[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
THE BATTLE AGAINST DIABETES: PROGRESS MADE; CHALLENGES UNMET
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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
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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
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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.]
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