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[Senate Hearing 108-790]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 108-790

                     ARTHRITIS: A NATIONAL EPIDEMIC

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON AGING

                                 OF THE

           COMMITTEE ON HEALTH, EDUCATION, LABOR AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                                   ON

   EXAMINING THE CURRENT AND FUTURE IMPACT OF ARTHRITIS, FOCUSING ON 
  PREVENTING, CONTROLLING AND CURING ARTHRITIS AND THE OPPORTUNITIES 
    PUBLIC HEALTH HAS TO MAKE A DIFFERENCE IN REDUCING THE PAIN AND 
 DISABILITY ASSOCIATED WITH ARTHRITIS, INCLUDING S. 2338, TO AMEND THE 
PUBLIC HEALTH SERVICE ACT TO PROVIDE FOR ARTHRITIS RESEARCH AND PUBLIC 
                                 HEALTH

                               2_________

                              JUNE 8, 2004

                               __________

 Printed for the use of the Committee on Health, Education, Labor and 
                                Pensions

                    U.S. GOVERNMENT PRINTING OFFICE
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           COMMITTEE ON HEALTH, EDUCATION, LABOR AND PENSIONS

                  JUDD GREGG, New Hampshire, Chairman
BILL FRIST, Tennessee                EDWARD M. KENNEDY, Massachusetts
MICHAEL B. ENZI, Wyoming             CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
CHRISTOPHER S. BOND, Missouri        BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio                    JAMES M. JEFFORDS, Vermont
PAT ROBERTS, Kansas                  JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama               PATTY MURRAY, Washington
JOHN ENSIGN, Nevada                  JACK REED, Rhode Island
LINDSEY GRAHAM, South Carolina       JOHN EDWARDS, North Carolina
JOHN WARNER, Virginia                HILLARY RODHAM CLINTON, New York
                  Sharon R. Soderstrom, Staff Director
      J. Michael Myers, Minority Staff Director and Chief Counsel

                              ----------                              

                         SUBCOMMITTEE ON AGING

                CHRISTOPHER S. BOND, Missouri, Chairman
LAMAR ALEXANDER, Tennessee           BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio                    EDWARD M. KENNEDY, Massachusetts
PAT ROBERTS, Kansas                  PATTY MURRAY, Washington
MIKE ENSIGN, Nevada                  JOHN EDWARDS, North Carolina
JOHN WARNER, Virginia                HILLARY RODHAM CLINTON, New York
                    Kara R. Vlasaty, Staff Director
                Rhonda Richards, Minority Staff Director

                            C O N T E N T S

                              ----------                              

                               STATEMENTS
                         Tuesday, June 8, 2004

                                                                   Page

Bond, Hon. Christopher S., Chairman, a U.S. Senator from the 
  State of Missouri, opening statement...........................     1
Mikulski, Hon. Barbara A., a U.S. Senator from the State of 
  Maryland, opening statement....................................     2
    Prepared statement...........................................     3
Sniezek, Joe, M.D., Director, Arthritis Program, Centers for 
  Disease Control and Prevention.................................     5
    Prepared statement...........................................     7
Serrate-Sztein, Susana, M.D., Chief, Rheumatic Diseases Branch, 
  National Institute of Arthritis and Musculoskeletal and Skin 
  Diseases, National Institutes of Health........................    13
    Prepared statement...........................................    15
Kunkel, Kalea, Patient...........................................    24
Jones, Virg, Patient.............................................    28
    Prepared statement...........................................    32
Rothman, Deborah, Ph.D., American College of Rheumatology........    33
    Prepared statement...........................................    36
    Letter to Senator Christopher S. Bond........................    38
Klippel, John H., M.D., President and Chief Executive Officer, 
  Arthritis Foundation...........................................    39
    Prepared statement...........................................    42

 
                     ARTHRITIS: A NATIONAL EPIDEMIC

                              ----------                              

                         TUESDAY, JUNE 8, 2004

                                       U.S. Senate,
                                     Subcommittee on Aging,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:05 a.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Christopher 
S. Bond (chairman of the subcommittee) presiding.
    Present: Senators Bond, Mikulski, and Murray.

                   Opening Statement of Senator Bond

    Senator Bond. Good morning. The Subcommittee on Aging of 
the Senate Committee on Health, Education, Labor and Pensions 
will come to order. We welcome you all here today to discuss 
arthritis, the disease and the cures.
    With more than 100 different forms, arthritis is one of the 
most widespread and devastating health conditions in the United 
States. Nearly 70 million, or 1 in every 3, American adults 
suffer from arthritis or chronic joint symptoms, and 300,000 
children live with the pain, disability, and emotional trauma 
caused by juvenile arthritis.
    The number of Americans who live with arthritis will grow 
as the number of us older Americans continues to increase 
dramatically in the next few decades. As the leading cause of 
disability in the United States, arthritis is a painful and 
debilitating chronic disease affecting men, women, and children 
alike. Arthritis has no boundaries.
    Simple daily tasks, like brushing teeth, pouring a cup of 
coffee, or even getting out of bed, become excruciating 
obstacles for millions of people who suffer from the disease. I 
watched firsthand as my mother suffered increasing arthritis 
pain throughout the last years of her life. She believed at the 
time that bedrest was the best way to deal with it. She held 
out the hope that perhaps when the arthritis fused in her back 
it might bring some relief from the pain. Unfortunately, it did 
not.
    As a faithful son, obviously, I inherited the arthritis and 
then made the mistake of playing rugby in college. As a result, 
I have had two neck operations, a fusion of two cervical 
vertebrae, brand new replaced thumb joint, and a new hip, which 
enables me to set off the alarms at airport security like a 
penny arcade.
    But to move from the specifics and our small problems to 
the general, the impact of the disease on our health system is 
also dramatic. Arthritis results in three-quarters of a million 
hospitalizations, 44 million outpatient visits, and 4 million 
days of hospital care every year, according to the Centers for 
Disease Control and Prevention. The CDC estimates that the 
annual cost of medical care for arthritis is $51 billion, and 
the annual total cost, including lost productivity, exceeds $86 
billion. Early diagnosis, treatment, and appropriate management 
of arthritis are critical to controlling symptoms and improving 
quality of life.
    To address these issues, Senator Kennedy and I have 
introduced S. 2338, the Arthritis Poverty, Control, and Cure 
Act, earlier this year. This bill would: No. 1, improve 
coordination among Federal agencies and the public regarding 
the Federal investment in arthritis research and public health 
activities through a National Arthritis and Rheumatic Diseases 
Summit; No. 2, accelerate research that would lead to improved 
treatments and a cure for juvenile arthritis; No. 3, invest in 
a nationwide public health initiative designed to reduce the 
pain and disability of arthritis through the early diagnosis 
and effective treatment of the disease; and, No. 4, ensure kids 
with arthritis have access to specialty care by addressing the 
nationwide shortage of pediatric rheumatologists.
    We have a responsibility to look for solutions to this 
issue in a comprehensive manner, and I think this bill can make 
a real difference in the lives of the millions of Americans, 
both young and old, who suffer from this debilitating disease.
    Today, we are honored to have before the subcommittee a 
distinguished panel of doctors, researchers, patients, and 
advocates to discuss arthritis, to tell us how we can improve 
the bill, what we need to do differently, what we should add to 
it, because the burden this disease places on our society and 
economy, the progress being made toward the understanding, 
diagnosis, treatment, and prevention of arthritis for both 
children and adults is an appropriate subject for this hearing. 
We look forward to learning from our witnesses.
    Now it is my great pleasure to turn to my good friend and 
colleague, the Senator from Maryland, Senator Barbara Mikulski.
    Senator Mikulski.

                 Opening Statement of Senator Mikulski

    Senator Mikulski. Good morning, Senator Bond, and to our 
witnesses, and to all who are here today
    First of all, I want to thank you, Senator, for holding 
this hearing on arthritis so that we could get the latest 
updates on both research as well as a navigational chart on 
where we need to proceed.
    I also want to acknowledge your leadership in introducing, 
along with our colleague, Senator Kennedy, the Arthritis 
Prevention, Control, and Cure Act of 2004. I am proud to be a 
cosponsor of that. Again, it is the spirit of bipartisanship 
that we need, you know, when we have to find cures or the 
ability to manage disease and so on. It does not really matter 
what party you are. It matters that you have arthritis or you 
have Alzheimer's, as our dear President and my father had, et 
cetera. I know that you saw the individual pain of both your 
mother and even had those challenges yourself.
    So we need to let people know we are on their side, and I 
want to tell our witnesses we are really looking forward to 
getting the best of the advice that they had to offer. I would 
also like to acknowledge that there are Marylanders here, 
Senator Bond--Jan Thompson, who is the president of the 
Maryland Chapter of Arthritis, and Brenda Crabbs, who is the 
past president and some others--who are here to say hello to 
you this morning. We welcome you to listen and then to get your 
advice, because I believe the people in the field and the 
people who are the most affected should have the most to say.
    Senator Bond has articulated already the many facts and 
data about how this strikes people, from osteoarthritis to 
rheumatoid arthritis, lupus, which affects so many women, and, 
of course, juvenile arthritis. The activities of daily living 
are just challenged when you are dealing with this, and what we 
need to do is to find out how we can both manage what people 
have, to either find the cure or either those other issues that 
could help them live a life full of vibrancy.
    What strikes me in looking at all the data and listening to 
letters from my own constituents is that arthritis has no 
boundaries on gender, race, or age. Often we think of it as 
something in an older person, but yet 300,000 children in our 
country are afflicted by it, which will impact their entire 
lives. This is a disease that affects women and it affects men. 
It affects black, white, and other color, which shows that it 
is an all-American disease. So we have to have an all-American 
effort.
    I recall back even 20 or 30 years ago, there was so little 
available. What they had was what they called ``the gold 
treatment.'' I don't know if your mom did that, Senator Bond, 
but remember where you would go and get the infusions of gold, 
and somehow or another the metallic impact eased pain and 
enabled more agile functioning of limbs.
    Now we are making other successful strides in treatment, 
research, and prevention, but we need to do more. With the 
boomers coming on age, this is also going to be an increasing 
challenge.
    I have been glad to work with Senator Bond as a cosponsor 
of this and also to work for initial funding for the Arthritis 
Plan, and also now I am looking at a $5,000 tax credit that 
would help people with home health care, prescription drugs, 
specialized day-care where children in need might be impacted. 
But today is not to listen about what I have got to say; it is 
to listen to what you have to say. So just in the real spirit 
of welcoming to an all-out, all-American effort, we just want 
to say good morning and look forward to hearing from you.
    [The prepared statement of Senator Mikulski follows:]

                 Prepared Statement of Senator Mikulski

                              INTRODUCTION

    Thank you to Chairman Bond for holding this hearing on 
arthritis. This issue is very important, and I thank you for 
your leadership.

                                 FACTS

    Seventy million Americans are afflicted with arthritis 
today. It is the number one cause of disability in the U.S. 
among Americans over the age of 15. There are over 1 million 
people living with arthritis in my home State of Maryland. 
Arthritis limits every day activity for over 7 million 
Americans.
    Arthritis and the disability it causes creates huge burdens 
for individuals, their families, and the Nation. In 1995, 
arthritis cost more than $22 billion in direct medical costs, 
and over $82 billion in total costs.
    People who suffer from prevalent forms of arthritis--such 
as osteoarthritis, rheumatoid arthritis, lupus, and juvenile 
arthritis--struggle with everyday activities like getting 
dressed, brushing their teeth, and pouring a cup of coffee.
    They may have to quit their job or change jobs because 
arthritis prevents them from doing jobs.

                         WHY ARE WE HERE TODAY?

    Our hearing today is titled Arthritis: A National Epidemic. 
Our witnesses will provide a human face for arthritis. The 
people who live with arthritis and the impact it has on them 
and their families.
    Arthritis knows no boundaries of gender, race, or age and 
affects nearly 300,000 children and afflicts both women and 
men. However, it is more prevalent in women.
    We need to hear from advocates, CDC, and researchers to see 
what can be done to prevent, treat, and cure arthritis.

                          WHERE ARE WE HEADED?

    In 1948, there was little or no money being spent on 
arthritis research. The medical community and the public felt 
that there was nothing that could be done about arthritis.
    Today, we know that is not true. We are making successful 
strides in treatments, research, and prevention. In 1999 the 
National Arthritis Action Plan was published. The plan is a 
true public health strategy for arthritis, guiding the use and 
organization of our Nation's health resources to combat the 
greatest single cause of chronic pain and disability among 
Americans. We must continue to focus on chronic diseases that 
many Americans will face. Arthritis is one of those diseases.
    Baby Boomers are now at prime risk for arthritis. More than 
half of the people affected by arthritis are under age 65. As 
the population ages, the numbers will increase dramatically.

                               BAM RECORD

    I'm proud to be on the side of arthritis patients and their 
families by increasing prevention, providing access to 
treatments, and supporting family caregivers; co-sponsor of the 
Bond/Kennedy arthritis bill; secured initial funding of $10 
million for the National Arthritis Action Plan; and worked to 
increase this funding.
    I supported Medicare coverage of self-injectable drugs that 
help arthritis patients, sponsoring a tax credit of up to 
$5,000 to help reduce financial burden on family caregivers 
caring for loved ones with chronic conditions.

                                CLOSING

    I look forward to hearing from our witnesses today, to 
learn how arthritis impacts the daily lives of adults and 
children; to discuss the current research that is being done on 
arthritis; and to get up-to-date information about how this 
disease impacts our society today and in the future with the 
aging Baby Boomer population. They are speaking for the 
millions of people who live with arthritis every day.
    Senator Bond. Thank you very much, Senator Mikulski, and I 
join with you in that welcome and tell you that we are very 
fortunate to have two outstanding panels. Their full 
biographies will be entered in the record. I would tell our 
witnesses that we will make their full statements available. We 
will include those in the record for all of our colleagues and 
staff to read, and we ask that you summarize your opening 
presentation so we will have some time for questions.
    Our first witness is Dr. Joe Sniezek, a medical 
epidemiologist and chief of the Arthritis Program at the 
Centers for Disease Control and Prevention in Atlanta. He leads 
the CDC's public health efforts to implement the National 
Arthritis Action Plan: A Public Health Strategy, through the 
expansion of public health science and the development of 
State-based public health practice.
    Our second witness is Dr. Susana Serrate-Sztein, chief, 
Rheumatic Diseases Branch Extramural Program at the National 
Institute of Arthritis and Musculoskeletal and Skin Diseases at 
the National Institutes of Health, where she directs the newly 
created program of genetics and clinical studies within the 
Rheumatic Diseases Branch.
    Thank you very much for being here.
    Dr. Sniezek.

 STATEMENT OF JOE SNIEZEK, M.D., DIRECTOR, ARTHRITIS PROGRAM, 
           CENTERS FOR DISEASE CONTROL AND PREVENTION

    Dr. Sniezek. Thank you, Mr. Chairman, Senator Mikulski, for 
the opportunity to address an important health problem in our 
society--that of preventing, controlling, and curing arthritis.
    Senator Mikulski. Doctor, pull up the mike.
    Dr. Sniezek. Is it on?
    Senator Bond. Is the little red light on?
    Dr. Sniezek. Yes, it is.
    Senator Bond. It is amazing how we can go to the moon, but 
we still have problems figuring out the--
    [Laughter.]
    Dr. Sniezek. Thanks. In my remarks today, I would like to 
focus on the impact of arthritis in the United States and the 
opportunities public health has to make a difference in 
reducing the pain and the disability associated with arthritis. 
Many of our efforts are guided by the ``National Arthritis 
Action Plan: A Public Health Strategy,'' which was published in 
1999. Our health priorities for the Nation, ``Healthy People 
2010,'' now include arthritis objectives for the very first 
time.
    Arthritis comprises over 100 different diseases and 
conditions. The most common are osteoarthritis, gout, 
fibromyalgia, and rheumatoid arthritis.
    In 2001, 49 million adults reported a doctor had told them 
they had arthritis, nearly one of every four adults--making it 
one of our most common chronic conditions. An additional 21 
million Americans reported chronic joint symptoms that may be 
arthritis, but have yet to be told by a physician they have 
arthritis. In the next 25 years, as our population ages, CDC 
estimates that 71 million adults will have arthritis, including 
a doubling of the number among those adults over the age of 65. 
This does not take into account the ongoing obesity epidemic in 
America, which may significantly contribute to the future 
prevalence of arthritis.
    Arthritis and its related disability cause an enormous 
burden for the people who have arthritis, their families, and 
society. Arthritis is the most frequent cause of activity 
limitation in America; more than 8 million citizens are limited 
in some way because of arthritis. CDC research has shown that 
each year 750,000 hospitalizations and 36 million outpatient 
medical care visits occur because of arthritis. In 1997, 
arthritis cost more than $51 billion in direct medical costs 
and another $35 billion in lost productivity. No doubt, these 
numbers will increase dramatically as our population ages and 
the number of people with arthritis increases.
    CDC is bringing a population-based focus, knowledge of what 
works, and making links to the clinical community. CDC is using 
its ability to evaluate health promotion programs and identify 
those that work, knowledge of the public health network, and 
the ability to work with States and communities to implement 
programs.
    We think the following items are critical to address 
arthritis:
    We need to increase early diagnosis and appropriate medical 
management of arthritis.
    We need to promote healthy lifestyles. Medical treatment 
alone is not sufficient. For example, physical activity is 
beneficial for people with arthritis.
    We need to increase the use of disease self-management 
strategies. We have a program that teaches people with 
arthritis to better manage their disease. It has been shown to 
decrease pain and decrease costs. Yet it is not readily 
available and few people take it.
    To address these needs, we need to increase awareness. 
Market research conducted by the Arthritis Foundation shows 
that many people are not aware of the available programs that 
improve the quality of life.
    We need to increase the availability of programs. There are 
simply not enough programs in our toolbox, and those that we 
have are not readily available.
    We need to increase accessibility and discover how best to 
reach people with arthritis.
    CDC works closely with the Arthritis Foundation, the voice 
for people with arthritis and their families now for 50 years.
    A core activity of the CDC Arthritis Program has been to 
fund State health departments to address arthritis. We 
currently fund programs in 36 States. For example, Illinois is 
increasing the availability of evidence-based arthritis 
physical activity programs in five counties, representing rural 
and underserved populations. These arthritis-specific 
interventions improve function and reduce pain, but are scarce 
in rural and underserved areas.
    CDC is working to identify and evaluate promising 
approaches. For example, the People with Arthritis Can Exercise 
Program, developed and disseminated by the Arthritis Foundation 
specifically for people with arthritis, is currently being 
evaluated at the Universities of Missouri and North Carolina. 
This program teaches exercises to reduce pain and improve the 
ability to move. Pilot results are promising.
    CDC and its partners are also working to reach Americans 
with arthritis through mass media, specifically radio, 
newspapers, and displays at local stores. CDC developed a 
marketing campaign to promote physical activity among people 
with arthritis. The campaign was designed to reflect a major 
motivator for people with arthritis. What they are most seeking 
is pain relief. This research led to the development of the 
marketing campaign, Physical Activity: The Arthritis Pain 
Reliever. This campaign is currently being used by 35 of the 36 
State health departments who receive arthritis funding from 
CDC.
    I thank the committee for its leadership and commitment to 
the health of our Nation and the interest in people affected by 
the epidemic of arthritis. Great progress has been made. We 
have a national plan that is catalyzing activities in both the 
public and private sectors. We need to continue our work to 
identify promising approaches, develop new approaches, and put 
science into action, getting programs that work out to the 
people who need them.
    Thank you.
    Senator Bond. Thank you very much, Dr. Sniezek.
    [The prepared statement of Dr. Sniezek follows:]

            Prepared Statement of Joe Sniezek, M.D., M.P.H.

    Thank you, Mr. Chairman, Members of the Committee, for the 
opportunity to address an important health problem in our society--that 
of preventing, controlling and curing arthritis.
    The National Arthritis Act of 1974 (Public Law 93-640) as enacted 
in 1975 has largely been successful in promoting basic and clinical 
arthritis research and establishing Multidisciplinary Clinical Research 
Centers. Arthritis is a large problem that is getting larger as our 
population ages. The public health efforts called for in the 1974 Act 
have only recently been initiated. The National Arthritis Action Plan: 
A Public Health Strategy was published in 1999. Our health priorities 
for the Nation, Healthy People 2010, include arthritis objectives for 
the very first time.
    In my remarks today, I would like to focus on the impact of 
arthritis in the United States and the opportunities public health has 
to make a difference in reducing the pain and the disability associated 
with arthritis. I would also like to highlight a few of our activities: 
an example from one of our state-funded arthritis programs; a research 
program examining the incidence and progression of arthritis; and, a 
health communications campaign designed to increase physical activity 
among persons with arthritis.

              IMPACT OF ARTHRITIS: TODAY AND IN THE FUTURE

    Arthritis comprises over 100 different diseases and conditions. The 
most common are osteoarthritis, gout, fibromyalgia, and rheumatoid 
arthritis. Common symptoms of arthritis include pain, aching, stiffness 
and swelling. Some forms of arthritis, such as rheumatoid arthritis and 
lupus, affect multiple organs, and associated with premature death.
    In 2001, 49 million adults reported a doctor had told them they had 
arthritis; nearly one of every four adults--making it among the most 
common health problems in the United States. An additional 21 million 
Americans reported chronic joint symptoms that may be arthritis, but 
have yet to be told by a physician they have arthritis. In the next 25 
years as the population ages, CDC estimates that 71 million adults will 
have arthritis, including a doubling of the rate among adults over age 
65. This is likely a conservative number, since it does not take into 
account the ongoing obesity epidemic in America, which may 
significantly contribute to the future prevalence of arthritis.
    Although rarely discussed, arthritis causes over nine thousand 
deaths each year. Most notable, is the fact that arthritis-related 
mortality disproportionately affects women and minorities. For example, 
systemic lupus deaths show marked age, sex, and race-specific 
disparities with the highest death rates occurring among working-age, 
black women.
    Arthritis and its related disability cause an enormous burden for 
the people who have arthritis, their families and society. Arthritis is 
the most frequent cause of activity limitation in America; more than 
eight million citizens are limited in some way because of arthritis. 
Arthritis is also a significant cause of work disability, especially 
for persons with inflammatory arthritis, such as rheumatoid arthritis, 
of which, as many as 30 percent may be work disabled. Each year, 
750,000 hospitalizations and 36 million outpatient medical care visits 
occur because of arthritis. Arthritis is costly to society and 
individuals. In 1997, arthritis cost more than $51 billion in direct 
medical costs and another $35 billion in indirect costs. No doubt, 
these numbers will increase dramatically as our population ages and the 
number of people with arthritis increases.
    We know other things about people with arthritis. People with 
arthritis:
     Are older, more often female, and have a much poorer 
quality of life.
     Are more likely to be overweight or obese, which is 
associated with further progression of disease and, given the obesity 
epidemic, means even more people affected in the future.
     Are less physically active, which is associated with 
higher medical costs.
     Often don't discuss their joint symptoms with their 
doctors, resulting in delayed diagnosis and greater progression of 
disease. 21 million Americans report joint pain but have not been told 
they have arthritis.
     Are not receiving existing interventions, such as 
counseling to increase physical activity, achieving a healthy weight, 
and learning about self-management.

                 THE ROLE OF PUBLIC HEALTH IN ARTHRITIS

    CDC has identified the following critical priorities to address 
arthritis:
     Increase early diagnosis and appropriate medical 
management of arthritis.--Although there is no cure for most types of 
arthritis, early diagnosis and appropriate management is important, 
especially for inflammatory types of arthritis. Early targeted therapy 
for rheumatoid arthritis had been shown to decrease joint destruction 
and improve outcomes.
     Promote healthy lifestyles.--Medical treatment alone, 
however, is not sufficient. Public health activities that reach broad 
population groups with arthritis are needed. Our challenge is to both 
identify and implement effective strategies to improve the health of 
entire population segments. Only since 1990, have the benefits of 
physical activity among people with arthritis been appreciated. Prior 
to 1990, people with arthritis were told by their physicians to rest 
their joints. Evidence now exists that shows physical activity is 
beneficial for most types of arthritis, can improve health AND 
function, and improve symptoms.
     Increase the use of disease self-management strategies.--
Programs that teach people with arthritis to better manage their 
disease and optimize function can reduce both pain and health care 
costs. There is a very robust science base that demonstrates the 
positive impacts of participation in the Arthritis Self Help Course--
participants report a 20 percent decrease in pain, and a 40 percent 
decrease in physician visits, even 4 years after course participation. 
A companion course, the Chronic Disease Self Management Program, has 
also been developed and has demonstrated positive impacts among people 
with a variety of chronic conditions including arthritis, heart 
disease, lung disease and diabetes. Less than 1 percent of Americans 
with arthritis who could benefit participate in such programs. Programs 
are not readily available in all areas.
    Reducing arthritis-related disability will benefit our aging 
population in America. In 7 years, the leading edge of the baby-boomers 
will reach age 65. Many older Americans, those most likely to have 
arthritis and to be limited by arthritis, may need to or wish to work 
longer. We will need to better understand how we can reduce arthritis-
related disability and how older Americans can be accommodated in the 
workplace so that they can remain active and, if they choose to be, 
employed. This aging trend will have enormous implications for our 
society.
    CDC and the public health community in our States and communities 
have a continued role to play in bringing the benefits of prevention to 
persons with arthritis. Public health brings the focus on population-
based approaches to health, the knowledge of what works, and links to 
the clinical community. What CDC brings to the table is its well-
recognized scientific expertise, long-standing experience in prevention 
research, the ability to evaluate health promotion programs and 
identify those that work, knowledge of the public health network and 
the ability to work with States and communities to implement disease 
prevention and health promotion programs, and unique surveillance 
capacity to better guide programmatic efforts.
    Priority areas to address:
     Awareness.--Market research conducted by the Arthritis 
Foundation showed that many people are not aware of the available 
programs that improve the quality of life for people with arthritis.
     Availability.--There are simply not enough programs 
available and we need to expand the toolbox of programs.
     Accessibility.--In addition to expanding the number and 
type of existing interventions available, we need to discover how best 
to reach people with arthritis.
    CDC works closely with the Arthritis Foundation, the voice for 
people with arthritis and their families for more than 50 years. The 
Arthritis Foundation recognizes the need for health promotion 
strategies for people with arthritis that are tested and proven 
effective. CDC's strength is its ability to demonstrate the 
effectiveness of an intervention strategy or program and help States 
and communities put it into practice.
    The growing evidence for the benefits of healthy behaviors 
(physical activity and weight control) and disease management 
strategies for people with arthritis must be shared and implemented 
widely in public health practice. CDC can, through its leadership role 
in the public health community, make sure that the growing body of 
evidence that we can improve the quality of life among people with 
arthritis is applied through public health practice and supported by 
clinical medical practice.

                          CURRENT CDC EFFORTS

    Despite the enormous burden of arthritis, public health efforts for 
arthritis are fairly new. Prior to 1998, we are aware of only two 
States that had organized activities addressing arthritis: Missouri and 
Ohio. There was no national public health plan for arthritis and 
arthritis had never been made a priority in our national health 
objectives. CDC, too, had limited efforts.
    The National Arthritis Action Plan: A Public Health Strategy was 
developed by CDC, the Association of State and Territorial Health 
Officials, and the Arthritis Foundation with the help and input of 90 
other organizations to address this large and growing problem. This 
landmark plan recommends national, coordinated efforts to reduce pain 
and disability and improve the quality of life for people with 
arthritis. This plan forms the foundation for CDC's arthritis efforts.
    The primary goal of the CDC Arthritis Program is to improve the 
quality of life for people affected by arthritis--decreasing the pain 
and disability that often accompany arthritis. Since 1999 when CDC 
received its first ever appropriation for arthritis, CDC has made 
progress.

Support to States
    A core activity of the CDC Arthritis Program has been to fund State 
health departments to develop activities to address the burden of 
arthritis in their State. CDC currently funds Arthritis Programs in 36 
State health departments. At present, 35 states have active coalitions 
which guide activities and share responsibility for reducing the burden 
of arthritis, and 31 States have published plans for reducing the 
burden of arthritis in their State. Partnerships and joint activities 
with the Arthritis Foundation are key features of these State programs. 
Prior to 1999, only 10 States had gathered data to measure the number 
of people with arthritis in their State; in 2001, all 50 States and the 
District of Columbia measured how many people with arthritis live in 
their State. Illinois is an example of CDC's state-based arthritis 
programs.

            Illinois: Reaching Rural and Underserved Populations: 
                    Promoting Physical Activity Interventions for 
                    People with Arthritis
    In Illinois, 2.1 million adults had doctor-diagnosed arthritis and 
an additional 940,000 reported chronic joint symptoms in 2001. In 
Illinois, the prevalence of arthritis in rural areas is 33 percent, 
higher than the prevalence in Chicago (24 percent) other Illinois urban 
areas (29 percent).
    With CDC support, Illinois is increasing its efforts to reduce the 
burden of arthritis by increasing the availability of evidence-based 
arthritis physical activity programs in five counties, representing 
rural and underserved populations. In partnership with county health 
departments, the Arthritis Foundation's PACE (People with Arthritis Can 
Exercise), Aquatics and Arthritis Self-Help Course programs are being 
offered, reaching over 700 new participants. The coordinators 
responsible for these projects at the county level report that interest 
in and demand for the programs has exceeded expectations. In fact, 
coordinators are recruiting more course leaders and looking for 
additional venues to offer programs to meet this demand. Working 
through local health departments may be an efficient way to provide 
evidenced-based programs to people with arthritis in rural and 
underserved areas.

            Implications and Impact
    Arthritis-specific interventions have been proven to reduce the 
impact of arthritis or chronic joint symptoms by improving function and 
reducing pain and the need for physician visits. These interventions, 
however, are scarce in rural and underserved areas where people at risk 
of arthritis-related disability reside. This Illinois strategy to 
expand these community-based programs can serve as a model to help 
other States increase the availability of similar programs in rural and 
underserved areas.
    We will continue to work with States, as many have limited 
resources--only enough to conduct modest demonstration projects. States 
will be challenged to ensure that self management education and 
physical activity programs for arthritis are available statewide.
Improve the Science Base
     CDC has provided long-term support to the Johnston County 
(NC) Osteoarthritis Project, a unique, population-based, longitudinal 
study of hip and knee osteoarthritis among 3200 rural white and black 
residents aged 45 and older. Hip and knee osteoarthritis are two of the 
most common, disabling, and expensive types of arthritis.
            The Project has already shown a higher rate of hip 
        and knee osteoarthritis among blacks than previously thought, 
        the importance of overweight in the development of 
        osteoarthritis among blacks, and the importance of pain in 
        determining the functional limitations that occur.
            Expected findings will better characterize the 
        impact of osteoarthritis on previously understudied groups 
        (e.g., blacks, rural residents) and suggest the high risk 
        groups among them for targeted interventions.
            Additional studies will find factors linked to the 
        initial occurrence as well as subsequent progression of 
        osteoarthritis, which will allow us to determine: (1) which 
        biomarkers (e.g., blood tests, genes) can be used to make an 
        earlier diagnosis and to suggest who needs more aggressive 
        treatment, (2) how single and combinations of factors (e.g., 
        joint injury, obesity, age, body composition, osteoarthritis in 
        other joints) put a person at higher risk, and (3) how a person 
        can modify these factors to reduce their impact.
     CDC co-sponsored ``Stepping Away from OA: Prevention of 
Onset, Progression, and Disability of Osteoarthritis.'' This NIH-led 
effort addressed the preventive aspects of this most common type of 
arthritis.
     CDC co-sponsored a 2003 international conference 
summarizing the evidence for exercise and physical activity as 
underused interventions to prevent arthritis disability. This 
conference also made recommendations about what needs to be done next 
for biomedical and population-based research.

Identify and Evaluate Promising Interventions
    Public health goals for arthritis include increasing the use of 
effective self-management strategies to minimize pain and optimize 
function among people with arthritis. Central to achieving this goal is 
identifying and evaluating promising interventions--those interventions 
that have demonstrated some potential to improve the quality of life 
for people with arthritis. We are working to develop sufficient 
scientific evidence so we can confidently tell Americans with arthritis 
`if you participate in this activity, you can receive this benefit'.
     CDC is also funding the evaluation of several public 
health interventions designed to increase physical activity among 
people with arthritis.
    The PACE (People with Arthritis CAN Exercise) program, developed 
and disseminated by the Arthritis Foundation specifically for people 
with arthritis, is currently being evaluated at the Universities of 
Missouri and North Carolina. This program teaches program participants 
exercises which can reduce their pain and improve there ability to 
move; pilot results are promising.
    Active Living Every Day, a program developed by the Cooper Clinic, 
is a program that has been demonstrated to help people increase their 
physical activity by specifically attending to barriers that get in 
their way. Past evaluations have shown that participants have improved 
cardio-respiratory fitness and reduce blood pressure and body fat 
percentage. These evaluations have not addressed people with arthritis. 
The University of North Carolina is evaluating the Active Living Every 
Day program among people with arthritis.

Increasing Awareness--Reaching the Public
    CDC and its partners are also reaching Americans with arthritis 
through mass media--specifically radio, newspapers, and displays at 
their local stores.
     CDC has developed a marketing campaign to promote physical 
activity among people with arthritis. The campaign was designed with an 
arthritis-specific message, to reflect a major motivator for people 
with arthritis. Audience research demonstrated that what people with 
arthritis are most seeking is pain relief, though most do not want to 
depend on medications for their pain relief. This research led to the 
development of the marketing campaign: Physical Activity. The Arthritis 
Pain Reliever. This campaign was quite successful in pilot testing: 50 
percent reported hearing or seeing the message and 20 percent reported 
increasing their physical activity in response to something they heard 
or read. This campaign is currently being used by 35 of the 36 State 
health departments who receive arthritis funding from CDC.

            Oregon: Using the Media to Reach People With Arthritis: 
                    Physical Activity. The Arthritis Pain Reliever

                         Public Health Problem

    In Oregon, 567,000 adults had doctor-diagnosed arthritis and an 
additional 365,000 reported chronic joint symptoms in 2001.

                            Program Example

    With CDC support, the Oregon Department of Human Services, 
Arthritis Program, pilot tested the CDC-developed health communications 
campaign, Physical Activity. The Arthritis Pain Reliever, in Bend, 
Oregon (Population 52,000). The campaign used a combination of radio, 
print and television media to reach the target population. Arthritis 
prevalence is estimated to be 39 percent in this area.

                        Implications and Impact

    The campaign reached its target audience. In a post campaign survey 
of 300 adults with arthritis.
     56 percent reported hearing a message about the health 
benefits of physical activity for arthritis;
     Of those who heard the message, 24 percent recalled the 
campaign theme, ``Physical activity. The arthritis pain reliever.'' 71 
percent recalled ``Physical activity is good for arthritis;''
     14 percent of people in the campaign target group (ages 45 
to 64, lower SES, white and African American) reported increasing their 
physical activity in response to something they read or heard.
    The CDC-developed campaign performed well in the Oregon 
implementation in both reaching the target audience and producing 
significant changes in reported health behavior. Most CDC-funded State 
arthritis programs are planning to implement Physical Activity. The 
Arthritis Pain Reliever. The Oregon implementation experience serves as 
a model for other States.
Improve How We Measure the Burden of Arthritis
     Consistent with recommendations in the National Arthritis 
Action Plan, CDC has improved methods used to monitor the burden and 
cost of arthritis in general, and as described above has established 
its impact on mortality, hospitalization, ambulatory care visits, and 
disability. We plan to do the same for specific types of arthritis, 
such as osteoarthritis, rheumatoid arthritis, and systemic lupus 
erythematosus, and for children as well, where arthritis impact is 
poorly understood. Standard data sources don't help much for rare 
diseases like systemic lupus erythematosus, so CDC is supporting the 
development of special registries in Michigan and Georgia to best 
determine the impact.
    In conclusion, I would like to thank the committee for its 
leadership and commitment to the health of our Nation and the interest 
in people affected by arthritis. Great progress has been made in 
addressing arthritis, one of our most common chronic conditions. The 
Nation has a national plan, catalyzing activities in both the public 
and private sectors. State programs, almost unheard of just 6 years ago 
exist in 36 States. The pain and disability of arthritis can be 
improved. We need to continue our work to identify promising 
approaches, develop new approaches, and put this science into action--
getting programs that work out to the people who need them.

    I would be happy to answer any questions from the committee.

                               REFERENCES

    1a. Arthritis Foundation, Association of State and Territorial 
Health Officials, CDC. National Arthritis Action Plan: A Public Health 
Strategy. Atlanta, Georgia: Arthritis Foundation, 1999.
    1b. HP2010 Health Objectives for the Nation.
    1c. Arthritis Foundation, Primer on the Rheumatic Diseases, 2001. 
12th Edition, John H. Klippel, Editor. Arthritis Foundation; Atlanta, 
GA.
    2. Bolen J, Helmick CG, Sacks J, Langmaid G. Prevalence of Self-
Reported Arthritis or Chronic Joint Symptoms Among Adults--United 
States, 2001, MMWR, 2002; 51(42):948-50.
    3. Hootman JM, Helmick CG, Langmaid G. Public Health and Aging: 
Projected Prevalence of Self-Reported Arthritis or Chronic Joint 
Symptoms Among Persons Aged *65 Years--United States, 2005-2030. MMWR, 
2003; 52(21):489-91.
    4. Sacks JJ, Helmick CG, Langmaid G. Deaths from Arthritis and 
Other Rheumatic Conditions, United States, 1979-1998. In Press: J 
Rheumatol, 2004.
    5. Sacks JJ, Helmick CG, Langmaid G, Sniezek JE. Trends in Deaths 
From Systemic Lupus Erythematosus--United States, 1979-1998. MMWR, 
2002; 51(17):371-4.
    6. Centers for Disease Control and Prevention. Prevalence of 
Arthritis--United States, 1997. MMWR; 2001; 50(17):334-6.
    7. Sokka, T. Work Disability in Early Rheumatoid Arthritis. Clin 
Exp Rheumatol, 2003; 21(5 suppl):S71-4.
    8. Lethbridge-Cejku M, Helmick CG, Popovic JR. Hospitalizations for 
Arthritis and Other Rheumatic Conditions: Data From the 1997 National 
Hospital Discharge Survey. Med Care, 2003; 41(12):1367-73.
    9. Hootman JM, Helmick CG, Schappert SM. Magnitude and 
Characteristics of Arthritis and Other Rheumatic Conditions on 
Ambulatory Medical Care Visits, United States, 1997. Arthritis Care 
Res, 2002; 47(6):571-81.
    10. Murphy L, Cisternas M, Yelin E, et al. Update: Direct and 
Indirect Costs of Arthritis and Other Rheumatic Conditions--United 
States, 1997. MMWR, 2004; 53(18):388-9.
    11. Mili FD, Helmick CG, Zack MM, Moriarty D. Health-Related 
Quality of Life Among Adults Reporting Arthritis: Behavioral Risk 
Factor Surveillance System, 15 States and Puerto Rico, 1996-1999. 
Journal of Rheumatology 2003; 30:160-6.
    12. Mehrotra C, Naimi T, Seruda M, Bolen J, Pearson K. Arthritis, 
Body Mass Index, and Professional Advice to Lose Weight: Implications 
for Clinical Medicine and Public Health. In press: Am J Prev Med.
    13. Hootman JM, Macera CA, Ham S, Helmick CG, Sniezek JE. Physical 
Activity Levels Among the General US Adult Population and in Adults 
With and Without Arthritis. Arthritis and Rheumatism (Arthritis Care 
and Research) 2003; 49(1):129-135.
    13a. Fontaine K, Heo M, Bathon J. Are U.S. Adults With Arthritis 
Meeting Public Health Recommendation for Physical Activity? Arthritis 
and Rheumatism 2004; 50(2):624-28.
    14. Wang G, Helmick CG, Macera A, Zhang P, Pratt M. Inactivity-
Associated Medical Costs Among U.S. Adults With Arthritis. Arthritis 
Care and Research 2001; 45:439-445.
    15. Rao JK, Callahan LF, Helmick CG. Characteristics of Persons 
With Self-
Reported Arthritis and Other Rheumatic Conditions Who Do Not See a 
Doctor. J Rheumatol 1997; 24:169-73.
    16. Bolen JC, Helmick CG, Sacks JJ, Langmaid G. Adults Who Have 
Never Seen a Health-Care Provider for Chronic Joint Symptoms--United 
States, 2001. Morbidity and Mortality Weekly Report 2003; 52:416-419.
    17. Boutaugh ML. Arthritis Foundation Community-Based Physical 
Activity Programs: Effectiveness and Implementation Issues. Arthritis & 
Rheumatism (Arthritis Care & Research) 49(3):463-470, 2003.
    18. Breedveld F, Kalden J. Appropriate and Effective Management of 
Rheumatoid Arthritis. Ann Rheum Dis 2004; 63:627-633.
    19. Minor M. 2002 Exercise and Physical Activity Conference, St. 
Louis, Missouri: Exercise and Arthritis ``We Know a Little Bit About a 
Lot of Things . . .'' Arthritis and Rheumatism (Arthritis Care and 
Research) 2003; 49(1):1-2.
    20. American College of Rheumatology/Association of Rheumatology 
Health Professionals. Proceedings from the International Conference on 
Health Promotion and Disability Prevention for Individuals and 
Populations With Rheumatic Disease: The Evidence for Exercise and 
Physical Activity. 2003. Atlanta, Georgia.
    21. Lorig K, Mazonson P, Holman HR: Evidence Suggesting That Health 
Education for Self-Management in Patients With Chronic Arthritis Has 
Sustained Health Benefits While Reducing Health Care Costs. Arthritis 
and Rheumatism, 36(4):439-446, 1993.
    22. Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW, Bandura A, 
Gonzales VM, Laurent DD, Holman HR. Chronic Disease Self-Management 
Program--2-Year Health Status and Health Care Utilization Outcomes. 
Medical Care 39(11): 1217-1223, 2001.
    23. ORC Macro. Market Research For The Arthritis Foundation. A 
Focus Group Study. May 2003.
    24. Toal S. Assessment of Arthritis Program Capacity. Unpublished 
Report Prepared for the Arthritis Council, Chronic Disease Directors, 
March 2004.
    25. Jordan JM, Renner JB, Luta G, Dragomir A, Fryer JG, Helmick CG, 
Hochberg MC. Hip Osteoarthritis (OA) Is Not Rare In African-Americans 
And Is Different Than In Caucasians. Arthritis Rheum. 1997; 40(9)suppl: 
S236 (#1232).
    26. Jordan JM, Luta G, Renner JB, Dragomir A, Fryer JG, Helmick CG, 
Hochberg MC. African-Americans Face An Increased Risk of Bilateral Knee 
Osteoarthritis (OA) From Obesity. Arthritis Rheum. 1997; 
40(9)suppl:S331 (#1796).
    27. Jordan JM, Luta G, Renner JB, Linder GF, Dragomir A, Helmick 
CG, Fryer JG. Self-Reported Functional Status in Osteoarthritis of the 
Knee in a Rural, Southern Community: The Role of Sociodemographic 
Factors, Obesity, and Knee Pain. Arthritis Care Res. 1996; 9:273-278.
    28. Jordan JM, Luta G, Renner JB, Dragomir A, Hochberg MC, Fryer 
JG. Knee Pain and Knee Osteoarthritis Severity in Self-Reported Task-
Specific Disability: The Johnston County Osteoarthritis Project. J 
Rheumatol. 1997; 24:1344-1349.
    29. Felson DT, Lawrence R, Dieppe PA, Hirsch R, Helmick CG, Jordan 
JM, et al. Osteoarthritis: New Insights. Ann Intern Med 2000; 133:635-
646.
    30. Dunn AL, Marcus BH, Kampert JB, et al. Comparison of Lifestyle 
and Structured Interventions to Increase Physical Activity and 
Cardiorespiratory Fitness: A Randomized Controlled Trial. JAMA, 1999; 
281(4):321-34.
    31. Geppert J. Physical Activity. The Arthritis Pain Reliever. 
Pilot Test Results--Unpublished Report. 2003.

    Senator Bond. Dr. Serrate-Sztein.

  STATEMENT OF SUSANA SERRATE-SZTEIN, M.D., CHIEF, RHEUMATIC 
     DISEASES BRANCH, NATIONAL INSTITUTE OF ARTHRITIS AND 
   MUSCULOSKELETAL AND SKIN DISEASES, NATIONAL INSTITUTES OF 
                             HEALTH

    Dr. Serrate-Sztein. Thank you very much. I am pleased to 
testify before you today to highlight recent research advances 
and new NIH initiatives in the field of arthritis research. The 
NIAMS is the lead institute at the NIH for research on 
arthritis and related diseases, though 18 other agency 
components also support research in this area. While the public 
health burden of arthritis and related diseases is 
significant--at the personal, community, and societal levels--
we have made great progress in understanding these diseases and 
how best to diagnose, treat, and prevent them. Indeed, as the 
number of Americans affected by arthritis increases with the 
growth and aging of the population, the research community is 
faced with growing challenges as well. The NIH is fully 
committed to meeting these new challenges and to taking 
advantage of the new promising scientific opportunities in this 
area of research.
    Arthritis and related rheumatic diseases are characterized 
by inflammation and loss of function in one or more of the 
connective or supporting structures of the body--bones, 
muscles, tendons, joints, and ligaments. There are over 100 
forms of arthritis. Most of them can affect children and 
adults, and they are often more serious and more common in 
women and minorities. Some of the more common forms include 
osteoarthritis, rheumatoid arthritis, fibromyalgia, lupus, and 
gout.
    Arthritis research supported by the NIH covers a broad 
spectrum of basic, translational, and clinical studies and 
includes funding for major research centers and research 
registries which serve as national resources. By way of 
example, in the pediatric arena, the NIAMS funds a 
Multidisciplinary Clinical Research Center at the Children's 
Hospital Medical Center in Cincinnati which focuses on diseases 
such as juvenile rheumatoid arthritis, juvenile fibro-
myalgia, and juvenile dermatomyositis. The Institute also 
supports a Core Center on pediatric rheumatic diseases and 
research registries on JRA and neonatal lupus. Centers and 
registries strengthen the overall foundation for rheumatology 
research across the country and provide training opportunities 
for scientists who are interested in working on these 
devastating diseases.
    In recent years, a number of important research advances 
have been made as a result of NIH-supported research. 
Highlights of these advances include:
    A better understanding of the intricacies of the 
inflammatory mechanisms that lead to joint destruction in 
osteoarthritis and rheumatoid arthritis;
    The discovery of a gene and gene polymorphisms that 
underlie susceptibility to diseases such as rheumatoid 
arthritis, juvenile arthritis, and lupus;
    The identification of genetic signatures in some patients 
with lupus who develop such life-threatening complications as 
blood disease, central nervous system damage, and kidney 
failure;
    The identification of biological markers that can predict 
rapid progression of rheumatoid arthritis and allow physicians 
to make early diagnosis and institute early aggressive 
treatment;
    Insights on the role that anxiety plays in long-term 
outcomes in children with juvenile arthritis.
    While this is by no means a comprehensive listing of 
critical advances, it paints a clear picture of the 
considerable progress that has been made through NIH 
investments in this area of research.
    There are many exciting initiatives across the NIH in 
arthritis research that are building on our growing body of 
evidence and understanding about these diseases. I will cite 
three examples that illustrate the promise of such initiatives 
to improve public health.
    The first one relates to osteoarthritis. Osteoarthritis is 
the most common form or type of arthritis, especially among 
older people. Currently, we have no treatments to halt the 
progression of joint destruction other than surgical joint 
replacement. Clinical trials for new therapies are long, 
difficult, and expensive. In an effort to speed up the 
discovery of markers of early disease, the NIH has launched a 
public-private partnership known as the Osteoarthritis 
Initiative, a collaborative effort between several NIH 
components and the private sector that will establish risk 
factors for onset and progression of disease. We have also 
launched an Osteoarthritis Biomarker Network that comprises 
researchers that will identify and move laboratory findings to 
the clinical arena for early diagnosis of disease.
    In lupus, we have launched a clinical trial to prevent the 
progression of atherosclerosis in children with lupus. Lupus is 
an inflammatory, autoimmune disease that can cause damage to 
various body tissues, including the skin, the heart, the lung, 
and the brain. Children who have lupus are at higher risk for 
cardiovascular disease due to the buildup of fat in blood 
vessels.
    This clinical trial, called the APPLE trial, is being 
conducted by a network of pediatric rheumatology centers, also 
supports by the Childhood Arthritis and Rheumatology Research 
Alliance, or CARRA, a national network supported in part by the 
Arthritis Foundation. Ultimately, the scientists in this trial 
hope that the statin treatment will have preventive effects on 
the arterial fat buildup that occurs in these young patients, 
often leading them to stroke and myocardial infarction in their 
20s.
    Finally, I want to mention an intramural effort here at the 
clinical center at NIH, the NIH Pediatric Rheumatology Clinic. 
The clinic is a specialty-care medical facility dedicated to 
evaluating and treating children with pediatric rheumatic 
diseases who are enrolled in clinical trials.
    In summary, the NIH is committed to supporting arthritis 
research across a broad spectrum, from basic and clinical 
studies to prevention and behavioral investigations. We are 
proud of the progress that we have made since the Institute was 
formed in 1986, and we are poised to take advantage of emerging 
opportunities in all areas of science for the benefit of 
affected patients.
    Thank you for the opportunity to present this testimony. I 
will be happy to answer any questions.
    [The prepared statement of Dr. Serrate-Sztein follows:]

           Prepared Statement of Susana Serrate-Sztein, M.D.

    Good morning Mr. Chairman and Members of the Subcommittee. I am Dr. 
Susana Serrate-Sztein, Chief of the Rheumatic Diseases Branch in the 
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
(NIAMS) at the National Institutes of Health (NIH). The NIAMS is the 
lead Institute at the NIH for research on arthritis and related 
diseases, though 18 other agency components also support research in 
this area. I am pleased to have this opportunity to testify before you 
today to highlight recent research advances and new NIH initiatives in 
the field of arthritis research. While the public health burden of 
arthritis and related conditions is significant--at the personal, 
community, and societal levels--we have made notable progress in 
understanding these diseases and how best to diagnose, treat, and 
ultimately prevent them. Indeed, as the number of Americans affected by 
arthritis increases with the aging of the population, the research 
community is faced with growing challenges as well. The NIH is fully 
committed to meeting these new challenges, and to pursuing the many 
promising scientific opportunities in this area of research.

                              INTRODUCTION

    Arthritis and related rheumatic diseases are characterized by 
inflammation and loss of function in one or more connecting or 
supporting structures of the body. These disorders especially affect 
the joints, tendons, ligaments, bones, and muscles. Common symptoms 
include pain, swelling, and stiffness that can be debilitating. Some 
rheumatic diseases also involve the internal organs. There are over 100 
forms of arthritis and related conditions, and many of them can affect 
both children and adults. Research has shown that a number of these 
disorders are autoimmune in nature, and affect women and minorities 
disproportionately. Some of the more common forms include 
osteoarthritis (OA), rheumatoid arthritis (RA), systemic lupus 
erythematosus (SLE), scleroderma, and fibromyalgia.

                            RECENT ADVANCES

    Arthritis research supported by the NIH covers a broad spectrum of 
basic, translational, and clinical studies, and includes funding for 
major research centers and research registries which serve as a 
national resource. By way of example, in the pediatric arena, the NIAMS 
funds a Multidisciplinary Clinical Research Center at the Children's 
Hospital Medical Center in Cincinnati which focuses on diseases such as 
juvenile rheumatoid arthritis (JRA), juvenile fibromyalgia, and 
juvenile dermatomyositis. The Institute also supports a Core Center on 
pediatric rheumatic diseases, and a research registry on JRA, at the 
Cincinnati Children's Hospital. At the Hospital for Joint Diseases in 
New York, the NIAMS is funding a research registry for neonatal lupus. 
Both the centers and the registries strengthen the overall foundation 
for rheumatology research across the country, and provide training 
opportunities for scientists who are interested in studying these often 
devastating diseases.
    In recent years, a number of important advances have been made as a 
result of NIH-supported research. Highlights of these advances include:
     A better understanding of the genetics of RA, including 
the role of inflammation in cells lining the joints, and how these 
inflammatory processes contribute to joint destruction.
     The identification of biological markers that can predict 
rapid progression of RA, allowing physicians to develop treatment 
strategies based on the likely course of disease in affected patients.
     The discovery that a variation within the interleukin-6 
(IL-6) gene increases susceptibility to systemic juvenile rheumatoid 
arthritis, the most severe type of this pediatric disease. Progress in 
uncovering such disease-associated genes may lead to clinically useful 
subgroupings for affected patients.
     New insights into the role that increased anxiety--rather 
than depressed mood--plays in heightening the fatigue and pain 
associated with juvenile arthritis. Researchers found that a 
comprehensive treatment approach that addresses pain and fatigue can 
optimize affected children's participation in school and social 
activities.
     A better understanding of the bone and cardiovascular 
changes experienced by young women with lupus. New findings indicate 
that women with lupus are at increased risk for both clinical 
osteoporosis and cardiovascular complications at a much younger age, 
suggesting that more aggressive treatments are needed for this 
population.
     The identification of a genetic ``signature'' in some 
patients with lupus who develop such life-threatening complications as 
blood disorders, central nervous system damage, and kidney failure.
     The discovery that scleroderma cells are resistant to 
factors that can normally regulate the production of collagen, a major 
protein component of the skin and connective tissue. The results 
suggest that, by targeting these factors, new therapeutics could be 
developed to restore a balanced collagen synthesis in scleroderma 
cells.
     The finding that the drug etanercept--one of the new 
``biologic'' therapies that are designed to interfere with specific 
biological processes associated with rheumatic disease--alleviates the 
pain and stiffness associated with ankylosing spondylitis (spinal 
arthritis). This type of arthritis typically strikes adolescent and 
young adult males.
    While this is by no means a comprehensive listing of critical 
advances, it paints a clear picture of the considerable progress that 
has been made through NIH's investments in this area of research.

                            NEW INITIATIVES

    There are many exciting initiatives across the NIH in arthritis 
research that are building on our growing understanding of the 
underlying mechanisms of disease, as well as the cellular, genetic, and 
environmental factors involved. I will cite three examples that 
illustrate the promise of such initiatives to improve public health.

The Osteoarthritis Initiative
    Osteoarthritis (OA) is a degenerative condition whose hallmarks are 
joint pain and limited movement resulting from progressive loss of 
cartilage. OA is the most common type of arthritis, especially among 
older people. Currently, there are no treatments, other than surgical 
joint replacement, that significantly change the course of this 
disease. Clinical trials for new therapies are long, difficult, and 
expensive.
    In an effort to hasten the discovery of new biological markers for 
OA which can be used in clinical studies of potential treatments, the 
NIH launched a public-private partnership known as the Osteoarthritis 
Initiative (OAI). This collaboration--which includes several NIH 
components as well as three private sector partners--is supporting four 
clinical sites around the country, and a data coordinating center. 
These sites will recruit a total of 5,000 men and women age 45 and 
older and follow them for 5 years. Through the collection and analysis 
of biological specimens, images, and clinical data, the researchers 
leading the OAI hope to find markers that will, ultimately, enable 
doctors to identify individuals at risk for OA and people with OA at 
risk for disease progression.
    In a related effort, the NIAMS is also supporting a new OA 
biomarkers network to bring together researchers to share clinical, 
biological, and human resources. Through this novel network, scientists 
will learn more about joint destruction by identifying and monitoring 
biomarkers in joint, bone, and synovial tissues. These efforts could 
provide the clues needed to better define the stages of OA on a more 
consistent and reliable basis.

The APPLE Trial
    Systemic lupus erythematosus (SLE) is a chronic, inflammatory, 
autoimmune disease that can cause damage to various body tissues, 
including the joints, skin, kidneys, heart, lungs, blood vessels, and 
the brain. Studies have shown that women are much more likely to have 
the disease than men, and that it affects African Americans, Asians, 
and Native Americans more commonly than Caucasians. Children who have 
lupus are at higher risk for cardiovascular disease, due to the buildup 
of fat in the blood vessels.
    To better understand this potentially life-threatening complication 
of lupus in pediatric patients, NIAMS is funding a study of statins--
drugs used to lower ``bad'' cholesterol levels--to test their effects 
against fat buildup in the blood vessels of these children. This 5-year 
study, the Atherosclerosis Prevention in Pediatric Lupus Erythematosus 
(APPLE) trial, will involve 280 children diagnosed with SLE. 
Recruitment will be facilitated by the Childhood Arthritis and 
Rheumatology Research Alliance (CARRA), a national network designed to 
enhance pediatric rheumatology studies. Researchers will use a double-
blind, placebo-controlled approach to randomize patients to receive 
either statins or a placebo for 36 months. Atherosclerosis will be 
measured at baseline and at 6-month intervals using ultrasound imaging. 
Ultimately, the scientists hope that the statin treatment will have 
preventive effects on the arterial fat buildup that occurs in these 
young patients.

The NIH Pediatric Rheumatology Clinic
    NIH's Pediatric Rheumatology Clinic, a component of our intramural 
research program, is a specialty-care medical facility dedicated to 
evaluating and treating children with pediatric rheumatic diseases who 
are enrolled in clinical trials. These trials may be studies of the 
natural history, signs, and symptoms of disease when standard treatment 
is given, or can include experimental treatment or diagnostic tests.
    Current studies at the Pediatric Rheumatology Clinic include:
     An investigation of the most effective dosing regime of 
the drug infliximab, one of the new biologic agents, for children with 
juvenile rheumatoid arthritis. The trial will look at the safety and 
effectiveness of a stepwise dosing regime, rather than a fixed dose, 
for eligible children between the ages of 4 and 17 with active JRA who 
do not respond to standard therapy. The drug's effects on bone and 
cartilage, and whether it can improve abnormal growth, metabolism, and 
hormones, will also be examined.
     A pilot trial to evaluate the safety and effectiveness of 
the drug anakinra, another novel biologic therapy, for treating 
patients with neonatal-onset multisystem inflammatory disease (NOMID). 
This disease can cause rash, joint deformities, brain inflammation, eye 
problems, and learning difficulties. Immune-suppressing medicines 
commonly used to treat NOMID do not completely control disease symptoms 
and, if used for a long time in high doses, can cause harmful side 
effects.

                               CONCLUSION

    In summary, the NIH is committed to supporting arthritis research 
across a broad spectrum: from basic and animal studies, to clinical 
trials, to prevention and behavioral investigations. We are proud of 
the progress that has been made since the Institute was formed in 1986, 
and are poised to take advantage of emerging areas of science for the 
benefit of affected patients.
    I would be happy to answer any questions you may have about 
arthritis research at the NIH.

    Senator Bond. Thank you very much to you both. You have 
outlined comprehensive efforts, collaborative efforts. Pardon 
me for expressing a personal interest. What are the most 
promising things you are seeing? Where are you going? What are 
you looking at? What seems to be the most promising areas in 
which you are looking? Obviously, we have got to do a lot of 
communication. There are some things we know about that we need 
to communicate. But what would you say are the best hopes in 
this area?
    Dr. Sniezek, do you want to start?
    Dr. Sniezek. Yes, I can speak from sort of a public health 
perspective. We know that people with arthritis tend to be less 
active and heavier than people without arthritis. We know both 
of these things are bad for folks with arthritis. Physical 
activity is actually good for arthritis. It seems a bit 
counterintuitive, but it is. We are actually promoting physical 
activity and trying to get folks with arthritis to be more 
physically active, obviously achieving and maintaining a more 
normal weight.
    We also know that people who learn how to manage their 
disease better do much better. They can learn how to better 
manage their disease. That is sort of the tack we are taking at 
this point in time, promoting physical and disease self-
management strategies.
    Senator Bond. Dr. Serrate-Sztein.
    Dr. Serrate-Sztein. In terms of research, I would mention 
three areas which I think could benefit from expedited efforts 
to accelerate research. The first one is on genetics. As I 
mentioned, at the NIH we support a number of projects on 
genetics. The identification of genetic factors for 
susceptibility and severity of disease that can also be used to 
identify patient subsets has the potential to allow physicians 
to make early diagnosis and treatment and identify those 
patients at high risk for bad disease that can tolerate the new 
treatments or more aggressive therapeutic approaches. So I 
think that is a very promising area of research. Technological 
advances really provide an opportunity for rapid progress.
    The second area, and related, is the area of biomarkers of 
disease.
    Senator Bond. I am sorry. Pardon?
    Dr. Serrate-Sztein. Biomarkers of disease onset and 
progression. We have a number of technological advances, from 
proteomics to molecular libraries, that would allow the 
subsetting of patients, the tailoring of individual treatments 
to particular patient subsets and so on. So I believe that the 
NIH and the research community are poised to make rapid 
progress in that area as well.
    Finally, I think the area of chronic pain and the 
measurement of subjective patient-reported outcomes is another 
area in which progress can be made. The NIH is now involved in 
an initiative to develop automated instrumentation and 
procedures to record in a reliable way patient-reported 
outcomes, such as pain and fatigue, which are so important in 
terms of quality of life for these patients.
    Senator Bond. You are talking about public health outreach. 
You talked about Illinois. Are there things that we ought to 
add in legislation that would assist you in communicating the 
``Be active, lose weight'' concept to those of our fellow 
arthritis sufferers? What can we do to help you get the word 
across?
    Dr. Sniezek. Well, awareness is an important issue, and 
part of that is in the bill now. The devil is in the details. 
Getting people physically active, getting people at a normal 
weight, and getting these programs out is what we need to do. 
Those are some of the things that we need to do. We need to 
develop programs because we need more tools in the toolbox, so 
to speak. So those are some of the research challenges we will 
have. So awareness will be an important issue.
    Senator Bond. You stated that 21 million Americans reported 
chronic joint symptoms. What does that really mean? And how can 
we define it so people understand it better?
    Dr. Sniezek. The 21 million are people who have had chronic 
joint symptoms for more than 3 months and they have not 
received a diagnosis from a doctor. These people may have 
arthritis, they may not have arthritis. There are other things 
that could account for this. But these people should see their 
physician and figure out whether they do have arthritis or not 
so they can have appropriate management and learn how to do 
appropriate self-management.
    Senator Bond. Dr. Serrate-Sztein, you mentioned 
fibromyalgia, which my mother-in-law suffers from. What is 
happening in that area?
    Dr. Serrate-Sztein. Well, the Institute has been involved 
in a number of activities in fibromyalgia. As you know, we have 
had two major initiatives over the last 10 years to try to 
promote basic and clinical research on fibromyalgia.
    Last September, we conducted an assessment of the portfolio 
of grants at the NIH that relate to fibromyalgia research, and 
as a consequence, we produced a report that is published on our 
website that identifies areas of research that may benefit from 
further activity, including the need for agreement on clinical 
diagnostic criteria; the need for integrated studies of central 
nervous system mechanisms and peripheral mechanisms of pain; 
the need for natural history studies that identify the 
characteristics of disease in adolescents, young adults, and 
older adults.
    We are also in the process of organizing another national 
meeting on fibromyalgia that will be in place or will be 
conducted later this year.
    We have a number of studies on behavioral research looking 
at how to tailor treatments to patients with fibromyalgia 
according to certain characteristics related not only to their 
disease but also to their particular personalities and ability 
to cope with the disease.
    So we are investing in a growing portfolio of research 
projects to cover all these areas of research on fibromyalgia.
    Senator Bond. Thank you very much.
    I will turn to Senator Mikulski.
    Senator Mikulski. Thank you very much, Senator Bond.
    I want to thank both of you for your outstanding work, so 
please don't misunderstand, but I am going to be a little bit 
aggressive here. It is more of an interest than an outcome.
    I am really concerned that, for example, in my own State--
this goes to this whole public awareness issue--that only 13 
percent of the adults with arthritis in Maryland have utilized 
an arthritis education, self-help, or physical activity 
program. So my question, Dr. Sniezek, I am concerned that--two 
things. One, of course, we need more research; of course, we 
need more breakthroughs across all ages. There is no doubt 
about it. But we already know some things, and my belief is the 
only thing people know is go to your doctor and he is going to 
give you a pill.
    My point is I don't think our awareness is working. Again, 
this is a no-fault conversation. I am going to ask you to 
respond, and I am going to also then take you to a physician's 
office and ask you what are you doing there.
    Dorothy Hamill, one of our beloved ice skaters, is a 
Maryland resident, and she has arthritis, and we see her on TV 
actually advertising one of the pain management, agile 
management drugs. She also works out ice skating every single 
day at a workout center in Maryland.
    Now, the drug ads seem to be more effective in telling you 
what to do than anything we do. That is number one. You know, I 
have got faith-based initiative, and these are all nice, but 
they have no traction. I really am beginning to think that our 
statewide efforts are of very limited utility. You could argue 
with me, and I invite you to argue with me.
    The second thing is: Where do people go? They go see their 
doctor. What is it they want? They want two things: No. 1, the 
alleviation of pain, which is indeed severe; and, No. 2, 
anything that will increase their agility and their mobility, 
the ability to do--there are people who would cry their eyes 
out to do just what I just did right here.
    So my questions are: No. 1, why are our State programs a 
flop? Are they a flop? And, No. 2, what are we doing in terms 
of getting into the physician's office? Because you get very 
little advice about weight, activity, and so on there.
    Dr. Sniezek. Calling our State programs a flop seems a bit 
strong.
    Senator Mikulski. Okay. But do you understand, 13 percent 
in Maryland----
    Dr. Sniezek. I do understand and----
    Senator Mikulski [continuing]. That is why I said I am 
going to raise it in the spirit of great collegiality, but 
within a devil's advocate framework.
    Dr. Sniezek [continuing]. Yes, and I understand.
    Senator Bond. That should be good that it is in the spirit 
of collegiality because what Senator Mikulski really means, it 
is much different.
    [Laughter.]
    Dr. Sniezek. Our State programs are fairly new. We have 
really only had money out to the States since about 2000 when 
activities began, and efforts at the State are limited.
    Now, you talked about awareness of it. We do have our 
health communications campaign that has been implemented by 
some of our States. Now, the campaign, which has had limited 
implementation because it can only be done in limited areas of 
States, seems to be effective. The way I want to respond is we 
need to do more of this sort of thing where we can reach 
people. From our health communications campaign, 50 percent of 
the people who were in the target area seem to have heard the 
campaign; 20 percent got the message. This is very positive for 
a health communications campaign.
    One of the things that we really need to learn to do is how 
to better reach people. You are absolutely right in that people 
don't know about the physical activity programs. We have done 
some market research. The Arthritis Foundation has done some 
market research recently. People don't know these programs are 
out there.
    Senator Mikulski. What do they do when they go to a 
doctor's office? Are you really doing a massive public 
education for clinicians?
    Dr. Sniezek. We are not doing a massive public education 
for clinicians.
    Senator Mikulski. Where do people get most of their 
information?
    Dr. Sniezek. People get most of their information--well, 
what we found in our market research for our health 
communications campaign is people get information when they 
stumble upon it.
    The other thing we learned from the research we did for the 
health communications campaign, people aren't necessarily 
looking for a pill. This was surprising. However, physicians 
felt like their patients were looking for a pill. Physicians 
had very, very limited knowledge of other things.
    Senator Mikulski. So then what are you doing about the 
physicians?
    Dr. Sniezek. We have only begun our efforts trying to think 
about how we are going to impact----
    Senator Mikulski. Do you have a plan on doing this yet?
    Dr. Sniezek [continuing]. We have started working with the 
health system. We have gone into Missouri and in Florida trying 
to change the system to provide better care for people with 
arthritis. What we actually did was we worked with teams of 
physicians treating people with arthritis and trying to get 
them to better assess function, pain, and support people in 
their self-management activities and then promote those 
activities. But we need to do more of this.
    Senator Mikulski. Well, my time is up. I would like to urge 
two things. No. 1, there is a saying in social work--of which I 
am--you meet people where they are, not where you want them to 
be. Where people are in physicians' offices, or at least for an 
older group of people, often through Offices of Aging that do 
an incredible sense of outreach, and they are the ones that do 
the physical activity, the food, nutrition work. I would urge, 
No. 1, a real coordination with the Office on Aging if you are 
not doing it already. But I really would emphasize the need to 
really work with the physician community, because every doctor 
I know wants to, No. 1, help patients, alleviate suffering, and 
increase the quality of life of a person. I think that is where 
a lot of what we need to do lies. I think the State programs 
are nice, but I believe the real State effort is not through 
health departments, though that is an important step. It is 
really through the Offices on Aging.
    So I look forward to hearing what those plans are.
    Senator Bond. Thank you very much, Senator Mikulski, and 
thank you for your clear-cut directions.
    Now we are very pleased to be joined by the Senator from 
Washington, Senator Murray.
    Senator Murray. Thank you, Mr. Chairman, and I echo the 
comments of Senator Mikulski as well, and her advocacy on 
behalf of this issue I really, really appreciate. I agree with 
her that this is kind of the silent epidemic out there. People 
who suffer from it suffer in silence a lot of times, just 
simply not going out. I think this kind of hearing really helps 
make the awareness, and I really appreciate you, Mr. Chairman, 
bringing this up.
    The costs are staggering for arthritis. I have heard as 
high as $51 billion. But there is also an economic cost 
associated with loss productivity, even younger women and men 
who get arthritis early and can't work, contribute to their 
families, and the costs to families are overwhelming. So I 
think it is really important that we start putting more 
emphasis on this at all levels. I know Senators Kennedy and 
Bond have introduced a bill on arthritis prevention, control, 
and cure, and I commend you for that. There is a lot in that 
that I have supported and have pushed for.
    I am worried about the funding on it. Putting it out there 
is nice, but we need to make sure that CDC and NIH have the 
resources to carry out the parts of it.
    I think also we should be aware that there is a lot of new, 
exciting treatments for arthritis. Unfortunately, a lot of our 
Medicare rules prohibit people from using them, and I am 
specifically talking about some of the self-injectables like 
Enbrel that are out there, and Medicare covers them if you go 
to your doctor's office. It does not cover you if it is a self-
injectable and you do it at home. We all know people with 
arthritis have trouble getting out of their home. So requiring 
them to go to the doctor in order to be reimbursed is really 
the wrong policy. I have been working on that for some time and 
hope to continue to do that because I think Medicare rules need 
to be written so that it helps patients, not help the 
reimbursement procedures.
    Let me just ask quickly, I think, Dr. Serrate-Sztein, you 
mentioned that women are impacted more than men, and I wanted 
to particularly ask you about gender equity in clinical trials. 
Are we making sure that there are enough reviews to make sure 
that women are a part of these clinical trials so that the 
research does not go in the wrong direction and not take into 
account the number of women who are impacted by this disease?
    Dr. Serrate-Sztein. Absolutely. We are committed not only 
to having women but also minorities adequately represented in 
clinical trials and all clinical studies supported by the NIH. 
Just as a way of example, for our atherosclerosis prevention 
trial in children with lupus, we monitor those numbers on a 
monthly basis and are in contact with investigators and the 
nurse clinical coordinators in each of the sites on a monthly 
basis to make sure that they are recruiting and attracting 
patients that represent the entire spectrum affected by this 
disease. This happens for all of the clinical trials that we 
are supporting.
    Senator Murray. So do you monitor that and make sure that 
there is gender equity?
    Dr. Serrate-Sztein. We monitor recruitment and minority 
inclusion in the clinical trials supported by NIAMS on a 
monthly basis, yes.
    Senator Murray. Okay. Very good. Let's make sure----
    Dr. Serrate-Sztein. I should say also that investigators 
are committed to having representation of women and minorities.
    Senator Murray [continuing]. I just think it is important 
that all of us continue to remind each other that that is a 
critical part of research and trials.
    Dr. Serrate-Sztein. Absolutely.
    Senator Murray. I was curious whether there is any research 
going on in better early diagnosis of arthritis, rheumatoid 
arthritis.
    Dr. Serrate-Sztein. Yes. We support a number of projects 
where investigators are looking at molecules that may help, if 
present, identify patients who are at risk for more severe 
disease or for rapidly progressing disease. We have a number of 
projects, including one that I will mention by name, the 
Autoimmune Biomarker Consortium, which is funded--two 
universities participate: North Shore University Hospital in 
New York and the University of Minnesota. They are working with 
state-of-the-art new technology to identify patients who are at 
risk for either more severe disease or rapidly progressing 
disease, as well as to identify those who do not respond to 
some of the new biological treatments such as the ones that you 
mentioned.
    Senator Murray. Dr. Sniezek, how many States currently have 
Arthritis Action Plans?
    Dr. Sniezek. Almost all of them do.
    Senator Murray. Almost all of them?
    Dr. Sniezek. Yes.
    Senator Murray. Are they all implementing them?
    Dr. Sniezek. I am sorry. Let me rephrase that. Of those 
funded.
    Senator Murray. Okay. How many were funded?
    Dr. Sniezek. Thirty-six.
    Senator Murray. All of them have actions plans or almost 
all of them do. What additional funding does CDC need to make 
sure that all 50 States do?
    Dr. Sniezek. That is a difficult question to answer. Right 
now Congress gives us $14.8 million for arthritis, and we have 
made some progress with that $14.8 million. But we will be glad 
to get an answer back to you.
    Senator Murray. Okay. I would appreciate knowing that 
because I think it is important. Arthritis does not limit 
itself to a few States.
    One other question for you. How does CDC include pediatric 
cases in the action plans?
    Dr. Sniezek. Pediatric arthritis does appear in the State 
action plans. As you know, it is a very rare condition, and 
trying to reach people through public health efforts for very 
rare conditions is difficult. But it is represented. We do not 
have any specific activities at this point in time.
    Senator Murray. Okay.
    Dr. Sniezek. Let me just add, one of the things we need to 
do is to better define the size of this problem and who is it 
and where.
    Senator Murray. I am surprised you said it was a rare 
disorder. It seems to me I know a lot of people who have----
    Dr. Sniezek. ``Rare'' is a relative term; 300,000 may not 
be rare, but compared to 21 million, yes.
    Senator Murray [continuing]. Are there some States with 
higher populations of pediatric----
    Dr. Sniezek. We do not know the answer to that--arthritis 
or pediatric arthritis?
    Senator Murray. Pediatric.
    Dr. Sniezek. We do not, I do not know the answer to that.
    Senator Murray. Arthritis in general, you do not know?
    Dr. Sniezek. Well, States that tend to have older 
populations will have more people with arthritis. Obviously, 
larger States will have more people with arthritis.
    Senator Murray. Okay. Thank you very much, Mr. Chairman.
    Senator Bond. Thank you very much, Senator Murray.
    I just want to know--proudly, we have more than doubled the 
funding on NIH. How much of that is going to arthritis, 
rheumatology and, specifically, how much of that doubling has 
gone to pediatric arthritis?
    Dr. Serrate-Sztein. I will have to provide those numbers 
for the record.
    Senator Bond. I would appreciate it. Thank you very much.
    Do you have any further questions, Senator Mikulski, 
Senator Murray?
    Senator Mikulski. No.
    Senator Murray. No.
    Senator Bond. Well, thank you very much. We appreciate it, 
and I assure you that we are going to continue to work with 
you, and we will have lots more questions. We welcome your 
suggestions on how we can improve the bill and other steps we 
are taking, and obviously, the same request goes to the 
following panel and our very interested guests in addition to 
the witnesses.
    Senator Bond. I would now like to call up the second panel, 
and we will have their full biographies included in the record. 
It gives me great pleasure to call on a Missourian, a neighbor, 
and good friends, and people who have a lot to say on this 
subject.
    Our first witness is KaLea Kunkel, a sophomore at GW, who 
grew up in Oregon, Missouri, in the northwest part of our 
State. At age 19, KaLea has had many years of experience 
overcoming the challenges of living with a chronic disease. At 
age 4, she was diagnosed with juvenile arthritis, diffuse 
scleroderma--I will let her explain it--and she began her 
advocacy work in 1998 and continues to be a patient advocate. I 
first met KaLea and her family in 1998 when I spoke at the 
Arthritis Foundation ``Kids Gets Arthritis, Too'' rally in the 
Capitol.
    Our second witness is Mr. Virg Jones, just across the 
border in Kansas City, KS, first diagnosed with rheumatoid 
arthritis 49 years ago at age 13. He has a remarkable story. He 
will share it with us. He has been an active volunteer with the 
Arthritis Foundation, currently sits on the board of directors, 
is a past chairman, has a degree in accounting and economics 
from Emporia State, and went to work for the Federal Reserve 
Bank as an officer in the Research Division until he retired in 
1994.
    Next we will hear from Dr. Deborah Rothman, Director of 
Pediatrics and Rheumatology at Shriners Hospital for Children 
in Springfield, MA. She is a board-certified pediatric 
rheumatologist and treats children with rheumatoid arthritis, 
lupus, and dermatomyositis. She focuses on the treatment of 
these diseases.
    Our final witness is Dr. John Klippel, president and CEO of 
the Arthritis Foundation. He has more than 30 years of 
experience in rheumatology and medical research. He joined the 
foundation in 1999 as medical director. Before that, he had 
served as clinical director of the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases at the National 
Institutes of Health.
    Welcome to all of you. KaLea, if you would begin, please.

         STATEMENT OF KALEA KUNKEL, PATIENT, OREGON, MO

    Ms. Kunkel. Thank you, Chairman Bond and Ranking Member 
Mikulski, and also the Members of the Subcommittee, for hosting 
today's hearing and for giving me an opportunity to testify on 
this important topic. As you know, my name is KaLea Kunkel, and 
I am 19 years old and a sophomore at----
    Senator Bond. Would you pull that microphone a little close 
to you? Thank you.
    Ms. Kunkel [continuing]. Is that better?
    Senator Bond. That will help.
    Ms. Kunkel. I am a sophomore at George Washington 
University. I grew up in Oregon, MO, a rural town of 900 
people. I am speaking to this committee today as one of the 70 
million Americans who live their life with the daily challenges 
of arthritis and rheumatic disease.
    I was diagnosed with arthritis at age 4. This makes me one 
of about 300,000 children diagnosed with childhood rheumatic 
disease in the United States. I say ``about'' because the 
Federal Government has not yet undertaken a national prevalence 
study that tells us exactly how many children in the United 
States are affected by the over 100 forms of arthritis and 
related diseases. This legislation that we are discussing today 
would authorize the Centers for Disease Control and Prevention 
to undertake this important study.
    My journey with arthritis began when my older sister, Kara, 
was diagnosed with a form of juvenile rheumatoid arthritis when 
she was 6 years old. My brother, sister, and I always 
accompanied Kara to her visits to the pediatric rheumatologist, 
2 hours away at the University of Kansas Medical Center. This 
was the only hospital remotely near us that had a pediatric 
rheumatologist.
    Two years after Kara was diagnosed, I began to experience 
strange changes in the color and temperature of my fingers and 
unusual changes in my skin. Following a battery of tests, I was 
diagnosed with an undifferentiated form of juvenile arthritis 
at the age of 4. However, it was another 3 years before we had 
the exact diagnosis of systemic scleroderma, a life-threatening 
autoimmune disease. Unlike JRA, which predominantly affects the 
joints and eyes in children, scleroderma is a disease of 
fibrosis or hardening of the skin and internal organs, and for 
me, particular the esophagus, intestinal tract, thyroid, and 
lungs. It is very rare in children. Some people have this 
disease for years before they get an accurate diagnosis 
because, like many other forms of arthritis, scleroderma can be 
an invisible disease. The fact that I was able to have 
aggressive treatment very early in my disease has given me an 
improved prognosis.
    I was fortunate that I had a pediatric rheumatologist 
nearby to treat my scleroderma. Children in many other States, 
such as South Carolina, Alabama, Wyoming, and New Hampshire, 
are not so fortunate. They do not have a pediatric 
rheumatologist in their State to provide them with the care 
that I received. The legislation before you today seeks to help 
families by establishing a limited loan repayment program for 
medical students who decide to pursue a career in pediatric 
rheumatology. This legislation also provides grants for those 
who conduct or promote the coordination of research, training, 
and studies related to the prevention of arthritis and other 
rheumatic diseases. Currently, less than half of the children 
who need treatment are receiving treatment by a pediatric 
rheumatologist. This program could mean the difference between 
life and death for children with juvenile arthritis and 
rheumatic disease.
    As I look back on my childhood, I cannot remember a time 
when I did not deal with the daily battles of scleroderma. In 
the early stages of my disease, I had severe skin reactions and 
breathing difficulties, for example, when I touched certain 
substances like soybeans, since I grew up on a farm. When our 
second grade class carved pumpkins, I had to wear rubber gloves 
to protect my skin, but I still had a reaction. I had to leave 
class frequently to take pills and breathing treatments, never 
failing to draw attention toward my disease. At sleepovers with 
my friends, I had to stop to take a breathing treatment for 15 
minutes while my friends stared at the machine producing a fog 
from the medication that opened my airways and helped alleviate 
daily breathing complications. I spent my recess time during 
the winter months watching my classmates play in the snow while 
I sat in the classroom and colored pictures; I was unable to 
explain why I could not join them outside, and I was always 
separated from kids my age. Adults were constantly reminding me 
to be careful, and I was not able to understand at the time the 
reasoning behind everyone's fears. I just wanted to be a normal 
kid like my friends, but every adult seemed terrified for me to 
do anything.
    During my early school years, my skin would become severely 
dry and tight. It would cause cracks, then bleeding. There were 
days when I had blood dripping from my hands and legs and feet. 
Every motion shot pain through my body and my skin would burn. 
Nothing would bring any type of relief. My skin scarred because 
it split open so frequently. I found myself hiding my hands and 
my legs from my friends. I even found myself making up excuses 
about why my skin looked the way it did and why it was rough 
and dry. I was embarrassed to tell my friends any details about 
my scleroderma. Even though I realized I had scleroderma, the 
disease was just a name to me. The symptoms were just a bad 
dream. I had always had health problems; they had simply become 
part of my daily life. Pain was normal for me, and I began to 
become immune to it. I got to a point long ago where I stopped 
wondering what normal was because normal had never been a 
concept that I was familiar with. I never understood what a 
normal pain level was or that my scleroderma could handicap me 
or even kill me one day.
    When I was in the sixth grade, I remember watching the 
movie ``For Hope.'' This movie is about television actor Bob 
Saget's sister and her struggle to cope with scleroderma. After 
the movie, I remember breaking down and bawling, which is 
something I would never do. I cried until my mother came into 
my room and found me. She did not want me to become alarmed, so 
she told me that the type of scleroderma the lady in the movie 
had was not the form I had, that I was not going to die like 
the lady in the movie. She said that my organs were not going 
to scar and stop functioning one day. I was not going to die 
like the woman in the movie did, in intense pain and unable to 
eat or even breathe. That day, she lied to protect me from the 
truth. Now I know that I do have the same form of scleroderma, 
and I dread the day that my medications stop controlling and 
slowing my disease activity.
    Following a serious flare-up of my disease in sixth grade, 
I have come to expect difficult times and increased internal 
damage from my scleroderma. Nearly 8 years ago marked the 
beginning of my trials with severe acid reflux and a lack of 
intestinal mobility. Many days I opted not to eat because the 
reflux was so severe it would aspirate into my lungs. It 
burned, and on top of the pain, I could barely breathe because 
of the burning. My digestive problems mounted during my junior 
year in high school. I found myself in so much pain that I was 
gritting my teeth and taking chronic pain medications several 
times a day just to make it through the daylight hours.
    My joints began to hurt so much that I could hardly walk or 
move. I was trying to play volleyball and cheer along with my 
friends, but I could not move my hips or even walk up a few 
stairs. I stopped eating because my reflux was too painful and 
the fatigue was so severe that I was doing nothing besides 
sleeping, but sleeping was even difficult because of the pain.
    Some days I had to leave school and return home for a few 
hours to try to hide the pain from my teachers and classmates. 
My treatment took 5 months, countless invasive tests, and three 
new medical specialists to stabilize the condition. Before this 
flare-up, I always tried to block out the pain, thinking it 
would pass, but now I can no longer do that. My scleroderma was 
slowly fossilizing my body and scarring my internal organs. I 
could not fight the shots, CAT scans, regular blood tests, and 
countless doctors' appointments.
    I began my freshman year at the George Washington 
University last fall, and I did well for the first several 
months of this semester. However, about the middle of October, 
my scleroderma became more intense than ever before due to 
reflux. I could not swallow or keep food down. My esophagus was 
not pushing food down into my stomach, my stomach was not 
breaking down what I ate, and my intestines were not absorbing 
and moving food through my system fast enough. Not only was my 
entire digestive system in constant cramping pain, but my hips, 
knees, and shoulders became stiff and popped with each 
movement. By the end of October, I could not stand without 
getting dizzy, and all I could do was sleep. It became hard for 
me to keep any food in my stomach, and soon blood was coming up 
with what I ate. This wasn't surprising, however, because I 
threw up everything. I missed classes because I would get so 
dizzy that I almost blacked out on several occasions. I felt 
helpless knowing that this flare-up would send me back to 
another trip of trial and error at the doctor's office in an 
attempt to stop my disease's activity. Hours in the doctor's 
office are difficult, but as a young adult, hiding shots, 
countless medications, and a disease that limits daily 
functions like holding on to your college ID is far more 
painful.
    Now, nearly 5 months later, I take 23 pills a day, a shot 
once a week, and I have five specialists, all of whom require 
regular appointments and specialized tests to monitor my 
scleroderma at least every 3 months. Blood and urine tests 
follow each appointment, and endoscopies with biopsies, lung 
function tests, and CAT scans remain among my annual medical 
examinations and tests. I have come to expect at least one 
flare-up a year, and each year I grow more nervous and worried 
as I watch my disease change my body. As I look back over the 
last 19 years, I do not remember the physical pain. I remember 
the ways I have tried to hide the pain and my disease from 
everyone, fighting the fact that it exists. I think of the 
progression of my scleroderma and wonder how long it will 
remain stable. But despite all the complications I deal with 
daily, I realize I am one of the lucky ones because I am still 
alive. I can still walk even if it is painful. I am still able 
to partially disguise my scleroderma while fighting what before 
has always been an inevitable outcome. I have grown to 
appreciate my doctors. If there is one thing I realize today, 
it is how lucky I am to have a family with health insurance and 
that is able to afford the hundreds of dollars a month it takes 
for my medications that are needed to stabilize my disease. I 
appreciate the fact that my parents saw the necessity in 
finding a pediatric rheumatologist, and I know that we are 
still among the few who have access to pediatric 
rheumatologists. I would not be alive today without the medical 
attention of a pediatric rheumatologist who aggressively 
treated my disease.
    Most people do not think of arthritis as a fatal disease. 
But the fact remains that some forms of arthritis do result in 
death. My disease has always been closely monitored and 
treated, but without a pediatric rheumatologist and funding for 
research, people like myself who suffer from scleroderma and 
other forms of rheumatic disease will never be able to live a 
normal life.
    I close by thanking Senators Bond and Kennedy for 
introducing the Arthritis Prevention, Control, and Cure Act. 
This legislation provides hope to me and the thousands of kids 
living with this terrible disease.
    It is the hope that all children will have access to the 
special care they need and deserve.
    It is the hope for a better understanding of what causes 
juvenile arthritis.
    It is the hope that we will someday find a cure.
    Thank you.
    Senator Bond. Thank you, KaLea, for very compelling 
testimony, and we commend you for your bravery, and we thank 
you.
    Mr. Jones.

       STATEMENT OF VIRG JONES, PATIENT, KANSAS CITY, KA

    Mr. Jones. Yes, thank you, Chairman Bond and Ranking Member 
Mikulski, for giving me the opportunity to come and tell my 
story this morning. I am going to be encouraging you to pass 
legislation that is going to give hope to millions of 
individuals that have arthritis, and particularly the 300,000 
children. I think if I am asking you to provide hope, maybe the 
best thing I can do is to share with you what it is like when 
there is complete hopelessness for the individuals, and that 
would be my story.
    Forty-nine years ago, I was 13 years old. I was an active 
athlete, and I had just started playing basketball after 
football season, and my left wrist became swollen and inflamed. 
The coach sent me to the doctor, and the doctor assumed that I 
had suffered some kind of injury playing basketball. So he put 
my left wrist in a split that I could take off if I wanted to 
play. Being an active 13-year-old, I just took the splint off 
when I played and practiced, then put it back on.
    Three weeks later, my right knee started to swell up and 
become inflamed, and the doctor said, ``You really need to quit 
pushing yourself so hard. This is another athletic injury.'' So 
he encased my leg in a cast from my ankle up to my hip and said 
I needed to give it rest.
    I stayed that way for 5 weeks, when all of a sudden all the 
rest of my joints started to get inflamed and swollen, and it 
became obvious that the diagnosis wasn't correct. When they 
took the cast off, my right leg was stiff; it was completely 
atrophied, all the muscles. They sent me to KU Med Center where 
the doctors diagnosed me with juvenile rheumatoid arthritis. I 
can remember sitting down with my parents and the doctors and 
them telling me I had juvenile arthritis, and my dad, being a 
little crusty, said, ``You mean this kid has rheumatism.'' The 
doctor said, ``Well, it is something like that.'' He says, 
``The only thing we can do for your son is to give him large 
doses of steroids and up to 24 aspirins a day, depending on how 
many it would take to make his ears start ringing, and send him 
home and tell him to just be as active as possible so his 
joints will not get stiff.'' They said, ``You need to come back 
every 6 weeks, and we will check what the effect of the 
steroids are.''
    So I went home, and over the next 3 years, my condition 
deteriorated rather rapidly. It had a big impact on my family. 
My mom had to get up every 2 hours during the night to lift the 
sheets off of me because it was so painful, I couldn't even 
turn over in bed. She would even have extra sheets she would 
keep rolled up next to her so she could give me a warm sheet to 
help me go back to sleep. She would get up at 5 o'clock every 
morning, give me large doses of steroids and six aspirin so I 
could get up and go to school at 7 o'clock.
    School was difficult, and by the time noon rolled around, I 
was hurting so bad and was tired that I couldn't climb up the 
steps in a building that was not disabled-accessible, three 
floors. My friends would help carry me up the steps to classes. 
After school, I would come home and just crash on the couch, 
and my mom would put hot towels on my feet and on my ankles and 
my knees, and I would sit there and eat my dinner on the couch 
and try to do my homework.
    At the beginning of my junior year, I had a severe reaction 
to the steroids. The doctors didn't seem to know what to do. 
Some friends told my parents about a hospital in Hot Springs, 
AR, that specialized in the treatment of arthritis, and they 
took me to that hospital. That was a rather enlightening 
experience. At that time I got to meet 13 or 14 other children 
that had arthritis, and teenagers, and my parents got a chance 
for the first time to talk to other parents of children with 
arthritis. But even at that hospital, even though we took 
extensive therapy in hot water, there were no drugs available 
at that time to slow the progression of the disease.
    Three weeks after I entered the hospital, I was in a 
wheelchair and I stayed there for 5 years, and my legs were 
pronated to 90 degrees. I couldn't stand up. My left wrist, the 
one they had put the splint on, was also pronated to 90 
degrees, and I couldn't use my left hand at all. No matter what 
type of therapy--they tried some drugs, and as Senator Mikulski 
mentioned, gold. It looked pretty, but it didn't do any good 
for me. I tried that. I tried some Plaquenil, a malaria drug, 
but nothing worked. But it wasn't any different for me than it 
was the other children. All the children that were there were 
facing the same hopeless situation that I was facing. There was 
nothing to really help stop the disease.
    After 5 years, the doctors told me that I could just go 
home and learn to live in a wheelchair for the rest of my life 
and do the best that I could, or else I could let a doctor in 
Hot Springs try some experimental surgery to reconstruct my 
knees. Since I had tried everything else, I thought, well, I 
couldn't lose anything. So I let him try the surgery, but it 
didn't work because, being in a wheelchair for 5 years, my 
bones had completely calcified in my knees and they could not 
do reconstructive surgery. Of course, there were no artificial 
joints available back then. So the doctor fused both of my 
knees to give me a chance to stand up again. That was 
experimental, too, because my hips were completely 
dysfunctional. My ankles are almost fused. I didn't have any 
strength in my arms. It was just an attempt to see if I could 
stand up.
    Well, after a year of taking more extensive therapy to 
strengthen my muscles, I was able to walk out of the hospital 
on crutches, virtually like I am now, with two fused knees, two 
fused ankles, an elbow that was fused because of the arthritis, 
a wrist that was surgically fused. The hands they couldn't do 
anything with. Extreme pain all the time and very limited 
motion. I walked out of the hospital to face life. The thing I 
really learned in the hospital was that I was going to be 
fighting a war for the rest of my life with this disease. It 
was going to be relentless. I also learned that I better have a 
good sense of humor and not be too proud when it came to asking 
for help because I was going to need plenty of it.
    When I entered college at Emporia State University in 
September of 1965, I had to hire somebody to help me put on my 
shoes and socks every morning and take them off every night, 
somebody to button my shirts for me if I wore a shirt with 
buttons because I can't button a shirt. I had to hire kids to 
help carry my books to class and back again at night. When the 
weather was really nasty, some of the football players, if the 
snow got too deep, they just carried me up to class on their 
shoulders.
    That is the way I made it through school. I graduated in 
1968 with a major in accounting and economics and started to 
work for the Federal Reserve Bank in Kansas City, got married 6 
months later to my wife, Harriet.
    For a few years, everything went really well. My wife would 
help me with all the things I needed help with every single 
day, until the time I was promoted to the official staff and I 
started to have to travel extensively throughout the Federal 
Reserve System with my job responsibilities. You can imagine 
what it must have been like that first day when my wife took me 
to the airport, kicked me out with my suitcase, and said, 
``Good luck.'' I was coming to Washington, D.C., by the way, to 
the Board of Governors. When I got here, I had to on my own 
figure out, you know, figure out some way to have somebody help 
me with my shoes and socks in the morning and at night, tie my 
necktie--of course, we always had to wear ties back then. It 
wasn't informal. Tie my necktie, button the collar on my shirt. 
Even at times when these hotels had showers with sliding glass 
doors, I might even have to ask somebody to help me get into 
the shower. That is what it was like for the 12 or 14 years I 
was on the official staff.
    I got pretty creative in hotels where they didn't have 
bellmen. I got help from maintenance men, from the 
housekeepers, even from the hotel management. It didn't make 
any difference. Some guy was cutting the grass one time. I just 
said, you know, ``Come give me a hand.'' Everybody was willing 
to help. But I got it done. I can't carry an umbrella. When I 
would get out of the car and it was raining, I would have to 
either ask the cabby to hold the paper over my head until I got 
to the building or just wave at somebody on the street to bring 
me an umbrella, to lend me their umbrella.
    Climbing steps, and coming into your wonderful building 
this morning, I am glad I had my wife with me, or else I would 
have had to ask somebody to help me get up those steps.
    That is the way it was for that time. A real challenge, but 
I think that the lessons I learned about arthritis helped me 
get through this.
    My wife had asked me not to put anything in the testimony 
about our relationship and the adjustments she had to make in 
our married life, but I can tell you they were great. I married 
an angel, and she says she gets as much from me as she gives to 
me, but that is not true. Not only is she a housewife, she is a 
plumber, she is an electrician, she changes the oil in the 
tractor. She does all those things. She even gave up her 
teaching career early in our marriage because, for her, 
housekeeping was a full-time job.
    My children, we had to adopt our two children because all 
the steroids prevented us from having children of our own. 
Raising children was another big challenge, where the sense of 
humor came in very well, because when I tried to teach my kids 
to count, can you tell how many fingers I have up? Or my wife, 
when I ask her to get something and I point, can you tell which 
direction I am pointing? That is the type of thing that you 
live with every single day.
    The Arthritis Foundation over the last 22 years has given 
me a platform that gives me frequent opportunities to go out 
and talk to parents and children with arthritis. In those 
presentations and the time I have to talk with them, I have 
always told them about the war they are going to be fighting 
for their whole life. I have told them about the opportunities 
that are available for them to get help. I tell them about the 
tools that they need to have to fight this disease.
    But, surprisingly, what I see is not much different than 
what I faced 49 years ago. True, we have medications that can 
slow down some of the deformities that the kids are having if 
they get treatment early enough and it is aggressive enough. 
But the parents tell me that these medications don't always 
work on their children. These medications are developed of 
adults, and their children either can't tolerate it or they 
just don't work. They also tell me about how far they have to 
travel, 200 or 300 miles, to see a pediatric rheumatologist. 
They tell me how their disease wasn't diagnosed in time. All of 
these things show up, and the kids need help.
    In closing, I would simply like to say, you know, thousands 
of people have helped me get where I am today. I am very 
grateful for that. But the kids today need help, and I don't 
want these kids to have to get the kind of help I got. I don't 
want them to have to look for help to button their shirts, to 
put on their shoes and socks, to tie their ties, to have people 
carry them upstairs, carry them through snow. That isn't the 
type of help they need. They need the type of help that this 
legislation can provide where they know they can get access to 
good doctors, the brightest researchers in the country can seek 
out ways to develop medicines for children. They can do 
research to hopefully find some way to cure this disease. Of 
course, I would like them to be able to someday prevent it.
    It is my dream that someday before I die, I can stand up 
and talk about arthritis, juvenile arthritis, like people talk 
about polio and smallpox, and say, ``This is what it used to be 
like when kids got arthritis.'' I hope that you will share that 
dream with me. I hope that you will use your pen and your vote 
and try to convince your colleagues to cosponsor this bill and 
get it into action because that is where the help is going to 
come from.
    Thank you so much.
    Senator Bond. Thank you very much, Mr. Jones. A very 
difficult but inspiring story.
    [The prepared statement of Mr. Jones follows:]
                    Prepared Statement of Virg Jones
    Thank you Chairman Bond, Ranking Member Mikulski, and all of the 
Members of the Subcommittee for hosting today's hearing and offering me 
the opportunity to share my story.
    I was diagnosed with rheumatoid arthritis 49 years ago. At the age 
of 13, I was initially diagnosed with stress injuries from sports in 
which I was competing. This misdiagnosis resulted in the doctor putting 
my right leg in a cast and a splint on my left wrist. After about 5 
weeks, when all the rest of my joints began to swell and become 
painful, the doctors at Kansas University diagnosed my condition as 
juvenile arthritis. The doctors counseled me and my parents that the 
only treatment available would be large doses of steroids and up to 24 
aspirins a day, depending on how many it would take to make my ears 
start ringing.
    Additionally, they told us it was very important to ``keep going'' 
to maintain as much range of motion in my joints as possible. No 
regular exercise routines were discussed or prescribed and I was told 
to return to the doctor every 6 weeks to monitor the effects of the 
steroids. Over the next 3 years, my condition deteriorated steadily. My 
mom would have to get up every 2 hours during the night to help me turn 
over in bed because the weight of lifting the sheet was too painful. 
She even kept extra sheets rolled up next to her in bed because she 
knew the warm sheets would help me fall back to sleep easier. At 5 
o'clock in the morning, she would give me the steroids and 6 aspirins I 
could get out of bed by 7 o'clock.
    Staying in school was difficult. I was completely worn out by noon 
and the pain prevented me from climbing the steps in the three-story 
building. I thank god for strong friends who helped carry me up the 
flights when it was apparent I couldn't take another step. After 
school, I would crash on the couch and put hot towels on my hands and 
knees to relax and ease the pain.
    It was very difficult for me to see the anguish on my parents' 
faces when the doctors told them there was absolutely nothing more they 
could do to slow or prevent the crippling effects of this disease. I 
had to drop out of school at the beginning of my junior year because of 
a severe reaction to the steroids. At that time, I was admitted to a 
hospital in Hot Springs, Arkansas, which specialized in the treatment 
of arthritis. But even there, there were no new drugs or other 
therapies to help my condition. My situation was by no means unique. 
Virtually everyone at the hospital, including numerous other children 
and teenagers, was facing the same challenges without any hope.
    Three weeks after going to the hospital, I was confined to a 
wheelchair for the next 5 years. I only left the hospital for home a 
few weeks every summer. I suppose they kept me at the hospital for such 
a long time because I was so willing to try anything to improve my 
condition. After 5 years, they told me that I should go home and get 
use to being in a wheelchair for the rest of my life, or I might want 
to consider some experimental surgery to reconstruct my knees. I agreed 
to surgery, but it was not successful and the surgeon had to fuse my 
knees. That process entailed being flat on my back nearly 4 months with 
my legs in casts and traction.
    I remained in the hospital for another year taking extensive 
therapy to strengthen muscles in my legs and back. In the fall of 1965, 
I started my first semester at Emporia State University. Over the next 
3 years, I faced many new challenges as I dealt with the effects of 
having two fused knees; a fused left wrist and elbow, very limited use 
of my hands, and of course constant pain and limited range of motion in 
the rest of my joints. I had to hire a roommate to help me with my 
shoes and socks every morning and night, carry my books to class, and 
provide general assistance in getting around campus in inclement 
weather.
    After graduating in July 1968, with a double major in economics and 
accounting, I started working in the Research Division at the Federal 
Reserve Bank of Kansas City. When I was promoted to the official staff, 
my job duties required me to travel extensively throughout the Federal 
Reserve System. On every trip, I had to seek assistance to carry my 
luggage and briefcase, help with putting on and taking off my shoes and 
socks, buttoning my shirt buttons, and tying my neckties. In those 
instances that I stayed at facilities that did not have bellmen, I 
became very creative in getting assistance from housekeepers, 
maintenance men, and even hotel management. Complete strangers were 
also willing to help me climb stairs, use their umbrella to get from 
the cab to a building when it was raining, open heavy doors, carry 
trays in cafeterias, and pick up anything I dropped on the floor.
    I wish my experience with juvenile arthritis were unique; however, 
. . . .
    Almost 50 years after I first experienced the pain of juvenile 
rheumatoid arthritis, there are still children today who are living 
with the terrible pain and disability associated with this disease. 
Unfortunately, many children continue to be misdiagnosed. Or, they are 
not being seen by a physician who is knowledgeable and/or comfortable 
using the newest therapies to aggressively and properly treat the 
disease.
    There are less than 200 practicing pediatric rheumatologists in 
this country. In many States, there are none. The bill before you today 
would establish a limited loan forgiveness program as an incentive for 
medical students to become pediatric rheumatologists as well as several 
other incentives to address this shortage.
    Almost 50 years ago, I was prescribed 24 aspirins a day to treat my 
disease. Today doctors have much more powerful therapies to treat kids. 
However, we still have significant gaps in our understanding of what 
causes arthritis in kids and adults and we still have not discovered a 
cure.
    Currently, the National Institutes of Health is spending only $7 
million on juvenile arthritis research. This is out of a $28 billion 
budget. This means that our government spends only $23 a year on 
research per every child with arthritis.
    The bill before you today would authorize the NIH to make juvenile 
arthritis research a higher priority and intensify funding to find a 
cure. It is critically important that this happen if we are to help 
these children.
    Arthritis is a difficult and complicated disease. My story is proof 
of that fact. Winning the war against arthritis will require bringing 
together our best and brightest minds and the efficient use of taxpayer 
dollars as we seek to fund the best research, build a strong public 
health response, and ensure persons with arthritis have access to the 
care and medicines they need.
    The legislation would authorize the Secretary of Health and Human 
Services to establish an Arthritis and Rheumatic Diseases Interagency 
Coordinating Committee. This group would be charged with convening a 
Summit of researchers, public health professionals, Federal agency 
representatives, voluntary health agencies and professional and 
academic groups to review current NIH research activities and recommend 
future areas of collaboration between Federal agencies. This work is 
critically important as we seek to improve the lives of children and 
adults living with this disease.
    In closing, I want to extend my deep thanks to Senators Bond and 
Kennedy for introducing this landmark legislation. I hope that my story 
inspires other members of the Senate to co-sponsor this bill.
    Thank You.

    Senator Bond. Now we turn to Dr. Rothman.

STATEMENT OF DEBORAH ROTHMAN, PH.D., M.D., AMERICAN COLLEGE OF 
                 RHEUMATOLOGY, SPRINGFIELD, MA

    Dr. Rothman. Thank you, Chairman Bond, Ranking Member 
Mikulski, and all of the Members of the Subcommittee, for 
providing me with this opportunity to testify on behalf of 
children with arthritis. I would also like to thank Senators 
Bond and Kennedy for introducing the legislation that I intend 
to focus my remarks on today.
    I am a member of the American College of Rheumatology, an 
organization of over 7,000 members dedicated to helping take 
care of people with musculoskeletal disease. It is an honor to 
be here today.
    My name is Deborah Rothman. I am a pediatric 
rheumatologist. I take care of children with arthritis. There 
are only 192 pediatric board-certified pediatric 
rheumatologists in the United States today, so I may be the 
first one and the only one that many of you have ever seen. I 
am fortunate to practice at the Shriners Hospital for Children 
in Springfield, MA.
    People are often surprised to learn that very young 
children can get arthritis. In the United States today, nearly 
300,000 children under the age of 17 are afflicted by juvenile 
arthritis. Many of my patients became ill when they were less 
than 3 years old.
    There are different types of childhood arthritis, but they 
all have one thing in common: swollen, painful joints that make 
it hard for children to walk, run, and play. Their social 
development and their educational achievement may be affected. 
Their growth is often impaired, and their bodies may become 
deformed if they do not get proper treatment. Many of these 
children require frequent hospitalizations.
    I know my time here is limited today. With your permission, 
Chairman Bond, instead of telling you more about JRA, I would 
like to show you. I have great videos. The person running the 
equipment is my boss. This is Dr. Peter Armstrong. He is a 
pediatric orthopedic surgeon, and he is the chief medical 
director of all 22 Shriners Hospitals in the United States, 
Mexico, and Canada.
    In one second, I am going to ask him to start it running. 
For purposes of time, we have edited them down. What you are 
going to see on three of the children are their before and 
after videos--before meaning that these were taken within a day 
or two of first coming to see me at Shriners Hospital; the 
after videos, which will be--the before and after are each 
about 30 seconds. The after videos are anywhere from a week to 
6 months after their initial assessment. The final video is one 
that we just put in. I saw this child in my clinic on Monday 
morning right before I got on the plane. She is a 19-month-old 
girl and has been treated for 6 months by adult rheumatologists 
and no pediatric rheumatologist. It took her 6 months and it 
was a 4\1/2\-hour car trip to come see me at Shriners. So if 
Dr. Armstrong could start that.
    [Videotape shown.]
    Dr. Rothman. Just play close attention to how these 
children are walking. This is a child who only has one joint 
involved, but was this way for several years before she was 
seen. Here she is after intensive aggressive therapy and 
treatment. She is very happy. [Laughter.]
    The next one is a little girl with poly-JRA. She lives in a 
small town in Vermont. She was symptomatic for over a year. You 
can see how hard it is for her to walk. Every joint hurts. She 
is stiff, she is sore, she is miserable. You are going to see 
her after in one second. She received a new medication, and you 
can see that it has truly given her a life.
    The next one is a boy who was sick for 5 years, never saw a 
pediatric rheumatologist. You can see that he has trouble 
getting out of the chair. He can only walk with crutches, and 
even then with problems. His hips, his knees, one ankle, an 
elbow, and a thumb are affected by this. The physical therapist 
is lifting up the jacket so you can see. Here he is after 
treatment with a new medication and joint injections and 
traction. I don't know if you can tell. He is smiling.
    This is a child I saw who has been symptomatic for over 6 
months, and Monday was the first time she ever saw a 
rheumatologist. Her left knee is in fixed flexion at 40 
degrees. She is affected in her left elbow, both wrists, and I 
think she is starting to brew something in her ankle.
    I want to read you a letter that I received from the boy 
who you saw walking with crutches, and then you saw him just 
walking with his cane as an accessory.

          ``Thank you for your help. Now I have the medicine I need to 
        get better. I've been sick for 5 years and until now the 
        doctors did not know what was wrong with me. In the last 10 
        months the pain got worse and I could hardly walk. Thanks to 
        the new medicine I can walk again.''

    Why did it take so long for these children to get the help 
they needed? There is a critical shortage of pediatric 
rheumatologists. Fourteen States in our great land do not have 
any pediatric rheumatologists. Mr. Chairman, in your home State 
of Missouri, there are only four. In my State of Massachusetts, 
we are fortunate enough to have 10, but most of them practice 
in Boston. There are none in Maine. The States of New Hampshire 
and Vermont share one part-time pediatric rheumatologist. Some 
of my patients from New England travel over 4 hours for their 
clinic appointments. Nearly half of all medical schools in the 
United States do not have a pediatric rheumatologist. Of the 
fellows currently in training to become pediatric 
rheumatologists, 40 percent of them are from abroad and will 
return to their own countries.
    The ACR, therefore, strongly supports section 6 of the 
Arthritis Prevention, Control, and Cure Act, investment in 
tomorrow's pediatric rheumatologists. We commend your attention 
to the critical need of an increased pediatric workforce by 
including in the bill incentives to encourage medical students 
and residents to enter the field of pediatric rheumatology. The 
bill would establish a pediatric rheumatologist loan repayment 
program through the Health Resources and Services 
Administration.
    Section 6 of the Arthritis Prevention, Control, and Cure 
Act would also increase the number of career development awards 
through NIH for health professionals who intend to build 
careers in clinical and translational research relating to 
pediatric rheumatology.
    Training more pediatric rheumatologists is just a 
beginning. We do not yet know what treatments are the safest 
and most effective for children. This is because research for 
childhood arthritis desperately needs funding to study the 
causes, treatments, and natural history of the various forms of 
juvenile arthritis. The studies done in hospitals and 
universities show that childhood arthritis differs dramatically 
from adult rheumatoid arthritis. Multi-institution studies are 
needed to truly understand these distinct pediatric diseases 
and to find the best and safest treatments to control each of 
them.
    The pediatric rheumatologists in the United States have 
formed a research network, the Childhood Arthritis and 
Rheumatology Research Alliance, called CARRA, of which I am a 
member. This is a collaborative group formed to study juvenile 
arthritis in its many forms. We are working to understand the 
causes and to find the best treatments for children with 
arthritis. Our vision is to change the outcome of juvenile 
arthritis in as profound a way as the Childhood Oncology Group 
has changed the prognosis in pediatric leukemia and many other 
cancers.
    Other pediatric disease networks have Federal funding. This 
is not the case for researchers and physicians caring for 
children with arthritis. We also need to collect data on the 
outcomes associated with juvenile arthritis. Right now, when a 
parent of a child with arthritis asks me what the future holds, 
I am unable to answer. Section 5 of the Arthritis Prevention, 
Control, and Cure Act would increase funding for innovative 
research in juvenile arthritis and to study outcomes associated 
with juvenile arthritis at the CDC. This is strongly supported 
by the ACR.
    I thank the subcommittee for recognizing that arthritis is 
a serious national health problem. The legislation before us 
today represents an important milestone in efforts to improve 
our understanding of what causes arthritis and ensuring that 
all Americans, young and old, have access to the care they 
need. The American College of Rheumatology looks forward to 
being a partner with you to help improve the lives of persons 
with the Nation's leading cause of disability.
    Thank you.
    Senator Bond. Thank you, Dr. Rothman.
    [The prepared statement of Dr. Rothman follows:]

           Prepared Statement of Deborah Rothman, Ph.D., M.D.

    Thank you, Chairman Bond, Ranking Member Mikulski, and all of the 
Members of the Subcommittee, for providing me the opportunity to 
testify on behalf of children with arthritis. It is an honor to be here 
today. My name is Deborah Rothman. I am a board-certified pediatric 
rheumatologist. I take care of children with arthritis. There are only 
192 pediatric rheumatologists in the United States today so I may be 
the first one you've ever seen. I am fortunate to practice at Shriners 
Hospital for Children in Springfield, Massachusetts.
    On behalf of the 7,000 members of the American College of 
Rheumatology (ACR), I would like to thank Senators Bond and Kennedy for 
introducing the legislation I intend to focus my remarks on today, the 
Arthritis Prevention, Control, and Cure Act of 2004.
    The ACR is an organization of physicians, health professionals and 
scientists that serves its members through programs of education, 
research and advocacy that foster excellence in the care of people with 
arthritis, rheumatic and musculoskeletal diseases. As physicians 
involved in both research and specialized patient care, ACR members are 
acutely aware of the magnitude of the challenges that arthritis places 
on the health care delivery system.
    Arthritis means swelling, pain and loss of motion in the joints of 
the body. There are more than 100 rheumatic diseases that cause this 
condition, which can sometimes be fatal, in both children and adults. 
One in three adults, or 70 million people in the United States, is 
affected by arthritis and other rheumatic conditions. Arthritis and 
other chronic joint problems are the leading cause of disability among 
adults in the U.S., costing more than $86 billion a year in medical 
costs and lost productivity. This burden will surely increase as the 
baby boomers continue to age.
    Rheumatologists are internists or pediatricians who are uniquely 
qualified by additional training and experience in the diagnosis and 
treatment of arthritis and other diseases of the joints, muscles and 
bones. Rheumatologists are highly skilled in the clinical detective 
work necessary to discover the cause of swelling and pain. Typically 
rheumatologists act as consultants, determine diagnoses and recommend 
treatment plans to referring primary care physicians. When the patient 
is complicated, the rheumatologist may be asked to assume principal 
care of that patient. Typically a rheumatologist acts as a team leader 
coordinating the help of many skilled professionals including nurses, 
physical and occupational therapists, other subspecialty physicians 
when appropriate, psychologists and social workers. Health care 
professionals can help people with musculoskeletal diseases and their 
families cope with the changes the diseases cause in their lives. Many 
rheumatologists conduct research to determine the cause, prevention and 
improved treatments for these disabling and sometimes fatal diseases. 
After 4 years of medical school and 3 years of training in either 
internal medicine or pediatrics, rheumatologists devote an additional 2 
to 3 years in specialized rheumatology training.
    You may be surprised to learn that very young children can get 
arthritis. In the U.S. nearly 300,000 children under the age of 17 are 
affected by juvenile arthritis. Many of my patients became ill when 
they were less than 3 years old. There are different types of childhood 
arthritis but they all have one thing in common: swollen, painful 
joints that make it hard for children to walk, run, and play. Their 
social development and their educational achievement may be affected. 
Their growth is often impaired and their bodies become deformed if they 
do not get adequate treatment.
    I know my time is limited here today. So, instead of telling you 
more about juvenile rheumatoid arthritis, or JRA, I would like to show 
you. These are gait videos of three children with JRA before and after 
treatment. The first is of a little girl who has what we consider a 
mild form of JRA with only one joint involved. However, she did not 
receive appropriate treatment until she had been symptomatic for 
several years. You can see how hard it is for her to walk. The next 
video shows her after treatment. The next video shows a child with 
polyarticular JRA. She had symptoms for over a year before she was seen 
by a pediatric rheumatologist. You can see how stiff and uncomfortable 
she looks. The next video shows her after treatment. The last video 
shows an adolescent boy who had been symptomatic for 5 years before he 
was seen by a pediatric rheumatologist. You can see here he can barely 
get out of his chair and needs crutches to walk. The final video shows 
him after treatment walking without his crutches or cane. This is from 
a letter he sent us:

          ``Thank you for your help. Now I have the medicine I need to 
        get better. I've been sick for 5 years and until now the 
        doctors did not know what was wrong with me. In the last 10 
        months the pain got worse and I could hardly walk. Thanks to 
        the new medicine I can walk again.''

    Why did it take so long for these children to get help? There is a 
critical shortage of pediatric rheumatologists. Fifteen States do not 
have any pediatric rheumatol-
ogists. Mr. Chairman, in your home State of Missouri there are only 
four. In my State of Massachusetts we are fortunate enough to have 10 
but most of them practice in Boston. There are none in Maine and the 
States of New Hampshire and Vermont share one part-time pediatric 
rheumatologist. Some of my patients from New England travel over 5 
hours for their clinic appointments. Nearly half of all medical schools 
in the United States do not have a pediatric rheumatologist. Of the 
fellows currently in training now, 40 percent of them are from abroad 
and will return to their own countries when they have completed their 
training.
    The ACR is greatly concerned that there be an adequate future 
supply of both pediatric and adult rheumatologists to diagnose and 
treat arthritis patients of all ages. The ACR, therefore, is very 
supportive of section 6 of the Arthritis Prevention, Control, and Cure 
Act of 2004, investment in tomorrow's pediatric rheumatologists. We 
commend your attention to the critical need for an adequate pediatric 
rheumatology workforce by including in the bill incentives to encourage 
health professionals to enter the field of pediatric rheumatology. The 
bill would establish a pediatric rheumatology loan repayment program 
through the Health Resources and Services Administration to provide 
loan repayment assistance to pediatric rheumatologists who agree to 
provide health care in an area with a shortage of pediatric 
rheumatologists.
    Section 6 of the Arthritis Prevention, Control, and Cure Act would 
also increase the number of career development awards through the 
National Institutes of Health for health professionals who intend to 
build careers in clinical and translational research relating to 
pediatric rheumatology.
    Training more pediatric rheumatologists is just a beginning. We do 
not yet know what treatments are the safest and most effective for 
children. This is because research for childhood arthritis desperately 
needs funding to study the causes, treatments, and natural history of 
the various forms of juvenile arthritis. The studies done in single 
hospitals or universities show that childhood arthritis differs 
dramatically from adult rheumatoid arthritis, but multi-institution 
studies are needed to truly understand these distinct pediatric 
diseases, and to find the best and safest treatments to control each of 
them.
    The pediatric rheumatologists in the U.S. have formed a research 
network, the Childhood Arthritis and Rheumatology Research Alliance 
(CARRA) and are donating their time and energy to create this 
collaborative group to study juvenile arthritis in its many forms. They 
are working diligently to understand the causes, the different types of 
arthritis, and the best treatments for arthritic children. Their vision 
is to change the outcome of juvenile arthritis in as profound a way as 
the Childhood Oncology Group has changed the prognosis in pediatric 
leukemia and many other cancers. To do this, they need funding. Other 
pediatric disease networks, including specialists who care for children 
with cancers, immune deficiencies, juvenile diabetes, and the 
neonatologists who care for high risk newborns, all have Federal 
funding. This is not the case for researchers and physicians caring for 
children with arthritis. We also need to collect data on the outcomes 
associated with juvenile arthritis. Right now, when a parent of a child 
with arthritis asks me what the future holds I am unable to answer. 
Section 5 of the Arthritis Prevention, Control, and Cure Act would 
increase funding both for innovative research in Juvenile Arthritis and 
to study outcomes associated with juvenile arthritis at the CDC. This 
is strongly supported by the ACR.
    Again, thank you for your commitment to fighting arthritis. The ACR 
believes the Arthritis Prevention, Control, and Cure Act of 2004 will 
have a tremendous positive impact on research into arthritis, as well 
as its diagnosis, treatment and eventual cure. In addition to 
emphasizing the importance of research on juvenile arthritis and 
encouraging more health professionals to enter into pediatric 
rheumatology, the bill would increase support for the important work of 
the Centers for Disease Control and Prevention's (CDC) arthritis 
program and critical arthritis research at the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and create more 
interaction between Federal agencies that work to address all forms of 
arthritis that affect both children and adults.
    I am grateful for this opportunity to testify before the 
subcommittee today. I would be happy to answer any questions.
                                 ______
                                 
                           Shriners Hospitals for Children,
                                                     June 14, 2004.
Hon.  Barbara Milulski,
709 Hart Senate Office Building,
Washington, DC.
    Dear Senator Mikulski: Thank you for your support. Here is the 
information that you requested at the Senate Hearing on The Arthritis 
Prevention, Control and Cure Act of 2004.
    I will address your concerns in the order they were presented.

    Question 1. Who would do the epidemiologic survey of pediatric 
rheumatic diseases in the United States ?
    Answer 1. The epidemiologic data that are required for better 
planning and improving services for children with rheumatic disease 
would be best coordinated by the CDC in partnership with CARRA 
(Childhood Arthritis and Rheumatology Research Alliance).

    Question 2. What can we do now to help children with rheumatic 
diseases to ensure early recognition and referral to a pediatric 
rheumatologist as well as providing comprehensive care?
    Answer 2. There needs to be outreach and educational programs for 
pediatricians, family practitioners, adult rheumatologists, and 
orthopedists who practice in areas without pediatric rheumatologists. 
There is a successful program designed by Helen Emery, M.D. (Seattle 
WA) in Northern California that has been funded by the Arthritis 
Foundation summarized briefly here: Pediatric rheumatologists travel to 
underserved areas and conduct workshops to train community physicians 
to identify and diagnose children with rheumatic disease. Through these 
face-to-face meetings a clinical network is created providing the local 
physicians with access to pediatric rheumatologic expertise for advice 
and referral when needed. Pediatric rheuma-
tology centers will be able to coordinate ongoing care with local 
community physicians. This program can also be used for the nearly half 
of all medical schools that do not have a pediatric rheumatologist on 
faculty with an additional component for medical student and resident 
teaching, including residents in pediatrics, orthopedics, family 
practice, and osteopaths.
    The comprehensive care needed by these children requires additional 
funding for ancillary services including social services, nursing, 
transportation, occupational and physical therapy, and nutrition. 
Nurses, nurse practitioners, and physicians' assistants will also be 
needed to provide the additional manpower to allow the pediatric 
rheumatologists time to teach these outreach educational programs and 
to manage the increase in patient referrals and coordinated care 
resulting from the creation of these regional clinical networks.

    Approximate financial commitment: $250,000/center/year  50 
centers = $12,500,000/year.

    Funding for the clinical year for an additional 12 pediatric 
rheumatology fellows would also provide direct care for children with 
rheumatic disease. The clinical year of the 3-year pediatric 
rheumatology fellowship is devoted entirely to patient care and is not 
funded by any current mechanism, whereas the second and third year can 
be supported by research grants. Many fellowship programs cannot take 
fellows because they cannot support the clinical training year.

    Approximate financial commitment: 12 fellows  70,000/year 
= $840,000/year

    Question 3. What does CARRA need? (Childhood Arthritis and 
Rheumatology Research Alliance)
    Answer 3. The mission of CARRA is to facilitate, and conduct high 
quality clinical research in the field of pediatric rheumatology. A 
clinical research network can directly lead to advancements in 
therapies, resulting in improved outcomes as shown by the Children's 
Oncology Group (COG). Since its creation 3 years ago, CARRA has 
gathered the leading researchers and clinicians in pediatric 
rheumatology to create a network that includes most pediatric 
rheumatologists in North American and over 70 institutions. CARRA has 
designed a network structure that is based on regional centers (hubs) 
which support the affiliated smaller pediatric rheumatology programs 
and community physicians in each region to coordinate and perform 
clinical research studies. There are 2 critical steps necessary for 
CARRA's success over the next 3-5 years. The first is to support 
physician scientists who will design the studies needed to answer the 
important questions, write grants to funding agencies such as NIH and 
the Arthritis Foundation, and analyze and publish the results in the 
medical literature. The second part is to support the regional hubs and 
the many pediatric rheumatology sites that are required to recruit 
patients and implement the clinical trials.
    CARRA and the clinical network developed in the previous question 
will work together. CARRA can bring state-of-the-art care to any 
patient that has access to a CARRA site and the clinical network can 
work in the local communities to recruit patients. This support would 
enable the CARRA members to conduct multicenter research and drug 
studies funded by a variety of resources including NIH, national 
foundations (such as the Arthritis Foundation, Alliance for Lupus 
Research), and pharmaceutical companies.

    Question 4. Who would fund CARRA?
    Answer 4. Funding for the CARRA infrastructure should come from the 
NIH, similar to the Children's Oncology Group. The institutes that 
could be involved are NIAMS, NICHD and NIAID. Funding should be ramped 
up over 3-4 years to reach the following levels by Year 4:
     $4.6 million/year for the structure described.
     Creation of a data base to follow all children treated 
with medications with oncolgic potential, as well as other 
complications, for long-term outcome studies.

    Question 5. What is the role of the FDA?
    Answer 5. The majority of childhood rheumatic diseases are rare so 
medications used to treat them are not included under the pediatric 
rule. All medications that may be used to treat pediatric rheumatic 
diseases must be tested in children. As you know, there are many 
organizations doing work in this area who would have constructive 
suggestions. The comments here represent a preliminary consensus among 
the pediatric leadership of the American College of Rheumatology, the 
Arthritis Foundation, and CARRA.
    I appreciate your interest and the significant questions that you 
are asking about pediatric rheumatology.
            Sincerely,
                               Deborah Rothman, Ph.D., M.D.
                                 ______
                                 

    Senator Bond. Dr. Klippel.

    STATEMENT OF JOHN H. KLIPPEL, M.D., PRESIDENT AND CHIEF 
      EXECUTIVE OFFICER, ARTHRITIS FOUNDATION, ATLANTA, GA

    Dr. Klippel. Thank you, Mr. Chairman.
    It is a great privilege and honor for me to testify this 
morning on behalf of the Arthritis Foundation.
    It is also a great privilege and in fact humbling to share 
our testimony with KaLea Kunkel and Virg Jones. We applaud 
their courage for speaking up, and we value their partnership.
    The Arthritis Foundation is the voice of 70 million 
Americans with arthritis or chronic joint symptoms, including 
300,000 children with arthritis.
    The legislation before us today represents a significant 
step in our fight against arthritis. I will focus on several 
key elements in the bill, beginning with arthritis and public 
health.
    In 1998, the Arthritis Foundation, the Centers for Disease 
Control and Prevention, and more than 50 national organizations 
partnered on the first ever national public health strategy 
addressing arthritis--the National Arthritis Action Plan, or 
NAAP. The plan represents an ambitious effort to increase 
awareness about arthritis prevention and the greater use of 
evidence-based self-management strategies. It seeks to expand 
our knowledge of risk factors and the impact of arthritis, and 
the burden the disease places on our society and economy as we 
build our public health infrastructure through the formation of 
State and local partnerships.
    The launch of the NAAP has already led to several major 
accomplishments, the most important of which is the 
establishment of an arthritis program at the CDC, and the 
inclusion of several goals specifically related to arthritis in 
Healthy People 2010.
    In 1998, there was only one-half of one full-time position 
dedicated to arthritis at the Centers for Disease Control. 
Under the leadership of Dr. James Marks at the agency, and 
consistent with the goals of the NAAP, this condition has 
changed dramatically.
    CDC has established a highly successful arthritis program 
that supports arthritis prevention, leads the Nation's 
arthritis surveillance efforts, and has resulted in the 
development of arthritis public health programs in 36 States. 
This is an extraordinary record of accomplishment in a 
relatively short period of time, and the Arthritis Foundation 
is extremely proud to partner with this agency in this effort.
    Healthy People is the Nation's public health blueprint.
    The 2010 Healthy People Plan contains an entire chapter 
devoted to arthritis. It sets national goals on reducing the 
pain and physical limitations faced by people with arthritis. 
It sets goals on reducing health disparities that currently 
exist with many minority populations. In particular, it 
addresses the problem of the disparity with African Americans 
and the rest of the Nation in the area of total knee 
replacement surgery.
    Yet our Nation continues to face an epidemic of arthritis. 
As indicated earlier by Dr. Sniezek, 49 million Americans have 
doctor-
diagnosed arthritis, and an additional 21 million have chronic 
joint symptoms and have yet to see a health care provider.
    With the aging of the baby boomers, the CDC predicts that 
the number of people over the age of 65 with arthritis and 
chronic joint symptoms will double by the year 2030.
    Obesity, lack of physical activity, and premature 
cardiovascular disease are significant and modifiable risk 
factors for persons with arthritis and for people at risk for 
developing arthritis.
    Young women with diseases like rheumatoid arthritis and 
lupus die early. The cause of their death is cardiovascular 
disease.
    Osteoarthritis is the most common single form of arthritis. 
People normally associate this with aging. However, children 
and teenagers who are overweight and who do not engage in 
physical activity are more likely to develop osteoarthritis as 
they grow older. Similarly, joint injury in children and 
teenagers from rugby poses a similar risk for the early 
development of osteoarthritis.
    Senator Bond. Now you tell me.
    Dr. Klippel. We are seeing persons as young as 20 and 30 
years of age develop osteoarthritis. This Nation is indeed 
facing a crisis.
    This legislation would expand on the NAAP in two important 
areas. It would establish a national awareness initiative 
focused on ensuring that we meet or exceed the national 
objectives in Healthy People 2010. Second, it would address a 
significant gap in our understanding of arthritis among 
children by authorizing a national prevalence study on the 
impact of arthritis in children.
    Congress showed exceptional vision and leadership by 
doubling the research budget of the National Institutes of 
Health. The Arthritis Foundation is extremely proud of the role 
that we played in the creation of the National Arthritis, 
Musculoskeletal and Skin Diseases Institute at the National 
Institutes of Health. This unprecedented action represents the 
single largest and most significant investment in the health of 
mankind ever seen.
    However, not all areas of research have benefitted 
equitably from the dramatic increases in taxpayer support. For 
example, Congress appropriated $28 billion for the NIH in 
fiscal year 2003. Of these dollars, only $7 million was spent 
on juvenile arthritis research. When measured per child with 
arthritis, this equates to $23 per child.
    As a researcher, I understand the critical importance of 
funding research to acquire new knowledge that will help to 
provide more effective and safer approaches to treatment and 
eventually, ways to prevent and cure the disease. This 
legislation seeks to increase our investment in research to 
find a better solution to the serious problems facing everyone 
with arthritis, including children.
    Under the bill, at least two planning grants will be 
awarded to collaborative public-private partnerships to plan, 
establish and improve upon existing or new arthritis programs. 
I believe these grants will begin to attract new researchers to 
this field and build greater research capacity to drive 
innovation.
    The bill also authorizes the Secretary of Health and Human 
Services to convene an Arthritis and Musculoskeletal 
Coordinating Committee. This committee would host a national 
summit of the Nation's leading researchers, public health 
professionals, voluntary health association representatives, 
academic institutions, and Federal and State policymakers to 
provide a detailed overview of current research activities in 
the NIH as well as to solicit input related to potential areas 
of collaboration between NIH and other Federal agencies.
    This effort would be a catalyst for the collaborative 
initiatives that are included in NIH Director Zerhouni's NIH 
Road Map Initiative. In the spirit of the Road Map, the 
legislation will help to spark new and innovative research 
efforts, support cross-discipline research partnerships which 
better address the needs of people with arthritis in such areas 
as pain research, obesity, and cardiovascular disease, and 
would ensure that we continue to be good stewards of limited 
Federal research dollars.
    In 1975, Senator Alan Cranston of California introduced the 
last major piece of arthritis legislation. It was signed into 
law by President Gerald Ford. The bill, the National Arthritis 
Act, set our Nation on an important path in the fight against 
arthritis. It led to the creation of an institute at NIH of 
which we are all extremely proud, focused on arthritis, and 
laid the foundation for a national arthritis public health 
strategy.
    I can say with confidence that these actions have 
profoundly changed the lives of people like KaLea Kunkel and 
Virg Jones and millions of others. However, arthritis is still 
claiming the lives of millions of Americans, causing them 
terrible pain, disability, and premature death.
    I applaud both you and Senator Kennedy and other cosponsors 
of the bill for recognizing this silent problem that for far 
too long has been neglected. We thank you for taking a 
leadership role on behalf of people like KaLea and Virg.
    The Arthritis Foundation will continue to advocate for 
passage of this important legislation, which will set the 
Nation on a path toward a better life for people with arthritis 
and eventually, a cure.
    Thank you.
    Senator Bond. Thank you very much, Dr. Klippel, and my 
thanks to the entire panel for very compelling testimony.
    [The prepared statement of Dr. Klippel follows:]

              Prepared Statement of John H. Klippel, M.D.

    Thank you Mr. Chairman, Ranking Member Mikulski, and all of the 
Members of the Subcommittee for hosting today's hearing and for 
inviting me to testify on behalf of the Arthritis Foundation. I would 
also like to thank Senators Bond and Kennedy for their leadership in 
introducing the Arthritis Prevention, Control, and Cure Act, which will 
be the focus of my remarks today.
    My name is Dr. John Klippel and I'm President and CEO of the 
Arthritis Foundation. I've been with the Foundation for the past 5 
years, four of them as the Foundation's Medical Director. Prior to 
joining the Arthritis Foundation in 1999, I served as Clinical Director 
at the National Institute of Arthritis, Musculoskeletal and Skin 
Diseases at the National Institutes of Health. I'm an arthritis 
researcher and rheumatologist.
    The Arthritis Foundation is the voice of 70 million Americans with 
arthritis or chronic joint symptoms, including 300,000 children with 
arthritis. We are the single largest non-profit funder of arthritis 
research in the world, and the largest nationwide, nonprofit health 
organization dedicated to the prevention, control and cure of 
arthritis--the Nation's number one cause of disability.
    The legislation before us today represents a significant step in 
the fight against arthritis. I will focus on several key elements in 
the bill, starting with arthritis and public health.
    In 1998, the Arthritis Foundation, the Centers for Disease Control 
and Prevention, and more than 50 national organizations partnered on 
the first-ever national public health strategy addressing arthritis--
the National Arthritis Action Plan (NAAP). The plan represents an 
ambitious effort to increase awareness about arthritis prevention and 
evidence-based, self-management strategies. It also seeks to expand our 
knowledge of risk factors and the impact of arthritis, and the burden 
the disease places on our society and economy, as well as build our 
public health infrastructure through the formation of State and local 
partnerships.
    The launch of the NAAP has already led to several major 
accomplishments. The most important are the establishment of an 
arthritis program at the CDC, and the inclusion of several goals 
specifically related to arthritis in the Healthy People 2010 goals for 
the Nation.
    In 1998, there was only one-half of one full-time position 
dedicated to arthritis at CDC. Under the leadership of Dr. Jim Marks at 
the agency and consistent with the goals of the NAAP, this condition 
has changed significantly. CDC has established a highly successful 
arthritis program that supports prevention research, leads the Nation's 
arthritis surveillance efforts, and resulted in the development of 
arthritis public health programs in 36 States. This is an extraordinary 
record of accomplishment in a relatively short period of time, and the 
Foundation is proud to be a partner with the agency in this effort.
    Healthy People is the Nation's public health blueprint. Healthy 
People 2000 contained very little about arthritis. The 2010 plan 
contains an entire chapter devoted to arthritis. It sets national goals 
on reducing the pain and physical limitations faced by people with 
arthritis. It sets goals on reducing the health disparities that 
currently exists between African Americans and the rest of the Nation 
in the area of total knee replacement surgery.
    Yet, our Nation continues to face an arthritis epidemic. As CDC 
stated earlier, 49 million Americans have doctor-diagnosed arthritis 
and 21 million may have arthritis. With the aging of the baby boomers, 
CDC predicts the number of people over 65 with arthritis or chronic 
join symptoms will double by 2030.
    Obesity, lack of physical activity and premature cardiovascular 
disease are significant and modifiable risk factors for persons with 
arthritis and people at risk for developing arthritis. For example, on 
average, a young woman diagnosed with rheumatoid arthritis will die 10 
years before a person who does not have the disease. She will not die 
from RA, but rather from cardiovascular disease.
    Osteoarthritis is the most common form of arthritis that people 
normally associate with old age. However, children and teenagers who 
are overweight and do not engage in physical activity may be more 
likely to develop osteoarthritis as they grow older. Similarly joint 
injury in children and teenagers poses a similar risk for the early 
development of osteoarthritis. We are now seeing persons as young as 20 
and 30 years old develop osteoarthritis.
    This legislation would expand on the NAAP in two important areas. 
It would establish a national awareness initiative focused on ensuring 
we meet or exceed the national objectives in Health People 2010. 
Second, it would address a significant gap in our understanding of 
arthritis among kids by authorizing a national prevalence study on the 
impact of arthritis in children.
    Next, I'll address the area of biomedical research and arthritis. 
Congress showed exceptional vision and leadership by doubling the 
research budget at the National Institutes of Health. This 
unprecedented action represents the single largest and most significant 
investment in the health of mankind ever seen. However, not all areas 
of research have benefited equitably from the dramatic increases in 
taxpayer support.
    For example, Congress appropriated $28 billion for NIH in fiscal 
year 2003. Of these dollars, only $7 million was spent on juvenile 
arthritis research. In 2001, total NIH funding for juvenile arthritis 
research reached a low of $2.8 million.
    When measured by child with juvenile arthritis, this means $23 per 
child.
    As a researcher, I understand the critical importance of funding 
research to acquire new knowledge that will help to provide more 
effective and safer approaches to treatment of arthritis, and 
eventually ways to prevent and cure the disease. I also recognize the 
important responsibility to develop innovative solutions to 
circumstances where we lack research capacity to answer fundamental 
questions about a painful and disabling disease. Merely saying that 
there weren't enough quality research grants is not an appropriate 
answer.
    This legislation seeks to increase our investment in research to 
find a better solution to the serious problems facing children with 
arthritis. Under the bill, at least two planning grants will be awarded 
to collaborative public/private partnerships to plan, establish and 
improve upon existing or new research programs focused on innovative 
approaches to the treatment of juvenile arthritis. I believe that these 
grants will begin to attract new researchers to this field and build 
greater research capacity to drive the necessary innovation.
    The bill also authorizes the Secretary of Health and Human Services 
to convene an Arthritis and Musculoskeletal Coordinating Committee. A 
proven strategy in other disease States, this group would host a 
national summit of the Nation's leading researchers, public health 
professionals, voluntary health association representatives, academic 
institutions, and Federal and State policy makers to provide a detailed 
overview of current research activities of the NIH, as well as to 
solicit input related to potential areas of collaboration between NIH 
and other Federal agencies.
    It would focus on research areas critically important to progress 
in arthritis including basic biomedical research directed at better 
understanding of arthritis, translational (bench to bedside) research, 
epidemiological, psychosocial and rehabilitative issues; clinical 
research on development of new treatments; information and education 
programs for health professionals and the public; determination of 
research priorities for federally-supported initiatives; and address 
the challenges and opportunities faced by the research community and 
public.
    This effort would be a catalyst for the collaborative initiatives 
that are included in NIH Director Zerhoni's NIH Roadmap Initiative. In 
the spirit of the Roadmap, this legislation will help spark new and 
innovative research efforts, support cross-discipline research 
partnerships, which better address the needs of people with arthritis, 
in areas of pain research, obesity, and cardiovascular disease, and 
would ensure that we continue to be good stewards of limited Federal 
research dollars. This focus may lead to more solutions to the 
challenges facing juvenile arthritis research as well as the myriad of 
other challenges facing NIH and partnering Federal agencies like CDC, 
the Food and Drug Administration, and the Agency for Healthcare 
Research and Quality.
    In 1975, Senator Alan Cranston of California introduced the last 
major piece of arthritis legislation. It was signed into law by 
President Gerald Ford. The bill, the National Arthritis Act, set our 
Nation on an important path in the fight against arthritis. It led to 
the creation of an institute at NIH focused on arthritis, and laid the 
foundation for a national arthritis public health strategy.
    I can confidently say that these actions have profoundly changed 
the lives of people like KaLea Kunkel and Virg Jones and countless 
others. However, arthritis is still claiming the lives of millions of 
Americans, causing them terrible pain, disability, and premature death.
    I applaud Senators Bond and Kennedy and the other cosponsors of the 
bill for recognizing a problem that for far too long has been neglected 
and for taking a leadership role on behalf of people like KaLea and 
Virg. The Arthritis Foundation will continue to advocate for passage of 
this important legislation, which will set this Nation on the path 
toward a better life for people with arthritis and eventually a cure.
    Thank You.

    Senator Bond. Going back to KaLea, everybody is talking 
about physical activity being helpful. Are you able now to 
engage in physical activity, and do you have a regimen that is 
helpful in your particular case?
    Ms. Kunkel. Yes. I started swimming through a program with 
the Arthritis Foundation. They began a program I do not know 
how many years ago for children and I believe also adults with 
arthritis so they could learn joint exercises to help keep up 
their mobility. I started that in my first couple years of 
elementary school, and it taught me all these new strokes. 
Since then, I have loved swimming, and still today I notice a 
difference when I am out of the pool on how well my knees and 
my hips function, my shoulders. If I am out for very long, I 
begin to have more joint problems.
    The activity that they helped us learn, still today, I use. 
If I have more joint pain, I find myself doing those exercises 
in the pool and in the water, sometimes in the bathtub, to help 
with the joint pain.
    Also, I think the physical activity helps with your mental 
outlook over your disease, because it keeps you functional, 
which I think keeps up your attitude about it, and in my 
experience, one of the best things that you need to do is to 
remain functional and have a good outlook on it, because 
without it, the disease would be even worse, and I think it 
encourages that a lot, so it has been very beneficial.
    Senator Bond. Virg, do you have any physical activity that 
is helpful in your case?
    Mr. Jones. Well, I am kind of the herald that carries the 
banner for the water exercise programs of the Arthritis 
Foundation. The 6 years I was in the hospital, we had to get 
into hot water every day for exercise, and I never liked the 
exercise, but I did like the water. But since I got out of the 
hospital, and when I retired from the Federal Reserve System in 
1994, I started swimming. I am an avid swimmer. I have a pool 
at my house, and during the summer, I swim an average of 7 to 
10 miles a week--that is at least 2 hours a day. During the 
winter, I swim at a community center and try to go three times 
a week and swim for an hour.
    But I tell everybody I meet who has arthritis to get in the 
pool. There is no excuse. If you do not like the water, get in 
there anyway, because what I have found--of course, all my 
joints are destroyed; I do not have any cartilage, I do not 
have any rotator cuffs or anything like that that are in good 
shape--but swimming, and maintaining some range of motion and 
mostly muscle tone helps more than anything else. I have 
learned that no matter how hard I press myself, the more I can 
maintain the muscle and the cardiovascular system, the better I 
feel. I think it is just so important that all people who have 
arthritis get access to warm water therapy.
    Senator Bond. Thank you, Virg.
    Dr. Rothman, you made some amazing strides with those 
patients that you had. Has this come about in the last 10 years 
or so? What are the exciting new things that are making such a 
profound impact?
    Dr. Rothman. I think we have gotten much more aggressive 
about treating these children. I finished my fellowship in 
1994. From that time until now, there have been absolutely 
extraordinary developments. One of the most important has been 
the use of cytokine blockade. That would be a way to decrease 
the inflammation in children.
    You have heard of these drugs called etanercept and 
remicaid. The two children who showed the most extraordinary 
improvement both received etanercept. The boy whom you saw 
getting out of the wheelchair and then the after picture--the 
after was 2 weeks after he started etanercept. He had also been 
treated in our orthopedic hospital by joint injections with 
steroids, which have made a huge difference in children. He had 
also been put in traction for a week to stretch out his 
muscles; he was very contracted.
    But I would say that in my experience, etanercept and 
remicaid have absolutely turned the course for some children 
but not all. We still do not have good treatment for systemic-
onset JRA, which is the type of arthritis with high fever, 
systemic organ involvement. Those children are helped by the 
medicines oftentimes, but not to the same degree as children 
with polyarticular arthritis.
    The other thing that we have learned from our colleagues in 
oncology is that many of these children need multi or 
combination therapy, so these children will be on two or three 
or four drugs at once. They will receive high-dose steroids 
intravenously on a regular basis. They are frequently 
hospitalized--we refer to these children with great affection 
as our ``frequent fliers.'' They need a lot of care and 
ongoing, and we are very aggressive about therapy, we are very 
aggressive about getting them active.
    Senator Bond. Thank you.
    Dr. Klippel, you talked about the cardiovascular disease 
leading to premature death in people with arthritis. What is 
the relationship between cardiovascular disease and arthritis?
    Dr. Klippel. Well, Senator, thanks to the cover of Time 
Magazine, I think the American public was taught that 
inflammation is a key risk factor for atherosclerosis.
    What we have known for years is that people with some of 
the most serious forms of arthritis, like rheumatoid arthritis 
and lupus, develop cardiovascular disease early. So we believe 
it is the systemic inflammation and the attack of the immune 
system which is responsible for their underlying disease that 
contributes to this. We believe that that provides an 
opportunity for us to more effectively work with cardiovascular 
disease researchers to better understand atherosclerosis, to 
help our own patients as well as anyone in this Nation who 
suffers from atherosclerosis.
    Senator Bond. So Vioxx would have cardiovascular benefits, 
perhaps?
    Dr. Klippel. Well, that is an interesting question, because 
what we know is that COX-2, which is one of the enzymes 
involved in inflammation, certainly can play a role in heart 
disease, and I think there is a lot of research that needs to 
be done to better understand the detailed mechanisms of 
atherosclerosis and how we more effectively use not only drugs, 
but I think other preventive strategies like obesity 
management, physical exercise, as a way to benefit for 
atherosclerosis and arthritis.
    Senator Bond. Is there any other step? You have mentioned a 
number of things. What do you see from the Foundation's 
standpoint as additional steps that appear promising?
    Dr. Klippel. Well, I think several things--the Foundation 
is committed to getting the best and brightest minds in this 
country to dedicate their lives to arthritis, whether it is 
research or the provision of care. So we do want to invest in 
young people so that there will be a manpower force that can 
actually solve this problem and care for people with arthritis.
    We are committed to three things. We are committed to 
investing our resources in research and working with others who 
share that vision. We are committed to public health. We 
believe that the launch of public health initiatives is an 
extremely important strategy to address the problem of 
arthritis.
    Finally, we are privileged to work with you, because we 
recognize that many of the challenges faced by people with 
arthritis are only going to be solved through legislative and 
policy initiatives, so that you play an extremely valuable role 
in working with us to improve the lives of people with 
arthritis.
    Senator Bond. Thank you very much, Dr. Klippel.
    Senator Mikulski.
    Senator Mikulski. Thank you, Mr. Chairman.
    First, to Ms. Kunkel and Mr. Jones, thank you for your very 
poignant and compelling testimony. I think the words that I 
would like to use are ``courage'' and ``determination.''
    First of all, I want to thank you for your public advocacy 
and the fact of the trauma that you went through not only from 
the disease but being able to have a life, a social life, et 
cetera. The fact, Ms. Kunkel, that you are in college, and Mr. 
Jones finished college and was able to make a contribution and 
raise a family, is a tribute first of all to your grit. So we 
thank you for what you said.
    It also brings up another issue of caregiving, which we 
have not discussed here, and the caregiver. First of all, Mr. 
Jones, where is Harriet?
    Could Harriet stand up? Harriet, we want to give you a 
round of applause.
    [Applause.]
    I do not know if your mother is still with you, Mr. Jones, 
but God bless her for getting up those 2 hours early every 
morning.
    Ms. Kunkel, is your family here with you today?
    Ms. Kunkel. My mother is here, sitting behind me.
    Senator Mikulski. Let us hear your mother's name.
    Ms. Kunkel. I am sorry--Anne Kunkel.
    Senator Mikulski. Let us give her a hand, too.
    [Applause.]
    Mr. Chairman, I think that is the subject of another 
hearing, which is caregiving for families where there are 
chronic situations, and of course, the first caregiver is 
always the family, and how we can support the family as they 
try to help people with really very severe chronic conditions. 
So we salute you.
    Another topic would be the cost of insurance. As you have 
talked about, Dr. Rothman and Dr. Klippel, the 
hospitalizations, the prescription drugs, the breakthroughs 
that we hope will come--it is great to have breakthroughs, but 
are we going to be able to afford to do it? Will the families 
be able to afford a prescription drug benefit? What we are 
seeing is that we are now struggling with a prescription drug 
benefit for seniors under Medicare, but if you have lupus, you 
tend to be in your thirties and forties, and you have talked 
about these wonderful children--that was like out of a miracle 
movie. I was so touched. We just wanted to cheer for those kids 
and give them T-shirts and pompons. It was just so wonderful to 
see that. But that is also another topic.
    So just know that we want to be on your side and look at 
these issues.
    Dr. Rothman, I want to come to your very compelling 
testimony. Ms. Kunkel raised the issue that there has been no 
prevalency study of this. Can you tell me who should do that 
and how we can get it?
    Dr. Rothman. I think there are other experts more qualified 
than I. My opinion would be that that is something that we need 
to work with with the CDC.
    Senator Mikulski. I think this is another way that we can 
improve the legislation as it goes through markup, because I do 
think we need the basic tools of epidemiology and a prevalancy 
study for juvenile arthritis as well as the various 
manifestations of it. Ms. Kunkel has one manifestation, other 
siblings had it, and the boys and girls in the very compelling 
videos.
    So prevalency is number one.
    Number two, let me get to your articulation about the need 
for pediatric rheumatologists, which Ms. Kunkel spoke to as 
well. We really want to support Section 6, so that is decided. 
But as we move legislation, the pipeline can take a while, and 
your own extensive training that you articulated. Are there 
ways now that we can encourage--or maybe it has no efficacy--
ways that we can use pediatricians and others now. What you did 
there was really stunning for us to see, and thank you for 
bringing the video. But are there other ways that we can reach 
those people who treat children, not as a substitute, but as 
you know, it is going to be 3 years, 4 years, et cetera, where 
they have got to recruit, they have got to do these wonderful 
fellowships like you participated in, opportunities at places 
like Shriner's, but what can we do now--or do you think that 
that is of limited utility?
    Dr. Rothman. I think there are two issues, and that is a 
very good question. One possible solution or at least help 
would be if we can educate pediatricians and adult 
rheumatologists in communities. I will go anywhere and talk to 
anyone at any time about arthritis, and as part of Shriner's 
Hospitals, we do a lot of outreach clinics, we do a lot of 
teaching seminars so that pediatricians in not only our 
community but throughout know about the importance of early 
referral.
    The other issue is that medical students and pediatric 
residents need to be exposed to rheumatologists, and there are 
some programs now for medical schools that do not have a 
pediatric rheumatologist on faculty, where a guest pediatric 
rheumatologist will go to the institution for 1 to 3 days, give 
lectures, see patients, and raise awareness.
    I can tell you that the medical school I attended did not 
have a pediatric rheumatologist. I did not know the existence 
of the field until I did my residency at New England Medical 
Center. So I think we need to have residents being exposed.
    Since I have been at Shriner's, we have actually had one 
pediatric resident become so interested in rheumatology that 
she is doing a fellowship starting this July at Duke 
University. I think that once pediatric residents get exposure 
to rheumatology, see how wonderful and amazing our patients are 
and learn about the diseases, they will want to go into it, 
because it is an amazing field to be in.
    Senator Mikulski. Well, Doctor, first of all, let me say 
that in reading your testimony, it seems that so much of the 
efforts that you and your colleagues in pediatric rheumatology 
are--I do not mean making it up--but you are making up 
organizational efforts. When you talk here about the lack of a 
network and so on, I found this troubling, in the same way Dr. 
Klippel just talked about that out of the whole $28 billion, we 
are spending $7 million. That is beyond being skimpy.
    I am going to then ask you, because the time is limited 
here, as you look to both the Academy and also the Foundation, 
to give us recommendations on, first, what should we be 
encouraging in terms of prevalency studies; second, how can we 
move thinking into other clinical areas of practice, just like 
you have said; and then also, your whole issue here about the 
fact that you do not have what you have in childhood oncology, 
which was this collaborative effort. Collaboration can also 
mean a lot of process, but it seems like practical minds and 
breakthrough minds are getting together to see what we can do.
    You talk about Section 5 would increase the funding for 
innovative research--but you all need to talk with each other, 
and there need to be ways of encouraging--again, as you heard 
me earlier--with CDC to get what you all know into the 
physician's office while we are, again, absolutely committed to 
expanding the fellowship and other programs and seeing the 
implementation of Section 6.
    Can you help us out here, where you would like to really 
improve the bill or put in report language, because it would 
seem to me that NIH and CDC should be doing a lot of this on 
their own, without us telling them what to do.
    Dr. Rothman. Could you be a little more specific in how you 
would like us to proceed?
    Senator Mikulski. Well, first of all, I do not know what 
prevalency studies we have and what we do not have, so I am 
ready to write a letter or report language to say what should 
we get.
    Number two, you in your own testimony on page 4 say that 
you formed a research network, the Childhood Arthritis and 
Rheumatoid Research Alliance, and you are donating your time. 
You say that this needs funding. Well, I am not sure what you 
are talking about. Is it in the legislation? Do we have to put 
in legislation? Do we have to direct funding--for you all to be 
you and to be the best that you can be and maximize and 
synergize the information.
    So I am looking at that paragraph in your own testimony and 
would welcome insights on how you want to implement that.
    Dr. Rothman. I was on the telephone yesterday with one of 
the leaders of CARRA, Carol Wallace, and we were talking about 
a budget and exactly how much we would need----
    Senator Mikulski. Where is that? Is that at NIH? Is that at 
CDC? Where is it?
    Dr. Rothman. CARRA is a separate organization, and we are 
trying to work in collaboration with all of these other 
organizations.
    Senator Mikulski. But who would you get the money from?
    Dr. Rothman. We are in the process of applying for funds 
from the government.
    Senator Mikulski. What government? You see, this is my 
whole point about the CDCs and the NIHs. Everybody is 
communicating and collaborating until you find out that maybe 
it is not working the way we all would like.
    Dr. Rothman. I will be on the telephone with several of the 
leaders of CARRA as soon as we are through with this hearing.
    Senator Mikulski. You see, that is what I mean.
    Dr. Rothman. Yes. I will get a letter together for you with 
more specifics of what we need. I am not on the finance 
committee of CARRA, so I am not the best person to be 
addressing those questions to.
    Senator Mikulski. But if CARRA is going to be CARRA, and 
you think this is important, then, that is it.
    Dr. Rothman. Yes.
    Senator Mikulski. The other issue is also--and I again 
welcome your advice and insight as well as NIH, which goes to 
FDA and the whole issue of juvenile arthritic medications.
    We have a wonderful colleague, Senator DeWine, who has 
really championed to be sure that we evaluate the pediatric 
implications of drugs, because taking something at age 70 is 
not the same as at the age of 7 or 47. We want to be sure again 
that we are getting the proper analysis at FDA.
    Do you see where I am?
    Dr. Rothman. Yes, I do, and I am very honored that you 
agree with us that we absolutely need funding, and I understand 
that we need to get more specific information. That is simply 
something that I need to talk to my colleagues about.
    Senator Mikulski. Why don't we do that? I know that our 
time is up. Then, the other is ideas on how we can encourage 
more information going out to pediatricians and adult 
rheumatologists, not as a substitute but as a way of at least 
bridging as we try to increase the number of people going into 
the field so that people like Ms. Kunkel and Mr. Jones do not 
have to drive 4 hours, with the tremendous strain on the 
families emotionally as well as on the budget.
    These are compelling studies, and behind them, we know 
there are 300,000 kids, but we have got to start getting value 
for our dollar here.
    So thank you, and Dr. Klippel, thank you for your work.
    Senator Bond. Thank you very much, Senator Mikulski.
    My sincere thanks to all of our witnesses today.
    KaLea and Virg, you have really given us a new vision of 
how juvenile arthritis can be an all-consuming fact in your 
lives.
    Dr. Rothman, you have given us hope that there are things 
that can be done.
    Dr. Klippel, the work that you are doing, I know you have 
things that you need for us to do, but the impact of this 
disease on millions of Americans, with its costs, first maybe 
in dollars, but in human terms as well, is very, very 
significant.
    I would welcome any suggestion specifically that any of you 
or even those in the audience may have about our bill. We 
appreciate the comments on the particular sections of the bill, 
and working together, I think there is a lot more we can do to 
ensure that Americans with arthritis in all of its forms have a 
better chance for a full and pain-free life.
    We appreciate your work and thank you very much.
    The hearing is adjourned.
    [Whereupon, at 11:55 a.m., the subcommittee was concluded.]
  

                                  
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