[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



 
      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            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
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
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois       MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin             MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas                  MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York          SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah                   JOHN SULLIVAN, Oklahoma
JANE HARMAN, California              TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas           MICHAEL C. BURGESS, 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
  
                             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
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


      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 better. 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.

  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 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. Fifty-seven 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 
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.
    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 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.

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.
    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.

   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 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 
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.
    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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    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 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 research. 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 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 five-State 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 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 
population-targeted 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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    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 
NIDDK-led 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 occurrence 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 
far-reaching 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 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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    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 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.
    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 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 
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.
    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 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.
    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 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.
    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 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 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 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.
    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 president-elect, 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----
    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.
    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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    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-
year-old 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 insulin-producing 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 Cartwright, 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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    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 program 
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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    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 cardiovascular disease 10 years later so 
that there was this short-term--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 improvements 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 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?
    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.
    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.
    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 
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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