medicare Part D plans are required to establish medication therapy management 

(MTM) programs. Plans are required to make MTM available to targeted beneficiaries -

those with multiple chronic conditions who take multiple prescription drugs, and whose drug 

spending is likely to reach a designated amount. Congress recently took steps to strengthen 

the MTM program by codifying into statute changes that will help in standardizing benefits. 

Unfortunately, under current law, fewer than 13% of all Medicare beneficiaries have access 

to the MTM benefit due to the eligibility requirements. 

As you know, of the 24 million Americans with diabetes, approximately 20-25% of them are 

Medicare beneficiaries. Pharmacies are often the most accessible healthcare providers and 

pharmacists can playa critical role in helping patients to manage their diabetes. Are you 

familiar with MTM and what can Congress do to better utilize trusted healthcare 

professionals like pharmacists to combat diabetes? 

FRADKIN : You have identified a very important problem. Many people with diabetes have 

high blood pressure, high cholesterol, and other health problems requiring multiple medications. 

Team care involving multiple health professionals has proven enormously valuable in helping 

people with diabetes manage their disease and adhere to complex medical therapies. Pharmacists 

and other health care professionals can play critical roles in helping diabetes patients achieve 

treatment goals, including through MTM partnerships. Indeed, the Asheville Project, a study 

funded and run by the city of Asheville, NC, showed that the pharmacist can make a tremendous 

difference in outcomes for people with diabetes. In this study, participants were paired with 

pharmacists, who met with them to discuss goals, and monitor progress. Over 14 months, 

participants experienced significant improvement in important measures of their health, 

including lower hemoglobin Al C levels, and improvements in their blood cholesterol levels. 

Building on this small study, NIDDK is supporting a larger trial assessing a clinical pharmacistbased intervention to improve diabetes risk factor control among hypertensive diabetes patients 

with poor control of blood pressure in two integrated delivery health systems: Kaiser Permanente 

and the Veterans Health Administration. This study is a component of our Translational 

Research for the Prevention and Control of Diabetes and Obesity program which tests cost 

effective approaches to diabetes improved care that can be widely disseminated. 

Pharmacists play an important role in the NIDDK-CDC National Diabetes Education Program. 

The NDEP has developed an important resource called Working Together to Manage Diabetes: 

A Guide for Pharmacists, Podiatrists, Optometrists, and Dental Professionals 

(llill&"~~YjY:Ilq.ClJ.nih. gOY· publications' PuhlicatismJ)etail.<L'lpx?Publd=;2.JU, which provides 

resources for key professionals, including pharmacists, in the diabetes care team. 

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The Honorable Michael C. Burgess 

1. The CDC indicates that there are nearly 24 million Americans diagnosed with diabetes and as 

many as 57 million Americans with pre-diabetes. I know there are not nearly enough 

endocrinologists or other physicians who have received specialized training in diabetes to 

care for all of these patients. What is the federal government doing to ensure that primary 

care physicians and other professionals who may not have specialized training in diabetes 

have the resources and tools to provide quality care to diabetes patients? 

FRADKIN: The NIH and the Centers for Disease Control and Prevention co-sponsor the 

National Diabetes Education Program (l1ttp;/!nQ~lLIlliL!L<lyD in order to provide information and 

tools to primary care physicians and other health care providers to help them translate best 

practices for diabetes care and prevention of type 2 diabetes into their practices. Not only does 

the NDEP provide information on how best to treat and prevent diabetes, it also provides a 

valuable resource to help primary care providers assess and evaluate the diabetes care they 

deliver through the Better Diabetes Care website (http:'''ny~v.Q~!1".n1j!1betescare._nih.gov). 

The NIH is also testing approaches to improve the quality of care by identifying aspects of health 

care that lead to better outcomes and improved risk factor control, and using that information to 

test strategies to improve health care delivery for the millions of people with or at risk for 

diabetes through its Translational Research for the Prevention and Control of Diabetes and 

Obesity program. Some studies look at how electronic health records can be used to guide 

treatment decisions and ensure that proven therapies are delivered. Other studies examine 

approaches to supplement the care that can be delivered by physicians through use of diabetes 

educators, pharmacists, or community health workers. Many physicians do not have the time or 

tools needed to help patients make lifestyle changes that can prevent or delay type 2 diabetes. 

Their patients might benefit from referral to programs that can deliver effective lifestyle change 

cost effectively in a community setting. Successful pilot studies funded through this program 

include research to use a group-based lifestyle intervention delivered by professional and lay 

health counselors in a community setting and research testing a similar group-based approach 

delivered in YMCAs. Already based on these exciting pilot results, the CDC and private 

insurers are moving to expand access to the YMCA program. 

2. Healthy lifestyle intervention, according to the findings in the clinical trials, appears to one of 

the most successful methods of controlling diabetes. With a disproportionate impact on 

minority populations - many Medicare eligible how do you propose encouraging these 

populations to change their eating habits/exercise habits, which may require the spending of 

additional money, when their resources are already strained? 

FRADKIN: The NIH and NIDDK are committed to research aimed at helping to eliminate health 

disparities such as those associated with type 2 diabetes. The Diabetes Prevention Program, 

Look AHEAD, HEALTHY, and other major type 2 diabetes prevention and control trials at the 

NIH have recruited a large proportion of disproportionately affected minority participants, to 

help ensure that the results of those trials will be of broadly applicable. Moreover, these studies 

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developed culturally sensitive and validated programs to foster lifestyle change that are now 

being disseminated by government and private sector efforts. 

The Translational Research for the Prevention and Control of Diabetes and Obesity program is 

an important approach to help make the lifesaving discoveries of that research program 

accessible and affordable to as many of those in need as possible. This initiative has funded 

exciting research to deliver proven diabetes prevention methods efficiently and at relatively low 

cost. For example, studies from this program have shown that the lifestyle intervention that was 

successful in the DPP can be delivered in group settings by fituess trainers or community health 

workers at much lower cost without loss of efficacy. In addition, a new program recently 

announced by the NIDDK is a funding opportunity for NIDDK Centers for Diabetes Translation 

Research. The program will emphasize bedside to practice and community translation and will 

be a nexus for research in such areas as effectiveness, dissemination, implementation, and cost 

effectiveness research, health disparities, health literacy and numeracy, diabetes self 

management, lifestyle change, and health communication. 

3. As an Ob/GYN for over 25 years, GDM (Gestational Diabetes Mellitus) is an important issue 

to me. You mentioned that a recent panel of experts has recommended changing the 

diagnostic criteria for GDM to be less stringent. By lowering the criteria, could this have 

adverse effects of doctors misdiagnosing GDM and inadvertently over treating women? 

FRADKIN: I appreciate your concerns. These recommendations are based on the results of the 

Hyperglycemia and Adverse Pregnancy Outcomes, or HAPO, study, supported by the Eunice 

Kennedy Shriver National Institute of Child Health and Human Development and NIDDK. By 

examining blood glucose levels and pregnancy outcomes in over 23,000 women around the 

world, the HAPO study demonstrated that there is a continuum of risk according to glycemia at 

levels below those currently used to diagnose gestational diabetes. In the study, the higher a 

pregnant woman's blood glucose levels following an oral glucose tolerance test, the more likely 

she was to deliver a high birth weight baby, and the more likely the baby was to have signs of 

hyperinsulinemia. Elevated blood glucose also raised risk for problems such as preeclampsia 

and shoulder dystocia. Most significantly, there was no clear threshold level at which these 

outcomes began-that is, there is apparently no "safe" level of hyperglycemia. The increasing 

rates of GDM are driven in large part by increased rates of overweight and obesity in women of 

child bearing age. Thus, one approach to minimizing risk for these women and their babies 

would be to monitor and minimize excessive weight gain during pregnancy. NIDDK is also 

pursuing multiple efforts to address and prevent GDM. For example, in addition to ongoing 

research efforts to better understand causes of GDM, we are considering new clinical trials that 

would test lifestyle interventions to improve maternal metabolic status-for example, lipids, 

glycemia, and optimal weight gain-and examine impact on offspring nsing markers identified 

in the HAPO study. These trials could result in highly cost-effective, short-term interventions 

with a significant impact on future health of mothers and their offspring. 

4. What is being done to research the correlation between gestational diabetes and the mother or 

child developing type 2 diabetes? 

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FRADKIN: We are very interested in understanding these correlations, as it could help our 

efforts to reduce the burden of diabetes in women and children. Important information on the 

relationship between diabetes during pregnancy and future type 2 diabetes risk in offspring 

emerged from a collaboration between NIDDK intramural researchers and the Pima Indians of 

the American Southwest. The Pima have an extremely high rate of type 2 diabetes, a fact that 

enabled NIDDK investigators to see the long-term effects of maternal diabetes in the same 

family, when one child was born before a mother had diabetes, and another was born after she 

had developed diabetes-thus helping to distinguish the effect of diabetic pregnancy from simple 

heredity. Other population studies have revealed that mothers with GDM have a greatly 

increased risk for developing diabetes within 10 years after pregnancy. Together, these findings 

have spurred a wealth of research in recent years on factors that influence maternal metabolism 

and fetal development during pregnancy and post-partum. For example, we are now supporting 

studies that are using primates and other animal models of pregnancy to study the effects of diet 

on outcomes for both mothers and offspring. We are also identifying appropriate human cohorts 

in which to study correlations and outcomes. For example, we are planning a follow up study in 

children from the HAPO study. This new project will help us to identify markers that link 

exposures in utero with the development during youth of known risk factors for chronic 

disease-for example, adolescent obesity. This effort may also help us to better understand how 

differing levels of maternal hyperglycemia influence long-term outcomes. 

Encouragingly, the DPP found that lifestyle change aimed at modest weight loss reduced the risk 

of type 2 diabetes in women with a history of gestational diabetes. The NIDDK is partnering 

with the Nlli Office of Research on Women's Health to disseminate the results of this important 

study to pediatricians and OB/GYNs who are likely to interact with women with a history of 

GDM. 

5. In June, it was recently announced that HHS will spend $250M to increase the number of 

healthcare providers and strengthen the training of the primary care workforce. What steps 

are being taken to ensure appropriate diabetes-related education for these new providers? 

FRADKIN: Most people with diabetes receive care from their primary care providers, rather 

than from endocrinologists. The current guidelines that these providers use to treat their diabetes 

patients derive from Nlli-supported research, and the Nlli plans to continue its vigorous support 

of research to inform prevention and treatment strategies for people with diabetes. Moreover, the 

NIDDK and CDC co-led National Diabetes Education Program has developed several resources 

for use by health care providers to promulgate these guidelines, including an at-a-glance pocket 

guide that provides a list of current recommendations to diagnose and manage pre-diabetes and 

diabetes. More detailed information is found in the NDEP's "Guiding Principles for Diabetes 

Care," which outlines important patient-centered principles of diabetes care, helping health care 

professionals identify people with pre-diabetes and undiagnosed diabetes for treatment aimed at 

preventing long-term complications. Another useful resource is the Better Diabetes Care 

website, which focuses on helping health care providers assess and evaluate systems of care, or 

how they deliver care to their patients with diabetes. Representatives from the American 

Academy of Family Physicians and the American College of Physicians, the leading professional 

associations for primary care physicians, participate in the NDEP and help to promulgate NDEP 

materials and messages to members of these associations. 

16 
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Question by the Honorable Diana DeGette to Buford Rolin: 

Thank you for your work combating diabetes in Native American communities, where the 

disease is all too prevalent. Advocates such as those from JDRF have consistently impressed 

upon me the need to reauthorize the Special Diabetes Programs in a timely manner because of 

the timing of the NIH grant cycles. Given that the Special Diabetes Program for Indians 

addresses treatment, education, and prevention-rather than bench-to-beside research-can you 

please elaborate on what it would mean for Indian populations were it not to be reauthorized this 

year? 

Response: 

Funds from the Special Diabetes Program for Indians (SDPI) support personnel and program 

costs through grants and sub-grants in over 450 Indian communities in 35 states. If the funding is 

discontinued, those 450 progranls will mostly disappear. This will result in a loss of services, 

such as children's weight management programs, after school physical activity programs, 

community-based diabetes prevention programs, community nutrition counseling programs, 

group diabetes education sessions, community-based amputation prevention activities through 

home visits, and many more. This will result in a real loss of services in real people's lives, 

people who are at risk for the devastation that diabetes wreaks. It will result in a loss of hope for 

AlAN communities that the diabetes epidemic can be turned around. In some tribal 

communities, the programs supported by SDPI funds are the only diabetes education, treatment 

and prevention efforts underway. [fthese programs disappear, some communities will be left 

with no federal effort focused on diabetes. It addition, it is critical that Congress renew SDPI 

this year so that program staff can focus on continuing successful programs as opposed to how to 

begin to close them down. 
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Juvenlle 

Diabetes 

Research 

Foundation 

international 

dtdicated to finding a OJre 

August 4, 2010 

The Honorable Diana DeGette 

c/o Earley Green, Chief Clerk 

House Energy and Commerce Committee 

2125 Rayburn House Office Building 

Washington, D.C. 20515-6115 

Dear Representative DeGette: 

Juvenile Diabetes Research 

Foundation International 

26 Broadway. 14" Floor 

New York, NY 10004 

t 212.785·9500 f. 212·785·9595 

1-8()o"533·2873 info@jdrl,org 

www,jdrl,org 

On behalf of the Juvenile Diabetes Research Foundation (JDRF), I am deeply appreciative of 

your strong leadership and interest in type 1 diabetes research issues and am pleased to provide 

you with the attached answer to your follow-up question from the Subcommittee on Health's 

July 1, 2010 hearing entitled "The Battle Against Diabetes: Progress Made; Challenges Unmet.' 

Thanks to the strong public-private partnership between the federal government and JDRF as ! 

reference in my attached response, we are at a pivotal point in type 1 diabetes research. JDRF 

and our countless individuals and families who are affected by type 1 diabetes will continue to 

do our part. As you know, we need the renewal of the Special Diabetes Program (SDP) this yea! 

to ensure that the large-scale, multi-center clinical trials responsible for much of the advances to 

date can continue uninterrupted. 

I look forward to working with you and your staff further to achieve our mutual goal of a cure. 

Please do not hesitate to contact me or Laura Whitton, JDRF's National Director ofGovemment 

Relations at lwhitton@jdrf.org or 202-465-41 03 if we can be of any assistance. 

Sincerely, 

Robert 

~~ 

A. Goldstein, M.D., Ph.D. 

Senior Vice President, Scientific Affairs 

Attachment 
176 


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Juvenile 

Oi,bele, 

Research 

Foundation 

International 

dedicated to finding a cure 

Dr. Robert Goldstein, M.D., Ph.D., Senior Vice President, Scientific Affairs 

Response to the Honorable Diana DeGette' Question 

from the July 1, 2010 Hearing entitled 

"The Battle Against Diabetes: Progress Made; Challenges Unmet." 

The Honorable Diana DeGette 

"Dr. Goldstein, your testimony stressed the importance of the public-private partnership in 

accelerating research into type 1 diabetes, and I know that JDRF takes seriously its commitment 

to fonding the most promising research toward a cure for type 1 diabetes. Can you describe for 

the committee how JDRF's research priorities compare to the research goals of the Special 

Diabetes Program and how the two research portfolios complement each other toward the 

mutual goal of a cure for diabetes?" 

The Special Diabetes Program (SDP) has the following overarching goals: 

- Identify the genetic and environmental causes of type 1 diabetes; 

Prevent or reverse type I diabetes; 

- Develop cell replacement therapy; 

- Prevent or reduce hypoglycemia in type 1 diabetes; 

- Prevent or reduce the complications of type 1 diabetes; and 

- Attract new talent and apply new technologies to research on type 1 diabetes 

JDRF shares the same goals as the SDP. JDRF is pleased to work in close partnership with the 

National Institutes of Health to ensure we are doing all we can to efficiently and expeditiously 

reach our mutual goals. Two examples there are many more might serve to illuminate how 

the partnership accelerates the delivery of research results to people with type 1 diabetes: 

• NIH funded the original research which led to the glucose sensing technology used in 

many continuous glucose monitors (CGMs). This technology was then licensed by 

companies and developed into the products available today. The Special Diabetes 

Program-supported DirecNet program sponsored studies of the use of CGM devices in 

children and found them to be effective. In 2006, JDRF conducted an additional study --

a large, national, lO-site clinical trial-- to assess the effectiveness ofCGM use. The trial, 

results of which were published in The New England Journal of Medicine in 2008 and 

Diabetes Care in 2009, found that people with type I diabetes who used CGM devices to 

help manage their disease experienced significant improvements in blood sugar control. 

Based on these results, JDRF initiated a campaign to encourage health plans to provide 

coverage for CGMs. Today, all the national health plans - Aetna, CIGNA, Humana, 

United Healthcare, and WellPoint - cover CGMs, as do many regional plans. In addition, 

nationally recognized clinical guidelines recommend CGMs for people with type 1 

diabetes. 
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• Nlli-funded researchers first identified a drug a monoclonal antibody named anti-CD3 

- that can slow the progression of type 1 diabetes. Together, JDRF and NIH (with the 

SDP-funded Immune Tolerance Network and Type 1 Diabetes TrailNet) funded the 

proof-of-concept clinical trial that showed that a short 1-2 week treatment with anti-CD3 

helps patients maintain or increase their ability to produce insulin naturally for several 

years after diagnosis compared to a placebo. These findings are significant because 

patients use less insulin and have more stable blood glucose levels for an extended period 

oftime. 

Anti-CD3 is just the leading edge of a robust pipeline of potential therapies for reversing 

new onset type 1 diabetes. Promising other drug therapies, such as anti-CD20, are being 

tested currently in clinical trials funded by JDRF and Nlli with the strong support of the 

Special Diabetes Program. 
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Juvenile 

Diabetes 

Research 

Foundation 

International 

dedicated to finding a ct.'re 

August 4,2010 

The Honorable Gene Green 

c/o Earley Green, Chief Clerk 

House Energy and Commerce Committee 

2125 Rayburn House Office Building 

Washington, D.C. 20515-6115 

Dear Representative Green: 

Juvenile Diabetes Research 

Foundation International 

26 Broadway, 14111 Roor 

New York, NY 10004 

t 212·785·9500 f. 212·785·9595 

1.flOO.533.2873 info@jdrl.org 

www.jdrl.org 

On behalf of the Juvenile Diabetes Research Foundation (JDRF), I am deeply appreciative of 

your strong leadership and interest in type 1 diabetes research issues and am pleased to provide 

you with the attached answer to your follow-up question from the Subcommittee on Health's 

July 1, 2010 hearing entitled "The Battle Against Diabetes: Progress Made; Challenges Unmet." 

We are at a pivotal point in type 1 diabetes research and the renewal of the Special Diabetes 

Program (SDP) this year will ensure that the large-scale, multi-center clinical trials responsible 

for much of the advances to date can continue uninterrupted. One such example is the 

remarkable progress we have seen related to diabetic eye disease thanks to the SDP- supported 

Diabetic Retinopathy Clinical Research Network (DRCRNet) as referenced in my attached 

response. 

I look forward to working with you and your staff further to achieve our mutual goal of a cure. 

Please do not hesitate to contact me or Laura Whitton, JDRF's National Director of Government 

Relations at lwhitton@jdrf.orgor202-465-4103 if we can be of any assistance. 

Sincerely, 

Robert 

~~ 

A. Goldstein, M.D., Ph.D. 

Senior Vice President, Scientific Affairs 

Attachment 
179 


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Juvenile 

Diabetes 

Research 

Foundation 

Internatlon.! 

dedicate.d to finding it cure 

Dr. Robert Goldstein, M.D., Ph.D., Senior Vice President, Scientific Affairs 

Response to the Honorable Gene Green's Question 

from the July 1, 2010 Hearing entitled 

"The Battle Against Diabetes: Progress Made; Challenges Unmet." 

The Honorable Gene Green 

"Earlier this year. the House passed a resolution I authored to recognize the need for type 1 

diabetes researchfonding and the importance of the Special Diabetes Program at the NIH. This 

program is fonding important research across all stages of the disease. including the 

complications of diabetes. As the founder of the Congressional Vision Caucus. I know that 

diabetic eye disease is the leading cause of blindness in working age adults. As such. research in 

this area will have tremendous implications for society. I read recently that researchers have 

found a way to not only halt the progression of diabetic eye disease but reverse the disease in 

patients enrolled in clinical trials supported by the Special Diabetes Program. Can you please 

comment on this research and what you see for the foture for those affected by this complication 

of diabetes? .. 

The research cited was conducted throughout the United States by the Diabetic Retinopathy 

Clinical Research Network (DRCRNet), one of the clinical consortia established with the Special 

Diabetes Program (SDP) funds. 

The DRCR Network tested 3 different treatments for macular edema, a severe form of diabetic 

eye disease. An innovation of the trial design was that each treatment was a combination of drug 

with the standard laser treatment. 

Standard laser therapy leads to improved vision in only about 30% of treated eyes. In a previous 

trial, the DRCR found that steroid was also an effective treatment, but not as good as laser. One 

of the combinations for the new trial was steroid plus laser, testing whether the combination 

might give better results than either treatment alone. A newly developed drug, called antiVEGF, was tested in the other combinations: a combination of anti-VEGF plus laser; or a 

combination of anti-VEGF and then later laser. The results of the trial, reported in 

Ophthalmology in April 2010, showed that nearly half the people whose eyes were treated 

with the anti-VEGF combinations, had an improvement in vision of at least two lines on an 

eye chart after one year. And fewer people receiving treatment experienced big vision loss 

compared with those who got only standard laser. These results have been sustained through 

2 years ofthe 3-year trial. Dr. Frederick Ferris ill, clinical director of the National Eye Institute, 

which sponsored the trial, was quoted in The New York Times saying, "This is the first new 

treatment for people with diabetic macular edema in a quarter of a century." 

The DRCR Network is a collaborative network including over 320 physicians in 109 

participating sites ( offices) throughout the United States, dedicated to facilitating multicenter 

clinical research on diabetes-induced retinal disorders. 
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HENRY A. WAXMAN, CAllFOHNIA 

CHAlRMAN 

Robert R. Henry, M.D. 

Prulessor of Medicine 

ONE HUNDRED ELEVENTH CONGRESS 

COMMITTEE ON ENtR!3Y AND COMMERCE· 

2125 RAysuHN House OfFiCE BUILDiNG 

VVASH"'GTC"L DC 2D515·-6115 

July 21,2010 

University of California Department of Medicine 

Chlef, Section of Endocrinology, Metaoolism & Diabetes 

V A Medical Center, San Diego 

3350 La Jolla Village Drive (111 G) 

San Diego, CA 92161 

Dear Dr. Henry: 

JOE BARTON. TEXAS 

MEMBER 

Thank you forappearing before the Subconunittee on Health on July 1,2010, at the 

hearing entitled "The Battle Against Diabetes: Progress Made; Challenges Unmet." 

Pursuant to the Committee's Rules, attached are "Titten qllestions for the rccorddirected 

to you from certain Members of the Committee. In preparing your answers, please m:!dress your 

response to the Member who submitted the questions. 

Please provide your respQnses by Augost 4, 2010, to Earley Green, Chief Clerk, via email to Earlev,Qreent@mail.house.gov. Please contact Earley Green or Jennifer Bereultolz at 

(20:) 225-2927 if you have allY questions. 

Attachment 

Sincerely, 

Henry A. Wa.xman 

Chairman 
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The Honorable Diana DeGette 

Hemoglobin A1C Test 

1. New research is showing the power of some very practical, evidence-based tools in meeting the 

challenges of diabetes. For example, changes in diet and exercise that have been shown to 

reduce the onset of diabetes by 58%. In addition, nse of the hemoglobin A 1 C lab test to identify 

a person's blood glucose levels-and, thus, help detect diabetes. 

In fact, the American Diabetes Association recently recommended the hemoglobin A 1 C test as 

one of the tests that is appropriate for detecting diabetes. One of the reasons for recommending 

the test is that it is consumer friendly-patients no longer have to fast before taking it. What 

impact do you think this test might have in terms of constllner willingness to be tested and on 

overall diabetes detection and management? 

Since the tcst can be done without fasting, and isn't affected by short-term illness or stress, 

indh'iduals can be tested at any tinle (if they go to a doctor in ti,e afternoon, if they arc admitted 

to a hospital, etc.). Many people affected by type 2 diabetes haye no symptoms and require 

targeted testing in a healtll care setting to di'h'llose the disease. Type 2 also disproportionately 

affects popu1ations with less access to healthcare, who may only see a physician if they haye 

some other problem. Being able to take whatever opportunity to test high-risk indi,-iduals for 

diabetes (or prediabetes) using the hemoglobin A1C test is likely to reduce the number of people 

with the disease who are undiagnosed. In addition, it is essential tllat targeted diabetes testing, in 

accord with the American Diabetes _-\ssociation's recommendations, be provided without cost 

sharing through implementation of the ,\ffordable Care Act. A quarter of the nearly 24 million 

.-\merican with diabetes are currently un<liagnosed. Reliance upon the _-\ & B recommendations 

of the Cnited States Preventatin Sen"ices Task Force will thwart efforts to identify this 

population as well as the neatly 57 million people with pre-diabetes so that prevention and 

treatment efforts can be effectiycly implemented. 

Pre-Diabetes 

2. As legislators and as individuals, we often hear about the damages from diabetes-vision 

problems, nerve damage, kidney failure, and more. We also hear about its costs-some $174 

billion annually. But iliese costs-both in human and dollar terms-may jnst be the beginning 

in light of the fact that an additional 57 million Americans have what is known as pre-diabetes. 

• Pre-diabetes is a condition in which patients experience elevated blood glucose levels 

iliat are close to full-force diabetes, but are just shy of the threshold. 

• Pre-diabetes patients stand a 50 percent greater chance of stroke and heart disease than 

patients with glucose in the normal range. 

• Some 40 percent of pre-diabetes patients will become fully diabetic in 3 8 years. 

I know that a Representative from the ADA will be present at a diabetes caucus briefing on Ju1y 

12 about pre-diabetes and its costs, its impact, and practical solutions in dealing with it. Can you 
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corrunent about how we can best support efforts at combating pre-diabetes from becoming fullblown diabetes? 

\'Ve know that type 2 diabetes can be pre,-ented or delayed if people with pre-diabetes have 

education and ongoing support to lose 5_7°,(, of their body weight and to 'exercise (such as 

walking) at least 150 minutes a week. The barriers to this e-idence-based approach are two-fold: 

most people with prediabetes are not aware that they have it because they haven't been tested, 

and evidence-based prevention is only just beginning to be carried out in less costly community 

settings. The best way to support prevention efforts would be: 1) to support more screening 

(targeting testing of high-risk people) for diabetes and prediabetes (the same risk factors and 

tests apply); and 2) support the development and dissemination of community-based pre,-ention, 

through the National Diabetes Pre,-ention Program (NDPP). 

The NDPP was authorized through the Aff01'dable Care Act because it has proven its ability to 

dramatically and affordably - reduce diabetes. It is based on the Diabetes Prevention Program 

(DPP), an NIH funded clinical trial that showed people with pre-diabetes can rednce their risk 

of deYeloping type 2 diabetes by 58% with modest lifestyle changes. Through the CDC, tllis was 

translated into a community-based group intcJTention, where it has been shown through places 

like the YMCA that the same results can be achieved at a lower cost of around $300 per person. 

NDPP includes grants for model sites, and provides for training, quality assurance, outreach and 

further research. \'Ve know this works; we now need to deYelop the infrastrncture to bring it to 

scale. However, although authorized in the Affordable Care Act, the NDPP has not Yet been 

funded. We believe that in order to stem the diabetes epidemic, it is critical that the NDPP be 

implemented at $80 million dollars in FY 2011. 

Comprehensive & Coordinated Federal Strategy 

3. More than 24 million Americans have diabetes and almost 60 million are at great risk of 

developing it. This is an overwhehning public health problem that requires a comprehensive 

and coordinated response, similar to the Ryan White CARE Act of 1990. That landmark 

legislation launched a nationwide program to fight HIV I AIDS and has achieved great success in 

halting the growth in cases of HIV I AIDS and providing betrer treatment options for those with 

the disease. Do you think that similar legislation would help us fight diabetes? 

Yes. Although the Association is grateful to Congress for providing vital resources to address 

the diabetes epidemic, it is painfnlly obvious that we as a country have not recognized the 

burden that diabetes has on our citizens and our fiscal health - or the juggernaut that awaits us if 

we don't take action to stop diabetes. Through the work of the National Institute of Diabetes 

and Digestive and Ejdney Diseases (NIDDK) at the National Institutes of Health, the Division 

of Diabetes Translation (DDT) at the CDC, and the Indian Health Service, our collective 

knowledge of tl,e disease has been elevated and expanded so the work towards ending the 

epidemic can continue. But the bottom line is more needs to be done if we want to change our 

future, one in which one out of eHIT tlltee American children faces a life with diabetes. 

On se"cral key occasions, including the passage of the National Diabetes Mellitus Research and 

Education Act in 1974, and tl,e creation of the Special Diabetes Program, Congress has 
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expanded the federal response to the diabetes epidemic. With the prevalence of the disease on 

the rise and the human and economic toll escalating, the Association would welcome a federal 

effort of the magniulde of the Ryan White CARE Act in order to stop diabetes. We believe that 

such an effort should strengthen the hands of the NIDDK, DDT, IHS, other key agencies, 

providers, community-based organizations, academic institutions, and patients to more 

aggressively address diabetes. Such an effort should quicken the pace of research and speed up 

the translation of new disco\'cries into imprm'ed prevention, treatment and management tools; 

broaden and intensity community-based prevention strategies; ensure access to health care for 

individuals with and at risk for diabetes; ensure that all federal agencies support the most 

appropriate and effecti\'e methods for screening and detection; and eliminate health disparities in 

diabetes research, preyention, and care. The I\ssociation stands ready to assist Members of 

Congress in dus needed commitment to stop diabetes. 

4. In 1974, when there were only 4 million people diagnosed with diabetes, Congress established 

the foundation for our nation's diabetes research and public health activities by passing that 

National Diabetes Mellitus Research and Education Act. Despite advancements in research and 

improvements in the Medicare program, today there are 24 million people suffering from the 

disease and the death tate continues to climb. The 1974 Act was a landmark effort to put the 

federal spoilight on diabetes likely for the first time; however, the bill only focused on the 

federal government's own approach and attitude towards diabetes. It seems to me that, today, 

that won't be enongh - we need the public engaged. Modernizing the Act would be a good step, 

but in doing so, from a legislative perspective, what can Congress do today - working with the 

Administration- to give the public tools to combat dUs terrible disease? 

We are thankful that Congress supports the DDT, NIDDK, IHS and other agencies to engage 

the public in diabetes awareness, prevention, care, and research, through NIDDK clinical trials, 

DDT prevention programs, the National Diabetes Education Program, and other efforts. 

However, as a volunta1}' health organization focused on individuals with and affected by 

diabetes, the Association believes that more should be done to further ensure public input and 

engagement in onr national diabetes strategy. For example, Congress, working widl the 

Admitustration, should cnsnre dlat individuals with expertise in diabetes are represented on 

federal advisory committees implementing the Affordable Care Act, such as dle Healdl 

Promotion and Public Health Ad"isory Committee and the eluted States Preventive Services 

Task Force. A key link to public engagement from the federal government is the work of DDT. 

Sadly, DDT remains woefully underfunded, prm'iding a mere 80 cents lor each American with 

diabetes or pre-diabetes. We cannot hope to fully engage the public without the means to reach 

and teach d,em about this disease. In addition, for people to have the tools to combat diabetes 

they must hm'e access to adequate and affordable health care. The Affordable Care Act is a 

milestone in making this a reality, but it is crucial that it be implemented in a war that makes its 

promise a reality for people \veith diabetes. This includes targeted testing for diabetes as 

discussed above and ensuring that the essential benefits package includes the tools needed tor 

effectiye diabetes management. Absent these efforts, we will continue to pay for an amputation 

caused by diabetes but not pro\'ide the tools needed to pre\'cnt d,at amputation. 
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The Honorable Michael C. Burgess 

1. How do we encourage payers to cover diabetes patient education and reimburse providers for 

time and resources need to properly guide patient self-management? 

TIle American Diabetes Association does not" take positions 011 issues" related to specific 

provider reimbursement legislation. However, the Association recognizes and supports the 

tremendous efforts that these prm-ider organizations make to imprm-e the lives of patients with 

diabetes and strongly supports reimbursement for the tools and services needed to effectively 

manage diabetes including diabetes self-management education (DSME)_ 

The Association is keenly aware of the problems many patients face in accessing the DSME they 

need to successfully manage their disease. Accordingly, we are firmly committed to promoting 

greater access to DSME and to supporting the crucial role of the diabetes educator. Over the 

past year, the Association has actively fought for a number of provisions in the federal healdl 

refonn debate that would greatly improve access to DSME. These include ending the 

discrinunation that permits insurance companies to refuse insurance to people with diabetes or 

to cllarge them significandy higher insurance rates because dley have diabetes, ending lifetime 

and annual caps on benefits, capping anntull out-of-pocket eJ,'penscs, and increasing aftordability 

of coverage through expanding Medicaid and implementing subsidies for dlOse who cannot 

otherwise aftord insurance. 

As the Affordable Care Act is implemented, it is essential dlat diabetes self- management 

education be included in dle benefits package and all cost-sharing (i.e., co-pays and deductibles) 

be eliminated for DSME under Medicare. In addition, pilots for new care delivery systems and 

associated payment structures should be used to develop systems that recognize the essential 

role of DS1\fE . 

2. Specifically is the ADA watching the MLR definitions coming out ofHHS? 

The Association recognizes the importance of the F-lF-lS l\ILR definitions to health care 

organizations, prm-iders, and patients and but is not taking a specific leadership role in reviewing the 

definitions. 

a. If they are too strict with their guidelines and management programs are excluded 

from MLR what do you think might happen? 

b. So it is essential that we keep a close eye on them because they could really hurt 

patients? 

3. There is a common myth that starting insulin means you are failing to appropriately manage 

your disease and many patients see taking insulin as a defeat. However, the most important 

thing is to get glucose levels stabilized using appropriate insulin as soon as possible. How do 

we de-stigmatize insulin therapy, as well other therapies, and encourage patients to see 
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aggressively managing their blood glucose levels as a positive lifestyle choice, instead of a 

negative? 

4. In your experience what is the best way to encourage patients to aggressively manage their 

blood glucose levels as a positive lifestyle choice, instead of a negative? 

The Association believes that your questions are related, and will answer them together. Patients 

need accurate infol1nation about dle benefits of taking care of ilieir diabetes, the progressive 

nature of type 2 diabetes (which requires additional therapies over time), and realities (\·s. myilis) 

about therapies. Patients are more likely to accept insnlin therapy if dley know from the 

beginning that it is often needed to manage diabetes and not because of failure on their part. In 

order to ensure dlat patients have the ability to effectively manage their diabetes, iliey also need 

healthy environments and support for exercise and healthy eating (as do all Americans). One 

barrier to effective diabetes management is that it is expensive. People wid1 diabetes are typically 

on multiple medications, and even \vith prescription drug coverage the co-pays are a problem for 

many. Mal1Y people with diabetes IiI'e in "food deserts" where fresh healiliy food is not available 

or in areas where even simple exercise such as walking is not feasiblc. Given these challenges, 

healthier communities and improved access to affordable heald1 care would benefit people wiili 

diabetes (and alI "-\mericans). 

c\nother barrier is iliat the media ha\'c sensationalized any negati,'e aspect of diabetes d1erapy 

widlout highlighting dle many positives. Patients hear greatly exaggerated stories abour oral 

medications and insulin, but do not hear the good news that complication rates are declining for 

people who appropriately manage ilieir diabetes. The message people are getting may be dlat 

glucose control doesn't work or is even dangerous. Nothing could be farther from the truth, yet 

patients, and even many health care providers, are confused. Ibat's why paticnts need accnrate 

information abont all aspects of their diabetes so that they can work with their prodders to 

develop and implement an effective diabetes management plan. 

o