[Senate Hearing 107-429]
[From the U.S. Government Printing Office]



                                                        S. Hrg. 107-429
 
                ADDRESSING UNMET NEEDS IN WOMEN'S HEALTH
=======================================================================




                                HEARING

                               BEFORE THE

                     SUBCOMMITTEE ON PUBLIC HEALTH

                                 OF THE

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

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

                                   ON



 EXAMINING WOMEN'S HEALTH ISSUES, INCLUDING THE ROLE OF THE DEPARTMENT 
   OF HEALTH AND HUMAN SERVICES IN IMPROVING THE HEALTH OF WOMEN AND 
                    MAKING PREVENTION A CENTERPIECE

                               __________

                             APRIL 25, 2002

                               __________

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










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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut     JUDD GREGG, New Hampshire
TOM HARKIN, Iowa                     BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland        MICHAEL B. ENZI, Wyoming
JAMES M. JEFFORDS (I), Vermont       TIM HUTCHINSON, Arkansas
JEFF BINGAMAN, New Mexico            JOHN W. WARNER, Virginia
PAUL D. WELLSTONE, Minnesota         CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington             PAT ROBERTS, Kansas
JACK REED, Rhode Island              SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina         JEFF SESSIONS, Alabama
HILLARY RODHAM CLINTON, New York     MIKE DeWINE, Ohio

           J. Michael Myers, Staff Director and Chief Counsel
             Townsend Lange McNitt, Minority Staff Director

                                 ______

                     Subcommittee on Public Health

                      EDWARD M. KENNEDY, Chairman

TOM HARKIN, Iowa                     BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland        JUDD GREGG, New Hampshire
JAMES M. JEFFORDS, Vermont           MICHAEL B. ENZI, Wyoming
JEFF BINGAMAN, New Mexico            TIM HUTCHINSON, Arkansas
PAUL D. WELLSTONE, Minnesota         PAT ROBERTS, Kansas
JACK REED, Rhode Island              SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina         JEFF SESSIONS, Alabama
HILLARY RODHAM CLINTON, New York     CHRISTOPHER S. BOND, Missouri

                      David Nexon, Staff Director
                 Dean A. Rosen, Minority Staff Director

                                  (ii)











                            C O N T E N T S

                               __________

                               STATEMENTS

                             APRIL 25, 2002

                                                                   Page
Clinton, Hon. Hillary Rodham, a U.S. Senator from the State of 
  New York, opening statement....................................     1
Carnahan, Hon. Jean, a U.S. Senator from the State of Missouri, 
  prepared statement.............................................     2
Chafee, Hon. Lincoln D., a U.S. Senator from the State of Rhode 
  Island, prepared statement.....................................     3
Slater, Eve E., M.D., Assistant Secretary for Health, U.S. 
  Department of Health and Human Services; and James S. Marks, 
  M.D., Director, National Center for Chronic Disease Prevention 
  and Health Promotion, Centers for Disease Control and 
  Prevention, U.S. Department of Health and Human Services.......     5
    Prepared statements of:
        Dr. Slater...............................................     7
        Dr. Marks................................................    16
Mikulski, Hon. Barbara, a U.S. Senator from the State of 
  Maryland, prepared statement...................................    13
Mazure, Carolyn, Yale University School of Medicine, on Behalf of 
  the Women's Health Research Coalition; Marlene B. Jezierski, 
  Violence Prevention Educator, Allina Hospitals and Clinics; 
  Thomas Gellhaus, M.D., Davenport, IA, on Behalf of the American 
  College of Obstetricians and Gynecologists; and Alice Ammerman, 
  University of North Carolina...................................    34
    Prepared statements of:
        Ms. Mazure...............................................    36
        Ms. Ammerman.............................................    44
        Ms. Jezierski............................................    49
        Dr. Gellhaus.............................................    56

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Questions of Senator Murray for Panel I and Panel II.........    32
    Questions of Senator Wellstone for Marlene Jezierski and 
      Thomas Gellhaus, M.D.......................................    33
    Women's Health Research Coalition............................    42
    Response to questions of Senator Harkin from Eve Slater, M.D.    62
    Michael M. Faenza............................................    65
    Kim Hoffman..................................................    66
    Jill Kagan...................................................    68
    Susan Scanlan................................................    74
    Pamela Noonan-Saraceni.......................................    75
    Esta Soler...................................................    78

                                 (iii)









                ADDRESSING UNMET NEEDS IN WOMEN'S HEALTH

                              ----------                              


                        THURSDAY, APRIL 25, 2002

                                       U.S. Senate,
Subcommittee on Public Health, of the Committee on Health, 
                            Education, Labor, and Pensions,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:30 p.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Hillary 
Rodham Clinton, presiding.
    Present: Senators Clinton, Mikulski, Wellstone, Murray, and 
Frist.

                  Opening Statement of Senator Clinton

    Senator Clinton. The committee will come to order.
    As many of you know, there is a lot of activity occurring 
today with respect to the energy legislation that we have been 
dealing with for some weeks, and there will be a series of 
votes starting at around 3 o'clock. A number of my colleagues 
are tied up in that as well as other pressing business, so I am 
going to get started.
    We have a very large, interested crowd here, and this is 
``Take Your Daughter to Work Day,'' so this is a particularly 
apt subject for our hearing on this day, and it is a real 
pleasure to welcome all of you.
    Less than 10 years ago, the Office of Research on Women's 
Health was created at the National Institutes of Health. I 
personally think that that was one of the earliest and best 
decisions of the Clinton Administration. At that time, we 
recognized that women's health issues needed and deserved more 
attention.
    I believe that we have come quite a long way in fulfilling 
that recognition and awareness, but we still have a lot of work 
ahead of us.
    I want to thank Senators Harkin and Kennedy for calling 
this hearing today. They clearly recognize, as I do, that our 
business is not finished. I also want to thank Senators Snowe, 
Harkin, and Mikulski for introducing a bill to establish an 
Office of Women's Health in every major Federal health agency.
    We have some unfinished business and then some new 
business. Among the areas of new business, I think we have to 
pay particular attention to the intersection between women's 
health and the environment. I held a hearing on Long Island, 
because we have a higher than the national average rate of 
breast cancer on Long Island, and there are other places in our 
country where that is also the case.
    We do not know if there is an environmental link or cause 
that we are missing, but we are now committed to finding out 
what the answer might be. I have introduced an environmental 
health tracking bill, and I also appreciate greatly Senator 
Chafee's Breast Cancer and Environmental Research Act.
    We know that many of our young people face challenges in 
developing healthy eating and exercise behaviors. Obesity is 
increasing in our country, and minority women are particularly 
affected, dying too early from diabetes and heart disease. We 
also know that women continue to suffer from eating disorders, 
constantly striving to be excessively thin, defining their 
values based on their dress size and too often dying in the 
process.
    Senator Bingaman and I are introducing a bill that would 
attempt to prevent the serious array of eating and health-
related problems by supporting research to identify the best 
ways to help young people, particularly young women, develop 
healthy eating habits.
    Although we tend to focus on diseases that afflict women, 
we also have to remember the special role that women play as 
our caregivers, both in our families and in society. We are 
particularly concerned about the large number of women who find 
themselves in the so-called sandwich generation. Twenty-six 
million Americans care for an adult family member who is ill 
and disabled; the vast majority of them are women. Eighteen 
million children have a condition that places significant 
demands on their parental caregivers, again, mostly caregiving 
mothers. Four million Americans with mental retardation or a 
developmental disability live with their families.
    These numbers are very high and I think not well-known 
among the general public. We often in America tend to think of 
the individual challenges facing our families as not shared 
necessarily by the larger society of which we are a part.
    I know that there are many people who are concerned about 
the health effects that flow from the emotional and physical 
demands of caregiving, and Senators Snowe, Mikulski, Breaux and 
I will be introducing the Lifespan Respite Care Act next week, 
which we hope will begin to both define and deal with these 
challenges.
    So there is a lot that we have to talk about today. We are 
going to try to get through all of our distinguished witnesses 
before what is called the ``vote-a-rama'' starts, which is 
where you have votes about every 10 minutes and you stay right 
there until the are done.
    At this time I would like to submit statements from Senator 
Carnahan and Senator Chafee for the record.
    [Prepared statements of Senators Carnahan and Chafee 
follow:]

                 Prepared Statement of Senator Carnahan

    Mr. Chairman, I would like to commend you for calling for 
this hearing and for your steadfast leadership on women's 
health issues.
    I want to bring the committee's attention to a serious 
health problem that affects women during their reproductive 
years--uterine fibroids. At least twenty to thirty percent of 
all women aged 35 and older have symptomatic uterine fibroids 
that require treatment. This number rises to approximately 
fifty percent for African-American women.
    Given that uterine fibroids affects millions of women and 
how little we know about it, I believe that it is important to 
increase research into the disease and also public awareness of 
it. I am proud to announce that I have introduced the Uterine 
Fibroids Research and Education Act of 2002, S. 2122.
    I would like to recognize two members of this committee, 
Senator Mikulski and Senator Jeffords, who are co-sponsoring 
this legislation. Both are strong advocates for women's health. 
I appreciate their support on this important issue and look 
forward to working with them to move the legislation through 
the HELP Committee as soon as possible.
    Uterine fibroids are a benign tumor that impacts the 
reproductive health of women, particularly minority women. If 
they go undetected or untreated, uterine fibroids can lead to 
childbirth complications or infertility, among other things.
    For those who do seek treatment, the option prescribed most 
often is a hysterectomy. Uterine fibroids are the top reason 
for hysterectomies currently being performed in this country. A 
hysterectomy is a major operation--the average recovery time is 
six weeks. This is just the physical impact, the emotional 
impact lasts much longer.
    We need to invest additional resources in research, so that 
there are more treatment options for women, including options 
less drastic than a hysterectomy. We also need to increase 
awareness of uterine fibroids, so that more women will 
recognize the symptoms and seek treatment. My legislation will 
provide a sustained Federal commitment to better understanding 
uterine fibroids.
    It has two components. First, it authorizes $10 million for 
the National Institutes of Health (NIH) for each of four years 
to conduct research on uterine fibroids.
    Second, the bill supports a public awareness campaign. It 
calls on the Secretary of the U.S. Department of Health and 
Human Services to carry out a program to provide information 
and education to the public regarding uterine fibroids. The 
content of the program shall include information on the 
incidence and prevalence of uterine fibroids and the elevated 
risk for minority women. The Secretary shall have the authority 
to carry out the program either directly or through contract.
    This legislation has been endorsed by the Society of 
Interventional Radiology, the American College of Obstetricians 
and Gynecologists, the National Uterine Fibroids Foundation, 
the American College of Surgeons, and the National Medical 
Association.
    This legislation will make a meaningful difference in the 
lives of women and their families across this country. I 
encourage the HELP Committee to support this important 
legislation. Thank you.

                  Prepared Statement of Senator Chafee

    Mr. Chairman, I am pleased to submit this testimony on 
behalf of S. 830, the Breast Cancer and Environmental Research 
Act. I am pleased that your committee is considering this 
important legislation, which will establish research centers 
that would be the first in the nation to specifically study the 
environmental factors that may be related to the development of 
breast cancer.
    According to the National Breast Cancer Coalition, an 
estimated 233,000 women in the United States will be diagnosed 
with breast cancer this year, and 40,000 women will die of this 
terrible disease. We owe it to these women who are diagnosed 
with this life-threatening disease to provide them with answers 
for the first time.
    It is generally believed that the environment plays some 
role in the development of breast cancer, but the extent of 
that role is not understood. S. 830 will enable scientists to 
conduct more conclusive and comprehensive research to determine 
the impact of the environment on breast cancer. While more 
research is being conducted into the relationship between 
breast cancer and the environment, there are still several 
issues that must be resolved to make this research more 
effective.
    There is no known cause of breast cancer. There is little 
agreement in the scientific community on how the environment 
affects breast cancer. While studies have been conducted on the 
links between environmental factors like pesticides, an 
individual's diet, and electromagnetic fields, no consensus has 
been reached. There are other factors that have not yet been 
studied that could provide valuable information. While there is 
much speculation, it is clear that the relationship between 
environmental exposures and breast cancer is not well 
understood.
    There are challenges in conducting environmental research. 
Identifying links between environmental factors and breast 
cancer is difficult. Laboratory experiments and cluster 
analyses, such as those in Long Island, New York, cannot reveal 
whether an environmental exposure increases a woman's risk of 
breast cancer. Epidemiological studies must be carefully 
designed because environmental exposures are difficult to 
measure.
    Coordination between the National Institutes of Health 
(NIH), the National Cancer Institute (NCI), and the National 
Institute of Environmental Health Sciences (NIEHS) needs to 
occur. NCI and NIEHS are the two institutes within the NIH that 
fund most of the research related to breast cancer and the 
environment; however, comprehensive information specific to 
environmental effects on breast cancer is not currently 
available.
    S. 830 will establish eight research centers to study these 
potential links. These ``Breast Cancer Environmental Research 
Centers'' would provide for multi-disciplinary research among 
basic, clinical, epidemiological and behavioral scientists 
interested in establishing outstanding, state-of-the-art 
research programs addressing potential links between the 
environment and breast cancer. The NIEHS would award grants 
based on a competitive peer-review process. This legislation 
would require each Center to collaborate with community 
organizations, including those that represent women with breast 
cancer. S. 830 authorizes $30 million each year over the next 
five years for these grants.
    Many scientists believe that certain groups of women have 
genetic variations that may make them more susceptible to 
adverse environmental exposures. We need to step back and 
gather evidence before we come to conclusions--that is the 
purpose of this bill. People are hungry for information, and 
there is a lot of inconclusive data, some of which has no 
scientific merit whatsoever. We have the opportunity through 
this legislation to gather legitimate and comprehensive data 
from premier research institutions across the nation.
    Finally, I would like to point out that S. 830 has an 
impressive list of 30 bipartisan cosponsors, and is the product 
of a very carefully crafted compromise negotiated between the 
Senate and House sponsors, the National Breast Cancer 
Coalition, and the National Institutes of Health. While one 
could argue that no product is perfect, a lot of thought went 
into the crafting of this legislation to ensure that all 
affected parties would be pleased with the outcome. At times, 
it was not an easy feat to produce a bill that the advocates 
and the Institute would both find acceptable, but we managed to 
achieve this goal after several meetings. I am happy to say 
that S. 830 is the product of these successful negotiations.
    Mr. Chairman and members of the committee, I appreciate 
this opportunity to present this testimony on behalf of this 
important legislation, and I look forward to working with you 
in the future to ensure its passage in the Senate.
    Senator Clinton. I want to begin now with the first panel. 
We have with us Dr. Eve Slater, Assistant Secretary for Health 
at the Department of Health and Human Services. She is 
responsible for overseeing the Office of Women's Health at HHS.
    We also have Dr. James S. Marks, who is also a master in 
public health. He is director of the National Center for 
Chronic Disease Prevention and Health Promotion at the Centers 
for Disease Control and Prevention. He oversees all chronic 
disease prevention programs, including the Wisewoman program.
    Welcome to both of you, and thank you for taking on these 
public responsibilities.
    Dr. Slater?

  STATEMENTS OF EVE E. SLATER, M.D., ASSISTANT SECRETARY FOR 
HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND JAMES 
 S. MARKS, M.D., DIRECTOR, NATIONAL CENTER FOR CHRONIC DISEASE 
 PREVENTION AND HEALTH PROMOTION, CENTERS FOR DISEASE CONTROL 
  AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Slater. Thank you very, very much. It is truly a 
pleasure to testify before you on behalf of this committee. I 
will state that this is actually my very first testimony before 
the Senate committee, and I am especially pleased to be 
testifying today on the topic of women's health. I think it is 
particularly appropriate and is again my pleasure.
    My colleague, Dr. Marks, my team at HHS, and of course, the 
Secretary, are very dedicated to improving women's health and 
to building a platform, working with this committee, in order 
to make some of our objectives, in fact as many as we can, 
achievable.
    In 2002, the Department of Health and Human Services will 
spend almost $70 billion on women's health. As you are well 
aware, just three agencies expend nearly 97 percent of these 
funds--the NIH, HRSA, and the Centers for Medicare and Medicaid 
Services. They are responsible for over $61 billion in 
spending.
    Doing the math, we can conclude that the majority of 
Federal expenditures on women's health support medical and 
public health services and research on diseases and conditions 
important to women.
    The remaining three percent of this year's budget for 
women's health is divided among eight other offices and 
agencies, and those include the CDC, the Indian Health Service, 
FDA, and of course, the Office of Public Health and Science 
which I oversee. In 2002, the Office of Public Health and 
Science has budgeted over $68 million for women's health.
    With strong support from this committee and others in 
Congress, the Department of Health and Human Services has 
contributed to a number of important successes in women's 
health over the past decade. For example, in 2000, nearly 85 
percent of women over age 18 received a pap smear in the 
previews 3 years, and 75 percent of women over 50 received a 
mammogram.
    These numbers represent not only the successful achievement 
of the Healthy People 2000 benchmarks for these preventive 
services, but most important, they represent saved lives. From 
1992 to 1998, the rate of breast cancer mortality declined by 
an average of almost 2.5 percent each year, and a similar rate 
of decline was seen for cervical cancers. Programs such as the 
Breast and Cervical Cancer Early Detection Program at CDC have 
made important contributions to meeting these goals for low-
income women across the country.
    Additionally, the Secretary's and CMMS' focus on approving 
Medicaid waivers for treatment services means that low-income 
women now in 39 States have access to services that they did 
not have just 2 years ago. Women are not only living longer, 
they are living more healthy and productive lives in their 
later years.
    Importantly, women today are becoming more informed and are 
appropriately asking for more details about the health issues 
that affect them. Our Department of Women's Health in the 
Office of the Secretary has encouraged this trend, and with 
support from this committee, they established the National 
Women's Health Information Center, the NWHIC, which targets 
public outreach to at-risk communities through neighborhood 
participation.
    The NWHIC website actually has received on the order of 
3,000 hits per month, which is I think a very impressive track 
record for that site.
    We all know, and you especially know, that there is still 
much work to be done. Chronic conditions such as cardiovascular 
disease and diabetes are among the most prevalent, costly, and 
preventable of all health problems. Cardiovascular disease and 
its manifestations--heart attack, stroke--is the leading cause 
of death for U.S. women, and deaths alone understate the burden 
of the illness of cardiovascular disease.
    Heart disease remains the leading cause of disability among 
working adults. Stroke alone accounts for disability among more 
than one million Americans, and almost 6 million 
hospitalizations each year are due to cardiovascular disease.
    Diabetes, often linked to obesity, has reached epidemic 
proportions in this country. It is the fifth leading cause of 
death among women. More than one out of every 10 women in the 
United States displays signs of pre-diabetes or diabetes. 
According to recent data from the NCEP/ATP3 study, 
approximately one-quarter of all U.S. women display signs of 
the metabolic syndrome, which is a condition that predisposes 
to developing diabetes and cardiovascular disease. That number 
stands for 35 percent of Hispanic women; and in African 
American women, women outnumber men 57 percent in metabolic 
syndrome; among Hispanics, 27.6 percent more women than men 
have signs of this very serious risk-prone condition.
    Among African American and Hispanic women in their mid-
sixties, nearly one of every three----
    Senator Mikulski [presiding]. Dr. Slater, please excuse me. 
I have just been advised that there will be votes through the 
afternoon. Could I ask you to summarize your testimony?
    Dr. Slater. Absolutely, Senator.
    Senator Mikulski. And I am going to ask unanimous consent 
that your very informative full statement be included in the 
record.
    Dr. Slater. Thank you very much.
    It is a pleasure to get to our focus. The focus of our 
department within HHS will be on preventing the truly 
preventable killers and debilitating diseases that affect 
women. These are chronic diseases. We will focus on 
cardiovascular disease, in particular stroke, with attention to 
lowering blood pressure and cholesterol; on cancer, with 
attention to increased screening and decreased smoking; on 
diabetes and obesity, with attention to improved diet and 
exercise; and HIV/AIDS.
    These conditions were selected first because they 
represented the leading causes of morbidity and mortality in 
women; but second, disparities exist between men and women for 
these diseases either in treatment, incidence or prevalence, 
and finally, they are all preventable.
    Additionally, as you are aware, the next Surgeon General's 
report will focus on the topic of osteoporosis, a disease that 
affects women disproportionately.
    The mission of our office, to perhaps Senator Frist, who 
published a recent editorial in JAMA, is, after establishing 
goals and research priorities--and we agree with the Senator 
here--we must ``move beyond input, means, and anecdotal 
evidence to develop new metrics to measure scientific advances 
and their causal relationship to improved outcomes.'' The focus 
is on prevention, on developing metrics to determine what works 
and to translate the best of science into improving these 
particular conditions that affect women.
    Thank you very much, Senator. I will conclude there.
    Senator Mikulski. Thank you, Dr. Slater. We could spend all 
afternoon just with you. Thank you for that excellent 
testimony.
    [The prepared statement of Dr. Slater follows:]
               Prepared Statement of Eve E. Slater, M.D.
    Mr. Chairman, Senator Frist and members of the subcommittee, I am 
pleased to appear before you today to testify about the role of the 
Department of Health and Human Services in improving the health of 
women in the United States and to highlight the Administration's plan 
to make prevention the centerpiece of the Departments activities on 
this important topic.
                      investment in women's health
    In 2002, the Department of Health and Human Services will spend 
almost $70 billion on women's health. Just three agencies expend nearly 
97 percent of these funds--the National Institutes of Health, the 
Health Resources and Services Administration and the Centers for 
Medicare and Medicaid Services which is responsible for over $61 
billion in spending. From this, we can conclude that the majority of 
Federal expenditures on women's health support medical and public 
health services and research on diseases and conditions important to 
women's health. The remaining three percent of this year's budget for 
women's health is divided among eight other offices and agencies--the 
Centers for Disease Control and Prevention, the Administration on 
Aging, the Administration for Children and Families, the Substance 
Abuse and Mental Health Services Administration, the Indian Health 
Service, the Agency for Healthcare Research and Quality, the Food and 
Drug Administration and the Office of Public Health and Science, which 
I oversee. In 2002, the Office of Public Health and Science has 
budgeted over $68 million for women's health.
                       success in women's health
    With strong support from this committee and others in Congress, the 
Department of Health and Human Services has contributed to a number of 
important successes in women's health over the past decade. In 2000, 
nearly 85 percent of women over age 18 received a pap smear in the 
previous three years and 75 percent of women over 50 received a 
mammogram. These numbers not only represent the successful achievement 
of the Healthy People 2000 benchmarks for these prevention services--
but most importantly they also represent saved lives. From 1992-98, the 
rate of breast cancer mortality declined by an average of 2.4 percent 
each year and a similar rate of decline was seen for cervical cancer. 
Programs such as the Breast and Cervical Cancer Early Detection Program 
at CDC have made important contributions to meeting these goals for 
low-income women across the country. Additionally, the Secretary's and 
CMS' focus on approving Medicaid waivers for these services means that 
low-income women in 39 States now have access to these services that 
didn't just two years ago.
    Women are not only living longer, they are living more healthy and 
productive lives in their later years. This allows them to remain fully 
engaged with family and friends and continue to make essential 
contributions to their communities and the nation as they age. 
Importantly, women today are becoming more informed and are asking for 
more details about the health issues that affect them. The Department 
has encouraged this trend, with support from this committee, by 
establishing the National Women's Health Information Center and 
targeting public outreach to at risk communities through neighborhood 
partnerships. Both of these efforts are managed through the 
Department's Office on Women's Health.
                          focus on prevention
    There is still much work to be done. Chronic conditions such as 
cardiovascular disease and diabetes are among the most prevalent, 
costly and preventable of all health problems. Cardiovascular disease 
and its manifestations such as heart attack and stroke are the leading 
cause of death for U.S. women. However, consideration of deaths alone 
understates the burden of cardiovascular disease. Heart disease is the 
leading cause of disability among working adults. Stroke alone accounts 
for disability among more than one million Americans and almost six 
million hospitalizations each year are due to cardiovascular disease.
    Diabetes linked to obesity has reached epidemic proportions in this 
country. It is the fifth leading cause of death among women. More than 
one out of every ten women in the U.S. displays signs of prediabetes or 
diabetes. Twenty three percent of all U.S. women display signs of 
metabolic syndromes that predispose them to developing diabetes and 
cardiovascular disease--a number that stands at 35 percent for Hispanic 
women. Among African American and Hispanic women in their mid-sixties, 
nearly one out of every three suffers from diabetes and for Native 
American women this number may be as high as two out of every three.
    The DHHS/OWH sponsors a national education campaign to promote 
healthy behaviors among minority women. The Pick Your Path to Health 
Campaign (PYPTH) offers practical, culturally appropriate action steps 
that women can take to improve their health. Through public/private 
partnerships, the Campaign's materials are distributed to local 
neighborhood groups and local media that are trusted by minority women. 
This year DHHS/OWH will launch a series of pilot programs in each of 
the ten HHS regions, in which underserved women will be individually 
coached to develop their own personal action steps. In 2003, the 
campaign will be expanded to include rural women and women with 
disabilities.
    The medical care costs of people with chronic diseases such as 
diabetes and cardiovascular disease account for over 70 percent of the 
$1 trillion spent nationally on health care each year. Effective 
prevention measures exist today to substantially curtail illnesses, 
disabilities and unnecessary or early deaths caused by these chronic 
illnesses and other preventable diseases.
                      the office on women's health
    President Bush and Secretary Thompson have made prevention a 
cornerstone of the nation's health agenda. During the announcement of 
his candidate for Surgeon General on March 26, 2002, the President 
reiterated his prevention message, noting, ``Simple improvements in 
diet and exercise would result in dramatic improvements in America's 
health.'' The Office of the Surgeon General, the public health service 
corp and the Centers for Disease Control and Prevention are key players 
in the development and implementation of disease prevention strategies. 
On women's health, The Office on Women's Health in the Office of Public 
Health and Science will be responsible for seeing that health promotion 
and disease prevention goals are met for women.
    The Office on Women's Health both runs programs that target women 
and also helps to coordinate the research, health promotion and disease 
prevention strategies of offices and agencies throughout the Department 
of Health and Human Services.
    As part of implementing the President's and Secretary Thompson's 
health agenda, the Office on Women's Health is refining its performance 
goals to focus on activities that will result in measurable reductions 
in the rate of preventable diseases in women over the next few years. 
Initially, the office will focus on cardiovascular disease, cancer, 
diabetes and HIV/AIDS. These diseases were selected because, first, 
they represent leading causes of morbidity and mortality in women, 
second, disparities exist between men and women for these diseases--
either in treatment, incidence or prevalence--and finally, they are all 
preventable.
                            the action plan
    The keys to achieving these goals is to understand what strategies 
and interventions work to prevent these diseases in women and to ensure 
that proven and effective measures are deployed by the Department and 
replicated throughout the country. The Department, with the Office on 
Women's Health acting to help coordinate these efforts, will be 
identifying successful, evidenced based prevention and treatment 
strategies, promoting innovations based on new research, replicating 
successful models and disseminating information about these successful 
interventions to other public and private partners. Particular 
attention will be given to those models that successfully address 
health disparities seen among racial and ethnic minorities.
    The Department's effort to reduce cardiovascular disease in women 
is a helpful illustration of this model. Today, the Agency for 
Healthcare Research and Quality is supporting work to understand why 
women are not treated as aggressively for cardiovascular disease as men 
and to determine which interventions result in the best outcomes for 
women suffering from cardiovascular disease. The Health Resources and 
Services Administration is helping to promote quality health care 
services among health professionals who serve populations of women in 
need, and CDC and HRSA have joined as partners to implement the 
WISEWOMAN program which provides low income women with risk factor 
screening, intervention services and medical referrals. Finally, the 
Office on Women's Health supports tailored public outreach, including 
the ``For your heart'' public education program and a partnership 
effort with the Association of Black Cardiologists and African American 
churches to bring health and prevention messages to women at high risk 
for cardiovascular disease.
    In these efforts--we capture the essential elements of the 
Department's vision: research to understand what works and what does 
not; programs to bring this information to health professionals who are 
providing medical care and prevention services; and public outreach 
efforts to inform women about effective health behaviors and medical 
interventions.
    In the future, the Department can do more to coordinate this bench 
to hearthside translation. For instance, recent exciting studies 
supported by NIH indicate that there are both protein markers and 
genetic ones that could help physicians identify women who are at high 
risk for poor outcomes from cardiovascular disease. If these early 
findings hold up to additional studies, we would then want to make sure 
this knowledge is incorporated into other HHS programs on women's 
cardiovascular disease. Over the next year, the Office on Women's 
Health will develop mechanisms to track new health and research 
findings, help promote assessments of their effectiveness and ensure 
this knowledge is disseminated within and outside the Department.
                           program activities
    I will now highlight a few examples of women's health program 
activities across HHS. Several broad initiatives among the agencies 
target multiple related health issues and I will cover these first.

Cardiovascular Disease

    During the last 3 years, several members of Congress have asked 
DHHS/OWH and other agencies in the Department to review and develop 
programs to stem the risk of cardiovascular disease in women. The DHHS/
OWH has collaborated with the American Heart Association in the 
development of a tailored heart disease prevention interactive website 
program, accessible through the National Women's Health Information 
Center, entitled, ``For Your Heart.'' A tailored story and message are 
given to a woman based upon her self-identified race/ethnicity, 
behavioral risk factors, and stage in changing these factors.
    The OWH also is partnering with the Association of Black 
Cardiologists (ABC) Center for Women's Health. The initiative will 
incorporate cardiovascular health education programs in churches with 
large African American populations, with the ultimate goal of reducing 
cardiovascular mortality and morbidity among women.
    Two years ago, the AHRQ women's program launched an ongoing 
collaborative research initiative to understand why women receive less 
aggressive treatment for heart disease than do men, and what is known 
about the use and effectiveness of diagnostic testing and treatment of 
heart disease and stroke in women. The initiative involves 
representatives from several DHHS agencies, including the NIH Office of 
Research on Women's Health (ORWH) and the NHLBI, as well as the DHHS/
OWH. Private sector partners include the American Heart Association, 
the Jacobs Institute on Women's Health, the Society for Women's Health 
Research, WomenHeart, and a number of professional organizations.
    AHRQ and NIH/ORWH are also co-funding development of an evidence 
report at Stanford University and the University of Califormia/San 
Francisco that is systematically reviewing the literature on 
cardiovascular disease as it specifically relates to women. It will 
establish a baseline for what is currently known (or not known) about 
the diagnosis and treatment of women with heart disease, as well as 
identify gaps in the scientific information on optimum care for women.
    AHRQ also is conducting a cardiovascular care study which compares 
treatments and prevention services provided to men versus women (and 
minorities) in a large managed care organization. The results will be 
used to develop better benchmarks for care to women and minorities.

Diabetes

    In May 2002, the Food and Drug Administration's Office on Women's 
Health (OWH) will launch Take Time To Care About Diabetes. This program 
will be co-sponsored by the National Association of Chain Drug Stores 
(NACDS) and the American Diabetes Association (ADA). This campaign, 
following on the success of the award winning campaign ``Take Time to 
Care: Use Medicines Wisely,'' leverages extensive resources, 
infrastructure, and visibility through its partnerships with outside 
organizations, thus greatly enhancing the impact and effectiveness of 
the effort by FDA and HHS.
    The campaign materials will consist of a brochure with background 
information, key messages, risk assessment questions, and a recipe 
booklet with meal ideas for diabetics. These materials will be 
distributed in partnership with local health organizations, pharmacies, 
senior centers, religious groups, universities, women's groups, and 
many others. Minority communities will be reached through several 
professional nursing associations.
    Other HHS agencies are providing program assistance to FDA. The 
National Institutes of Health will supply Community Outreach Kits 
prepared by the National Diabetes Education Program for use by local 
organizations, the Centers for Disease Control and Prevention will 
provide an information pack on Women and Diabetes, covering each stage 
of a woman's life; the Centers for Medicare and Medicaid Services (CMS) 
will feature CMS comprehensive information about Federal benefits for 
diabetics on their website; the Indian Health Service will distribute 
campaign materials through selected Indian Health clinics in urban and 
reservation areas nationwide; and the Administration on Aging will 
distribute campaign materials through State units on aging, area 
agencies on aging, and Indian Tribal Organizations.
    The NIH/ORWH supports a number of research grants in the area of 
Diabetes Prevention. The National Institute of Diabetes and Digestive 
and Kidney Diseases (NIDDK) currently has the Diabetes Prevention 
Program (DPP). This multi-centered randomized trial is designed to 
determine whether type 2 diabetes can be prevented or delayed in a 
population of high-risk individuals. Included in the high-risk 
population are women with a history of gestational diabetes mellitus 
(GDM) and individuals with impaired glucose tolerance.
                                obesity
    The NIH has a very active and well-coordinated program of research 
on obesity that involves many institutes and centers. Examples of some 
current research avenues include: the genetic underpinnings of obesity; 
the molecular and neuroendocrinological regulation of food intake, 
energy expenditure, and fat storage; epidemiological studies to help 
understand the etiologies, interrelationships, course, and health 
effects of overweight and obesity and weight change among children and 
pregnant women; prevention studies targeted at the population level 
with special emphasis on high risk populations; and intervention 
studies including modification of behavior, activity and dietary 
patterns and the use of pharmacological agents.
    The National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK) has initiated a major education/translation activity 
focused on the topic of overweight and obesity. This initiative 
includes a national information service, the Weight-control Information 
Network (WIN), which provides health professionals and consumers with 
science-based material on obesity, weight control, and nutrition. WIN 
provides fact sheets, brochures, article reprints and conference and 
workshop proceedings. Additionally, a quarterly newsletter for health 
professionals is disseminated featuring the latest information from NIH 
and other organizations on obesity and related topics.
    CDC, as the nation's ``prevention'' agency, supports chronic 
disease programs in State Health Departments, and supports State and 
Local Departments of Education to establish school-based prevention 
programs. CDC also supports surveillance to measure disease burden, 
identifies populations at risk, targets program efforts, and evaluates 
program effectiveness; educates the public and providers; and invests 
in research to evaluate and improve programs. CDC's chronic disease 
program WISEWOMAN provides high blood pressure and cholesterol 
screening and, in follow-up, intensive dietary and physical activity 
interventions for high-risk women.
    HRSA, the Department's ``access'' agency, has created the Diabetes, 
Asthma and Cardiovascular Collaboratives. Education regarding healthy 
nutrition and regular physical activity are integral parts of these 
collaborative training and services models. Partnerships with local 
recreational departments, grocery stores, restaurants and fitness 
centers are also encouraged in the Collaborative care model.
    HRSA's Innovative Approaches to Promoting Positive Health Behaviors 
in Women program identifies women in communities who may not seek 
health care and develops interventions for them to stimulate positive 
health behavior practices.
                           domestic violence
    Violence against women does not discriminate: it spans all racial, 
age, and economic boundaries. One in four women report that they have 
been victims of violence or stalking by a spouse, partner, or date. 
Violence against women is a leading cause of injury for American women 
between the ages of 15 and 54, increasingly a major public health issue 
for the United States. These acts of violence take several forms, 
including spousal and domestic partner violence, sexual assault and 
abuse, rape, incest, and elder abuse. Today there is much more 
awareness that violence against women is a major problem in our 
country, but this increased awareness has not yet translated into 
measurable decreases. Almost one-third of American women murdered each 
year are killed by their current or former partners, often a husband. 
And sadly, many children suffer or witness abuse in their homes, which 
can spawn legacies of violence for families across America. Violence at 
home often spills over into schools and places of work, and it affects 
people from every walk of life.
    The HHS Violence Against Women Steering Committee, under the 
leadership of DHHS/OWH, coordinates the Department's responses to 
research needs, program implementation, service provision, and crisis 
intervention. This committee has proposed and coordinated department-
wide budget initiatives, hosted seminars, and proposed actions to 
address evolving needs. They develop the bi-annual HHS Progress Report 
to the Secretary presented at the National Advisory Council on Violence 
Against Women. The Council is a presidentially appointed council 
consisting of experts in the fields of domestic violence and sexual 
assault, it is co-chaired by the Attorney General and the Secretary of 
Health and Human Services. The Department's Violence Against Women 
Steering Committee is instrumental in assuring that the recommendations 
from the Council are implemented where possible throughout the 
Department.
    One of the major reasons that health care providers give for not 
screening patients for domestic violence is their belief that they have 
no ability or training to assist patients who disclose that they are 
victims of violence. To test this barrier and overcome the reluctance 
of the health care system to offer screening and intervention programs, 
even simple ones that refer patients to community social resources, 
AHRQ is supporting a series of studies to assess the impact of health 
care interventions on the women they are intended to serve. The 
Agency's work is also exploring other aspects of providing health care 
services, including the use of health codes, reimbursement levels, and 
better use of technologies and information systems. Last year, AHRQ 
joined with the Family Violence Prevention Fund to develop a DHHS 
Visiting Scholar in Domestic Violence, the first such program to be 
offered by a DHHS agency. The Scholar Program brought a researcher to 
AHRQ for a year to assist in shaping a long-term research agenda that 
would be responsive to the needs of the private sector.
    On an ongoing basis, HRSA's Area Health Education Centers (AHECs) 
provide training to primary care professionals in how to identify and 
treat spousal and domestic partner violence among patients. HRSA also 
provides support for primary care and clinical specialist programs to 
prepare nurses at an advanced level to care for women's unique health 
care needs. Finally, HRSA's Geriatric Education Centers (GECs) provide 
training to geriatric healthcare professionals to identify types of 
abuse and neglect in the elderly, assess at-risk patients and their 
families, and provide case management for victims of violence.
    In addition, HHS regional Offices on Women's Health have been 
active in training health care professionals in identifying, treating 
and referring patients who are victims of family violence. For example, 
the Region X Women's Health Committee has been working with the 
Washington State Department of Health Perinatal Partnership Against 
Domestic Violence (PPADV), which seeks to train medical providers in 
identifying patients who are victims of family violence.
                          maternal oral health
    The National Institute of Dental and Craniofacial Research (NIDCR) 
at the National Institutes of Health (NIH) supports research addressing 
the link between the mother's oral health and the health of their 
infants/toddlers on two major areas, dental caries (cavities) and 
periodontal disease (gum disease).
    The NIH/ORWH and the National Institute of Dental and Craniofacial 
Research (NIDCR) have a study underway that will evaluate whether 
periodontitis is a risk factor for adverse pregnancy outcomes--by 
adding an oral component to the ongoing Project Viva, a prospective 
study of 6,000 pregnant women, to evaluate this association. Maternal 
infection during pregnancy has been demonstrated to play an important 
role in etiology of preterm delivery. Periodontal infection can serve 
as a reservoir of gram negative anaerobic organisms and their products, 
and proinflammatory mediators which could target the placental 
membranes via systemic circulation, thus leading to preterm delivery or 
fetal growth restriction.
                    public information and education
    Today's women lead complex lives and are sometimes overwhelmed by 
the amount of health information and misinformation in the media and on 
the Internet when they seek details about the health issues that affect 
them. The Department's National Women's Health Information Center 
(NWHIC), managed by the DHHS Office on Women's Health, provides both 
Internet (www.4woman.gov) and telephone access (1-800-994-WOMAN or TTD: 
1-888-220-5446) to reliable noncommercial health information for women. 
NWHIC offers a single point-of-entry to over 4,000 publications, the 
vast majority from Federal agencies and 1,600 organizations on more 
than 800 health topics; eight specialty sections, including women with 
disabilities, healthy pregnancy, violence against women, breastfeeding, 
young women's health, and a Spanish-language section, 150 frequently 
asked questions (FAQs); national health education campaigns; a calendar 
of events; daily women's health news; and online journals and 
dictionaries. It currently averages over 6 million hits and 350,000 
individual visitors to the web site and an additional 3000 phone 
inquiries per month. Women and their families can trust the information 
they find on NWHIC about all of their women's health issues.
                             looking ahead
    In my over thirty years in medicine and health research, I--like 
each of you--have seen incredible advances in our understanding of 
disease and our ability to target interventions to improve health. With 
Congress' generous support of biomedical and health research, strongly 
supported by this Administration, we are poised to reap enormous 
benefits for citizens of our country. However, what we have learned 
through research must be translated into medical practice and to the 
actions and activities of individual citizens. The Administration 
welcomes your focus on women's health and looks forward to working with 
you to develop targeted but flexible strategies that can continue to 
achieve the goal of improving the health and welfare of women in the 
United States.
    That concludes my testimony. At this time I would be happy to 
answer questions from the subcommittee.

    Senator Mikulski. I am also going to follow my own 
encouragement and not present an opening statement but just ask 
unanimous consent that it be included in the record. I know you 
would find me equally as mesmerizing, but we will put me aside.
    [The prepared statement of Senator Mikulski follows:]

                 Prepared Statement of Senator Mikulski

    Women's health needs have traditionally been overlooked and 
underfunded.
    As recently as 10 years ago, women were excluded from 
medical research but the results of these research studies were 
applied to both women and men. This neglect put women's health 
and lives at risk.
    I fought to make sure women were included in research 
studies and clinical drug trials. These efforts have paid off. 
We have made great strides on women's health in the last 
decade. Now this committee is looking to the future. I am 
pleased the committee will be considering women's health bills 
in May. I am the lead cosponsor of the Women's Health Office 
Act to make Women's Health Offices at the Department of Health 
and Human Services permanent. I am also a cosponsor of the 
WISEWOMAN Expansion Act that Senator Frist has sponsored to 
make sure low-income women have access to screenings for 
cardiovascular disease and osteoporosis.
    I am also a proud cosponsor of SMART MOMS, a bill to 
address the disturbing fact that the United States ranks 20th 
out of 49 countries in maternal deaths.
    I am fortunate to be here today with one of the great 
Galahads for women's health--Senator Harkin. From mammograms to 
maternal health, the women of this country owe a tremendous 
debt of gratitude to Senator Harkin for his leadership and 
commitment to women's health.
    Women and men have different bodies and different health 
care needs. Some diseases--like ovarian cancer--affect only 
women. Some diseases are far more common in women than in men. 
High blood pressure is two to three times more common in women 
than men. Women are four times more likely than men to develop 
osteoporosis.
    Women often use the health care system differently from 
men. Women make \3/4\ of all health care decisions in the U.S. 
The number of uninsured women has grown three times faster than 
the number of uninsured men over the past five years.
    For years, despite these differences, men's health needs 
set the standard for our health care system and our health care 
research. I was appalled to learn that women were excluded from 
medical research because our hormone cycles complicated the 
results. This is no reason to put women's health at risk. The 
important differences between men's and women's health needs 
must be addressed in an ongoing, comprehensive way, not 
excluded or ignored to make research simpler.
    More than ten years ago [in 1990], my colleagues in the 
House and took action. Women were not being included in 
research trials at NIH. A study on heart disease risk factors 
was conducted on 13,000 men--and not one woman. So we went out 
to NIH to get a plan and a timetable to include women in 
research protocols. When we pulled up to the curb at the front 
door of NIH, they knew we were here, they knew we were serious. 
They knew we were going to have a Seneca Falls on NIH if 
necessary.
    One month later, I worked with Ted Kennedy, Tom Harkin, and 
the women of the House. There was an Office of Research on 
Women's Health at NIH. I worked with these same Galahads and 
others in Congress to make sure that the women's health office 
would stay at NIH by putting it into law.
    This Office has made a real difference in how women are 
treated for certain illnesses. We now know that men and women 
often have different symptoms before a heart attack. Women's 
symptoms are more subtle, like nausea and back pain. Knowing 
these symptoms means women can get to the hospital sooner and 
can be treated earlier. That's turning women's health research 
into life-saving information.
    Women's Health Offices--like the one at NIH--mean that 
women's health needs are always at the table, focusing on real, 
life-saving results. These offices make sure women are included 
in clinical drug trials, reach out to low-income and minority 
women to make sure they are getting vaccines and cancer 
screenings and work with health care providers to put research 
on women's health into practice.
    I have introduced the Women's Health Office Act with my 
colleague, Senator Olympia Snowe to make sure that Women's 
Health Offices at HHS, CDC, FDA, Agency for Healthcare Research 
and Quality, and the Health Resources and Services 
Administration, are there for the women who count on them and 
can't be abolished without the consent of Congress.
    Nearly every Federal agency within the Department of Health 
and Human Services has an office or officer of women's health, 
but today these offices and the important work they do can be 
abolished with the stroke of a pen, without the consent of 
Congress. Going back to the days when women's health needs were 
ignored by eliminating the offices we fought to put in place 
over the last 10 years is an unacceptable step backwards.
    The Women's Health Office Act will ensure that we keep 
moving forward by making these offices permanent and providing 
a strong framework for these offices to give women's health a 
clear, consistent voice at the Department.
    I look forward to hearing from the Society for Women's 
Health Research on the Women's Health Office Act legislation 
and from other witnesses to talk about Safe Motherhood, 
cardiovascular disease, and domestic violence. I look forward 
to working with my colleagues to get a women's health bill 
signed into law this year.
    Senator Mikulski. Dr. Marks, we welcome you with your 
excellent background, from the Center for Chronic Disease 
Prevention and Health Promotion at CDC. CDC has been a very 
good friend to the women of America.
    Please proceed, and I am going to ask you to summarize as 
well, Dr. Marks, and ask unanimous consent that your full 
statement be included the record.
    Dr. Marks. Thank you very much.
    I am pleased to be here, and I do want to thank you, 
Senator, and the other members of the committee for their long 
history of support for CDC's work to improve the health of 
women.
    I will summarize my remarks.
    First, it is well-established that chronic diseases cause 
most of the deaths among women in this country, so this hearing 
really could not come at a more opportune time.
    Probably foremost among the CDC programs that deal mostly 
with the health of women is the Breast and Cervical Cancer 
Early Detection Program, which has now supported over 3 million 
screening exams for women who have no health insurance and has 
detected over 10,000 cancers.
    We have seen large increases in the screening rates for 
poor and near-poor women, and we have begun to see, as you have 
heard, the mortality from breast cancer decline as treatment 
for cancer detected early has become increasingly effective. We 
hope to see the number of deaths, now about 50,000 a year, 
decline over time.
    Heart disease and stroke are often thought of as diseases 
that are more common in men, and actually, they kill more women 
than men--nearly 500,000 a year. This led us to develop the 
Wisewoman demonstration program.
    In the Breast and Cervical Cancer Program, they identify 
women who really have no connection to health care in selected 
States, and the Wisewoman program works with those women to 
determine if they have high blood pressure, high cholesterol, 
or other risk factors for heart disease, and to see that they 
get screening, lifestyle----
    Senator Mikulski. Diabetes is included in that as well, 
isn't it?
    Dr. Marks [continuing]. Increasingly, diabetes, and in some 
States, osteoporosis as well--so that they can get treatment if 
necessary and screening and lifestyle interventions.
    We have been excited at how the States have responded to 
this. We know that there are still challenges with it. But it 
is an important program because it does help women who have no 
other source of health insurance to get treatment for the other 
conditions, not just the screening for breast and cervical 
cancer.
    There are unique health risks that women are subject to in 
pregnancy and delivery, and they have shown little or no 
progress in the last two decades in deaths and serious 
complications. We sponsored a Summit on Safe Motherhood last 
year to bring together researchers, clinicians, and 
policymakers to raise the visibility and concern about this 
lack of progress.
    The concern has increased because there are large 
disparities between majority and minority populations. African 
American women are three to four times as likely to die as 
white women during pregnancy.
    We have begun a series of research projects and 
collaborations with State health departments to better 
understand the causes and the severe complications and to begin 
to provide them with support for getting local data and looking 
at emerging issues like postpartum depression.
    Dr. Slater has already commented on the twin epidemics of 
obesity and diabetes. They are more common in women than they 
have been in the past. They are increasing rapidly and are 
increasing even more rapidly among minority women.
    Just this past year, with partners like the American 
Diabetes Association, the State and Territorial Health Officers 
and others, we launched a new initiative for diabetes and 
women's health to focus attention on the large and unique 
impact that diabetes has in women.
    Some of the State programs, New York being among those, 
have developed networks in rural areas to reduce amputations 
and to improve the quality of care for people with diabetes. In 
the New York project that is based out of Syracuse, they have 
seen a reduction of about one-quarter to one-third in 
amputations and hospitalizations among people with diabetes.
    I can only mention a few of the areas where CDC is working 
with States and communities to develop these responses, but 
make no mistake that it is important that we deal with the 
conditions of the chronic illnesses that are either unique to 
women, more common in women, or are major causes of death, 
disability, and suffering among women in the U.S.
    Effective measures exist today to prevent much of the 
chronic disease burden and curtail the consequences. Another 
generation of women should not suffer unnecessarily or die when 
there is so much that we already know that we are not getting 
out. We at CDC and others in the Department are working to 
minimize this delay.
    Thank you for the opportunity to testify, and I will be 
happy to answer questions, as I am sure Dr. Slater will as 
well.
    [The prepared statement of Dr. Marks follows:]
           Prepared Statement of James S. Marks, M.D., M.P.H.
                              introduction
    I am Dr. James Marks, Director of the Centers for Disease Control 
and Prevention's National Center for Chronic Disease Prevention and 
Health Promotion. I am pleased to be here today to participate in this 
important public health hearing on women's health.
                           burden background
    As this committee knows, the burden placed on our society by 
chronic diseases is enormous. Heart disease, stroke, diabetes, and 
cancer combine to cause 63 percent of the deaths or 1.5 million 
Americans in the United States each year. In addition, more than ten 
percent or 25 million Americans experience major limitations in daily 
living due to a chronic disease or condition. The combination of 
chronic disease death and disability accounts for roughly 70 percent of 
the $1.2 trillion spent on health care each year in the United States. 
The increasing burden these diseases and risk factors impose on the 
health of women in our society is also problematic. Let me be more 
specific, while heart disease and stroke are commonly viewed as 
diseases that primarily affect men, more than half of all people who 
die of heart disease and stroke are women. Lung cancer has now 
surpassed breast cancer as the leading cause of cancer deaths among 
women and a woman who smokes has over four times the risk of dying from 
lung cancer as she does from breast cancer. Despite that fact, 22 
million adult women currently smoke and over two million high school 
girls smoked during the past month. Diabetes is now the sixth leading 
cause of death in the general population, and diabetes 
disproportionately affects racial and ethnic minority populations, the 
elderly, and women. More women than men have diabetes and subgroups of 
women suffer disproportionately from this disease. For example, between 
1990-2000, diabetes rates in women aged 30-39 years increased 50 
percent. In addition, women with gestational diabetes, a unique and 
serious condition in women, have up to a 63 percent risk of developing 
type 2 diabetes later in life.
    Unfortunately many of these cases are undiagnosed and these women 
with diabetes are at a greater risk--two to four times--for 
cardiovascular disease and stroke. Physical activity is a key factor in 
reducing a woman's risk for cardiovascular disease and stroke and yet 
75 percent of adults are not physically active. This figure is even 
more striking when you consider more women than men are physically 
inactive. Further complicating this problem is the growing obesity 
epidemic in our society and among women with an estimated 50 percent of 
U.S. women older than 20 overweight.
    The onset of chronic diseases and conditions are not the only 
preventable health risks facing American women today.
    Maternal mortality remains an important public health issue in the 
21st century. Over the last 20 years trends in maternal morbidity and 
mortality have not improved and, even more alarming, the racial and 
ethnic disparities associated with maternal death in the United States 
have not decreased. About one in four women, or one million women 
annually will have serious complications during labor. For every 
100,000 deliveries in the United States, approximately 20 women will 
die from pregnancy and its complications. Racial and ethnic disparities 
persisted among black, Native American, Hispanic and Asian immigrants, 
or older women who were more likely to die (300 to 400 percent) than 
their white or younger counterparts. The Healthy People 2010 goal is to 
reduce the maternal mortality ratio to 3.3 maternal deaths per 100,000 
live births and eliminate racial disparities in health outcomes. With 
the current ratio at 9.9 per 100,000 live births, we have much work to 
do to reach this goal and prevent needless maternal deaths. In 
addition, we are also striving to prevent the even more common 
pregnancy-related complications such as hemorrhage, ectopic (tubal) 
pregnancies, pregnancy-induced hypertension, infection, and postpartum 
depression. For every 100 pregnant women who go to the hospital for 
delivery, 20 are hospitalized before delivery for complications. For 
every 100 women who deliver an infant, 31 have a complication during 
labor and delivery. Again, Healthy People 2010 sets a reasonable goal 
of no more than 24 women with complications per 100 deliveries and we 
have a long way to meet this goal.
    CDC has accomplished many noteworthy improvements in the area of 
women's health, particularly in the areas of breast and cervical cancer 
and in diabetes with effective prevention strategies designed to reduce 
the burden of risk factors of these diseases.
                          prevention research
    Prevention research represents the scientific foundation upon which 
CDC relies, to engage in our mission as the nation's prevention agency. 
Prevention research identifies the risk factors for disease, designs 
and tests interventions to prevent them, and develops and evaluates 
systems to deliver the interventions to the populations who need them. 
Prevention research serves as a transition vehicle that carries the 
basic biomedical research from the lab bench to the public health 
trench where the preventive services can be effectively delivered and 
sustained over time. Prevention research results form the backbone of 
public health policies, standards and guidelines, best practices, and 
evaluation of their impact on health outcomes.
    CDC's prevention research activities include two complementary 
areas: the Prevention Research Centers and the Extramural Prevention 
Research Program. CDC's Prevention Research Centers are a national 
network of academic, public health, and community partners that 
collaborate to conduct scientific research and put the results into 
everyday practice. The first three centers were funded in 1986, and 
over 15 years later, the program is comprised of 26 academic research 
centers in 24 States. Each center conducts at least one core research 
project with an underserved population that has a disproportionately 
large burden of death and disability, often due to adverse 
socioeconomic conditions. The centers work with diverse groups, such as 
women, adolescents, and the elderly and in geographically distinct 
areas, such as Harlem, Appalachia, and the U.S.-Mexico border.
    The unique contribution comes from the close and long-standing 
relationships that develop between researchers at the academic 
institutions and the people they serve. Because of ties to surrounding 
communities, built through community advisory groups, researchers can 
develop and introduce prevention strategies desired by the communities. 
Moreover, by understanding community attitudes and beliefs and by 
making the most of community resources, researchers can simultaneously 
address multiple health risk factors. Further, academic affiliations 
often enable researchers to engage with communities in which government 
researchers traditionally might not have been welcomed. Prevention 
researchers also help develop community capacity to sustain healthy 
behaviors and activities after the researchers are gone.
    In other CDC supported studies, investigators developed and pilot-
tested materials appropriate for different socio-cultural groups. 
Researchers also have tested the effects of church-based interventions 
and health promotion strategies that incorporate spirituality. Some 
studies resulted in highly tangible benefits--such as walking trails 
that promote physical activity among men as well as women in a 
community. The contributions to women's health research also included 
more than 50 research instruments and assessment tools--such as 
measurement scales, surveys, and focus group guides--and more than 20 
training curricula and instructional materials. The measurable 
improvements that occurred in the health of the women who participated 
in these studies also should not be overlooked or underestimated.
    CDC's Prevention Research Centers at the University of Alabama at 
Birmingham (The Wilcox County Health Project) and the University of 
North Carolina at Chapel Hill (Health Works for Women) are two examples 
of this program in action. While death and disability from heart 
disease are higher for African Americans than whites, less is known 
about how to reduce heart disease risk factors among African Americans 
than for whites. In 1998, the University of Alabama's Center for Health 
Promotion started a demonstration project to reduce the risk for cancer 
and heart disease among African Americans living in three rural 
communities in Wilcox County, Alabama. About 70 percent of the county's 
residents are African American, and nearly half live below the poverty 
level. The intervention began by recruiting Community Health Advisors 
(CHAs), who were trained in leadership skills, community problem 
solving, and strategies for reducing risks for chronic diseases--in 
themselves, in their families, and among their neighbors. Nearly all of 
the more than 50 CHAs who graduated from the project's training were 
women. The CHAs conducted community wide health promotion activities as 
well as classes on nutrition, physical activity, and smoking cessation. 
Ongoing activities that hold promise of reducing disease risks include 
the creation of walking clubs and Farmer's Markets (to compensate for 
fresh fruits and vegetables not readily available at local grocery 
stores), the distribution of anti-smoking materials and heart healthy 
cookbooks, and the construction of a walking trail. While the 
participants benefit from this research, the researchers collect 
valuable data about how to design cost-effective interventions that can 
be articulated and widely disseminated to women and men in comparable 
communities. Only through close community participation, trust, and 
mutual benefits is such knowledge gained through the Prevention 
Research Centers.
    The University of North Carolina's Center for Health Promotion and 
Disease Prevention conducts some prevention research in the workplace, 
an environment that serves as a creative partner for research and 
dissemination. Health Works for Women focuses on women working in 
textile manufacturing in a rural section of North Carolina. Many of the 
women who live and work in the area are at a higher than average risk 
of developing chronic diseases such as heart disease, cancer, or 
diabetes. The program, which is unique in its focus on blue-collar 
women, is increasing physical activity, improving nutrition, and 
decreasing smoking, and increasing screening for breast and cervical 
cancer among participants. As in Alabama, women are recruited as lay 
health advisors and trained to educate co-workers about healthy ways of 
living. The women engaged in the study have credited the program with 
having given them guidelines and group support. Researchers codify the 
elements that contribute to the program's success and replicate them at 
other sites. They also note the extra benefit from this type of 
intervention: the reach beyond the worksite, into the participants' 
homes, churches, and communities. Testing and disseminating approaches 
such as these does not require a research laboratory but partnership 
and shared values.
    In discussing women's health, it is important to recognize that our 
prevention researchers also are addressing the passage into womanhood, 
which does not begin at one given age. Several centers, including the 
Johns Hopkins University's (JHU) Center for Adolescent Health Promotion 
and Disease Prevention and the University of Minnesota's National Teen 
Pregnancy Prevention Research Center, are promoting healthy development 
among young women. At JHU, researchers are studying relationships 
between health behaviors and school performance of middle school 
youths. At Minnesota, researchers are conducting peer health education 
training to evaluate its effectiveness on preventing pregnancy among 13 
to 17 year olds at high risk for pregnancy.
    The Prevention Research Centers have the flexibility--as well as 
the requirement--to draw on multidisciplinary faculty with expertise in 
public health, medicine, psychology, nursing, social work, education, 
and business. The knowledge from all these disciplines must converge so 
that the research and practice communities can understand and 
successfully address the inherent complexity of chronic health 
problems. The Prevention Research Centers long-term alliances with 
State and local health departments, other health care delivery 
programs, and community and voluntary organizations have enabled the 
translation of research findings into practice.
    Over many years now, prevention research in general and CDC's 
Prevention Research Centers in particular have demonstrated remarkable 
contributions to enhancing women's health, contributions crucial to 
sustain.
    In 1999, CDC established the Extramural Prevention Research 
Initiative to begin to unlock the extraordinary benefits of prevention 
research. A $15 million appropriation launched this initiative and 
provided support for investigators in academic settings with linkages 
to communities. The driving principles of the initiative are to:
     Support population-based research priorities identified by 
CDC and external experts in prevention science and public health 
practice;
     Incorporate community goals and perspectives in research 
design and conduct;
     Support investigator-initiated extramural research;
     Use external peer review to identify the highest quality 
research; and
     Ensure translation of research findings into public health 
tools and best practices.
    The initiative is now in its second funding cycle and anticipates 
about 30 new projects will be funded in fiscal year 2002. What is 
unique about this second funding cycle is that practitioners, 
policymakers, and community members are being invited to participate 
with researchers in identifying important research questions and in 
interpreting and applying the research findings so that the research 
will have greater relevance and usefulness for individual communities. 
The program announcement was published on February 21, 2002 and can be 
accessed on CDC's website at the following address: http://
www.phppo.cdc.gov/eprp/PRPA02003.asp.
    While CDC has dedicated significant resources to the prevention 
research, the value of this research lies in the ability of the public 
health community to translate this research into effective public 
health practice. Without this translation the potential savings in 
lives and dollars will never be realized and prevention research will 
fall into the abyss of ``research for research's sake.'' At CDC, we are 
dedicated to developing public health programs that are built in the 
foundation on prevention research and dedicated to saving lives and 
reducing the economic burden of health care on our society. Prevention 
research can play a vital role in developing prevention interventions, 
improving the delivery of prevention services and improving the quality 
of health care. The following programs will describe how prevention 
research has and will provide the necessary foundation for current and 
future public health initiatives.
          developing prevention interventions through research
    Safe Motherhood is a universal issue that affects women, men, 
children, the workplace, health systems, and society as a whole. It 
encompasses women's health before, during, and after pregnancy, and is 
grounded in the understanding that healthy pregnancies can occur only 
in the context of general good health for women. Safe motherhood 
addresses the physical, mental, cultural, and socioeconomic aspects of 
women's lives. In the fall of 2001, CDC and its partners held the 
National Summit on Safe Motherhood, which brought together a broad 
spectrum of researchers, clinicians, program experts, policymakers, and 
advocates to address the complex challenges of safe motherhood. This 
summit established four major goals that need to be considered to 
address the health risks associated with motherhood in this society. 
These goals include: reducing the rates of maternal mortality and 
complications; eliminating disparities in maternal health outcomes; 
collecting good data on the frequency of these complications and good 
research to find out why these problems occur; and, utilizing these 
research findings and moving to evidence-based prevention 
interventions. I would like to take this opportunity to review the 
challenges associated with these goals and the current CDC efforts to 
address these challenges.
    Maternal mortality, which is about three deaths per day, is not 
decreasing according to evidence compiled by CDC's National Center for 
Health Statistics. This rate is unchanged for the past 20 years. In 
addition, CDC's Pregnancy Mortality Surveillance System (PMSS), a 
cooperative effort with State health departments, provides evidence 
that the risk of maternal death is generally underestimated by relying 
on death certificate information alone. Through PMSS, CDC collects 
birth and death certificates for pregnancy-related deaths and compiles 
all available information in PMSS. This information can be used to 
monitor the number of pregnancy-related deaths and to analyze factors 
associated with them. For pregnancy complications, we have estimated 
their magnitude from data based on numbers of hospitalizations during 
pregnancy; however, due to changes in prenatal medical management, 
today this information is unable to capture the complexity and spectrum 
of these complications.
    The elimination of population disparities is key to reducing the 
rates of complications and mortality. PMSS has also given us 
information about disparities. A woman's race, ethnicity, and age 
affect her risk of pregnancy-related health consequences. These 
disparities are most evident for pregnancy-related deaths. In addition 
to racial and ethnic disparities, the risk of death also differs by 
age. Women aged 35-39 are twice as likely to have a pregnancy-related 
death compared with women age 20-24, and the risk is even greater for 
women over 40. Since pregnancies among women in their late 30s have 
increased by 74 percent, and among women over 40 by 38 percent in the 
last quarter of a century, the number of women exposed to this 
increased risk is rising. CDC collaborates with private and public 
partners across the United States to address the disparities issues. 
These collaborations include:
     A study with University of Illinois at Chicago to define 
severe complications during pregnancy and risk factors for these 
conditions;
     A study with Columbia University to investigate illness 
during pregnancy from infectious causes;
     A research effort with the State of Massachusetts to 
determine the reasons some women who have had a cesarean section 
experience uterine rupture during a vaginal birth later in life;
     A collaboration with the Massachusetts Department of 
Health to develop the fast comprehensive data set for a State 
population of births conceived using assisted reproductive technology;
     A publication with professional and public health 
organizations, and other Federal agencies to guide States in the 
conduct of maternal mortality reviews, titled ``Strategies to Reduce 
Pregnancy-Related Deaths. From Identification and Review to Action;''
     A project with Wake Forest University to investigate risks 
for maternal mortality and the reasons risks differ according to race;
     A collaboration with the Health Resources and Services 
Administration through the Maternal and Child Health Epidemiology 
Program (MCHEP) to provide technical assistance to States to enhance 
their capacity to gather and use data. Through MCHEP, epidemiologists 
specializing in maternal and child health serve eleven States 
(California, Georgia, Hawaii, Mississippi, Michigan, Louisiana, Ohio, 
Maryland, Colorado, Maine, and Kentucky) and two Indian Health Agencies 
(Northwest Portland Indian Health Board and the Indian Health Service 
regional office in Albuquerque);
     A collaboration with States on the Pregnancy Risk 
Assessment Monitoring System (PRAMS) to monitor risk factors for 
adverse pregnancy outcomes; and,
     A National STD-related Infertility Prevention Project 
which provides routine screening for chlamydia of at-risk women at 
family planning clinics and in managed care settings.
    Despite these efforts, neither complications nor disparities among 
American women can be fully addressed due to inadequate data sources. 
There is no standardized method to define conditions that are 
considered pregnancy-related illness. Even pregnancy-related deaths, 
events that generate vital records, are undercounted and sometimes 
improperly classified. The recent shift to management of complications 
in an outpatient setting further hinders our ability to accurately 
measure these conditions. Therefore, estimating the burden of these 
conditions on a State and national level is difficult. CDC is planning 
a workshop to address problems associated with defining and measuring 
maternal morbidity, and to investigate the use of previously unexplored 
data sources. Collecting accurate data is essential to drive a 
meaningful research agenda.
    Finally, we learned from the National Summit on Safe Motherhood 
that local, evidence-based public health prevention will occur only 
when we have improved maternal health data and enhanced research in 
maternal health. As we learn more about maternal complications and 
their risk factors, researchers at national and State levels, 
universities, and in the private sector will have a rational basis to 
design interventions and demonstration projects. We have made much 
progress but there is still much to do to reduce maternal deaths and 
complications and eliminate disparities.
                     improving prevention services
    One of CDC's most successful prevention interventions has been the 
National Breast and Cervical Cancer Early Detection program. 
Recognizing the value of appropriate cancer screening, Congress passed 
the Breast and Cervical Cancer Mortality Prevention Act of 1990 (Public 
Law 101-354) which enables CDC's National Breast and Cervical Cancer 
Early Detection Program to provide critical breast and cervical cancer 
screening services to underserved women, including older women, women 
with low incomes, and women of racial and ethnic minorities. As the 
flagship of CDC's cancer control efforts, this program has saved lives, 
and raised the consciousness of Americans everywhere about the 
importance of screening and early detection in preventing deaths from 
cancer.
    Through September of 2000, more than 3.0 million screening tests 
have been provided to over 1.8 million women. That number includes 1.6 
million Pap tests and 1.4 million mammograms. Almost half of these 
screenings were to minority women, who have traditionally had less 
access to these services. Over 9,500 women have been diagnosed with 
breast cancer, more than 40,000 women were diagnosed with precancerous 
cervical lesions, and 715 women had invasive cervical cancer.
    The program's success is due in part, to a large network of 
professionals, coalitions and national organizations dedicated to the 
early detection of breast and cervical cancer. This success has been 
reflected in a broader effort to promote screening to the general 
public. As a result, the percentage of women aged 40 and older who 
reported ever having a mammogram increased from 64 percent in 1989 to 
85 percent in 1997, and the percentage of women who reported receiving 
a mammogram within the previous two years increased from 54 percent in 
1989 to 71 percent in 1997. Disparity rates for mammography utilization 
among most minority groups have either been eliminated or reduced 
substantially, and overall, there has also been a recent decline in the 
rate of breast cancer mortality among all women. While there remains 
much to be done, our most recent mortality data shows that 18.8 women 
per 100,000 die of breast cancer. This achieves our Healthy People 2010 
goal of reducing mortality from 23 women per 100,000 to 20.6 women per 
100,000.
    While we acknowledged the importance of preventing or curing all 
cancers, let me be clear: we know today how to prevent up to 30 percent 
of all deaths from breast cancer. It's not a new scientific 
breakthrough; it's mammography--this technology and the recommendation 
for regular screening has been around since the late 70's. Mammography 
is currently the single most effective method for diagnosing breast 
cancer early. The longer breast cancer remains undetected and 
untreated, the greater the likelihood it will spread. The five-year 
survival rate drops from 97 percent when breast cancer is diagnosed at 
the local stage to 21 percent when it is detected after having spread. 
We know these figures are not lost on this committee. In fact, 
exemplifying Congress's commitment to saving lives was demonstrated in 
October 2000 with the signing of the Breast and Cervical Cancer 
Treatment Act of 2000 into law. This law gives States the option of 
providing full Medicaid benefits to uninsured women who are screened 
with breast or cervical cancer by the CDC screening program and found 
to need treatment. We commend Congress, this committee, the National 
Breast Cancer Coalition, and the American Cancer Society for this 
unprecedented legislation. To date, 37 cover the new Medicaid option.
    What's our vision for the future of the breast and cervical cancer 
early detection program? Quite simply, we want no woman to die because 
she lacked knowledge, access or finances for screening services. The 
science is there but the challenge lies in identifying, educating and 
motivating women who have rarely or never been screened for cancer. 
This is challenging and labor intensive work that relies on CDC's 
outreach efforts to bring the science of screening into the lives of 
the women who need it the most--those most at risk for cancers that are 
preventable and survivable.
                       improving quality of care
    Today, through the diligence of science and research, and the 
constancy of surveillance, we know a lot about diabetes--and that 
knowledge base is expanding rapidly. Through significant advances in 
diabetes research, we know that improving nutrition, increasing 
physical activity, controlling blood glucose levels and improving 
access to proper medical treatment can delay or stop the onset and 
progression of diabetes complications. Applying our knowledge could 
prevent much of the suffering caused by the devastating complications 
from diabetes. And now, there is strong evidence that prevention or 
delay of the onset of diabetes is possible if we can develop effective 
strategies and interventions targeting weight loss, increased physical 
activity, and improved nutrition.
    As part of a comprehensive effort to improve women's health, CDC 
launched a new National Initiative for Diabetes and Women's Health to 
focus national attention on the unique impact diabetes has on women's 
health and how it can affect future generations. Cosponsors in this 
endeavor include the American Diabetes Association (ADA), the American 
Public Health Association (APHA), and the Association of State and 
Territorial Health Officials (ASTHO). This initiative consists of three 
phases: the preparation and publication of Diabetes & Women's Health 
Across the Life Stages: A Public Health Perspective, a monograph that 
examined the issues that make diabetes a serious public health problem 
for women (available at http://www/cdc/gov/od/oc/media/r010509.htm or 
http://wwwv/cdc/gov/diabetes); the development of Proposed 
Recommendations for Public Health Action focused on the strategies, 
policies, surveillance, and research for improving the lives of women 
diagnosed with or at risk for diabetes (completed in November 2001); 
and finally, the preparation of the National Action Plan for Diabetes 
and Women's Health--A Public Health Initiative that will outline how 
the recommendations should be implemented, by whom, and in what time 
frame during a national diabetes summit scheduled for August 2002.
    This year marks the 25th anniversary of CDC's diabetes program--a 
program established by Congress to translate diabetes research into 
public health practice. The program began in 1977 with an appropriation 
of $1.5 million to fund 10 States and 10 FTE's. Today, the diabetes 
program funds all 50 States, the District of Columbia and eight U.S. 
territories to implement diabetes prevention and control programs. 
Since its inception, the goal of CDC's diabetes program has been to 
reduce the preventable burden of diabetes by translating diabetes 
research into public health practice. CDC's diabetes program 
accomplishes its mission by developing surveillance systems for use at 
State and local levels, especially for monitoring the diabetes burden 
among certain racial and ethnic populations; developing and 
implementing innovative interventions and prevention strategies for 
eliminating racial and ethnic health disparities; and by informing and 
educating people with diabetes, providers and policy makers about the 
seriousness of diabetes and the importance of preventing diabetes 
related complications. The program has built a national network of 
State-based diabetes control programs, and it has a strong track record 
and impressive outcome data.
    The diabetes program to date has focused on tertiary and secondary 
prevention. The program has evolved with advances in diabetes research 
science; and since 1994, moved away from providing direct care for a 
few to influencing improved quality of care on a large scale (i.e. 
health systems) to help all people with diabetes. This approach 
requires strong partnerships at the national and State levels and 
accountability based on the progress achieved in meeting explicit and 
concrete national objectives.
    CDC relies heavily upon the States to provide the essential 
framework for delivering population-based diabetes prevention and 
control programs. The programs are required to work with partners to 
improve the quality of, and increase access to diabetes care, to 
involve communities in improving diabetes control, to inform and 
educate health professionals and people with diabetes about the 
disease, and to identify high risk populations, including American 
Indians. These State-based diabetes control programs are the primary 
implementation arm of CDC's National Diabetes Program.
    The accomplishments of the State-based diabetes control programs 
reflect several process and intermediate outcome measures. One example 
of these measures is glucose control, which is measured by the blood 
test--A1C (the blood glucose test all persons with diabetes should have 
about twice a year which provides a long-term measure of glucose in the 
blood). A1C levels predict future diabetes complications, and in 
general, the lower the A1C measurement, the better. Obtaining this test 
is the first step; reducing the A1C level is a necessary second step. 
Both performance indicators are now used within the HEDIS system. Other 
indicators of program performance include prevention behaviors, e.g. 
examining eyes or feet; and some data on more distal outcomes, such as 
lower extremity amputations.
    To illustrate the depth and breadth of the impact of the diabetes 
control programs, I will share the accomplishments of four Diabetes 
Control Programs (DCPs)--Michigan, New York, Project DIRECT in NC, and 
Minnesota. These programs represent efforts in rural, urban, community 
and managed care settings. They focus on different populations and 
approaches, but common elements cut across them--funding, technical 
guidance, effort, time and commitment to evaluation. These programs 
represent a small number of DCPs, currently 16, that receive expanded 
funding to provide statewide diabetes control activities.

Michigan

    The six regional Diabetes Outreach Networks are the cornerstone of 
the Michigan DCP. These networks, especially in rural areas, create 
partnerships among hundreds of community agencies to strengthen 
diabetes prevention, detection, and treatment throughout the State. The 
first network UPDON was established in the rural Upper Peninsula. It 
was our first indication that improved distal outcomes could be 
examined. After its first 5 years, UPDON showed promising decreases in 
hospitalizations and lower extremity amputations, in the 25 percent 
range. More recent data from 1997 show continued, impressive 
improvement in key preventive care practices, including A1C testing, 
foot exams, eye exams, flu and pneumococcal vaccinations, and lipid 
profiles.
    The remaining Diabetes Outreach Networks of MI have expanded this 
model, and there are now more than 26,000 persons with diabetes in the 
Quality Care Improvement Project. The the rate of A1C testing has 
doubled in about 4 years. Getting the right test at the right time is 
the first step in preventing diabetes complications. The next step will 
be to improve A1C levels. Because of such compelling data, the State of 
Michigan itself now contributes more money to diabetes prevention and 
control than CDC--just over $3 million per year, in essence a 4 to 1 
match with CDC's funds.

New York

    The New York State Diabetes Prevention and Control Program adopted 
and modified the Michigan model for more urban settings by establishing 
regional community coalitions and academic Centers of Excellence to 
improve the quality of diabetes preventive care and access to care. 
Examples of the interventions include complex programs to get community 
groups and clinicians to achieve consensus on what should be done, and 
then to identify specific activities to convert this consensus into 
reality, e.g. mailing reminders about pending clinic visits; or having 
people with diabetes take their shoes and socks off in the exam rooms 
to help stem the rate of amputation.
    From 1996 to 1999, hospitalization rates for persons with diabetes 
decreased by 30 percent and lower extremity amputation rates decreased 
by 36 percent. In addition, rates of annual A1C testing more than 
quadrupled, increasing from about 15 percent in 1994 to 77 percent in 
1999. The public health interventions that underlie these impressive 
gains do not rely on new molecular or genetic science. Rather, they 
represent thoughtful, cooperative, and sustained efforts to take 
existing science, and then decide how to change the actual delivery of 
diabetes preventive care.

Minnesota

    Project IDEAL, Improving Diabetes Care through Empowerment, Active 
Collaboration, and Leadership, is an important DCP project which 
targets a managed care setting. The Minnesota Health Department and 
HealthPartners developed project IDEAL, a large managed care 
organization. IDEAL is a system-wide approach that enables clinics to 
re-engineer delivery of chronic disease care by changing the structure 
and process of diabetes care, through a variant of case management.
    The IDEAL project demonstrates that it does take time to achieve, 
document, and publish concrete results. For IDEAL, teams were formed in 
1994, baseline data were collected from 1995 to 1996, the intervention 
was conducted in 1997-98, and the project is now in the dissemination 
phase.
    During the pilot, substantial increases were observed in annual eye 
exams, foot exams, and microalbumin testing, and these findings were 
replicated in the intervention. In addition, average A1C values 
decreased during the trial from 9.2 percent at baseline to 7.7 percent 
in the second year, and this contribution effect has been duplicated in 
cross-sectional data for the entire medical group, with reductions from 
8.6 percent in 1994 to 7.4 percent in 1999. For reference, a one 
percent decrease in A1C is associated with a 40 percent decrease in 
microvascular complications. Another important note: these levels of 
A1C--in the low 7's--are comparable to those obtained with intensive 
treatment in the Diabetes Control and Complications Trial and the U.K. 
Prospective Diabetes Study, two landmark clinical trials with 
relatively unlimited resources.
    Similarly, average LDL-cholesterol concentrations decreased from 
132 to 116 mg/dL from 1995 to 1999. Other impacts of this strong 
collaboration include a higher priority for diabetes care in 
GroupHealth, application of the IDEAL methodology to address asthma, 
heart disease, hypertension, and other conditions. In addition, Stratis 
Health, the Minnesota Medicare PRO, is implementing IDEAL with its 
clinics.
    This strong collaboration has resulted in a higher priority for 
diabetes in managed care, and application of the IDEAL methodology to 
address heart disease, hypertension, and asthma.
    These examples, from diverse settings--rural, urban, community and 
managed care--demonstrate that DCP's can make a real difference in 
improving the quality of diabetes care. These interventions provide an 
array of proven, effective programs for other States and communities. 
With adequate funding, guidance, and time, they clearly work. They 
achieve outcomes comparable to those in the most rigorous clinical 
research studies. If the approaches are further disseminated, the 
public health impact will be substantial.
    Diabetes is a prototypical chronic disease. It is serious, common, 
costly, and complex. It imposes an enormous and growing public health 
and societal burden. For women, the impact of diabetes is unique and 
profound. The quality of care for many people with diabetes, while 
improving, still remains poor. Through translation research, State 
DCP's and their collaborators have developed a potent and growing array 
of science-based interventions to reduce the burden of diabetes, 
through secondary and tertiary prevention.
    The compelling new evidence for primary prevention of diabetes 
indicates that investment in translation research for primary 
prevention must now complement ongoing work to improve the quality of 
care. The States and CDC are beginning to wrestle with this important 
and exciting challenge.
                       building on our successes
    Finally, let me describe an ongoing effort to utilize the success 
of one prevention program as a springboard for testing the efficacy of 
another prevention program. As this committee knows, Congress 
established CDC's Well Integrated Screening and Evaluation for Women 
Across the Nation (WISEWOMAN) program in 1993 as a pilot preventative 
services program that utilized the existing breast and cervical cancer-
screening program as an opportunity to offer low-income women 
additional screening services.
    CDC currently supports 12 WISEWOMAN projects in 11 States. These 
projects utilize the existing State-based breast and cervical cancer 
screening system to offer women heart disease screenings, chronic 
disease risk factor screening, dietary and physical activity 
interventions, and medical referrals when appropriate. Since the 
programs inception, approximately 10,000 low income and uninsured women 
have been screened for heart disease risk factors. Between 50 and 75 
percent of the women screened at each site were found to have either 
high blood pressure or high cholesterol. Women screened for these risk 
factors were provided intensive individual counseling, group 
counseling, and lifestyle classes aimed at improving nutrition and 
physical activities levels.
    CDC is currently evaluating the effectiveness of these 
interventions. The goal of this preventive research effort is to 
determine interventions that most effectively prevent or delay 
cardiovascular and other chronic diseases among these at-risk women. 
CDC is currently in the process of evaluating the effectiveness of 
these programs, in part, through collaboration with the Prevention 
Research Centers and anticipates that the program will continue to test 
prevention interventions and disseminate the successful strategies as 
they are identified through the program. Once these interventions are 
identified, CDC will work with States to implement the interventions 
where appropriate.
                               conclusion
    Prevention research provides us with the opportunity to link basic 
biomedical research to the world of public health. The biomedical 
breakthroughs of today and tomorrow provides the fuel to ignite public 
health interventions that will save lives and reduce spiraling economic 
costs. The ideal of a cure for these diseases is something we should 
always strive for no matter the circumstances. However, until these 
cures are discovered, we need to use the basic research as effectively 
as possible and save lives through prevention. We should always strive 
for prevention even after cures are found, since there are often side 
effects to disease and to medication.
    Let me share a story about one life saved by the prevention 
research I have described here today. It's Beth's story. Beth's husband 
David lost his job after 28 years. Before David lost his job, Beth made 
sure to get a mammogram every year. This time, Beth waited five years 
before she was checked. She might never have had another one if she 
hadn't found out about Ladies First, the Vermont breast and cervical 
cancer-screening program. When Beth went in for her free mammogram, it 
was none too soon. Beth's mammogram showed a lesion that turned out to 
be cancer. The good news is that doctors caught Beth's cancer early 
enough to treat it successfully. With other help from Ladies First, the 
cancer treatment was not a financial burden for Beth or her husband. 
Beth credits Ladies First with saving her life.
    There are many Beths out there, and we love to hear their stories. 
But what concerns us most are the Beths we don't hear about--the women 
who do not get regular screening because they don't know about the 
programs or the programs do not exist yet. We want to identify as many 
of these women as possible and catch their diseases early so that we 
can make the science work for those who need it the most and those who 
need it now.
    That concludes my testimony. I would be happy to answer questions 
from the committee.

    Senator Mikulski. Thank you for that excellent testimony.
    Senator Clinton, do you want to go first?
    Senator Clinton. I want to thank both of you, and I think 
that your testimony is very helpful in raising the visibility 
of some of the challenges that we confront, and I believe that 
adult-onset, Type II diabetes has not been given the attention 
that it needs. I was struck by Dr. Slater's statement that it 
is the fifth leading cause of death among women. I can 
guarantee you that not many of us knew that before your 
testimony.
    Dr. Slater, in your written testimony, you also talked 
about the role of violence in the lives of women, and that too 
is an area where we need to look at it as a health issue, not 
just as a law enforcement issue and a cultural concern.
    Could you give us some information about what you are doing 
to address domestic violence and the health impacts?
    Dr. Slater. Yes, a pleasure, Senator. Again because of the 
limited time, I truncated the presentation.
    I believe you are familiar with the Healthy People 
objectives for the year 2000 and again for the year 2010, which 
is a very important way of tracking our progress in terms of 
interventions in public health. Twenty-six of the Healthy 
People 2010 objectives relate in some way, shape or form to 
domestic violence, and this administration is very, very 
committed to this very important problem that you are aware of 
and that is a problem that again appears to disproportionately 
affect women. You are well aware of the statistics--one-third 
of women are murdered by individuals with whom they are quite 
familiar; roughly one million women per year report being 
stalked. So there is really great difficulty.
    Health and Human Services has a Violence Against Women 
Steering Committee, as you know, That committee is chaired 
within my office and reports to the National Advisory Council 
on Violence Against Women, which is Presidentially-mandated and 
co-chaired by the Attorney General and Secretary Thompson.
    HRSA is responsible for a large number of domestic violence 
training programs. They have a 1-800 number--or perhaps it is a 
1-888 number--ASK-HRSA, and one can log onto information 
regarding their many programs which are primarily focused on 
training the health care professionals who need to be more 
sophisticated in recognizing the signs of domestic violence. I 
think this is in some ways a reiteration of the issues of 
childhood abuse, and it was largely learned that by training 
the health care community, the interface, to recognize the 
signs and symptoms is how we will hopefully be able to make the 
first set of inroads.
    Another topic that is sad to recognize for me, but one that 
we are also taking interest in, is the apparent increase in 
elder abuse. It is subtle. It is often missed. It is often 
unrecognized. But it is again something that unfortunately is 
rearing its ugly head and needs to be a concern of all of ours 
as we develop programs to deal with that.
    There is an Intimate Partner Fact Sheet that CDC and Dr. 
Marks, my colleague, has on his website, which again is a very 
useful resource for the statistics, and again, we share your 
concern about that issue.
    Senator Clinton. Thank you.
    Dr. Marks, I do not have a question. I just want to applaud 
you and CDC for what you are doing in prevention research. I 
think we have really woefully underfunded prevention research, 
and it is such a complicated area to get at behaviors and 
environmental impacts and the like, but I think it is key to 
devising successful public health strategies about how to deal 
with these various chronic disease challenges, and I really 
appreciate your leadership and look forward to working with you 
as you do more in the area of prevention research.
    Dr. Marks. Thank you very much.
    Senator Mikulski. Thank you very much.
    Dr. Frist?
    Senator Frist. Thank you, and I apologize to both of you. I 
had to speak at another hearing.
    Let me just thank you, Madam Chairman, for calling this 
hearing today to examine the gaps which are so obvious in 
women's health care. I think we made huge progress in the last 
administration and are making real progress in this 
administration, and I want to applaud President Bush for all of 
his efforts in providing funds for research and prevention 
activities and treatment to improve the health of women 
throughout this country.
    However, there are many, many additional steps that we can 
take and should take, and I appreciate your written testimony 
and look forward to the next panel to explore further what 
steps might be taken in an orderly, systematic, directed way, 
so we can close many of these gaps that exist.
    Jumping right in, Dr. Marks, when we initially talked about 
S. 208, the Wisewoman Expansion Act, you had some reservations 
about the feasibility of the expansion, primarily related to 
the concern that the women who were being screened through the 
program would not be able to receive appropriate follow-up and 
medical services.
    Do you still have those reservations, and if not, have 
things happened to change your mind?
    Dr. Marks. Thank you, Senator.
    That is a good question, and I think that that is the most 
difficult part of the Wisewoman program. It basically screens 
women who have been brought in through the Breast and Cervical 
Cancer Program, and a number of those women because they have 
no form of health insurance are not well-connected and have not 
been making anything resembling regular visits to health care 
provides. So some of them have very high elevations in blood 
pressure, cholesterol, and so on.
    It was critical to us that we not just identify them but 
that we get them to treatment, so we require that of the States 
that apply. It is a demonstration program, and one of the 
things that we evaluate is whether they can do that.
    Because these women have no insurance, the solutions are 
local. That is, sometimes they may have to contract with or get 
a local provider to be willing to see the women, to work with 
the neighborhood health centers that HRSA has.
    The information that we are starting to get from the States 
suggests that they are able to do it, or at least do it in a 
majority of the cases, so I am starting to feel better about 
that, but we do have to recognize that it will be different in 
each place. We have to both capture the strategies that the 
early States have done to make those available for the new 
ones, but we also have to continue to monitor that it is 
effective and that we are getting them to them. As you know, 
conditions like blood pressure and cholesterol require lifetime 
treatment, so it is not something where we can be secure just 
because they got the first prescription filled, and that is all 
that is necessary.
    Senator Frist. Thank you. I very much appreciate your 
response. It is clear that we need to make sure that through 
our mutual discussion, we do everything possible to ensure that 
Wisewoman expansion is an efficient use of resources, so that 
ongoing input is very helpful to this committee.
    Dr. Slater, in your written statement, you outlined that 
the Department of Health and Human Services will spend nearly 
$70 billion this year on women's health, most of those 
expenditures concentrated on the medical and public health 
services as well as research on diseases and conditions 
important specifically to the health of women.
    Additionally, you describe in your testimony a myriad of 
activities which are ongoing at the Department. From your broad 
perspective, are there particular areas in which we need to 
refocus our efforts so that women receive the information, the 
prevention, and the care services they need?
    Dr. Slater. It is a wonderful question, Senator, and I wish 
we could spend hours discussing it. We all know that the 
ability to prevent a variety of diseases can be easy on the one 
hand--something like a baby aspirin--to something much more 
difficult when we tackle situations like diabetes and obesity 
which, as Senator Clinton mentioned before you arrived, involve 
issues of environment, genetics, behavior, a whole host of 
complex problems. You and I have struggled for years trying to 
get people to take a cholesterol-lowering drug or a blood 
pressure drug every day. Well, trying to alter one's diet and 
exercise on a daily basis is probably one order of magnitude 
more difficult.
    One of the things that we would like to do is to take stock 
of all the wonderful expertise, some of which is contained in 
my briefing books and in your briefing books, on the public 
health interventions across all agencies, across departments, 
in academe. There is a certain thread that some of these 
actually do work, some of them resonate. They may resonate for 
a variety of reasons, but what we would like to do at this 
point, in addition to all the wonderful creativity and 
invention that is going on, is take stock of those programs 
that actually do work and begin to develop the wherewithal to 
share those programs from one geography to the next.
    I will share with you--hopefully, Jim and I will become a 
little bit of a tag team for you, because we have already begun 
to work a little bit--but Jim and I took a trip, actually, in 
November to a place in Michigan that had a diabetes 
intervention program. This is in your briefing book, and Jim 
describes this.
    I was so impressed by the reduction in diabetes 
complications that were provided really on a shoestring simply 
by improved care. This was in the Michigan Upper Peninsula. 
Amputations were reduced by greater than 25 percent in a 2-year 
period of time. That is an enormous reduction in morbidity, 
human suffering, emotional suffering, disability, and the cost, 
obviously, to care for these people.
    So that, actually, as a pilot in our department, we have 
developed a best practice initiative where we ask the 
successful program to just sum up what they did in two pages or 
so, and we are putting that on our website. We were just 
discussing this morning--we have a new one once a month, and we 
welcome anyone who wishes to submit these programs. We are 
going to try to figure out additional ways to share them, to 
clone them, and we might even be able to put more initiatives 
on here.
    What I am saying in a nutshell is that we would like to 
take what we have learned, take stock of what we have learned, 
and then see if we cannot disseminate what we have learned in 
the best practice sense to improve and make a difference.
    Senator Frist. Thank you. I think that that focus and 
refocusing is something that is critically important as we go 
through to sharpen the use of the resources that we do have 
available and try to make the appropriate resources available.
    Madam Chairman, I know we are going to have votes soon, so 
I know that we need to move along, but I want to take the 
liberty of saying that I first met Dr. Slater 25 years ago at 
around 5 o'clock in the morning when I was a bleary-eyed third-
year medical student at Massachusetts General Hospital. In 
walked the chief resident, and her first words were, ``Why 
aren't you working faster?'' We used to have to draw blood in 
the morning from 20 patients, and she was a real workhorse. She 
said, ``Soon-to-be Dr. Frist, get on that, work faster, be more 
efficient''--and it was all at 5 o'clock in the morning. And 
here we are 25 years later. That was all on the Bullfinch ward 
at Massachusetts General Hospital.
    Senator Mikulski. Well, I think she is right--why don't we 
start working faster?
    [Laughter.]
    Senator Frist. I know, I know. This is my one opportunity 
to tell her to use resources harder, more aggressively.
    Senator Mikulski. I think that is great. I think that is 
right, and I am ready to draw a little blood on this committee, 
I will tell you that.
    [Laughter.]
    I think that sounds just right.
    Senator Frist. Thank you.
    Senator Mikulski. Dr. Slater, we are looking forward to 
getting better acquainted with you, and because of another item 
before I walked in, I did not have the chance to really welcome 
you most warmly, as well as Dr. Marks, and to say that when it 
comes to working on the women's health initiative, we really 
work on a bipartisan basis. So I look forward to getting to 
know you better and the work better.
    Dr. Marks, I also want to thank you personally as well as 
CDC for the way in which they implemented the breast and 
cervical cancer legislation. It is something that I helped 
initiate a number of years ago. We have continued to improve on 
it, and now, the way it is a gateway to other preventive 
screening under Dr. Frist and his excellent Wisewoman approach, 
I think is outstanding. So we want to thank you for what you 
have done.
    Let me just go for a few quick comments and then to my own 
set of questions. First, just to step back, we have been 
working on the women's health agenda for a number of years, and 
it has focused primarily on, number one, getting women included 
in the research protocols--for a number of years, as you 
recall, they were not included--and also on improving research 
and focus on prevention and treatment of those things which 
were gender-specific to us, particularly things like breast and 
cervical cancer.
    While we continue that focus, now, I think it is time that 
we also take a fresh look at those illnesses or conditions that 
we are really being adversely affected by. You have outlined 
them. The leading cause of women's cancer deaths is lung 
cancer, not breast cancer. On the issue of heart disease which 
has been raised also by our wonderful friend, Mrs. Irene 
Pollin, who has done a great deal in her preventive work--women 
are dying of heart disease, and women are treated differently. 
Men go into acute care and run off to Pritikin or Dean Ornish, 
and women go to Weight Watchers, which might be as much if not 
more effective. Somebody like me has been on the asparagus 
diet, told not to eat carbos, then eat carbos, and while you 
are at it, have more--whatever. So there is a lot of confusion.
    But when it comes to us, we really need to take a look at 
what are the additional things affecting women and how they 
affect us perhaps differently, and also how, even within the 
treatment system, we are treated differently.
    So for your ongoing thinking--and the testimony from both 
of you was outstanding, and we hated to have you condense it--
but we really welcome you to think anew about this. Many of us 
have a variety of legislation pending--Wisewoman, etc.--but one 
that I have, and I just wonder if it would help--you see, the 
whole idea when we established the Office of Research on 
Women's Health at NIH was that it would work across all the 
Institutes and would not be a segregated issue, when we look at 
CDC, when we look at the variety of programs at HHS.
    Senator Snowe and I are considering permanantly 
establishing Offices of Women's Health at FDA and other HHS 
agencies--you have one at CDC, Dr. Marks, and I am going to ask 
you for your observations on that--perhaps a permanent one-stop 
shop at HHS, Dr. Slater--so that again, across the spectrum of 
illnesses and diseases, or where we have conditions but they 
are treated like a disease, a la menopause--which is a 
condition, not a disease, but it requires treatment and 
management--I wonder what you think about the idea of having 
Offices of Women's Health in law to be coordinating and to 
think across condition or disease lines.
    Dr. Marks, could you tell us what the Office of Women's 
Health has meant at CDC, if you are prepared to comment; and 
Dr. Slater, what do you think about that?
    Dr. Slater. Sure. Jim, do you want to go first?
    Dr. Marks. Thank you.
    Ms. Yvonne Green, who directs the Office of Women's Health 
at CDC, is here, and you should know that it has been a very 
useful office at CDC. I am sure it reflects the importance of 
the number of issues we have to deal with.
    It is important to link across them, and I can name several 
areas--for example, in the area of reproductive health, there 
are issues related to infection, there are issues related to 
quality of care, there are issues related to some of the 
chronic diseases that need to be addressed, and Yvonne's office 
in fact does that for us and helps to make those bridges 
possible.
    Yvonne, would you comment?
    Senator Mikulski. Would you introduce the director?
    Dr. Marks. This is Ms. Yvonne Green. Yvonne is director of 
the Office of Women's Health at CDC. She is a nurse-midwife by 
training.
    Senator Mikulski. Do you have any response to my question?
    Ms. Green. Our office serves a role through advocacy, 
communication, and helping to promote women's health in a 
variety of ways, including funding research through the 
different centers, institutes, and offices at CDC.
    So we promote women's health; we work both internally and 
externally to coordinate and to form partnerships and other 
endeavors to promote women's health.
    Senator Mikulski. Excellent. That is exactly what we wanted 
to do. Excellent.
    Dr. Slater?
    Dr. Slater. Senator, I will take this opportunity--this is 
my first appearance before the HELP Committee--to tell you that 
I am so impressed by your particular interventions in women's 
health over the course of your career on this committee. Your 
track record really speaks for itself.
    The issue of creating special offices or having groups 
nonlegislatively dedicated to women's health is a topic that I 
will leave to others who know best about governmental 
organizations.
    This is certainly a very bipartisan theme in the sense that 
Secretary Thompson--you have probably heard him say this over 
and over again; I certainly have--he believes so much in this 
one-agency concept that regardless of how many dedicated groups 
we have within the various agencies dedicated to women's 
health, whatever their legislative mandate and purview, it is 
very important that we all speak as one voice. So it is the 
one-agency concept that Secretary Thompson speaks of and the 
fact that indeed we do have to now look at what are we doing 
across these agencies for menopause or for violence prevention 
or for heart disease. And it is hopefully my job, one of the 
contributions that I can make as assistant secretary, to try to 
take these various sections of an orchestra, perhaps, and bring 
to you one theme of the various contributions and initiatives.
    Senator Mikulski. Dr. Slater, we would really welcome your 
doing that, and we want to hold additional hearings on this. So 
we really do welcome your thinking.
    Dr. Slater. Thank you, Senator.
    Senator Mikulski. I want to note that Senator Paul 
Wellstone and Senator Patty Murray have arrived. Senators, I 
have been advised that there is a vote at 3:30, and if you have 
no questions for the panel or would like to submit them for the 
record, may we go to the second panel?
    Senator Murray. Madam Chairman, let me just thank you for 
having this important hearing. I do have some questions for 
this panel on cardiovascular research, mostly education for 
women, which I think is critical, and on the issue of violence 
which affects women and better ways to educate our health care 
providers and women on that.
    I will submit those for the record. I know that we have 
some people here waiting to testify, and we want to get them in 
before we have to vote.
    [Prepared Statement and Questions of Senator Murray 
follow:]

                  Prepared Statement of Senator Murray

    Mr. Chairman, I want to thank you for working to put 
together this important hearing. As a member of this 
committee--as well as the Labor, HHS and Education 
Appropriations Subcommittee--I know how committed Senator 
Harkin is to improving women's health, and I'm grateful for his 
leadership. I am pleased to see this committee focus on women's 
health issues, including improvements in the Safe Motherhood 
Act and the Wise Women Cardiovascular Disease Screening 
Program.
    Many women don't realize the threat posed by cardiovascular 
disease.
    The Wise Women program, which builds on the Breast and 
Cervical Cancer Screening Program at CDC, would allow for 
greater screening and detection of potentially fatal 
cardiovascular disease. Improvements in reproductive health, 
including the Safe Motherhood Act, are critical for improving 
women's health. We've made a lot of progress in reducing 
maternal mortality rates over the last 100 years.
    While health risks associated with pregnancy and child 
birth have improved significantly, there are still real health 
threats that have to be addressed. There are also huge gaps in 
research in post and prenatal care for women. I think the 
proposed changes to the Safe Motherhood Act will begin to close 
these gaps. However, we also need to address the issue of 
contraception and unintentional pregnancy.
    We know that more than 50 percent of pregnancies in this 
country are unplanned--not unwanted--just unplanned. Prenatal 
care is more effective if it begins early. In fact, it's most 
effective when it begins prior to pregnancy. And we know that 
strategies for preventing birth defects are most effective 
prior to a woman becoming pregnant. Unplanned pregnancies can 
mean prenatal care is delayed by weeks. This delay can have 
serious consequences for both the woman and child. Access to 
safe, affordable family planning options is an important part 
of improving women's health and ensuring safe motherhood.
    I appreciate all of the witnesses who are here today. Your 
testimony will be extremely helpful as we move this women's 
health initiative forward.

                      Questions of Senator Murray

    Question 1. As we work to expand the Wise Women program to 
screen and detect cardiovascular disease, how can we best get 
this message out to all women? Cardiovascular disease is the 
number one killer of women in this country. More women will die 
this year from cardiovascular disease than breast and cervical 
cancer combined. We need to better educate women and health 
care providers about this threat, and we need to focus on 
preventing these deaths. Unlike breast or cervical cancers, 
there are proven prevention strategies for heart disease, yet 
women are not getting this information. What can we do?
    Many women and health care providers are not fully aware of 
the health threat posed by violence. We know that the number 
one reason women age 16 to 35 end up in the ER is due to 
violence. One and three women can expect to be a victim of 
violence at some point in their lives, yet we have no formal or 
established screening. I know that HHS and CDC administer 
important programs aimed at reducing violence against women and 
the serious health consequences of this violence.
    Question 2. What additional steps can we take to reduce 
violence against women and to ensure that battered and abused 
women have access to safe, quality health care?
    Question 3. Can we develop uniformed screening and 
treatment protocols for women who are victims of violence that 
will be closely followed by health care providers?
    One of the programs recently implemented by CDC with the 
help of the Chairman (LHHS) is the Folic Acid outreach and 
education program. This program educates women on the benefits 
of folic acid in preventing birth defects. I have supported 
this program for a number of years and have been pleased by the 
progress being made in providing this important prevention 
message to women. However, this strategy is most successful 
prior to pregnancy. It is still effective during pregnancy, but 
the guidelines clearly support women taking folic acid prior to 
becoming pregnant. Planned pregnancies clearly afford a better 
opportunity for a healthy outcome for both the mother and the 
child.
    Question 4. What steps can we take to improve access to 
effective family planning services and education? Would over-
the-counter status for emergency contraception, as proposed by 
AGOG and the AMA, reduce the number of unintentional 
pregnancies and improve health outcomes for the mother and 
child?

                              FOR PANEL II

    Question 5. Dr. Gellhaus, in your prepared statement, you 
highlight the importance of family planning as preventive 
health. Can you expand further on why access to effective and 
safe family planning is important as a prevention strategy and 
does this include access to emergency contraception?
    I have introduced S. 1990, the Emergency Contraception 
Education Act in order to provide women with access to 
education on the safe and effective use of emergency 
contraception. As you may know less than 12 percent of women 
even know that safe and FDA approved emergency contraceptives 
are available.
    We know that cardiovascular disease is the number one 
killer of women. It is also the number one killer of men. 
However, the survival rate for men after their first heart 
attack is sufficiently higher than women. Heart disease has 
been considered a man's disease for too long. l have seen many 
explanations for the different treatment and different level of 
care provided to women in diagnosing and screening for heart 
disease. The bottom line is that women are not treated with the 
same aggressive strategies as men. It is not just about 
economics or access to health care.
    Question 6. How can we improve this situation and how do we 
get health care providers and women to seek aggressive 
treatments?
    Question 7. Is this solely due to gender bias in research 
or lack of provider education?

    Senator Mikulski. Thank you, Senator Murray.
    Senator Wellstone?
    Senator Wellstone. Madam Chair, like Senator Murray, I have 
questions for the record. But I think we should move on; 
otherwise, we will not get a chance to hear from the second 
panel.
    Thank you, and thank you for the hearing.
    [Questions of Senator Wellstone follow:]
          Question of Senator Wellstone for Marlene Jezierski
    Why is having an infrastructure within health care settings to 
support screening for domestic violence so important?
             Question of Senator Wellstone for Dr. Gellhaus
    In your judgment, what is the impact of lack of access to good 
health care on the frequency and severity of pregnancy complications?

    Senator Mikulski. Thank you very much.
    We look forward to more collaboration with you both.
    The chair now calls forward Dr. Carolyn Mazure, Marlene 
Jezierski, Dr. Thomas Gellhaus, and Dr. Alice Ammerman.
    Senator Wellstone, I understand you have a witness that you 
would like to introduce.
    Senator Wellstone. Thank you. I will be brief.
    Marlene Jezierski is from the State of Minnesota and is a 
good friend to me and good friend to Sheila.
    For years, she has worked as an emergency nurse. She has 
published numerous articles, and specifically, Senator Murray, 
her articles deal with identifying domestic violence in 
emergency settings.
    I have known Marlene's work for many years, and she has 
been a pioneer in the life-saving work of promoting screening 
for domestic violence in health care settings. She is the 
violence prevention educator for Allina Hospitals and Clinics 
in Minnesota, and she has a unique perspective, rich in 
experience. I could go on and on, but I will not. She has a 
very long resume, and I thank her so much for being here.
    Senator Mikulski. Thank you very much.
    Rather than long introductions, we want to go right to the 
panelists. We acknowledge that Dr. Mazure is here from the Yale 
University School of Medicine and is a distinguished professor 
of psychiatry, but she is speaking on behalf of the Society for 
Women's Health Research.
    Marlene is here to speak as a violence prevention educator.
    Dr. Tom Gellhaus, whom we just saw at the Safe Motherhood 
press conference, is here on behalf of the American College of 
Obstetricians and Gynecologists.
    And Dr. Ammerman is here to also speak in terms of women's 
health with your extensive background in public health.
    Dr. Mazure, why don't we start with you?

  STATEMENTS OF CAROLYN M. MAZURE, YALE UNIVERSITY SCHOOL OF 
 MEDICINE, ON BEHALF OF THE WOMEN'S HEALTH RESEARCH COALITION; 
  MARLENE B. JEZIERSKI, VIOLENCE PREVENTION EDUCATOR, ALLINA 
HOSPITALS AND CLINICS; THOMAS GELLHAUS, M.D., DAVENPORT, IA, ON 
      BEHALF OF THE AMERICAN COLLEGE OF OBSTETRICIANS AND 
GYNECOLOGISTS; AND ALICE AMMERMAN, UNIVERSITY OF NORTH CAROLINA

    Ms. Mazure. Thank you, Madam Chairman.
    Thank you for the opportunity to testify today in my 
capacity, as you mentioned, as the chair of the Women's Health 
Research Coalition which was created by the Society for Women's 
Health Research.
    In the interest of time, I would like to make three points 
today in my remarks.
    First, I want to acknowledge the important array of 
programs and initiatives within the Department of Health and 
Human Services designed to promote the health of women and 
their families, and we have heard about a number of those 
today.
    Second, I would like to emphasize the point that despite 
the progress that has been made that has resulted directly from 
many of these programs, there is much work yet to be done to 
serve the many populations of women that are in need of care.
    Third, I respectfully submit that a critical element in 
accomplishing the work that is yet to be done is that Congress 
support by statute the various Offices of Women's Health within 
the Department of Health and Human Services. I would maintain 
that these office are important because they provide a base of 
operations that focus the energy and galvanize the interest 
that already exists within the Department of Health and Human 
Services for women's health.
    Of equal importance, however, each of these offices is in 
an ideal position to supply specialized information on women 
and on their health needs.
    So, recognizing the importance of women's health as it 
relates to topics managed by its agencies, the Department of 
Health and Human Services, as we have heard today, has really 
begun the process of addressing multidimensional and diverse 
issues that surround the field we summarize with the words 
``women's health.''
    In fact, existing offices and positions for women's health 
have been responsible for the initiatives that have been talked 
about today in some measure. Also, I would like to mention a 
few other examples of the important work that they do by 
office.
    The AHRQ, Agency for Healthcare Research and Quality, 
senior advisor on women's health is responding to concerns 
expressed by the Congress and others about the unmet need for 
standards of care for women with cardiovascular disease.
    The CDC Office of Women's Health--you have met the 
representative from that office today, Yvonne Green, who does a 
terrific job--is assessing the magnitude of the severity, 
treatment, and service utilization differences between men and 
women with asthma. This is a growing health care concern since 
women have higher rates of office visits, hospitalizations and 
deaths due to asthma and asthma-related conditions than do men.
    The FDA Office of Women's Health is spearheading efforts to 
investigate the safety, the efficacy, and the appropriate 
dosage of medications in pregnant women, an area of study in 
which little is known, but one in which there are major 
implications for a woman's safe pregnancy.
    HRSA's Office of Women's Health coordinates women's 
activities across more than 80 HRSA programs. One indication of 
the success of HRSA's women's health programs is that women who 
receive care through HRSA-supported community health centers 
have more up-to-date mammograms and pap smears than women 
nationwide.
    The Office of Women's Health in the Office of the Secretary 
is coordinating activities and programs across many of the 
women's health efforts that exist within DHHS. Included in 
those efforts is the coordination of the DHHS Steering 
Committee on Violence Against Women. As you know, approximately 
2 million women each year are assaulted by their partners, and 
domestic violence is the leading cause for emergency room 
visits for women in this country.
    Also of great importance, the Office works with State and 
local governments and with private entities to form effective 
clinical research and training partnerships that really can 
leverage Federal resources and service communities across the 
Nation.
    But as I mentioned, in spite of the fine programs, in spite 
of the advances, there are many examples of the work that has 
yet to be done. We need to understand more about the diseases 
and conditions that are unique to women, such as ovarian and 
cervical cancer, endometriosis, and postpartum disorders.
    For example, we need to know why the child-bearing years 
have been shown to be a time of increased vulnerability to 
psychiatric disorders and why rates of postpartum depression 
have been estimated to be as high as 22 percent.
    We also need a better understanding of why certain diseases 
and conditions have a differential impact on women and men. The 
example given today is cardiovascular disease; it also applies, 
of course, to stroke.
    For example, we need to learn more about why women's risk 
of heart disease rises with age and why women are more likely 
than men to have a second heart attack within several years 
after their first attack.
    Further, we need to know why women are more likely to die 
from stroke even though women and men are equally likely to 
have strokes.
    Finally, we need a better understanding of the disorders 
and conditions that are more common in women, and here, there 
is a long laundry list--depression, breast cancer, migraines, 
osteoporosis, and a variety of autoimmune disorders like lupus 
which, for example, affects nine times more women than men, 
especially African American women.
    And we need to tackle behaviors and conditions that are 
becoming more common in women, such as smoking and substance 
abuse. In reference to smoking, for example, we know that with 
the same lifetime exposure to cigarettes, the risk of 
developing cancer is greater in women than in men. Death rates 
from smoking-related diseases are rising for women, and 
unfortunately now in the United States, one in four girls under 
the age of 18 smokes.
    It is equally important that the Offices of Women's Health 
evaluate ways to provide women with the best treatment and 
services possible, and they need to investigate ways to deliver 
effectively the type of care that women need. In addition, they 
need to translate their research findings into practices, but 
focus on preventing disease before it develops and takes a toll 
on women's health and well-being.
    These serious issues require carefully-thought-out 
comprehensive solutions from a wide-ranging partnership of 
governmental and nongovernmental experts, including State and 
local officials, nonprofit organizations, universities, and 
private industry. They require an unwavering commitment from 
the administration and Congress to look broadly, think deeply, 
and act smartly. That approach, however, is hampered when 
offices do not know from year to year what they are expected to 
do, if they will be funded, and at what level.
    For these reasons, it is critical that Congress support by 
statute the various Offices of Women's Health within the 
Department of Health and Human Services.
    In conclusion, S. 946, the Women's Health Offices Act of 
2001, which was introduced by Senators Snowe, Harkin, and 
Mikulski and has since been cosponsored by additional Members 
of the Senate, takes an important step in addressing this 
issue. By giving statutory authority to the Offices of Women's 
Health in AHRQ, CDC, FDA, HRSA, and the Office of the 
Secretary, this legislation creates a stable and focused 
presence for women's health throughout the Department.
    S. 946 has been endorsed by nearly 50 organizations, and 
with your permission, I would like to submit for the record a 
copy of the letter signed by these groups.
    Senator Mikulski. Without objection.
    Ms. Mazure. Thank you again for the opportunity to address 
the subcommittee this afternoon. I appreciate the difficult 
task of trying to move forward on these complicated issues, and 
I thank you for your time.
    Senator Mikulski. Thank you very much, Dr. Mazure. We 
really thank you for that content-rich presentation.
    [The prepared statement of Ms. Mazure follows:]
                Prepared Statement of Carolyn M. Mazure
    Thank you, Mr. Chairman, for the opportunity to testify before the 
subcommittee today. I am Dr. Carolyn M. Mazure, Professor of 
Psychiatry, Associate Dean for Faculty Affairs at the Yale University 
School of Medicine, Director of the Department of Psychiatry's Women's 
Behavioral Health Research Division, and Director of Women's Health 
Research at Yale--a large interdisciplinary women's health research 
program at Yale.
    I am testifying before the subcommittee in my capacity as the Chair 
of the Women's Health Research Coalition, which was created by the 
Society for Women's Health Research approximately three years ago. The 
membership of the Coalition, which stands at nearly 350 persons 
throughout the country, includes leaders within scientific and medical 
research, as well as leading voluntary health associations, 
pharmaceutical and biotechnology companies--all with a commitment to 
women's health.
    I would like to make three points in my remarks today. First, I 
want to acknowledge the important array of programs and initiatives--
within the Department of Health and Human Services--designed to promote 
the health of women and their families. Second, I would like to note 
that, despite the progress resulting from these programs, there is much 
work yet to be done to serve the many populations of women in need of 
care. And, third, I respectfully submit that a critical element in 
accomplishing the ``work yet to be done'' is that Congress support, by 
statute, the various Offices of Women's Health within the DHHS. These 
offices provide a base of operations that focus the energy and 
galvanize the interest within each agency regarding the health of 
women. Of equal importance, each of these offices is in an ideal 
position to supply specialized information on women and their health 
needs.
    Mr. Chairman, I wish to thank you and the members of the 
subcommittee for addressing the issue of women's health and working to 
identify the initiatives needed to improve the health of women 
throughout the nation. Improving the health of women is a critically 
important goal because women comprise over half of the U.S. population, 
women are largely responsible for the health care decisions in their 
households, and women comprise the large majority of primary caretakers 
for their children and their aging parents. Thus, promoting women's 
health helps women and advances the health of entire families, thereby 
affecting far more than half the people in this nation.
    As you know, the Department of Health and Human Services (DHHS) is 
committed to monitoring, protecting and improving the health of the 
nation. Recognizing the importance of women's health as it relates to 
topics managed by its agencies, the DHHS also has been committed to 
developing a focus on the health of women. Currently, there are women's 
health offices and positions within the agencies of the Department of 
Health and Human Services whose primary responsibility is to promote 
the health of women and their families. These women's health 
representatives, whose jobs are specific to the mission of each agency, 
are dedicated to understanding the unique roles and health concerns of 
women across the U.S., and to initiating and supporting programs that 
will advance the health of women. They provide a base of operations for 
focusing the energy and galvanizing the interest within each agency 
regarding the health of women and, importantly, they bring specialized 
information on women and their health needs. The programs initiated and 
supported by women's health staff provide for new and effective medical 
research studies, prevention strategies, treatment interventions and, 
often, make the difference between a productive life and one 
incapacitated by ill health and disability.
    This subcommittee has a special opportunity to assure that women 
will receive the health-related attention needed from dedicated 
representatives by voting for legislation which statutorily assures 
that women's health offices exist within individual DHHS agencies. 
Support of the provisions of S. 946--the Women's Health Office Act of 
2001, a bill introduced originally by Senators Snowe, Mikulski and 
Harkin and since cosponsored by several more of your colleagues, 
provides a clear demonstration to constituents and colleagues that you 
are ensuring opportunities to improve the health of women and their 
families.
    Before I discuss the legislation further, I would like to provide a 
few brief examples of women's health programs that are the outgrowth of 
the women's health entities within the DHHS agencies under discussion. 
I believe these illustrations demonstrate the importance of leadership 
and coordination by women's health offices that is necessary in order 
to serve the fundamental health needs of women.
               agency for healthcare research and quality
    As you know, Mr. Chairman, the Agency for Healthcare Research and 
Quality (AHRQ) is the government's leader in health services research. 
It supports and conducts research and disseminates information derived 
from research that improves access to care and the outcomes, quality, 
cost, and utilization of health care services. Since the reorganization 
of the agency, advanced by this committee under your leadership and 
that of Senator Frist, AHRQ has distinguished itself as a leading voice 
in determining what systems of service work best in healthcare.
    The AHRQ senior advisor on women's health specifically is dedicated 
to improving the quality and outcomes of health care for women within 
two broad categories of initiatives. The first category relates to 
improvement in the quality of life and prevention of functional decline 
for mid-life and older women. The second relates to improvement in the 
quality and delivery of care for conditions that are common to women. 
Concurrently, the publication and dissemination of research findings 
referable to women's health are a high priority for the senior advisor 
within AHRQ. The following are but a few examples of the important work 
of the Senior Advisor and point to the kinds of initiatives that would 
be enhanced with a secured OWH. With regard to the first category of 
initiatives, the AHRQ women's health advisor has played a key role in 
responding to concern from Congress, advocacy and policy groups about 
the need for standards of care for women with cardiovascular disease--
the leading cause of death for women in this country. Women are more 
likely to manifest heart disease when they are older, and symptoms can 
be different than in men so that they may not be recognized. Women also 
receive fewer therapies and are more likely to die after a heart 
attack. After convening an expert steering committee of stakeholders in 
the health community, AHRQ in collaboration with the National 
Institutes of Health Office of Research on Women's Health, provided for 
a review of the knowledge in risk, diagnosis and treatment of 
cardiovascular disease in women, particularly minority women. Among the 
outcomes of this collaborative effort will be an evidence-based 
assessment for health professionals and organizations that want to 
develop materials for education of health care providers and patients. 
This result exemplifies how the efforts of the Senior Advisor 
complement the larger goals of the agency which, in this case, relate 
to the agency's commitment to translate research into practice across 
the U.S.
    As examples of the second category of initiatives, the AHRQ women's 
health advisor has been instrumental in the agency's efforts to enhance 
management of chronic illnesses, improve quality and utilization of 
maternal health services for minority and other populations of women, 
create tools for assessing the quality of health care for women, and 
improve treatment outcomes for victims of domestic violence (including 
the elderly). As part of the analytic and communication functions 
related to determining the unique status of women in our healthcare 
system, the senior advisor was instrumental in initiating the 
publication of a new and useable chart-book publication on women's 
health status, insurance and access to care. She also successfully 
recommended adding questions to the ongoing Medical Expenditures Panel 
Survey that soon will provide detailed information on women's health 
expenditures.
    Also of note, working with the Office of Research on Women's Health 
at the NIH, AHRQ supports training for the next generation of women's 
health researchers. Nearly half of all programs funded under the 
Building Interdisciplinary Research Careers in Women's Health (BIRCWH) 
program involve health services research components. Increasing the 
numbers and skills of researchers to do this work will lead the way to 
solutions for a multitude of our nation's health concerns.
               centers for disease control and prevention
    The Centers for Disease Control and Prevention (CDC) is committed 
to promoting health by preventing and controlling disease, injury and 
disability. The Office of Women's Health within the CDC is dedicated to 
supporting prevention research programs within and outside the CDC 
directed toward improving women's health, advocating for public health 
and policy programs created to enhance women's health, and 
communicating messages that promote health for women.
    As one example of these efforts, the CDC OWH has focused on a 
serious affliction for Americans--namely, asthma. This is a growing 
healthcare concern for women since they have higher rates of office 
visits, hospitalizations, and deaths due to asthma and asthma-related 
complications. Yet, little is known whether women would benefit from 
different asthma management strategies than those used for men. The CDC 
Office of Women's Health is funding work to assess severity, co-
occurrence of other diseases and the value of different treatments for 
men and women with asthma. This will be followed by the development of 
educational interventions to reduce the severity of asthma in women and 
evaluate the effectiveness of this intervention. Because chronic 
diseases, like asthma, can reduce ability to work and perform other 
necessary daily life activities, results of this work will have direct 
practical benefit.
    Other funded projects supported by the CDC OWH focus on screening 
for osteoporosis in older women, expanding women's access to 
tuberculosis treatment, disease prevention for women working in the dry 
cleaning industry who are at increased risk of cervical cancer related 
to chemical exposure, enhanced delivery of immunizations and cancer 
screening to African American women enrolled in Medicare, reduction of 
female adolescent risk behavior, and development of a national public 
health action plan for diabetes in women.
                      food and drug administration
    The Office of Women's Health in the Food and Drug Administration 
(FDA) addresses differences between women and men in drug, device, and 
biologic testing. It ensures that FDA's regulatory and oversight 
functions remain gender sensitive and responsive, and it provides 
leadership and an integrated approach across the agency with regard to 
women's health issues across all organizational components of the FDA. 
The FDA OWH also forms partnerships with government and non-government 
entities to promote the FDA's women's health objectives. It does this 
through cost-effective and scientifically valid initiatives.
    Since the office was created, the FDA OWH has funded approximately 
100 scientific projects in areas of women's health, including breast 
and ovarian cancer, HIV transmission in women, cardiovascular disease 
in women, osteoporosis, the safety of breast implants, estrogen and its 
effects, and autoimmune diseases. Utilizing a competitive, intramural, 
peer-review process, OWH has funded the highest caliber scientific 
projects related to women's health. Projects selected are those that 
can affect the regulatory process and offer the highest potential yield 
in new information on women's health in a minimum amount of time.
    Currently, the FDA OWH has provided funding to investigate the 
safety and effectiveness of prescription medication used during 
pregnancy. This work is designed to understand the metabolism and 
effectiveness of medications for high blood pressure in pregnant women 
while also examining whether important dosing information can be 
ethically and economically obtained from studies conducted in pregnant 
women. Because medications are not tested in pregnant women prior to 
the medications coming on the market, this investigation seeks to 
develop model studies for measuring the drug metabolism for products 
that are in fact used during pregnancy. For some women with conditions 
such as high blood pressure, epilepsy, or an autoimmune disease who 
must continue or begin to take prescription drugs for their medical 
conditions during pregnancy, results of this work are vital to their 
health and their potential to have healthy children.
    The FDA OWH also has coordinated action to develop regulatory 
policy related to such topics as women as subjects in clinical trials. 
It has undertaken outreach programs such as ``Take Time to Care'' that 
alert women to the importance of the correct use of medicines for 
themselves and their family members. Millions of Americans have 
participated in this educational campaign that included dissemination 
of copies of a brochure entitled ``My Medicines'' published in English, 
Spanish and several other languages. An upcoming ``Take Time to Care'' 
campaign on diabetes will provide valuable information for women to be 
aware of the impact of this disease and methods of prevention and 
management.
              health resources and services administration
    The mission of the Health Resources and Services Administration 
(HRSA) is to assure access to health care that has no disparities for 
underserved, special needs, and vulnerable populations. HRSA promotes 
health care infrastructure and systems development, and training for a 
diverse and culturally competent health professions workforce. The HRSA 
OWH is the principal advisor for agency activities and policies that 
address women's health.
    As a consequence of lower employment rates among women, lower pay 
and a greater likelihood to be in a job that does not include health 
benefits, unequal access to health care is a problem more likely to 
affect women. In fact, about 15 percent of women under the age of 65 
years lack health insurance and many women are underinsured. The HRSA 
Office of Women's Health plays an important role in assuring the 
delivery of health care services to medically underserved and 
underinsured women. It coordinates women's activities across more than 
80 HRSA programs, working to ensure that the health needs of these 
women and girls are addressed across the life span. One indication of 
the success of the office and, as a result, of the agency is that women 
of childbearing age who are served in community-based health facilities 
have higher rates of mammograms and pap smears than comparable women 
across the nation.
    ``The Bright Futures for Women's Health & Wellness'' program is 
just one example of a program managed by the HRSA OWH. This program is 
designed to provide health care information for every woman served, 
regardless of her education or ethnicity, and for every health care 
provider within the community health care system so that every clinical 
encounter is an opportunity to practice disease prevention and 
education. This community-wide health promotion program includes 
materials development and training for community health professionals 
and families, as well as an evaluation component to refine the program. 
Another example of a HRSA program, in collaboration with CDC and the 
States, is ``Statewide Partnerships in Women's Health.'' The 
partnerships encourage statewide collaboration in developing the 
capacity among partner organizations to leverage resources and 
establish an integrated approach to coordinating health services for 
underserved women.
    In addition, the HRSA OWH, at the request of Congress, has 
performed detailed assessments of women's health curricula in medical, 
dental and nursing schools. It also has developed a model medical 
school core curriculum on women's health and strategies for 
implementation along with summaries of opportunities to improve the 
dental and nursing curricula. Assuring the nation's health care 
providers are educated with the most up-to-date information is another 
step to assuring this nation's wellbeing.
        office on women's health in the office of the secretary
    The Office on Women's Health in the Office of the Secretary is the 
focal point and advisory body in DHHS for developing and advancing 
women's health research, health services, and public and professional 
education across the public health service. One crucial component of 
the Office's effort is its coordinating function. Just as the 
Secretary's Office weaves together the common threads of the entire 
department so, too, does OWH weave together those common threads 
related to women's health services, treatment and research throughout 
DHHS.
    In this role, the Office oversees the Coordinating Committee on 
Women's Health, comprised of senior level representatives throughout 
the DHHS, for the purpose of fostering collaboration and coordination 
in women's health initiatives and activities across the DHHS. The OWH 
oversees regional women's health coordinators throughout the country 
assisting with State and community involvement in eliminating health 
disparities. The Office regularly coordinates DHHS activity on key 
issues such as domestic violence through the DHHS Steering Committee on 
Violence Against Women. Still more coordinating and oversight 
activities include working with representatives from all agencies of 
the Federal Government on priority areas in women's health which are 
regularly updated and outlined on the National Women's Health 
Information Center web site managed by the DHHS OWH. The Women's Health 
Information Center offers a single entry point for access to more than 
4,000 publications and 1,600 organizations addressing more than 800 
health topics.
    The DHHS OWH also has been responsible for multiple public 
information campaigns such as ``The Pick Your Path to Health Campaign'' 
which provides comprehensive, culturally-appropriate health information 
for women of color. Another campaign, in which the OWH partnered with 
the Society for Women's Health Research, focused on educating young 
women regarding maintenance of behaviors leading to healthier lives.
    The OWH also has funded and supported National Centers of 
Excellence in Women's Health across the country that provide important 
models for delivering care to women while offering educational and 
research opportunities. In this regard, the OWH in the Office of the 
Secretary, in collaboration with HRSA and the Office of Minority 
Health, has been responsible for establishing seven Community Centers 
of Excellence in Women's Health. These Centers identify, support and 
replicate promising community based approaches to women's health 
services, training, research and outreach in various parts of the 
country.
                               conclusion
    Mr. Chairman, women's health has made important strides in the last 
decade as a consequence of it being increasingly recognized as a 
national priority. Through the offices and positions for women's health 
within the DHHS, efforts have been successful in initiating research 
studies that examine major women's health issues, education campaigns 
that enhance public awareness of women's health concerns, and clinical 
services and screening projects that improve women's health. We need to 
remain vigilant that our recent successes in addressing the health of 
women are not followed by a decline, because much work remains to be 
done for many different subgroups and populations of women in need of 
care. We must acknowledge that there are many examples of work that has 
yet to be done.
     We need to understand more about the diseases and 
conditions that are unique to women such as ovarian and cervical 
cancer, endometriosis, and post-partum disorders. For example, we need 
to know why the childbearing years have been shown to be a time of 
increased vulnerability to psychiatric disorders, and why rates of 
post-partum depression have been estimated to be as high as 22 percent.
     We also need a better understanding of why certain 
diseases and conditions have a differential impact on women and men, 
such as cardiovascular disease and stroke. For example, we need to 
learn more about why women's risk of heart disease rises with age and 
why women are more likely than men to have a second heart attack within 
several years after their first attack. Further, we need to know why 
women are more likely to die from a stroke, even though women and men 
are equally likely to have strokes.
     Finally, Mr. Chairman, we need a better understanding of 
the disorders and conditions that are more common in women such as 
smoking and substance abuse. In reference to smoking, for example, we 
know that with the same lifetime exposure to cigarettes, the risk of 
developing cancer is greater in women than men. Death rates from 
smoking-related diseases are rising for women and unfortunately, one in 
four girls under the age of eighteen now smokes.
    And it is equally important that the Offices' of Women's Health 
evaluate ways to provide women with the best treatment and services 
possible and they need to investigate ways to deliver effectively the 
type of care that women need. In addition, they need to translate their 
research findings into practices that focus on preventing disease 
before it develops and takes a toll on women's health and well-being.
    There is a clear need to stabilize representation for women's 
health within the DHHS in order to maintain current productive efforts, 
coordinate existing and developing initiatives, and integrate new 
topics of significance to women's health into each agency. This can be 
accomplished by establishing structured offices by statute and, 
subsequently, assuring future funding commensurate with the mission of 
each office.
    Currently, actual designated representation for women's health 
varies across agencies. The women's health representatives have varying 
relationships with their agencies based on a number of factors 
including the mission and function of the office or position within the 
agency, the reporting structure for the office or position, whether 
there is a budget line for the office or position within the agency, 
and whether the office or position is present by way of statute.
    Mr. Chairman, these serious issues require carefully thought-out, 
comprehensive solutions from a wide-ranging partnership of governmental 
and non-governmental experts, including State and local officials, 
nonprofit organizations, universities and private industry. They 
require an unwavering commitment from the administration and the 
Congress to look broadly, think deeply, and act smartly. That approach, 
however, is hampered when offices do not know from year to year--and 
sometimes from month to month--what they are expected to do, if they 
will be funded and at what level. For these reasons, it is critical 
that Congress support by statute the various Offices of Women's Health 
within the DHHS.
    I would respectfully submit to the subcommittee that one of the 
most effective and efficient means of addressing women's health needs 
would be to include provisions that are substantially similar to those 
in S. 946, the Women's Health Office Act of 2001 bipartisan legislation 
introduced by Senators Snowe, Mikulski and Harkin, in any comprehensive 
legislation. These provisions, which would authorize appropriations 
through 2006, would enable and enforce a level of security critical for 
the future of these offices.
    Only through strong support from the Congress and the 
Administration can these offices address the complex and very 
specialized area that is women's health. It is critically important 
that dedicated representatives for women's health are ``at the table'' 
at the highest levels, and are participants in designing and 
implementing the agenda for an agency, whether it is the AHRQ, FDA, CDC 
or HRSA. When each agency has a women's health office by statute, a 
clear and direct reporting structure, and a budget line for women's 
health commensurate with its mission, it will be possible to build upon 
the success of the current women's health offices and positions, and 
further evaluate the impact and voice of the office within the agency.
    Women's health has reached a critical point of awareness in 
America, and only with continued and dedicated representation will it 
remain a significant and growing part of our national health agenda for 
this new century. There is a positive, constructive effort to assure 
that this message is heard. The various offices, coordinators and 
advisors on women's health that exist throughout the Department of 
Health and Human Services personify that voice. On behalf of the 
Women's Health Research Coalition, I would respectfully request that 
the subcommittee include statutory authority for Offices of Women's 
Health in the Office of the Secretary, AHRQ, FDA, CDC and HRSA in any 
legislation addressing women's health that it may advance. The presence 
of women's health offices makes a difference to the health of American 
women and, thus, will benefit us all.
    S. 946 has been endorsed by nearly 50 organizations and, with your 
permission, I would like to submit for the record, a copy of a letter 
signed by these groups. Mr. Chairman, thank you for the opportunity to 
address the subcommittee this afternoon. I appreciate the difficult 
task you are undertaking and would be pleased to answer any questions 
you or any other member of the subcommittee may have concerning my 
remarks. 
---------------------------------------------------------------------------
    Endnote: Information has been drawn from the Report to Congress on 
Women's Health Offices, Programs and Activities in the Department of 
Health and Human Services, Arthur L. Lawrence, Ph.D., Assistant Surgeon 
General, March 2001; Mazure et al., J Women's Health & Gender-Based 
Medicine, 10(9), 2001; (1)DHHS web sites.
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                 Women's Health Research Coalition,
                                     Washington, DC  20036,
                                                      May 14, 2001.
Hon. Barbara Mikulski,
U.S. Senate,
Washington, DC 20510.

    Dear Senator Mikulski: As organizations representing millions of 
patients, health care professionals, advocates and consumers, we thank 
you for your leadership in introducing the ``Women's Health Office Act 
of 2001.'' We enthusiastically support this legislation and look 
forward to its passage.
    Historically, women's health has not been a focus of study nor has 
there been adequate recognition of the ways in which medical conditions 
solely or differently affect women and girls. In the decade since 
attention began to focus on disparities between the genders, scientific 
knowledge has accumulated alerting us to the importance of considering 
the biological and psychosocial effects of sex and gender on health and 
disease.
    We support the work of the offices of women's health in ensuring 
that women and girls benefit equitably in the advances made in medical 
research and health care services. The legislation will provide for the 
continued existence, coordination and support of these offices so that 
they analyze new areas of research, education, prevention, treatment 
and service delivery.
    We appreciate your firm commitment to improving the health of women 
throughout the nation.
    Sincerely, Women's Health Research Coalition; Society for Women's 
Health Research; American Association of University Women; American 
Medical Women's Association; American Osteopathic Association; American 
Physical Therapy Association; American Psychological Association; 
American Urological Association; Association for Women in Science; 
Association of Women Psychiatrists; Association of Women's Health, 
Obstetric and Neonatal Nurses; Center for Ethics in Action; Center for 
Reproductive Law and Policy; Center for Women Policy Studies; Church 
Women United; Coalition of Labor Union Women; General Board of Church 
and Society, the United Methodist Church; Girls Incorporated; Hadassah; 
Jewish Women's Coalition, Inc.; McAuley Institute; National Abortion 
Federation; National Association of Commissions for Women; National 
Center on Women and Aging; National Coalition Against Domestic 
Violence; National Council of Jewish Women; National Organization for 
Women; National Partnership for Women and Families; National Women's 
Health Network; National Women's Health Resource Center; National 
Women's Law Center; NOW Legal Defense and Education Fund; Organization 
of Chinese American Women; OWL; Religious Coalition for Reproductive 
Choice; Society for Gynecologic Investigation; Soroptimist 
International of the Americas; The General Federation of Women's Clubs; 
The Woman Activist Fund, Inc.; Voters for Choice Action Fund; Women 
Employed; Women Heart: The National Coalition for Women with Heart 
Disease; Women Work!; Women's Business Development Center; Women's 
Health Fund at University of Minnesota; Women's Institute for Freedom 
of the Press; Women's Research and Education Institute; YWCA of the 
U.S.A.
                                 ______
                                 
    Senator Mikulski. Dr. Ammerman, I am going to turn to you 
now and then to Ms. Jezierski and then to Dr. Gellhaus and ask 
you to proceed. I did not give you enough due when I failed to 
introduce you as someone who comes here with not only a 
doctorate in public health, but you are an associate professor 
of nutrition at the School of Public Health at the University 
of North Carolina, Chapel Hill, which is, outside of the 
Hopkins School of Public Health, one of the great ones.
    So much that we hear about is related to diet. We hear 
about this all the time, and yet it seems to be lacking in any 
kind of consultative way. Would you present that, please?
    Ms. Ammerman. Thank you.
    I am not sure that it is mentioned on the program, but I am 
here actually to talk about the Wisewoman program in particular 
and our experience in North Carolina.
    I am very pleased to talk about Wisewoman, because I 
believe it really has great potential to benefit disadvantaged 
women who, as we have heard, are at very high risk for chronic 
disease but are really poorly-served by our health care system.
    I will speak very briefly about what Wisewoman is--you have 
heard much about that--and what some of the challenges and 
successes in North Carolina have been, and then how our 
experience can benefit other Wisewoman States and other 
disadvantaged women across the country.
    As you have heard, Wisewoman builds on an existing 
prevention program, the National Breast and Cervical Cancer 
Early Detection Program. We like to say about Wisewoman that it 
offers one-stop shopping so that women who come in to get 
screened for breast and cervical cancer also get a chance to be 
screened in terms of heart disease and then, more important 
perhaps, that we provide interventions in terms of dietary and 
physical activity, and smoking cessation.
    In North Carolina, we received funding for Wisewoman in 
1995 when it first began. We started with an existing nutrition 
intervention program that we called Food for Heart, and we 
expanded it to include physical activity, smoking cessation, 
osteoporosis prevention, diabetes control, and we renamed it 
the New Leaf program.
    Senator Mikulski. Dr. Ammerman, I am going to interrupt 
here. The vote has started, and we will have to leave here in 
about 15 minutes, and there are five votes scheduled in a row.
    This is in no way to ask you to shrink your testimony, but 
I guess it is. So I am going to ask you if you could summarize 
the Wisewoman program, and then we will go to Ms. Jezierski and 
Dr. Gellhaus, because after the presentations, we will submit 
questions only because these 5 to 12 votes are going to occur.
    Would you please proceed, but know that that is how we are 
going to be operating.
    Ms. Ammerman. OK. I tried to mark a few key sentences in my 
testimony, so I will go to them.
    Essentially, I think you have heard what the Wisewoman 
program does. I think it is really extremely well-designed to 
reach a very high-risk population, and we have some very 
practical strategies that we have developed.
    We developed this New Leaf intervention which is based on 
low-literacy materials development for women who do need 
materials that are practical for their lives. We focus on 
walking rather than aerobics classes and things that may not be 
appropriate for lower-income women. We focus on modifying 
Southern-style recipes rather than expecting people to eat tofu 
and bean sprouts. So we try to make an attempt to really make 
it relevant to the people who are in the program.
    The program now has been expanded to 12 programs in 11 
States. We have worked with a variety of the other programs to 
develop materials as well. We started with New Leaf, and we 
have worked with the Alaska program, but we found that ``new 
leaf'' was not a useful term, because people do not think of 
turning over a new leaf in either a Native Alaskan population 
or a Hispanic population; so in Alaska, they renamed the 
program Traditions of the Heart and really built in a lot of 
Native American traditions, and the Hispanic version translated 
is Healthy Diet, Happy Heart.
    So these things are being incorporated across the country 
and adapted to reach the populations at highest risk.
    I will go to my summary paragraph. In summary, Wisewoman 
reaches a very highly vulnerable population with an efficient 
screening and prevention program as the rates of chronic 
disease soar and health care resources remain limited.
    I would like to thank Congress and the CDC for recognizing 
that financially disadvantaged women and the providers who 
serve them need substantial help if they are to fight off heart 
disease, diabetes, and obesity.
    I think it is critical that all States have the opportunity 
to provide the benefits of Wisewoman to their disadvantaged 
women. At the same time, I think expansion of the program 
should be done thoughtfully, with adequate resources devoted to 
evaluation so that we can determine the most cost-effective 
approaches to reach these women.
    Thank you.
    Senator Mikulski. That was outstanding.
    I just want to say to you, Dr. Ammerman, that I am going to 
be holding a hearing in my subcommittee on Aging later on this 
summer on obesity and diabetes and a focus on what are the 
programs and the whole issue of prevention, and we are going to 
invite you back--in fact, we would like to invite all of you 
back.
    [The prepared statement of Ms. Ammerman follows:]
             Prepared Statement of Alice Ammerman, DrPH, RD
    Hello, my name is Dr. Alice Ammerman. I am an Associate Professor 
in the Department of Nutrition, Schools of Public Health and Medicine, 
at the University of North Carolina at Chapel Hill. My research focuses 
on developing and evaluating innovative approaches to nutrition and 
physical activity interventions for minority and disadvantaged 
populations. Over the last 20 years, I have developed, tested, and 
refined the program: New Leaf, Choices for Healthy Living, which is 
designed to be culturally sensitive and clinically feasible for 
application by front line public health workers who face multiple 
demands with limited resources. In this work, I have collaborated with 
my husband who is a general internist and has practiced in community 
health centers in rural North Carolina. I became involved with 
WISEWOMAN in 1995 soon after the program began. In addition to serving 
as the lead nutrition and physical activity interventionist and 
evaluator for North Carolina, my staff and I have assisted many other 
WISEWOMAN States with adapting the New Leaf intervention for their 
regions and have consulted with the CDC regarding future directions of 
the WISEWOMAN program.
    I am very pleased to speak with you today about the WISEWOMAN 
program, because I believe it has great potential to benefit 
disadvantaged women who are at high risk for chronic disease, but 
poorly served by our health care system. I will address the following 
three questions:
    (1) What is the WISEWOMAN Program?
    (2) What have been the challenges and successes of the North 
Carolina WISEWOMAN program?
    (3) How can our experience benefit other WW States and 
disadvantaged women across the nation?

(1) What Is the WISEWOMAN Program?

    Briefly, WISEWOMAN is designed to improve the health of financially 
vulnerable women. Heart disease is the leading cause of death among 
women, and we are experiencing epidemic rises in obesity and diabetes 
particularly among disadvantaged women. Because most of the original 
research on CVD was done on men, heart disease is often not viewed as a 
``women's problem.'' However, heart disease kills more than 370,000 
women each year and affects 1 in 4 women over the age of 65. Women are 
more likely to: delay seeking care after the onset of heart attach 
symptoms, suffer a severely damaging heart attack, and suffer a second 
heart attack within six years of the first one. They are less likely 
to: receive preventive counseling from their physicians on their CVD 
risk factors, have their heart attack symptoms recognized by a health 
care provider, or be enrolled in rehabilitation programs after a heart 
attack.
    Women in North Carolina are particularly vulnerable. North Carolina 
sits firmly in the ``stroke belt,'' where deaths from heart disease and 
stroke exceed the national average. Among North Carolina women, the 
heart disease death rate for all women is 400/100,000. However, 
disparities exist, with rates of 513/100,000 for African American 
women, 485 for Native Americans and 375 for Caucasian women.
    The most cost effective approach is to prevent or delay the onset 
of these diseases through lifestyle modification--improved diet and 
increased physical activity. WISEWOMAN does this by building on an 
existing program--the National Breast and Cervical Cancer Early 
Detection Program. The beauty of WISEWOMAN is that these women who may 
hold multiple jobs or face transportation problems, can make just one 
stop and receive both services. In North Carolina, WISEWOMAN is a 
partnership between our State and local health departments and the UNC 
Center for Health Promotion and Disease Prevention, which is one of 26 
prevention research centers at universities across the nation funded 
through legislation initiated by this committee.

(2) What Have Been the Challenges and Successes of the North Carolina 
                    WISEWOMAN Program?

    North Carolina received funding from CDC for a WISEWOMAN grant in 
1995 when the program first began. We have built our intervention 
around an assessment and counseling program, called Food for Heart, 
that we had developed and tested over the past 15 years in community 
health centers and local health departments. The design of Food for 
Heart was based on sound behavior change theory as well as personal 
experience ``in the trenches'' of public health care delivery. Our 
studies had demonstrated the effectiveness of this program in improving 
diet, curbing weight gain, and reducing serum cholesterol. In our 
WISEWOMAN proposal, we expanded Food for Heart to include physical 
activity, smoking cessation, osteoporosis prevention and a diabetes 
module, and renamed it ``New Leaf, Choices for Healthy Living.'' This 
truly allows ``one stop shopping'' for women's health needs. (ref. New 
Leaf Notebook)
    In the first phases of NC WISEWOMAN, we have tested the New Leaf 
intervention in 42 counties, reaching over 4,000 women. We learned much 
about the challenges of implementing and evaluating such a program in 
resource-strapped health departments. For example, public health staff 
lacked culturally appropriate intervention materials, lacked confidence 
in their ability to help patients make lifestyle changes, and have very 
limited time to counsel. The New Leaf addresses these problems by 
providing easy to read, culturally relevant materials designed to guide 
counseling by practitioners who have little background in nutrition. We 
have further streamlined the intervention and built in more 
flexibility, such as a telephone counseling option for those with 
transportation problems.
    The response from participants and front line staff has been very 
positive. The staff feel that they finally have the tools they need, 
and participants are pleased that the approach is relevant to their 
lives. For them, walking with friends, as promoted by our intervention, 
is much more realistic than aerobics classes and jogging. Similarly, 
lower fat recipes for southern favorites are better received than 
exhortations to eat tofu and beansprouts! Describing her experience in 
delivering the program, Betty Person, a nurse in Person County North 
Carolina said ``These ladies have not had anyone sit down with them and 
take the time to discuss healthy eating habits and the importance of 
exercise . . . I can see the light bulbs go on. The patients appreciate 
the interest shown in them by the phone calls to check on their 
progress, mailings, and handouts; especially the New Leaf notebook and 
cookbook. We have a few patients that are now being treated for 
diabetes because of the blood work done through the WISEWOMAN Program. 
Some wanted their cholesterol checked but did not have the money to 
have the blood test. The WISEWOMAN Project has enabled them to do 
this.''
    Quotes from women in the South Central Foundation WISEWOMAN program 
in Anchorage Alaska include the following:
    ``Some things I already knew but didn't practice. Some things I 
didn't know and appreciate the enlightenment on some topics. I enjoyed 
all the classes and am eager to practice what I have learned. There was 
something about the setting that was making me willing to change for 
the better.''
    ``It was very organized and planned. The leaders were very 
thoughtful to what the group wanted and sensitive to the Native way. 
Everyone was made to feel welcome and it was easy to talk.''
    ``I think it is wonderful that this program is helping to maintain, 
protect and practice preventive maintenance for Native Women. It would 
be great to expand for all people Native and NonNatives and educate 
people about good health practices. It is also a great way to curb and 
cut down on rising health care costs. Thank you very much!''
    Given the unique role of women as gatekeepers and nurturers in 
their families and communities, WISEWOMAN has the potential to 
positively effect a much broader population as the participants share 
and apply what they learn. Many health department staff in North 
Carolina have commented on their own successful lifestyle changes 
inspired by the program and talk about ``taking it home'' to the 
family. One public health nurse in North Carolina said ``Several 
patients have told me their husbands are supposed to be on low fat, low 
sodium, low sugar diets due to heart disease, diabetes, or 
hypertension. The wives are delighted to have this information to 
better help their husbands eat healthier, so it is benefiting the whole 
family. In the Anchorage-based WISEWOMAN program, one Native Alaskan 
woman said ``This has been a fabulous class for me and my husband! I 
shared all the information with him. I am motivated to exercise and eat 
right. This is the best I have felt in years. I have lost nine 
pounds!''
    Perhaps the biggest challenge of the NC WISEWOMAN program has been 
collecting data of adequate quality to allow us to determine the health 
benefits of participation. County health department staff are not 
trained in research methods and have little time or inclination for 
extra paperwork. To send research assistants to each county would be 
enormously expensive. We have some reliable evidence of positive 
dietary change based on WISEWOMAN, but are continuing to work on the 
best approach to collect good health outcome data.

(3) How Can Our Experience Benefit Other WISEWOMAN States and 
                    Disadvantaged Women Across the Nation?

    CDC has now expanded WISEWOMAN to a total of 12 programs in 11 
States. The North Carolina team has shared our experiences with these 
new sites, and produced a practical manual to help others integrate 
WISEWOMAN into existing health services (ref. monograph). Some WW 
programs are developing their own approach to interventions, while a 
number have chosen to adapt our New Leaf intervention. Two groups in 
Alaska have adapted the New Leaf for a Native Alaskan population (ref. 
Traditional of the Heart). Other States making more modest changes in 
New Leaf include Vermont, Connecticut, South Dakota, and California. We 
are also testing a recently completed Spanish translation of the New 
Leaf Materials (ref. Vida Saludable, Corazon Contento). These 
collaborations have highlighted the importance of culturally tailoring 
lifestyle interventions. In North Carolina we eat pork chops and worry 
about heat and humidity while exercising in the summer. In Alaska, they 
eat moose meat and worry about avalanches and bears while being active 
in the winter. Even the name of the program needed to change. The idea 
of ``turning over a new leaf'' does not exist in either Native Alaskan 
or Hispanic Cultures, thus the program was renamed ``Traditions of the 
Heart'' in Alaska, and ``Vida Saludable, Corazon Contento'' (Healthy 
Living, Happy Heart) in the Hispanic version.
    To further assist other States with intervention development and 
implementation, we are developing a week-long national training course 
for WISEWOMAN project staff, safety net providers, and others 
implementing programs to improve the diet of financially disadvantaged 
populations. This course will be offered for the first time in October, 
2002.
    We also continue to develop and refine our approach to WISEWOMAN 
screening and intervention in hopes that it will ultimately be useful 
to other States. We have recently been funded by CDC to test new 
strategies aimed at improving the efficiency of the program by using 
lay health advisors to link participants with existing community 
resources, identifying neighborhood influences on diet and physical 
activity through geocoding, and using group education opportunities. 
Fortunately, this funding will also allow us to evaluate the health 
outcomes of the program more rigorously by focusing data collection 
efforts on a smaller number of representative sites. This evaluation 
will include a cost-effectiveness analysis.
    As the rates of chronic disease soar and health care resources 
remain limited, the WISEWOMAN funding has helped our North Carolina 
team develop and refine the New Leaf counseling tool and in turn help 
others adapt it for their use. The funding has allowed us to build 
capacity in local heath departments to provide substantially improved 
health promotion interventions and to link with existing complementary 
public health resources in the community. We'd like to thank the 
Congress and CDC for having had the foresight in 1995 to recognize that 
financially disadvantaged women and their providers need substantial 
help if they are to fight off heart disease, diabetes, and obesity. In 
my estimation, the WISEWOMAN projects are providing this much needed 
help to women and their families. I think it is critical that all 
States have the opportunity to provide the benefits of WISEWOMAN to 
their disadvantaged women. At the same time, I believe that expansion 
of the program should be done thoughtfully and with adequate resources 
devoted to evaluation so that we can determine the most cost-effective 
approaches to reach these women and improve their health.
                list of relevant websites for wisewoman
WISEWOMAN Web site http://www.cdc.gov/wisewoman
University of North Carolina at Chapel Hill (New Leaf and WISEWOMAN 
    Manual) http://www.hpdp.unc.edu/WISEWOMAN
South East Alaska Regional Health Consortium (SEARHC) WISEWOMAN http://
    www.searhc.org
South Dakota WISEWOMAN http://www.state.sd.us/doh/Disease2/cancer.htmn
American Heart Association http:/www.americanheart.org
National Heart, Lung, and Blood Institute (NHLBI) http://
    www.nhlbi.nih.gov/

    Senator Mikulski. Marlene, please proceed.
    Ms. Jezierski. I am truly honored to be here, and I am so 
thrilled that domestic violence is a high priority.
    You have heard my background; I will not give you much more 
on that. But I want to tell you a couple of things. I have 
worked very extensively in the last decade in developing 
educational programs for health care providers, and I have 
learned a lot. I have learned from advocates, I have learned 
from survivors, and I have learned from patients and health 
care professionals.
    When we do our work well, it is marvelous, and when we do 
not, it can really stink. When we do it well, we have things 
happen like an obstetrics doctor told me that he had seen a 
patient who acknowledged abuse, he spoke with her, and a year 
later, she came back to see him, and she said, ``Thank you so 
much for what you did for me a year ago.'' And he looked at 
her, and he said, ``Tell me what was so helpful.''
    She said, ``You told me, you do not deserve it.''
    Those words are powerful medicine, and if we can teach 
people how to say them right, we can save lives.
    I have four main points that I will really try to truncate 
with respect to the time. First, I think we recognize that 
physical, sexual, and psychological abuse has a huge impact on 
women's health, and many of the processes that were discussed 
today are part of what can happen to women in abuse 
relationships--not just physical injury, but chronic chest, 
abdominal, and pelvic pain, migraines, irritable bowel 
syndrome, fibromyalgia--a whole, huge list of things that 
overlap into all of these other presentations today.
    In addition, individuals in abusive relationships indulge 
in--and ``indulge'' is not the right word--injurious health 
behaviors. They are known to smoke more. They are known to be 
heavier. There is known to be a high rate of substance abuse in 
these patients.
    My second point is that health care professionals must be 
well-educated, and this is a key message in Senator Wellstone's 
proposed legislation. If they are not educated well--and out 
there right now, many have no education at all, or little; they 
might squeeze it in on their lunch hour at the clinic when they 
have a production level to adhere to, so they are in and out as 
fast as they can--it is inadequate for them to learn how to be 
sensitive and responsive.
    Little or no education not only results in little or no 
screening, but sometimes it is offensive, and at worst, it can 
be dangerous. People have asked people about their safety in 
front of abusers. They have called abusers on the phone after 
they have left. So it is a key elemental piece. They must be 
well-educated.
    Third is that screening should be universal. You cannot 
tell someone who is abused by looking at them, so you must ask, 
and we must ask everyone. There is a precedent for that, and it 
is in blood pressure screening. Twenty-three percent of people 
develop hypertension. Twenty-five percent of women have a 
lifetime history of physical or sexual abuse.
    There is a real classic example of that from an urgent care 
visit of a patient who had a bee sting in one of our urgent 
cares. She was screened, she said no, she went home. She sent a 
fax the next day. The fax described the horrific life that she 
was experiencing, and the staff was able to call her. At the 
end, she said, ``Please put this in my medical record in case 
something happens to me.'' This was not a call for putting 
something in a medical record; this was a cry for help. Had we 
not routinely screened, this woman never would have gotten 
help.
    Fourth, a successful program requires partnerships with 
domestic violence agencies and infrastructure--and that again 
is in Senator Wellstone's legislation. And we cannot just do 
the education and then set them loose. I have seen that. I have 
seen it fail, I have seen it struggle. Part of it is in terms 
of partnerships with domestic violence agencies--this is how 
our patients receive help. We do not know how to do that. The 
experts are the advocates, and we need to connect our patients 
with them preferably in person.
    The other piece is that you cannot just have them hanging 
out there. One of Jackie Campbell's recent articles discussed 
that you can have all the other things in place, but if you do 
not have administrative support, you will not get a good 
program and be able to sustain it.
    When I was a manager in the emergency department, I 
actually had it in the performance review; so if they did not 
screen, I had a conversation with them--I was very nice, but I 
had a conversation with them.
    Finally, one example from Allina's experience is at United 
Hospital in St. Paul. After 4 hours of mandatory education, our 
identification and referral rate to advocacy services--we do 
have an onsite advocacy service there--shot up from one or two 
per quarter to 100 per quarter. We have served almost 2,000 
women, and I know we have helped improve their health. It is a 
journey, and the way we need to learn how to serve them is to 
be sensitive, nonjudgmental, accepting, and not tell them what 
to do. And you cannot learn how to do that unless you are 
educated. Some people can.
    One example of that is a physician who wrote a 
prescription: ``Leave your husband.'' So I cannot say it loud 
enough.
    This is the last story. A survivor told me this story. She 
said that she had had her head bashed in the driveway multiple 
times, went to the ER with a head injury, and she said she 
believed she was dying--she felt that she was floating above 
her body--and she said, ``If they had asked me, I would have 
spilled my guts. But nobody asked, and I went back with my 
abuser.''
    This concludes my testimony. Thank you so much.
    Senator Mikulski. Outstanding. Thank you very much.
    [The prepared statement of Ms. Jezierski follows:]
           Prepared Statement of Marlene B. Jezierski, RN, BA
    The purpose of my testimony is to discuss why domestic violence is 
a health care problem and must have high priority in legislation 
dealing with women's health. In my work at Allina Hospitals and 
Clinics, a health care system that owns 12 hospitals and 40 clinics, I 
have worked as a violence prevention educator and coordinator, 
educating health care professionals and developing systems that support 
ongoing, routine and effective screening for domestic violence.
    I have worked with health care professionals for more than a decade 
teaching them why they should ask their patients if they are being hurt 
by someone in their life and how they should do that. I have worked 
with leaders incorporating supportive infrastructure so abuse screening 
practices can be sustained. Working with front line providers I 
understand the barriers they encounter and what it takes to establish 
routine screening. I have heard dozens of survivor stories. I have 
spent countless hours with domestic abuse advocates I know from these 
experiences that hundreds of abuse victims can be helped. I have heard 
many stories from domestic abuse victims describing how their lives 
have been positively impacted by health care professionals' sensitivity 
and knowledge. I know screening and referral in the health care setting 
helps battered women. I believe our work has saved lives.
    There are four recommendations I would like to make.
     First, to assure competent screening and intervention, 
health care professionals must be educated in schools and the clinical 
environment.
     Second, a health care ``best of practice'' should be 
established; adults and teens should be universally screened for 
histories of family and domestic violence.
     Third, partnerships should be developed between health 
care and domestic abuse advocacy services. The most preferable 
arrangement is provision of on-site advocacy.
     Fourth, infrastructure must be in place to maintain 
sustainability of abuse screening protocols. This includes measurement, 
leadership support, policy changes, forms revisions and clearly stated 
performance expectations.
                 when abuse screening is done properly
    During an annual physical at one of our clinics, a gynecologist 
screened his patient for domestic abuse. She disclosed her history of 
abuse by her husband. The physician's response was kind and very 
gentle. He said to her ``You don't deserve that''. A year later when 
she returned for her annual visit, the woman looked at him with great 
appreciation and said ``Thank you for what you said to me when I was in 
here last year.'' Not remembering, the physician asked his patient what 
he had said that was so helpful. She repeated ``You said `you don't 
deserve that'. I want you to know that I am no longer in an abusive 
relationship. What you said to me that day helped me make a change''.
    This scenario has been repeated many times in our health care 
settings. It exemplifies the value of screening all of our patients. 
Women want us to ask and to care.
                  domestic violence and women's health
    Domestic violence has been identified as a significant health 
problem by every major professional organization. The Joint Commission 
on Accreditation of Healthcare Organizations requires institutions it 
accredits to identify family violence victims.

Incidence of Abuse

    Research documenting the incidence of abuse includes:
     30 to 40 percent of murdered women in the U.S. are victims 
of intimate partner violence (IPV).
     37 percent to 54 percent of women seen in the Emergency 
Department have been abused by an intimate partner at some point in 
their lives.
     Each year over 2 million women experience intimate partner 
violence severe enough to cause physical injury.
     At least 13-30 percent of all women in the U.S. will 
experience one or more incidents of IPV in their lifetime.
     20 percent of pregnancy-associated deaths were caused by 
homicide.
     The incidence of violence during pregnancy occurs at a 
rate of 4 percent to 8 percent.
     21 percent to 34 percemt of women experience emotional 
abuse, a major factor contributing to chronic health problems.
                  emotional abuse: a survivor's story

Response to Abuse

    If he had hit me, I wouldn't think it was my fault. Instead he told 
me ``everything'' was my fault and I kept quiet to keep peace. 
Eventually, I guess I believed him. If he had tried to kill me, 
everyone would agree I needed to leave him to preserve my life, and 
support me when I did. Instead, he tried to kill my spirit, and I 
struggle alone with a sense of failure and inadequacy, questioning what 
have I done wrong, and why did I have to leave.
    If he had been a thief, I would have been afraid of him and stayed 
away. Instead, he was a smooth-talking charmer whose heart was willing 
to take from my soul, and then tell me what I owed him. I continually 
search my soul and seek the Lord and His wholeness. I wonder why I 
allowed him to hurt me so many times before I finally realized he 
didn't love me, instead of wondering why he had no conscience in doing 
what he did to me. If he had used fists or weapons, I would have 
thought it was his action and his decision. But since he used words, I 
blame myself. I should have known. I shouldn't have allowed it. If he 
had been willing to listen when I tried to talk, maybe that twisted 
relationship could have been healed as we allowed the truth to enter. 
Instead, he would get angry and turn my concern into what was wrong 
with me, twisting it further. At first I innocently believed him. Later 
I got angry. Then I doubted myself. Then I was broken. When I gave up 
trying to have a voice, I knew I had to leave.
    Of course I want to forgive him, but it's scary to even acknowledge 
that a person can treat someone the way he treated me. So even though I 
found the strength to leave, even though I've been gone for two years, 
I struggle daily to get free. When will I be free of all the wounds, 
received at the hand of someone who claimed to love me, free of the 
self-doubt and self-rejection? When will I see the sins as belonging to 
him instead of me? (Anonymous, Registered Nurse, Health Care 
Consultant, survivor of domestic abuse)

Domestic Abuse Contributes to Poorer Health

    Intimate partner violence is associated with many adverse health 
effects. The obvious are trauma caused by physical and sexual violence. 
Many additional health effects, most of which are difficult to treat, 
include: chest pain, sleeping/eating disorders, abdominal pain, 
intestinal disorders, miscarriages, substance abuse, depression, 
anxiety, chronic headaches, chronic pain, fatigue, fibromyalgia, 
sexually transmitted diseases, urinary tract infections, and post-
traumatic stress disorder. Childhood sexual abuse has a significant 
relationship to health problems and abuse in adulthood.
              survivor story: the health effects of abuse

Would You Recognize Me if You met Me?

    Would you recognize me? I could be your sister, your daughter, your 
mother or your wife.
    I grew up in a loving, supportive, caring family. My parents have 
been married for over 55 years. They taught us to care for and about 
one another. I became a nurse. In my professional experiences, I saw 
the effects of abuse on patients and their families. Now, after thirty 
years, I carry my own diagnoses of dysthymia which led to depression, 
post traumatic stress disorder, hypothyroidism, fibromyalgia and am 
currently undergoing a cardiac workup. My psychotherapist and I agree 
that my diagnoses are the result of the myriad of abusive experiences I 
have endured over the past thirty years. My family and I have undergone 
marital and family counseling, school counseling, physical therapy and 
hospitalizations. My ex-husband(s) have undergone domestic abuse 
counseling and anger management. My ex-husband got part of my 
retirement (I got none of his) and has access to health care at my 
employer's expense (though he never contributed). I still work full 
time as a health professional. Most people who meet me have no idea of 
what my life has been like. I now have a life free of abuse, but my 
diagnoses will be with me and my family until we die.
    Would you recognize me if you met me? I could be, and others like 
me could be your sister, your daughter, your mother; or your wife. 
(Anonymous, Registered Nurse, Staff Educator, survivor of domestic 
abuse)
    Abuse victims not only develop poorer health, they are more likely 
to practice a variety of injurious and non-compliant health behaviors 
including: tobacco use, alcohol and/or drug use, risk-taking sexual 
behaviors, obesity, physical inactivity, lack of seat belt use, lack of 
helmet use, little or no gun safety practices, decreased self-care, and 
poor adherence to medication regimes for chronic illnesses.
                       survivor story--a success
    A family practice physician was seeing a woman who had a work-
related injury that simply would not improve. Because of this, he did 
an in-depth interview, seeking to identify underlying causative issues. 
The patient disclosed her history of severe emotional and physical 
abuse by her husband. He provided her with reassurance, support, 
encouragement and resources. Ten years later the patient saw this 
physician in a discount store, approached him and said with great 
appreciation how thankful she was for his insight and his support. She 
was no longer in an abusive relationship and attributed her current 
safe situation to the physician who had known how to ask and, most 
importantly, how to support his patient.

Health Care Cost

    While the full extent of the cost of violence against women to 
individuals and to society is not fully determined, these figures are 
unarguably tremendous. Some facts include:
     Direct medical costs for abused women are estimated to be 
$1.8 billion annually.
     Abuse victims have more hospitalizations, general clinic 
use, mental health services use and out-of-plan referrals.
     Abused women have a 3.5 fold higher incidence of admission 
and required hospital care than non-abused women.
     Medical expenses are 2.5 times higher among severely 
victimized women compared with non-victimized women, On the other hand, 
data analysis has identified a cost-benefit value to programs that 
address issues of safe and peaceful lives for women. It was recently 
reported that the Violence Against Women Act (VAWA) saved $14.8 billion 
in net averted social costs.
     health care professionals and domestic abuse: what we must do

Health Care Professionals Must Be Educated

    Generally, family violence curricula is incomplete; instruction 
time is generally minimal, the content and teaching methods vary and 
subject matter is not well integrated. As a result, health care 
professionals often enter their professional lives lacking insight into 
the dynamics of abusive relationships, the issues related to making 
change in these relationships, and the skills necessary to perform a 
sensitive and nonjudgmental screening and referral. Many have had no 
education in this area. Many institutions have incorporated abuse 
screening requirements without providing staff education. Lack of 
education is a major barrier to identification, treatment and referral. 
It is optimal for education to be provided by a team including someone 
from the health care environment and from a domestic abuse agency.
    Schools of medicine and nursing should have advanced curriculum 
that integrates family violence content throughout. Health care 
professionals should receive an initial four hours of education. The 
entire health care team should receive education as well. Initial 
education should be followed with information to include child abuse, 
elder abuse, teen violence, cultural sensitivity, childhood sexual 
abuse and competency building. It is a process, not a ``one-stop-
shop''. Often, those who have not received adequate education have made 
several, sometimes dangerous, mistakes.

Inappropriate Screening

    I have heard countless stories of inadequate or inappropriate 
screening practices. Consider these examples. A nurse poked her head 
around the curtain and said to the patient in an offhand, casual 
manner, ``Oh, by the way, you aren't abused by anyone, are you.'' Two 
different pregnant women (an advocate for a domestic abuse agency and a 
family physician who teaches family practice residents to screen for 
abuse) were screened in the hospital in the presence of their partners. 
Others have noted that the nurse doing the screening would introduce 
the subject by saying ``Our hospital policy requires me to ask these 
questions'' or ``I know this isn't happening to you but I have to ask 
you: are you being hurt by anyone at home?'' Each of these examples 
illustrates the gross inadequacy of health care professionals' 
knowledge base. In these cases, because of their ineffectiveness and 
potential for jeopardizing the safety of the patient, it would have 
been better if the nurse had done no screening at all.

Universal Screening

    It is important that all patients be screened. Screening should not 
be selective. Because the health effects of domestic violence result in 
much more than physical injury, universal screening and interviewing 
should be an essential component of assessment in health care 
encounters. It is unrealistic for any health care professional to 
assume one patient is being abused and another is not. More often than 
not, it is impossible to tell.
    A current medical best-of-practice universally taught and practiced 
is routine screening for hypertension (high blood pressure). Today, 
blood pressures are routinely taken in most health care encounters 
regardless of the reason for the visit. The incidence of high blood 
pressure in the population is 23 percent. Considering the fact that the 
lifetime incidence of abuse of women is minimally 25 percent coupled by 
the significant effect current or past abuse has on health, routine 
screening is the obvious best of practice recommendation.
             survivor story--a case for universal screening
    A middle-aged woman was seen in one of our urgent care clinics for 
a bee sting. ``The clinic routinely screens patients for abuse. The day 
following her visit, the nurses received the following fax:
    ``While at the urgent care clinic, one of the nurses was asking a 
number of probably very normal medical history questions. She also 
asked a question about domestic abuse. At the time, since my bee sting 
was totally unrelated to any domestic abuse, I responded by saying no. 
However that was not a totally true statement. I am concerned about my 
living situation and do not feel safe.
    My husband has a violent temper and at times I am afraid for my 
life. He has raised both hands towards my neck as a choking gesture and 
says ``Do you want to hear a funny sound?'' He has said he'd like to 
whip me with a garden hose in order to ``beat the meanness out of me . 
. . I am involved in a number of volunteer activities and this upsets 
him very much. He blows up, throws a temper tantrum, slams doors, when 
I mention another activity. He knew I (volunteered) before we were 
married and did not object then, in fact he seemed to admire the many 
things I am able to do. Now however, he is adamant that I retire early 
from my job and would like me to spend all of my time with him and him 
alone. I am not allowed to go to the store alone, for instance. He 
insists on taking me anywhere and everywhere I go.
    . . . I am concerned and want to have this on my medical history 
charts in case anything does happen to me.''
    This message is more than a request for documentation in the 
medical record. It is a cry for help. The nursing staff was able to 
contact this woman, provide reassurance, support and resources.

Develop Partnerships With Local Domestic Abuse Agencies

    A key element of success in implementation of screening programs 
includes developing a working relationship with a local advocacy agency 
and seeking ways to support advocate visits in the clinical 
environment. This provides a trusted resource to health care 
professionals as well as the best case scenarios for victims. We feel 
the most effective system is to support a health care advocate program 
where the advocate is employed by the outside agency and works within 
the health care environment.

Infrastructure and Support of Leadership

    Successfully sustained screening practices require a supportive 
infrastructure. This can include skill-based teaching of screening in 
employee orientation, evaluating competence and measurements of program 
compliance and effectiveness. Policies and procedures must be in place 
to support screening. Most importantly, without the support of leaders, 
even the most excellent education and screening programs will encounter 
sustainability challenges.

Health Care Settings Should Be Made ``Safe Places'' To Disclose

    Creating a safe place includes having an aware, sensitive staff; 
educational and community resource information easily available to 
patients i.e. posters and brochures, and domestic abuse advocates 
available to see their patients.
           universal screening at allina hospitals & clinics

The Process

    In 1996, Allina Health System (now Allina Hospitals & Clinics) 
announced a system-wide focus on violence prevention. Over $1,300,000 
was given in violence-prevention research, education and community 
violence prevention grants. A portion of the grant funds included 
implementing domestic abuse screening and advocacy referral in Allina's 
12 hospitals, over \1/2\ of their 40 clinics and in their obstetric 
home visiting service. Several educational tools were utilized 
extensively throughout the system. These include a core curriculum, 
teaching video and patient educational materials.

The Impact

    We have identified a clear and positive relationship between 
education of health care providers and identification of abuse victims 
and subsequent referrals to advocates. One example is United Hospital 
and a nearby clinic, United Family Practice Center, in St. Paul. They 
also budgeted funding for on-site advocacy services. Prior to 
education, an occasional victim was identified, one or two a month at 
the most. After a mandatory education provided to employees beginning 
with the clinic, Emergency Department and the Birth Center, there was a 
sharp rise in referrals. These referrals rose steadily and now that the 
universal screening is implemented hospital-wide have leveled off at 
100 per quarter for the last ten quarters. Since the education occurred 
in 1996, nearly 2000 abuse victims received services from the on-site 
advocacy service. No one would have received any on-site services prior 
1996. Most would not have been identified as abuse victims. Mercy and 
Unity Hospitals in the suburban Minneapolis area experienced a 
significant rise in referrals after a major launching of screening and 
education in 1995-96. Throughout ensuing years through 1999, referrals 
consistently averaged around 100 per quarter. During that time the 
hospitals budget supported on-site advocacy. In the last two years, 
program changes, decreased leadership support and budget cuts at these 
two hospitals have resulted in elimination of education funding, 
support for on-site advocacy and a decrease in leadership support As a 
result, the referral rate decreased by nearly 50 percent. Some leaders 
have now identified this as a problem and are working on solutions.
    By making patient educational materials available to the public, 
literally thousands of community members have been provided with basic 
information educating them about unhealthy, violent relationships and 
telling them how to get help. It is not uncommon that half of the 
community does not know how to access domestic violence services.
    Another significant benefit is creation of culture changes within 
the work place. Creating a ``safe place'' provides support not only to 
our patients but to our employees. Respondents to a 1996 health 
questionnaire mailed to new members by Medica, an insurance provider 
for Allina, revealed that 22 percent of them answered yes to the 
question ``Have you ever been hit, kicked, pushed, or otherwise hurt or 
mistreated by someone important to you?'' In cultures of ``safe 
places'' employees who are being hurt feel supported and encouraged to 
seek help.
                  survivor story--standing beside you
    ``A few months ago, my husband broke one of my fingers. I came in 
to the emergency department for treatment and told them I fell. I was 
so hurt and confused that someone I loved could treat me so horribly. I 
was too embarrassed to tell them what really happened. Quite a few of 
my coworkers jokingly asked, ``What happened to your finger? You and 
your husband been fighting?' I wanted to say, yes, can you help me? But 
just like my coworkers, I couldn't believe that I, an emergency nurse 
who sees abused women, helps abused women . . . could be an abused 
woman.''
    Research is needed to establish a basis for practice. However, 
unless professionals are well educated on the subject, have supportive 
policies in place, have an ongoing evaluation of their program and have 
leadership support, assessment and intervention will be ineffective at 
best and potentially dangerous at worst.
              we believe what we are doing can save lives

Survivor Story--No one Asked

    A survivor of domestic abuse shared her health care experience with 
me. She had sustained a serious head injury when her husband repeatedly 
smashed her head into the cement of their driveway. In desperate fear 
for her life, she went to a local Emergency Department to have her 
injuries evaluated. She disclosed her feelings about what she wanted 
from the health care professionals in that hospital. ``I thought I was 
dying. I felt as though I was floating above my body. If someone had 
asked me if I was being hurt by someone in my life, I would have 
spilled my guts. But no one asked me. And I went back home with my 
abuser.''

    Senator Mikulski. Dr. Gellhaus?
    Dr. Gellhaus. Thank you very much.
    Good afternoon, distinguished members of the committee. I 
am Dr. Tom Gellhaus. I appear before you on behalf of the 
American College of Obstetricians and Gynecologists and as a 
practicing physician from Iowa.
    ACOG represents 44,000 physicians dedicated to improving 
women's health care. I am honored to be here today at this 
important hearing.
    My comments focus on safe motherhood--a woman's ability to 
have a safe and healthy pregnancy, delivery, and postpartum 
period free of health complications. But I should add that the 
full range of issues explored by this hearing is important to 
ACOG members.
    Approximately 4 million Americans become pregnant each 
year, and more than 10,000 give birth each day. Most women can 
count on having a healthy pregnancy. However, every pregnancy 
faces risks, and every pregnant woman can develop sudden life-
threatening complications that require high-quality obstetric 
care.
    Each year in the United States, 30 percent of pregnant 
women have pregnancy-related complications before, during, and 
after delivery that may lead to long-term health problems. 
Approximately 1,000 of these women die each year; that is two 
to three deaths each and every day. Over half of these deaths 
could be prevented through improved health care access, 
improved quality of care, and changes in maternal health and 
lifestyle habits.
    The importance of legislation to ensure a safe pregnancy 
for all women in the United States must not be underestimated, 
and ACOG fully supports these efforts. Unfortunately, there is 
still much that we do not know about pregnancy and its 
complications. Why do some women have life-threatening 
complications? Why do some women survive and others do not? 
What causes these complications? How do factors of race, age, 
and education level affect maternal health?
    Reducing maternal morbidity through coordinated Federal 
action is essential. ACOG has a long history of collaborating 
with the Centers for Disease Control and Prevention on the 
production of State-level educational materials on mortality 
reviews.
    We also strongly support grants to assist States in their 
transition to a national standard of tracking pregnancy-related 
deaths. Collaborative partnerships among Government agencies, 
physicians, universities, and community groups are the first 
step to systematic change.
    Increased funding for research in maternal health could 
shed light on a breadth of issues that could save women's 
lives. Pre-term labor and hypertension in pregnancy are two of 
the leading pregnancy complications, yet little is known about 
the causes of these conditions or possible preventive 
treatments.
    We know very little on effective intervention against 
maternal smoking, alcohol, and drug use. We need more 
information on the causes and ways to prevent postpartum 
depression so we can diagnose and treat our patients 
appropriately.
    Very alarming is the disparity in maternal mortality and 
morbidity in relation to race and ethnicity. Why are African 
American women four times more likely than Caucasian women to 
die from pregnancy-related causes? How do we protect minority 
women and low-income women who are already at increased risk 
for chronic disease?
    Family planning is preventive health care. Without 
contraception, the average woman could become pregnant more 
than 12 times over her life--a prospect too risky for most 
women. Family planning is critical to improved maternal health 
by allowing women to space the number and timing of their 
pregnancies.
    Women who conceive within 6 months following childbirth are 
70 percent more likely to have their membranes rupture 
prematurely. Pregnancy can be life-threatening for women with 
serious medical conditions such as heart disease, diabetes, 
lupus, and hypertension. For these women, family planning can 
be life-saving. It can help them prevent pregnancy altogether, 
or it can help these women postpone pregnancy until they are 
healthy enough to support a pregnancy.
    As a practicing physician, I applaud your effort to 
increase knowledge and data on the effects of drugs on pregnant 
women. Pregnant women become ill just as we all do. The 
difference is that we do not know how even some of the most 
commonly prescribed medications affect the pregnant woman or 
the developing fetus. Currently, approximately two-thirds fall 
into FDA's Category C, which is considered potentially unsafe 
to use during pregnancy, either because no studies 
demonstrating their safety for pregnant women are available or 
because they have been shown to harm animal fetuses.
    Many women who become pregnant discontinue medications 
during pregnancy--for example, high blood pressure medicines 
and cholesterol-lowering drugs. Yet women who suffer from 
chronic diseases like epilepsy, HIV, or depression do not have 
the luxury of going without these medications for 9 months. 
Indeed, pregnancy can actually exacerbate conditions like 
asthma and high blood pressure, making it even more critical 
for physicians to make informed decisions about the treatment 
of their pregnant patients.
    Physicians make the best decisions we can with the 
information available. We are trained to make medical decisions 
based on professional judgment, yet I cannot overstate the need 
for more research and data in this area. Pregnant women are the 
last population for which we do not have drug information.
    Thank you for giving me this opportunity to testify on 
behalf of my patients and ACOG on this important subject of 
safe motherhood. It is time to move forward with new research, 
new interventions, and new cooperation to ensure that women and 
their doctors have the best information available to make 
informed decisions about their lives and their pregnancies.
    I thank the committee for holding this hearing today and 
for allowing me the opportunity to testify. This legislation is 
critical to the health of our Nation's women.
    Thank you.
    [The prepared statement of Dr. Gellhaus follows:]
    Prepared Statement of the American College of Obstetricians and 
                             Gynecologists
    Good afternoon Mr. Chairman and distinguished members of the 
committee. I am Dr. Thomas Gellhaus. I appear before you on behalf of 
the American College of Obstetricians and Gynecologists (ACOG). I am 
currently in practice at Obstetrics and Gynecology Specialists, PC, in 
Davenport, Iowa, and teach in the Department of Obstetrics and 
Gynecology at the University of Iowa's College of Medicine.
    I am honored to be here today, and on behalf of ACOG, we couldn't 
be more pleased with the attention and commitment to women's health 
consistently demonstrated by members of this committee and by the 
scheduling of this important hearing. The American College of 
Obstetricians and Gynecologists (ACOG) represents 44,000 physicians 
dedicated to improving women's health care. Ninety-five percent of 
board certified obstetricians and gynecologists in the U.S. are members 
of ACOG.
    I have been asked to focus my comments specifically on the issue of 
``safe motherhood'' and issues related to pregnancy and women's health, 
but I should add that the full range of issues explored by this hearing 
is important to ACOG members. As Ob-Gyns we not only care for and treat 
patients during their pregnancies but throughout their lifetime. We 
believe that improving women's health is a vital investment.
    Safe motherhood is a necessarily broad term but in the context of 
this discussion my remarks will narrow the focus of safe motherhood to 
refer to a woman's ability to have a safe and healthy pregnancy, 
delivery, and postpartum period free of life or health threatening 
complications.
    Approximately 4 million American women become pregnant each year, 
and more than 10,000 give birth each day. Most women can count on 
having a healthy pregnancy. However, every pregnancy faces risks: every 
pregnant woman--regardless of income or education--can develop sudden, 
life-threatening complications that require high quality obstetric 
care. Although rates of maternal morbidity and mortality decreased 
dramatically in the U.S. between 1950 and 1990, the last two decades 
have seen little progress.
    Each year in the U.S., 30 percent of pregnant women have pregnancy-
related complications before, during, or after delivery that often lead 
to long-term health problems. Approximately 1,000 of these women die 
each year. Over half of pregnancy-related deaths could be prevented 
through improved health care access, improved quality of care, and 
changes in maternal health and lifestyle habits.
    The importance of legislation to help ensure a safe pregnancy for 
all women in the United States must not be underestimated and ACOG 
fully supports these efforts. Unfortunately there is still much we do 
not know about pregnancy and its complications. Why do some women have 
life-threatening complications? Why do some women survive them and 
others do not? Why are there racial and ethnic disparities in maternal 
morbidity and mortality? How do the factors of age, marital status, and 
education levels affect maternal health? What causes certain 
complications and how can we treat them?
     reducing maternal morbidity through coordinated federal action
    ACOG has a long history of collaborating with the Centers for 
Disease Control and Prevention (CDC) on the development and publication 
of educational materials regarding mortality reviews at the State 
level, and we have collaborated with the American Academy of 
Pediatrics, March of Dimes, and others to promote healthy pregnancy. We 
appreciate the efforts to broaden this focus to include morbidity and 
to take it to the next level by formalizing collaborative partnerships 
among government agencies, physicians, and community groups. We 
strongly support grants to assist States' transition to a national 
standard of tracking pregnancy-related deaths through certificates of 
death. States can improve identification of cases, review of pregnancy-
related deaths, and interpretation of the findings. These efforts will 
go a long way toward implementing systemic change in improving 
pregnancy outcomes.
    It is essential that we seek to understand what trends and 
differences between populations may play a role in maternal mortality. 
Through community partnerships we can provide information and direction 
for public health efforts to improve women's health. For example, 
ectopic pregnancy, when the fetus develops in the Fallopian tube 
instead of the uterus, is the leading cause of death during the first 
trimester. While collecting data on these pregnancies is imperative, 
ectopic pregnancies are currently the only maternal complication 
regularly monitored in the U.S. We must work together to broaden the 
scope of the data available for other common complications.
                     increased funding for research
    We are pleased with the recognition for increased funding for 
research in every aspect of safe motherhood. Each day in the U.S. 
between two and three women die of pregnancy related causes. And each 
year at least 30 percent of pregnant women in the United States have a 
pregnancy-related complication before, during, or after delivery. These 
complications can cause long-term health problems even when they do not 
result in death. According to the CDC, childbirth remains the most 
common reason for hospitalization in the United States, and pregnancies 
with complications lead to more costly hospitalizations. A commitment 
to research in maternal health could shed light on a breadth of issues 
that could save women's lives. Pre-term labor is one of the leading and 
most profound complications affecting pregnancy, yet little is known 
about causation of this condition or possible preventive treatments. 
Likewise, pre-eclampsia, pregnancy-induced high blood pressure and 
swelling, is a very common complication, and there is the same paucity 
of research on how we can prevent it. Studies of maternal behavioral 
practices could lead physicians to new interventions against alcohol, 
cigarette, and drug use during pregnancy. More information on the 
causes and the diagnoses of postpartum depression could educate 
physicians on appropriate preventive and follow-up care for at risk 
women. Perhaps one of the most alarming trends to address is the 
disparity in maternal mortality and morbidity in relation to race and 
ethnicity. African American women are four times more likely than 
Caucasian women to die from pregnancy-related causes. Hispanic women 
are 1.7 times more likely to die than their Caucasian counterparts. 
Racial and ethnic minority women, as well as women with low incomes, 
are already at increased risk to develop chronic disease. This risk, 
compounded with high risk for poor pregnancy outcomes, creates an 
inequality that we can no longer ignore.
                  family planning as preventive health
    Biologically, most women can become pregnant for nearly forty years 
of their lives. Without contraception, the average women could become 
pregnant more than twelve times, a prospect that would carry an 
unnecessary amount of risk for most women.
    Family planning is critical to improved maternal health by allowing 
women to space the number and timing of their pregnancies. Studies show 
that women who conceive within six months following childbirth increase 
the risk of pregnancy complications. According to the November 2000 
British Medical Journal, ``women who became pregnant less than six 
months after their previous pregnancy were 70 percent more likely to 
have membranes rupture prematurely and had a 30 percent higher risk of 
other complications.''
    Pregnancy can be life threatening for women with serious medical 
conditions such as heart disease, diabetes, lupus, and high blood 
pressure. For these women, family planning can be life saving. It can 
help them prevent pregnancy altogether, or it can help these women 
postpone pregnancy until they are healthy enough to support a 
pregnancy.
    One half of all pregnancies in the U.S. are unintended. Effective 
contraception can give women suffering from chronic disease more 
autonomy over their own health decisions. These women have the chance 
for better health outcomes, whether they choose to become pregnant or 
not.
                     pregnancy and drug interaction
    As a practicing physician, I applaud your effort to increase 
knowledge and data on the effects of drugs on pregnant women. Pregnant 
women get sick just like we all do. The difference is that for even the 
most commonly prescribed medications, there is very little information 
available to help doctors know what the best dose of a particular 
medicine is for pregnant women and how that medication may affect the 
developing fetus.
    Currently, approximately \2/3\ of all drugs fall into Category C, 
under FDA guidelines. Drugs in this category are considered potentially 
unsafe to use during pregnancy, either because no studies demonstrating 
their safety for pregnant women are available or because they have been 
shown to harm animal fetuses. In prescribing medications to my 
patients, I can only make my best judgment based on the little data 
that is available.
    Many women who become pregnant discontinue their medications during 
pregnancy, for example allergy medications or dermatological drugs. Yet 
women who suffer from chronic diseases like epilepsy, HIV, or 
depression do not have the luxury of going without treatment for nine 
months. Indeed, pregnancy actually can exacerbate conditions like 
asthma and high blood pressure, making it even more critical for the 
physician to make informed decisions about the treatment of their 
pregnant patients. In addition to general questions about safety, 
almost no information is available to help doctors know what the best 
dose of a particular medicine is for pregnant women. Changes in the 
body's physiology during pregnancy have the potential to require that 
doses be increased or decreased.
    Physicians make the best decisions we can with the information 
available. We are trained to make medical decisions based on 
professional judgment. Yet, I cannot overstate the need for more 
research and data in this area. Pregnant women are the last population 
for which we don't have drug information.
                               conclusion
    Thank you for giving me the opportunity to testify on behalf of my 
patients and ACOG on this important subject of safe motherhood. The 
goals of the legislation being introduced today, with the support of so 
many other groups committed to women's health, are laudable and 
overdue. Together, physicians, advocates, and government agencies can 
make a difference in maternal mortality and morbidity rates.
    Despite our best efforts to decrease pregnancy-related 
complications, we have reached a plateau in the past decade. It is time 
to move forward with new research, new interventions, and new 
cooperation to ensure that women and their doctors have the best 
information available to make informed decisions about their lives and 
their pregnancies.
    I thank the Chair and this committee for holding this hearing today 
and for allowing me the opportunity to testify. This legislation is 
critical to the health of our nation's women.

    Senator Mikulski. Thank you, Dr. Gelhaus.
    Senator Harkin did want to be here, but he is in the 
Agriculture conference fighting for Iowa, so he sends his 
apologies.
    Dr. Gellhaus. Thank you.
    [The prepared statement of Senator Harkin follows:]

                  Prepared Statement of Senator Harkin

    I want to recognize Senator Mikulski for her leadership on 
issues related to women's health.
    Most recently, Senator Mikulski and I held a joint hearing 
on the efficacy and importance of mammography. We have also 
worked together to involve women in FDA clinical trials so that 
drugs and devices are tested as safe and effective for both men 
AND women. I thank her for her leadership on these and so many 
other women's health issues and I am also proud of our work 
together on women's health. I look forward to continue our 
successful collaboration in the future.
    Today's hearing will address the broad range of health 
issues affecting women. In addition to testimony from the 
Administration, we also hear from researchers and health 
providers about critical issues including pregnancy, health 
screening and prevention, and domestic violence.
    In addition to the direct testimony we will hear from the 
witnesses, a number of individuals and organizations have 
submitted written testimony on these and other important 
issues.
    Today, I would like to focus my remarks on two of the 
critical areas affecting women's health--early detection 
screenings for low-income and needed improvements in maternal 
health and safe motherhood.
    In the area of early detection, Senator Frist and I have 
introduced the WISEWOMAN Act, which would expand access to 
health care screening programs for low-income woman throughout 
the country.
    The existing WISEWOMAN program, which is modeled after the 
Breast and Cervical Cancer Screening Program, provides more 
comprehensive health care screenings to women in Massachusetts, 
Arizona, and North Carolina. The time has come to expand this 
successful program so that every woman has access to early 
detection screenings for diseases such as heart disease, 
diabetes, and osteoporosis. WISEWOMAN will save lives through 
early detection and save health care dollars by helping 
America's women lead healthier lives.
    We must also do more in the area of safe motherhood.
    Over the last decade there has been a significant 
recognition of the importance and increase in funding of 
women's health research, including the establishment of Offices 
of Women's Health throughout various government agencies. 
Women's health issues and women, as participants, are now 
routinely included in research studies.
    Despite this progress, many gaps still exist. In 
particular, there is a troubling lack of research on pregnancy-
related health issues. Too often we take pregnancy for granted; 
we do not view pregnancy as a woman's health issue with short 
and long term health consequences.
    Safe motherhood is a woman's ability to have a safe and 
healthy pregnancy and delivery. Of the four million women who 
give birth in the U.S. each year, over one-third--or one out of 
every three--have a pregnancy-related complication before, 
during, or after delivery. These complications may cause long-
term health problems or even death. Unfortunately, the causes 
and treatments of pregnancy-related complications are largely 
unknown and understudied.
    In fact, the U.S. ranks only 20th in maternal mortality 
rates out of 49 developed countries--that is barely better than 
the 50th percentile, behind Cyprus, Singapore and Malta. Every 
day, two to three women die from pregnancy related 
complications. And despite the fact that maternal mortality was 
targeted in 1987 as part of Healthy People 2000, the maternal 
mortality rate in this country has not decreased in twenty 
years.
    The scariest part of this problem is we can't answer the 
most basic questions--what causes the complications, what can 
we do to prevent them, and how can we treat them?
    One example of this problem is pre-eclampsia, or high blood 
pressure. Yes, we know some indicators that place some women at 
greater risk than others for this complication. And yes, we 
know some steps that can be taken to reduce a women's risk. But 
we know shamefully little, with the exception of inducing 
labor, of how to really prevent or treat this problem. Yet five 
percent of all pregnancies are affected by this complication, 
which can cause blindness or even death and there has been a 40 
percent increase in the incidence of pre-eclampsia over the 
last 10 years.
    Likewise, we know almost nothing about which prescription 
drugs are safe for the fetus and effective for the mother. Most 
prescription drugs women take during pregnancy are necessary to 
maintain health. But only one percent of FDA approved drugs 
have been shown in controlled studies to show no risk to 
pregnant women and their babies. And 80 percent of FDA approved 
drugs lack adequate scientific evidence about use in pregnancy. 
That means that pregnant women are essentially forced to take 
these medications with little or no knowledge about their 
impact on the fetus.
    Of course, we don't want pregnant women placed at risk by 
putting them in early stage clinical trials. But the fact is 
that pregnant women with chronic diseases, such as diabetes, 
asthma, or epilepsy, need to take medication to maintain their 
health and support the growth of the fetus. And even pregnant 
women who don't have chronic health conditions need access to 
safe and effective prescription drugs.
    And while people in Washington tend to throw around 
statistics to make a point, it is important to remember that 
behind each of these statistics is a real person and family. 
And yesterday, I had the opportunity to talk to a group of moms 
from my State of Iowa. Without exception, these moms talked 
about their frustration with a health care system that 
continues to fail to meet some of the most basic needs of 
pregnant women. They all rely on a group called Sidelines, that 
provides support and guidance to pregnant women on bed rest. 
While it is great that a group like Sidelines is there for our 
mom's, sisters, and daughters, it is shameful that there isn't 
more accurate and more widely available information to women 
and their providers.
    That is why earlier today, I, along with some of my 
colleagues, introduced the Safe Motherhood Act for Research and 
Treatment, or, SMART Mom Act. The SMART Mom Act will address 
these concerns by:
     increasing research and data collection to learn 
how to prevent, treat, and cure pregnancy related 
complications;
     providing comprehensive information to pregnant 
women, practitioners, and the public; and,
     improving information about medication and medical 
device use for pregnant women.
    Pregnancy is a natural and wonderful occurrence in a 
woman's life. The SMART Mom Act takes a critical step towards 
ensuring pregnancies and healthy outcomes for America's women.
    These are just two of the many important issues that will 
be addressed at today's hearing. I look forward to hearing from 
my colleagues on the subcommittee and from our distinguished 
witnesses.
    Senator Mikulski. To the panelists and also to Dr. Slater 
and Dr. Marks, first, we want to thank you for being you. We 
want to thank you for what you are doing each and every day in 
every way to make the lives of women and your patients better.
    We want to particularly thank you for your testimony today. 
It has given us a lot to think about and in many ways, a real 
action plan to pursue.
    We are going to have some questions, but we will get back 
to you in writing. We so regret--I cannot tell you how much we 
regret--that we have to adjourn this committee for the 5 to 12 
votes on the energy bill. So we offer our very sincere 
apologies, but it is in no way due to lack of interest.
    We again want to express our deep appreciation, and we are 
going to be seeing many of you again.
    Senator Wellstone. Mr. Chairman, could I just echo what you 
said, and also as a point of personal privilege, thank Phyliss 
Greenberger who is here for all of her work and leadership.
    This was great testimony. Thank you.
    Senator Mikulski. This committee stands adjourned.
    [Additional material follows].

                          ADDITIONAL MATERIAL

     Response to Questions of Senator Harkin From Eve Slater, M.D.
    Question 1. It has come to my attention that the Administration is 
planning to move the Office of Women's Health from their current 
location in Washington, DC to offices in Rockville, MD. How does this 
move reflect upon the Administration's commitment and interest in 
continuing and expanding upon the initiatives you described in your 
testimony?
    Answer 1. No decision has yet been made with regard to relocating 
the Office on Women's Health. The Department is still considering its 
options, consistent with Secretary Thompson's initiative aimed at 
greater departmental efficiency and effectiveness. We do not anticipate 
any change in the impact or visibility of the office.
    In fact, the Secretary and the President have made women's health 
one of the top priorities of their health agenda. As a demonstration of 
this Administration's commitment, the fiscal year 2002 budget included 
a $9+ million increase for women's health and the President has 
proposed an additional $2+ million for fiscal year 2003.

    Question 2. As you know, I introduced a bill today with Senators 
Kennedy and Mikulski which will increase research on pregnancy-related 
illness and death, address the racial and ethnic disparities in 
maternal health and mortality, and give pregnant women more information 
about the safety and efficacy of FDA approved medications during 
pregnancy. I have two questions about this bill.
    Question 2, subpart 1. First, the United States has one of the 
highest maternal mortality rates in the industrialized world, and as I 
mentioned in my opening statement, those rates have not improved in 20 
years. However, perinatal diseases rank as the second lowest NIH-funded 
group of diseases when comparisons take into account disability 
adjusted life years lost due to each disease. Given that \1/3\ of women 
will experience a complication during pregnancy, why hasn't pregnancy 
related complications been a higher priority in the past, and do you 
believe that the time has come to invest more resources in this field 
of research?
    Answer 2.1. Research is being supported by NIH on both ``normal'' 
as well as higher risk pregnancies. In order to increase our 
understanding of the causes of and potential therapies for disorders 
and other problems associated with pregnancy, we must first understand 
what constitutes and contributes to a normal pregnancy. At the National 
Institute of Child Health and Human Development (NICHD), for example, 
$138,215,974 was spent overall on pregnancy related research in fiscal 
year 2001, including extramural and intramural, human and animal, basic 
and clinical research. Of this total, in fiscal year 2001 NICHD 
expended ($113,072,685) over 80 percent in support of research on 
pregnancy-related problems, including high-risk pregnancy, fetal 
pathophysiology, premature labor and birth, and disorders of pregnancy 
such as gestational diabetes, pre-eclampsia and spontaneous abortion. 
About half of this funding came through the Pregnancy and Perinatology 
Branch in the Institute's Center for Research on Mothers and Children, 
and the other half was spread out among several other branches.
    Modern obstetrical management, especially the management of high-
risk pregnancies, has in some instances adopted principles of care and 
employed pharmaceuticals and methodologies that have not been 
rigorously tested using controlled observations. Often, procedures 
enthusiastically embraced at first are modified or replaced later after 
extensive experience has failed to support their usefulness or shown 
unexpected consequences. Regional differences have further complicated 
the field.
    Specifically, in an attempt to respond to the need for well-
designed clinical trials in maternal-fetal medicine, NICHD established 
a Network of Maternal-Fetal Medicine Units in 1986. The Network 
Steering Committee, which consists of representatives from each 
clinical center, NICHD staff, and data coordinating center staff, 
selects priority areas for study. The Data Monitoring and Safety 
Committee advises NICHD on research design issues, data quality and 
analysis, and ethical and human subject protection aspects of the trial 
protocols. More than 24 randomized clinical trials, cohort studies and 
registries have been completed or are in progress, including on 
questions relating to post-term pregnancy, predictors and management of 
preterm labor, and prevention of pre-eclampsia. Others are planned for 
the near future.
    The National Institute of Nursing Research (NINR) is also committed 
to supporting research that focuses on maximizing the health of 
pregnant minority women and their developing offspring with a 
particular focus on eliminating health disparities. A currently 
published initiative, Low Birth Weight in Minority Populations, 
solicits research to expand our understanding of the underlying 
mechanisms that contribute to the ethnic variations in low birth weight 
(LBW) and strategies for prevention.
    In addition, NINR is currently funding several promising studies 
related to pregnancy complications. Pre-eclampsia affects nearly 1 in 
20 pregnancies and is the leading cause of maternal deaths worldwide. 
Two studies are underway to examine the effects of exercise on 
preventing the onset or the recurrence of pre-eclampsia. Another area 
of investigation is gestational diabetes. Diabetes is a major risk 
factor during pregnancy, and African American women have higher rates 
of diabetes, more maternal complications, and a greater incidence of 
low birth weight. Researchers are examining the barriers to treatment 
adherence among African American women with gestational diabetes. 
Another researcher is testing a web-based outreach program for pregnant 
African American women. Other important areas of ongoing research 
related to pregnancy complications include smoking cessation, drug 
abuse, domestic violence, and perinatal HIV transmission.
    The Office of Research on Women's Health (ORWH) serves as the focal 
point for women's health research at NIH and has developed priorities 
for research based upon its Agenda for Research on Women's Health for 
the 21st Century. ORWH has identified, as a priority, new and expanded 
research on pregnancy related issues. These include research into the 
effects of infections ( including oral infections and inflammation) on 
adverse pregnancy outcomes; gestational diabetes and other disease 
manifestations and treatments during pregnancy; prevention, diagnosis, 
and treatment of pregnancy complications including fetal loss, low-
birth weight infants, and the development of neural tube defects; and 
the impact of pregnancy and lactation on the pharmacokinetics, 
pharmacodynamics, drug efficacy and side effects in pregnant women, 
including their genetic, molecular and cellular bases.
    The NIH Office of Research on Women's Health (ORWH) supports a 
number of research grants that focus on pregnancy and/or pregnancy 
outcomes in collaboration with other NIH institutes and centers, 
including the National Institute of Child Health and Development 
(NICHD), the National Institute of Dental and Craniofacial Research 
(NIDCR), the National Institute of Diabetes, and Digestive and Kidney 
Diseases (NIDDK), and the National Institute on Alcohol Abuse and 
Alcoholism (NIAAA).
    For example, in fiscal year 2001, the ORWH funded with NIDCR an 
innovative research project evaluating whether maternal peridontitis is 
a risk factor for adverse pregnancy outcomes. A total of 6,000 pregnant 
women were enrolled in the parent study, a number sufficient to permit 
detailed investigation as to whether maternal infection during 
pregnancy leads to preterm delivery. Peridontal infection, a highly 
prevalent condition that can be controlled, can serve as a reservoir of 
gram-negative anaerobic organisms. Certain mediators can target the 
placental membranes via systemic circulation, thereby leading to 
preterm delivery or fetal growth restriction. Increased understanding 
of these relationships can improve the well-being of mothers and 
infants.
    During both fiscal year 2000 and fiscal year 2001, ORWH co-funded 
several grants in the area of obesity and pregnancy with NIDDK. One 
study focused on slowing the accumulation of weight in women of child-
bearing age and recruited a group of women from lower income and rural 
locations. A second study targeted African-American women and used 
Internet-based interventions to prevent pregnancy-related obesity. The 
Internet-based interventions were used in face-to-face group sessions 
that allowed for more intensive behavioral feedback.
    Neuromuscular injury and recovery after vaginal delivery was 
studied in a group of Caucasian, African-American and Hispanic women 
who were in their third trimester of pregnancy in an NICHD and ORWH 
supported investigation. Specific labor events associated with 
neuromuscular maternal injury were studied longitudinally in relation 
to race/ethnicity. Outcomes included symptoms of prolapse and 
incontinence, as well as their pelvic neuromuscular function over time. 
By studying this problem longitudinally, an increased understanding 
will be obtained of the neuropathic role that delivery plays in the 
development of pelvic floor disorders.

    Question 2, subpart 2. And second, the bill also will also improve 
our understanding of the effects of prescription medications on 
pregnant women. Women with chronic illnesses, such as epilepsy or 
asthma, or who have even minor health problems, such as a sinus 
infection, currently must make choices about taking medication without 
sufficient information about the effect of the drug on the future 
health of their child. I understand that the FDA and NIH are 
undertaking several initiatives in this area. Can you expand on what is 
currently being done within the Department to address the lack of 
information on drug safety for pregnant women and whether you support 
the approach taken in our bill?
    Answer 2.2. We know that the metabolism of women changes during 
pregnancy. What we do not know - despite the fact that pregnant women 
with chronic conditions regularly continue their medications--is how 
much those changes impact the effectiveness of drugs for different 
conditions, nor what dosage may be safely taken by the pregnant woman 
without negatively affecting her developing child. The NIH, including 
NICHD and ORWH, and FDA explored this question in December 2000 at a 
groundbreaking conference that focused largely on the need for 
information about drugs used by pregnant women with chronic health 
conditions. Working in conjunction with the FDA since that time, NICHD 
has planned a major new initiative to test drugs frequently used by 
pregnant women who have conditions such as epilepsy, asthma, 
hypertension and diabetes. The NICHD plans to conduct physiological 
studies to explore the differences in metabolism during pregnancy, 
along with trials for dosage and effectiveness for the most commonly 
used drugs through a network of sites around the country.
    ORWH has also cosponsored with the CDC a workshop on Concepts and 
Strategies to Actively Monitor the Risk of Medication in Pregnancy: 
Enhancing Post-Marketing Surveillance.
    The Food and Drug Administration (FDA) works with drug sponsors at 
all stages of a drug's development to better understand how a drug will 
affect different populations once it is marketed. The Agency believes 
it must identify important information about a drug, such as dosages 
for different age groups, genders, and subgroups, and to use that 
information to refine labeling information, patient selection, and dose 
selection.
Research on Medications Used in Pregnancy
    Most pharmaceutical products are not studied in pregnant women, yet 
pregnancy may alter the safety and efficacy of prescription 
medications. Rational prescribing for the pregnant patient must attempt 
to ensure the greatest likelihood of clinical benefit for the mother 
and the safest exposure for her developing baby. This can only be 
achieved when adequate pharmacokinetic and pharmacodynamic information 
throughout the pregnancy is available.
    In fiscal year 2001, FDA Office of Women's Health funded research 
on prescription medications commonly used to treat high blood pressure 
(hypertension) during pregnancy to determine doses that provide the 
greatest benefit and least risk for the mother and her baby. The 
contracted studies are evaluating the safety and effectiveness of 
medications already being used by the pregnant women enrolled in the 
study. The studies are following all ethical and patient protection 
regulations. The studies are intended to demonstrate that this type of 
study can, and should be done for medications widely used during 
pregnancy. The studies are being conducted at two DHHS National Centers 
of Excellence in Women's Health.
    In fiscal year 2002, FDA Office of Women's Health and the Center 
for Drug Evaluation and Research (CDER) plans to fund research to use 
large automated health plan databases as well as clinical studies to 
evaluate maternal safety and/or fetal outcomes in women exposed to 
certain prescription medications during pregnancy with a focus on 
medications used for treatment of bioterrorism agents. Large automated 
health plan databases containing prescription drug use and health 
outcome information will provide timely monitoring of maternal and 
fetal safety.
Pregnancy Registry Website
    The FDA Office of Women's Health will launch a new website shortly 
to provide information for women taking medications during pregnancy 
and lactation.
Current Guidances
    In addition to proposing rulemaking to improve pregnancy and 
lactation labeling, and funding research to determine the best way to 
conduct studies in pregnant and lactating women, the agency has 
published the following guidances to help improve the quantity and 
quality of data available for inclusion in this section of the 
labeling:
    1) Guidance for Reviewers: Evaluating Human Pregnancy Outcome Data. 
Draft published June 1999.
    2) Guidance for Reviewers: Integration of Study Results to Assess 
Concerns about Human Reproductive and Developmental Toxicities. Draft 
published November 2001.
    3) Guidance for Industry: Establishing Pregnancy Registries. Draft 
published June 1999.
    4) Guidance for Industry: Non-clinical and Clinical Studies on the 
Transfer of Drugs and Biological Products into Breast Milk. In process.
    5) Guidance for Industry: General Considerations for 
Pharmacokinetic Studies in Pregnant Patients: Study Design, Data 
Analysis, and Impact on Dosing and Labeling.
    6) Guidance for Industry: Risk Management Approaches for Known or 
Suspected Human Teratogens.
                                 ______
                                 
                Prepared Statement of Michael M. Faenza
    On behalf of the National Mental Health Association, and our 340 
affiliates nationwide, representing the over 54 million individuals 
with mental illness in this country, I would like to commend Senators 
John Edwards and Patty Murray for introducing the Women in Trauma Act 
of 2002 (S. 2204). This legislation deals with one of the most tragic 
deficiencies in our mental health system-the widespread failure to 
address the traumatic incidents that are part of the histories of many 
women with mental health and/or substance abuse disorders.
    Research indicates that 50 to 70 percent of women treated in 
psychiatric settings have histories of trauma including sexual or 
physical abuse or both. According to one recent study, ninety-seven 
percent of homeless women with mental illness have experienced severe 
physical and/or sexual abuse. Trauma exposure can directly cause mental 
disorders, and even for those whose illness predates exposure to 
trauma, that trauma can worsen the course and overall impact of mental 
illness and substance abuse. Battered and abused women suffer serious 
mental health consequences from the trauma inflicted upon them, 
including higher levels of depression, drug and alcohol abuse, and 
suicide attempts. Many studies have shown that childhood sexual abuse 
is a high risk factor for mental health and substance abuse problems 
later in life. Women abused as children are four times more at risk for 
major depression and they are significantly more likely to develop 
eating disorders and chronic posttraumatic stress disorder. Research 
has also shown that a high percentage of women with alcoholism suffered 
abuse as children. Unresolved trauma-related symptoms can contribute to 
relapse into using alcohol or other drugs to cope with the long-term 
effects of trauma.
    However, mental health and substance abuse services for women 
rarely address the significant possibility that trauma, including 
physical abuse, sexual abuse, rape, or domestic battery, may have 
played a role in instigating, aggravating, and/or prolonging a woman's 
mental health or substance abuse disorder. There is widespread failure 
in the mental health and substance abuse systems to assess, diagnose, 
and address the complexities added to the treatment process by the 
effects of traumatic experiences. There is an urgent need to evaluate 
treatment strategies and models and improve treatment for female 
victims of violence with addictive and mental health disorders. The 
impact of violence on women with mental health and/or substance abuse 
disorders must be addressed.
    The Women in Trauma Act would establish an important milestone in 
authorizing funding to conduct research to expand our knowledge 
regarding effective treatment for mental health and substance abuse 
disorders in women who have experienced physical or sexual abuse or 
other types of trauma.
    In addition, this bill would help communities develop and implement 
comprehensive community-based mental health and substance abuse 
services for women with histories of trauma. These services are to be 
provided through cross-disciplinary systems of care that address mental 
health, substance abuse, and other needs in an integrated and trauma-
informed manner. Dysfunctional behaviors and/or symptoms in women 
impacted by violence often originate as coping responses to trauma. 
Moreover, women who have experienced repeated trauma in childhood often 
lack adult coping skills because they were deprived of the opportunity 
to develop them. The mental health and substance abuse interventions 
and support services that would be funded through the Edwards/Murray 
bill would help participants in this program overcome the complex and 
insidious influence of trauma and violence in their lives.
    Many women who have been repeatedly abused feel powerless and 
unable to protect themselves, often leading to isolation from others. 
Under this measure, community-based systems of care would provide women 
impacted by violence with the treatment and support systems they need 
to take control over their lives and overcome their mental health or 
substance abuse problems.
    A critically important component of the Women in Trauma Act is the 
requirement that grantees involve those women participating in a grant 
site's treatment program in all phases of service design and delivery. 
This provision in the bill recognizes the importance to these women of 
regaining control over their lives and confidence in their own 
abilities. Moreover, the perspective of these women on how treatment 
and support services should be structured would be essential to 
designing effective programs.
    Women suffering from traumatic experiences and related mental 
health and/or substance abuse disorders often need services that go 
beyond treatment, including housing, child care, and medical and 
employment assistance. To address the lack of coordination and barriers 
to accessing necessary services, entities awarded grants under the 
Edwards/Murray bill, would be required to implement an integrated, 
systems-of-care approach that incorporates cross-agency collaboration 
to improve access to the services and supports many of these women need 
to achieve empowerment and recovery.
    This bill also would improve the capacity of other types of service 
providers, including rape and domestic violence programs, hospital 
emergency rooms, appropriate branches of the criminal justice system, 
to recognize and address the trauma-based underpinnings of mental 
health and/or substance abuse disorders in many women.
    In addition, the Edwards/Murray bill recognizes the need to reach 
out to diverse communities. Such outreach serves two purposes. It is 
critical to ensuring effective treatment for members of diverse 
communities through recognition and accommodation of cultural 
differences. Such outreach is also vital to improving awareness and 
access among diverse groups to treatment programs that recognize the 
importance of addressing violence and trauma as a way to improve mental 
health and substance abuse treatment for many women.
    Recognizing that access to childcare is a primary barrier to 
treatment for many women, the Women in Trauma legislation would 
authorize the use of grant funds to provide childcare, either directly 
or through an off-site, licensed child care provider, to women 
receiving treatment through a grantee's treatment program.
    This bill is a crucial first step in remedying a grave shortcoming 
of current practice in mental health and substance abuse treatment for 
many women. The importance of modifying treatment practices to take 
into account the histories of trauma experienced by a significant 
percentage of women with mental health and/or substance abuse disorders 
has been ignored for far too long. By funding community-based services 
and research to address the profound impact of trauma and violence on 
substance abuse and mental health disorders in women, the Women in 
Trauma Act takes great strides to address this very important and long 
overlooked women's health issue. I applaud Senators Edwards and Murray 
for their efforts and their leadership.
                   Prepared Statement of Kim Hoffman
    Mr. Chairman, my name is Kim Hoffman. I am a breast implant 
recipient from Missouri.
    As the watchdog of public safety for food, drugs and medical 
devices, the FDA has failed specifically in its duties, by allowing a 
medical device with high complication rates to be marketed to American 
women by companies with dubious manufacturing practices.
    Like thousands of other women, I experienced numerous debilitating 
problems immediately after receiving my textured, silicone breast 
implants, manufactured by Mentor Corporation, in 1995. To receive 
silicone implants after the moratorium in 1992, I was required to 
participate in a clinical study. Because data collected in this study 
could effect FDA's decision as to whether the agency should approve the 
wide spread availability of the product, I recognized the importance of 
accurately documenting my problems and including them in the study.
    I reported my problems to my surgeon. He ignored me. I obtained a 
copy of the study protocol and realized a number of study rules had 
been violated. I reported the violations, and my physical problems to 
the manufacturer, who was the sponsor of the study and to the FDA; 
again, I was ignored. After numerous attempts to report my 
complications as a study participant, I received a form from my file at 
the manufacturer; it read, ``patient has no complaint.''
    Astonished by the apathetic responses I'd received, and being from 
the show me State, I began my own investigation. I interviewed several 
other study participants and found problems with their cases as well. I 
was able to talk to people who worked for the manufacturers and even a 
couple of industry whistle-blowers. From them I learned that not only 
were there problems with the study and the documentation of problems 
experienced by patients, but the companies were having major problems 
with quality control issues and were violating good manufacturing 
practices. These problems had gone on for years.
    These individuals alleged that there were problems with the implant 
design and gel suppliers; there were defects with the implants, valves, 
and outer shell; and there were inconsistencies in the gel used to fill 
implants. It appeared many of these problems had been concealed from 
the FDA. I reported this information to the FDA, several people at the 
FDA, but there was no apparent action.
    Disturbed by the lack of responsiveness at the FDA, in the summer 
of 1998 I put all of the information together, information about the 
clinical trials and the manufacturing problems alleged by industry 
employees, and gave it to Congressman Green, the FDA, the House Energy 
and Commerce Committee, and eventually to Congressman Blunt.
    The FDA's copy was given to James Austin Templer, a FDA compliance 
officer who oversaw Mentor Corporation, the manufacturer I had gathered 
the most data about. Mr. Templer referred the information to the FDA's 
Office of Criminal Investigations, and in 1998 a criminal investigation 
was opened.
    Throughout 1999, I continued to receive alarming information, which 
was given to Mr. Templer and then forwarded to the FDA's criminal 
investigators. Unfortunately, little was done, in spite of the shocking 
information that was uncovered and Mr. Templer's efforts to push the 
investigation forward. It became obvious to both of us that there were 
significant problems with the medical devices and the integrity of the 
manufacturing process. Furthermore, it appeared internal problems at 
the FDA were undermining consumer protection.
    The situation became critical in 2000. The FDA had announced that 
saline breast implants would be considered for market approval in the 
spring, and Mentor Corporation would be submitting a pre-market 
application (PMA) for approval of their products. The criminal 
investigation had gone nowhere and regulatory actions had been put on 
hold because of the criminal investigation. In January 2000, in 
frustration and out of a concern for American consumers, Mr. Templer 
tendered his resignation from a twelve-year career at the FDA. He hoped 
his resignation would get the attention of the agency. In his 
resignation letter to the commissioner, he, among other things, urged 
the agency to conduct a thorough investigation of the allegations, 
which had been made about the manufacturer and the study, prior to the 
agency's approval of saline breast implants. Unfortunately, the FDA 
again chose to look the other way.
    In May 2000, the FDA approved saline breast implants. The approval 
came in spite of Mr. Templer's recommendation, in spite of 
complications rates as high as 43% for cosmetic patients and 
complication rates of over 70% for reconstruction patients (in the 
first 3 years), and in spite of an ongoing open criminal investigation 
into one of the manufacturers, which remains open even today.
    Sadly, consumers believe ``FDA approval'' of a product means that 
the product has been adequately studied and has been found to be safe 
and effective for it's intended use. I'm not sure this should be 
concluded with this device. Unfortunately, the average consumer who 
might purchase this product will not have access to the information the 
FDA has ignored during the approval process, resulting in an 
inappropriate assumption of safety and effectiveness.
    It is my fear that by ignoring the regulatory problems, the 
criminal allegations, the high complication rates and the 
recommendation of the FDA's own staff, the agency has lowered the bar 
for what is considered a safe and effective medical device. 
Additionally, the ramifications of the FDA's decision could be 
widespread and ultimately effect other products and many American 
consumers.
    It was this concept which disturbed Mr. Templer and me so deeply. 
Mr. Templer couldn't be here today, however, he asked me to advise the 
committee of his professional opinion regarding this topic.
    Mr. Templer writes, ``Based upon information I was aware of as an 
FDA official it does not surprise me that breast implant recipients are 
experiencing significant health consequences. I was aware of many 
quality control issues as well as situations where FDA employees 
illegally assisted an implant manufacturer. I reported these issues, 
but the FDA wanted to sweep the matter under the rug. In my opinion, 
the FDA has not adequately monitored or investigated the safety of 
breast implants, and in fact, they have looked the other way when 
credible allegations of criminal conduct have been made. I urge the 
committee to take the actions necessary to protect the public health, 
because the FDA has clearly failed to do so.''
    I agree with Mr. Templer: it will take an act of Congress to get to 
the bottom of the breast implant debacle. However, Congress must insist 
that our country's watchdogs are doing their jobs. The passing of this 
bill is a great first step. S. 961, the Breast Implant Research and 
Information Act, will ensure the FDA has full oversight and will 
provide accountability. The passing of this bill will ultimately 
benefit women's health and could also impact FDA's oversight of all 
medical devices.
    I want to thank Senator Barbara Boxer and Senator John Edwards 
their leadership on this issue.
    I urge you to make it a goal to pass this bill in this Congress. 
Breast implants have been put in women's bodies for over 30 years; it's 
high time we understand the long-term effects of this product and 
insist that they be manufactured with integrity and in accordance with 
good manufacturing practices.
                    Prepared Statement of Jill Kagan
    Mr. Chairman and members of the subcommittee: On behalf of the 
National Respite Coalition, I am pleased to submit this testimony in 
support of the ``Lifespan Respite Care Act of 2002,'' to be introduced 
by Senators Clinton, Mikulski and Snowe. Seventy-five national, State 
and local organizations have already endorsed this bill, which grew out 
of the efforts of the National Respite Coalition's Lifespan Respite 
Task Force, a coalition of national organizations and State respite 
coalitions.
    The National Respite Coalition is the policy division of the ARCH 
National Respite Network and Resource Center. The ARCH Network is a 
membership organization of respite providers, State respite and crisis 
care coalitions, and the families and caregivers who rely on planned 
and crisis respite services. The ARCH National Resource Center on 
Respite and Crisis Care is a federally funded resource center 
providing: training and technical assistance; product development 
including a start-up manual, National Respite Guidelines, fact sheets, 
training manuals and evaluation reports; a National Respite Locator 
Service; networking opportunities; and evaluation and research.
    Over the last several years, the National Respite Coalition, 
following the leads of its State respite coalitions, helped spearhead a 
national movement to address the respite and caregiving needs of all 
families across generations, across disability groups, and regardless 
of family situation or income level. Partnering with over 25 other 
diverse national and State organizations in a working group called the 
Lifespan Respite Task Force, the NRC helped highlight the need for high 
quality, accessible and affordable respite services across the 
lifespan.
    We are extremely grateful for the strong national leadership 
Senator Clinton, Senator Mikulski and others on the subcommittee have 
already shown on family caregiving issues. We strongly support the 
implementation of the National Family Caregiver Support Program, which 
is helping expand and support respite and support services primarily 
for caregivers of the elderly. It is an important first step and we 
commend you for all your efforts in this area.
                            what is respite?
    Respite care provides temporary relief for caregivers from the 
ongoing responsibility of caring for an individual of any age with 
special needs, or who may be at risk of abuse or neglect.
    Respite is first and foremost a preventive strategy that 
strengthens families, protects the health and well-being of the family, 
and allows them to continue providing loving care at home. Respite is 
also an important component of a continuum of comprehensive family 
support and long-term care services that are available to caregivers 
not only on a planned basis, but also in the event of a crisis 
situation, such as sudden job loss or homelessness.
                           who needs respite?
    The sheer numbers of women in this country, many of whom place 
their own emotional and physical well-being in jeopardy by providing 
continuous care with no break and limited support, are enough to raise 
and justify concern. Current estimates suggest that there are between 
24 million and 28 million family caregivers in America. Nearly 45 
percent are caregivers of nonelderly adults and children. The remaining 
are caring for the elderly. By 2020, the number of adults requiring 
assistance with daily living will increase to almost 40 million, 
requiring a tremendous spurt in the numbers of family caregivers.
    This is especially relevant to women's health, since 75 percent of 
the caregivers nationwide are women.
    Moreover, new family arrangements, such as growing numbers of 
grandparents caring for grandchildren, also suggest a need for new and 
effective support services. Currently, there are more than 2.5 million 
grandparent-headed households raising 3.9 million children in the U.S. 
The number of these families without either parent present increased 53 
percent between 1990 and 1998 and now over 1.3 million children are 
being raised solely by their grandparents. Despite these statistics, 
most States and counties do not fund respite for these caregivers.
    Caregivers, who are raising young children while caring for an 
aging parent or relative, bring their own set of stressors and add to 
the growing need. It is estimated that between 20 and 40 percent of 
caregivers have children under the age of 18 to care for in addition to 
a parent or other relative with a disability.
    In addition, families of children with disabilities or chronic 
illness have unique and ongoing needs that present special demands and 
can increase family stress. Over six million children are eligible for 
or receive special education and related services under the Individuals 
with Disabilities Education Act (IDEA). Many have estimated the number 
of children with serious disabilities and chronic illness to be even 
higher.
                  unmet need and the dire consequences
    Survey after survey of family caregivers has shown respite to be 
the most often requested family support service, and yet it remains in 
critically short supply.
    Twenty of 35 State-sponsored respite programs surveyed in 1991 
reported that they were unable to meet the demand for respite services. 
In the last ten years, we expect that not too much has changed. The 
thirty State coalitions and other National Respite Network members 
confirm that long waiting lists or turning away of clients because of 
lack of resources is still the norm.
    According to the ARCH National Resource Center on Respite and 
Crisis Care, during an average week, nearly 1,500 families representing 
3,425 children are turned away from respite and crisis care programs 
because resources to meet the need are absent. In the absence of any 
hard data, but countless compelling family stories, we know that 
respite for adults with disabilities and chronic illness is also in 
critically short supply.
    The lack of support is taking its toll on caregivers. While a large 
proportion of caregivers, most of whom are women, report finding an 
inner strength they didn't know they had, a National Family Caregivers 
Association survey found that significant numbers report serious 
physical or mental health problems, including headaches, stomach 
disorders, back pain, sleepless nights and depression. Mortality risks 
are even higher for caregivers than for noncaregivers. A 1999 study 
reported in the Journal of the American Medical Association found that 
participants who were providing care for an elderly individual with a 
disability and experience caregiver strain had mortality risks that 
were 63 percent higher than noncaregivng controls.
    Grandparent caregivers report face enormous financial stress, as 
well as the poor health status. In 1997, grandparent caregivers were 60 
percent more likely to live in poverty than grandparents not raising 
grandchildren. In addition, one-third of grandparents in all 
grandparent maintained families self-report their general State of 
health as fair or poor.
    In fact, we cannot afford to lose any family caregivers to stress 
or illness. According to the National Long-Term Care Survey, if the 
work of family caregivers had to be replaced by paid home care staff, 
the cost to our nation would be $45 to $75 billion per year. Other 
studies have suggested that caregivers now provide nearly $200 billion 
per year in unpaid care, saving the government billions of dollars in 
paid institutional long-term care costs.
    Those who are being cared for are at high enough risk already 
without having their caregivers face uncertain illness or even death. 
And for many, the families suffer emotionally as well as economically. 
Families of children with disabilities face a significantly higher 
divorce rate than families of children without disabilities. Lack of 
respite care has even been found to interfere with parents of children 
with disabilities accepting job opportunities.
    Even tragedy can result. The number of children and the elderly who 
are annually reported as abused or neglected, whose families could 
benefit from respite services to prevent the abuse from happening in 
the first place, is unacceptable. Each year, CPS agencies investigate 
an estimated two million reports alleging the maltreatment of almost 
three million children. In addition, it is estimated that two to four 
million women are victims of domestic violence and between 3.3 and 10 
million children are exposed to domestic violence, each year. Without 
adequate family support, children with disabilities face an even higher 
risk of abuse and neglect (nearly four times higher).
    The abuse rate of the elderly is also unacceptably high. Experts 
estimate that as many as 32 out of 1,000 elderly people are victims of 
elder abuse. A 1996 national incidence study found that 450,000 persons 
ages 60 and over in domestic settings experienced abuse or neglect in a 
one year period. It is estimated that over five times as many new 
incidents of abuse and neglect were unreported than those that were 
reported to and substantiated by Adult Protective Services agencies 
that year. In 90 percent of cases, the perpetrator is a family member.
                     respite works and saves money
    While much more rigorous evaluation needs to be done, respite has 
been shown to improve family functioning, improve satisfaction with 
life, enhance the capacity to cope with stress, and improve attitudes 
toward the family member with a disability.
    Most compelling are recent preliminary data from Phase One of the 
ARCH National Resource Center Outcome Evaluation project. Twenty-nine 
respite and crisis care programs serving families across the lifespan 
in the Midwest, South, East Coast, West Coast, Southwest, Alaska and 
Hawaii volunteered to participate. Seventeen programs remained engaged 
in the project and participated in the field-testing of the 
instruments. Based on their knowledge of the families' activities and 
past history, project managers reported that in some instances 
caregivers were likely under reporting on issues such as maltreatment, 
out of home placement and marital status. Even with some 
qualifications, the preliminary data are very encouraging.
    Although parents were reluctant to admit that their child would 
have been at risk for maltreatment had crisis care not been available, 
caregivers reported that the crisis care they received helped protect 
their child from danger. Fifteen percent of the caregivers of children 
using crisis respite reported that it was ``somewhat likely'' to 
``highly likely'' that their child might have been mistreated or 
neglected if crisis care had not been available, and an additional 15 
percent responded ``not sure.'' Yet, 81 percent reported that the 
crisis care they received helped protect their child from danger. In 
terms of marital stability, nearly half (47 percent) of the caregivers 
surveyed in respite programs serving all age groups said that they 
would be somewhat, quite or highly likely to experience separation or 
divorce without respite services.
    Respite helps families avoid more costly out-of-home placements as 
well. Hospitalizations, institutionalization, nursing home and foster 
care placements have been shown to actually decline when respite or 
crisis care is the intervention. The Nebraska lifespan respite program 
conducted a statewide survey of a broad array of caregivers who had 
been receiving respite services, and found that one out of four 
families caring for a child under 21 and one out of two families caring 
for a family member over 21 reported that they were less likely to 
place their family member in out-of-home care once respite services 
were available.
    Most importantly, the health and well-being of women and others who 
provide the care has been shown to improve. Sixty-four percent of 
caregivers of the elderly receiving 4 hours of respite per week after 
one year reported improved physical health, 78 percent improved their 
emotional health, and 50 percent cited improvement in the care 
recipient as well. Forty percent said they were less likely to 
institutionalize the care recipient because of respite. Caregivers of 
relatives with dementia who use adult day care experience lower levels 
of caregiving related stress and better psychological well-being than a 
control group not using this service. These differences are found in 
both short-term (3 months) and long-term (12 months) users. In 
addition, the Nebraska Lifespan Respite program found that 79-80 
percent of the respondents reported decreased stress and 58-65 percent 
reported decreased isolation as a result of respite services received 
through the program.
                state family caregiver support programs
    Over the last decade, States have begun to respond to this growing 
need and have implemented caregiver support programs in various forms.
    In a Family Caregiver Alliance (FCA) survey of 33 caregiver support 
programs in 15 States, it was found that eligibility criteria for 
programs vary widely by diagnostic/functional level, age and income. 
Over two thirds of these programs provide five or more caregiver 
services, most typically respite care. For respite assistance in 
particular, service definition, eligibility, mode of delivery and 
funding vary widely across programs and within States. Key informants 
report that while respite care is among the most beneficial aspects of 
their programs, recruiting respite workers/raising worker wages is also 
among the biggest challenges these State programs face.
    Oregon's Lifespan Respite Care Program (see below) was identified 
as one of the five best practice models among the 33 programs surveyed 
by FCA and at the time of the survey was the only statewide program 
with no eligibility criteria based on disability, income, or age. 
Wisconsin, Nebraska and Oklahoma now all have statewide lifespan 
respite programs (see below). The private sector, including Easter 
Seals, United Cerebral Palsy, and the Alzheimer's Association are also 
involved in providing and supporting respite services. An 
intergenerational program, Family Friends, partners active senior 
volunteers with families of children with disabilities to provide 
respite, friendship and nurturing.
                      fragmentation and unmet need
    Despite the model efforts discussed so far, and the success respite 
brings in terms of family stability and cost-savings, the need for 
State and national respite care infrastructure is compelling. Most of 
the problem can be attributed to insufficient resources directed 
specifically at start-up, development, implementation and maintenance 
of quality respite care choices.
    The current supply of individuals available to provide respite care 
is woefully inadequate in many communities, especially respite care for 
individuals with certain disabilities such as mental illness or severe 
medical conditions, especially those over age 18, or in some rural and 
urban centers where these resources may be scarce.
    However, an equally difficult problem is the identification and 
coordination of existing resources that would aid caregivers and help 
State agencies improve access to respite programs.
    Implementation of the National Family Caregiver Support Program is 
helping develop statewide infrastructures and single points of entry 
through Area Agencies on Aging to help primarily caregivers of the 
elderly more easily find the respite and support they need. Existing 
statewide respite and caregiver support programs are also a small step 
in the right direction, providing access to some respite services 
statewide for some part of the needy population.
    While these efforts provide a critically important foundation on 
which to build, they currently do not do enough to reduce the 
fragmentation, the inaccessibility, and the confusion that exists 
around multiple eligibility criteria, numerous funding streams, and 
qualified provider shortages.
    Numerous funding sources with different eligibility criteria are 
partly to blame.
    A myriad of other Federal programs, including Medicaid, Medicaid 
Waiver programs, Title XX Social Services Block Grant, the Community-
Based Family Resource and Support Program, the Child Care and 
Development Block Grant, and the Developmental Disabilities Program, 
among others, have been identified which have the potential to fund or 
support respite care for caregivers, but only for caregivers of 
individuals with specific disabilities, specific ages, or for one 
narrow purpose.
    These limitations are confusing not only to families, but to the 
States that rely on them. In addition, while many of these programs 
have the potential to fund respite and crisis care, they are not 
mandated to do so. Competing demands for these funds or lack of 
information on the part of consumers as well as State agency heads 
often results in no or limited Federal funds from these various 
programs being used to support respite care.
    Currently, there is no single, coordinated, family/caregiver 
friendly Federal program to support the development or implementation 
of respite care infrastructures that would serve all families 
regardless of the age of the caregivers or the ages or disabilities of 
the care recipients. Families are now forced to search for services, 
funding, and support, where they may or may not exist, often in a 
complicated bureaucratic maze.
                            lifespan respite
    As of April 2002, three States had passed Lifespan Respite Acts 
(Oregon, Nebraska, Wisconsin), which establish State and local 
infrastructures for developing, providing, coordinating and improving 
access for respite to residents of the State. Oklahoma has implemented 
a statewide Lifespan Respite Program without legislation. Maryland has 
enacted legislation that establishes a State Coordinating Council for 
Family Caregiver Support. Part of Maryland's charge is to review 
successful lifespan respite care programs in other States, develop a 
model family caregiver support program that incorporates best practices 
from existing programs in the State and in other States; and coordinate 
activities of existing and proposed family caregiver support services 
among the State and local public agencies. Several other State 
coalitions or governments (Alabama, Connecticut, Florida, and Montana, 
among others) are actively considering or piloting similar lifespan 
respite programs or legislation.
    Each program has been adapted to meet their individual State needs, 
but the defining characteristic of each is the statewide, coordinated 
approach to ensure respite services for all who need it. Many of the 
lifespan respite programs have established community-based networks 
that rely on the development of local partnerships to build and ensure 
respite capacity. These local partnerships include family caregivers, 
providers, State and federally funded programs, area agencies on aging, 
non-profit organizations, health services, schools, local business, 
faith communities and volunteers.
    These networks are the central point of contact for families and 
caregivers seeking respite and related support regardless of age, 
income, race, ethnicity, special need or situation. Providing a single 
point of contact for families to access respite is crucial to assisting 
families in helping themselves.
    Services typically offered by Lifespan Respite Programs are 
providing public awareness information to the community and building 
diverse respite partnerships, recruitment of paid and volunteer respite 
providers, connecting families with respite payment resources, 
coordinating respite related training for providers and caregivers, 
identifying gaps in services and creating respite resources by building 
on existing services, and connecting families with respite providers.
    Oregon was the first State to implement a Lifespan Respite Program 
in 1997. The Director of the Oregon Department of Human Services (DHS) 
is charged by State law to develop and encourage statewide coordination 
of respite care services. The Department works with community-based 
nonprofits, businesses, public agencies and citizen groups to identify 
gaps in services, generate new resources and develop community programs 
to meet those needs. Oregon's Lifespan Respite Program is housed in the 
DHS Community Partnership Team and is responsible for implementing the 
Oregon Lifespan Respite Care Act, administrative rules, contracts, 
funding and program evaluation. The Program offers technical assistance 
with program specific issues, works directly with Lifespan networks and 
promotes the State respite agenda. Currently there are 29 Lifespan 
Respite Care Networks representing 34 Oregon counties. All of Oregon's 
counties are expected to be served by 2003.
    Nebraska builds on the Oregon model and is currently administered 
by the State's Department of Health and Human Services, which 
established the Nebraska Lifespan Respite Services Program. With the 
goal of helping create a permanent structure for a statewide system for 
respite, NLSRP designated and funded six community lifespan programs 
this past year. The organizations which received the contracts with 
Health and Human Services will be expected to accomplish the following 
five outcomes within the initial two-year contact period: (1) A 
knowledge of all existing respite resources within the designated HHS 
service area and the need for additional resources by lifespan 
populations; (2) An increased public awareness of lifespan respite 
among families, providers, local agencies, Medicaid staff and the 
private sector within the designated HHS Service Area; (3) An increase 
in the access to lifespan respite services; (4) Knowledge of and 
collaboration with existing agencies on best practices for a 
comprehensive training package for providers and family members; and 
(5) Documentation of an increase in the awareness of respite, an 
increase in Medicaid respite providers, an increase in the 
representation of all cultural groups, better access to respite 
services and other baseline data established by HHS to be used for 
program evaluation.
    In Wisconsin, the legislation authorizing the Wisconsin Lifespan 
Program requires that coordinated, noncategorical respite services be 
available locally to provide reliable respite services when needed by 
families and caregivers regardless of age, disability or geographic 
location in Wisconsin. In collaboration with the Department of Health 
and Family Services, the Respite Care Association of Wisconsin (RCAW), 
the State administering body of the Wisconsin Lifespan Respite Program 
provides administrative oversight to the lifespan grantees, offers 
technical assistance around program and workforce specific issues, and 
promotes the State respite agenda. In 2000, RCAW awarded grants to 
establish five regional lifespan programs, one in each of the five 
Department of Health and Family Services regions across the State. By 
2005, it is expected that 25 lifespan projects will be created in the 
State.
    The Oklahoma Respite Resource Network (ORRN) is a statewide 
partnership of public and private agencies whose goal is to support 
families and caregivers by increasing the availability of respite care. 
State agencies, including developmental disabilities, mental health, 
aging, maternal and child health and others, have come together 
voluntarily with private agencies to pool resources for respite and 
dispense them though a voucher program managed by a single State 
program. Families applying to the State for a respite voucher (families 
are entitled to $400 in vouchers for 3 months) are considered the 
employer of the respite care provider and are encouraged to consider as 
potential respite providers family, friends or co-workers, civic 
organizations, local churches, child care centers, or other appropriate 
public or private agencies. The Oklahoma Respite Resource Network also 
relies on an already existing statewide resource and referral system 
(OASIS) to link families to the program.
          time has come for a national lifespan respite policy
    Building on the fervent activity at the State level, and the 
converging demographic and social trends that face all families and 
caregivers across the nation, the National Respite Coalition has found 
unprecedented support among a diverse group of national organizations 
for pursuing a national lifespan respite policy.
    The NRC held a National Summit on Lifespan Respite in May 2000. 
Over thirty national organizations attended and a core group has been 
meeting as the Lifespan Respite Task Force regularly since then. Our 
first major activity was the development of a common respite 
definition, a vision statement and a set of principles of quality 
respite care. Twenty-seven national organizations and 17 statewide 
organizations endorsed the vision statement and principles.
    The Task Force's efforts were bolstered by the National Conference 
of State Legislatures response to assist States in planning around the 
Olmstead decision, a Supreme Court decision which requires every effort 
by the Federal Government, States and local agencies to serve 
individuals with disabilities in the community, rather than in 
institutional settings. NCSL published an issue brief on implementing 
long-term care in community-based settings which highlighted lifespan 
respite as one of three best practices models for State action. The 
Nebraska program was highlighted as an example.
    We are also heartened by the Administration's Department of Health 
and Human Service's focus on respite care for supporting family 
caregivers during implementation of the Olmstead decision in its 
recently released report ``Delivering on the Promise.'' Recommendations 
included two new demonstrations for respite for the adults with 
disabilities and for children with severe disabilities to be 
administered through the Center on Medicaid and Medicare. While we 
applaud the Department's recognition that respite is needed by all age 
groups, and their efforts to increase the availability of respite care, 
it is another piecemeal approach that does not go as far as the 
Lifespan Respite Care Act of 2002 to ensure that duplication and 
fragmentation of services are eliminated, and that barriers to quality 
respite care across the lifespan will be reduced for caregivers 
struggling to keep their loved ones at home.
                   lifespan respite care act of 2002
    We know how families are changing and how rapidly a large 
proportion of the population is aging. The demographics make that 
clear. Fortunately we know what to do to support families. We commend 
the cosponsors of the ``Lifespan Respite Care Act of 2002'' for 
following the States' leads to make sure that every State has the 
resources and encouragement to institute their own lifespan respite 
program. This bill would authorize funds for:
     development of lifespan respite programs at the State and 
local levels; evaluation of such programs; planned or emergency respite 
care services;
     training and recruitment of respite care workers and 
volunteers; and
     caregiver training to help make informed decisions about 
respite care services.
    Lifespan respite programs are defined in the bill ``as coordinated 
systems of accessible, community-based respite care services for all 
caregivers of individuals regardless of the individual's age, race, 
ethnicity or special need.''
    Caregivers who are family members (including grandparents caring 
for grandchildren), foster parents, or other adults providing ongoing 
unpaid care for an individual with a special need. Special need is 
defined broadly as: Alzheimer's disease and related disorders; 
developmental disabilities; mental retardation; physical disabilities; 
chronic illness; behavioral, mental and emotional conditions; 
situations in which there exists a high risk of abuse or neglect or of 
being placed in the foster care system; in which a child's parent is 
unavailable due to parent's death, incapacitation, or incarceration of 
a parent; or any other conditions established by regulation.
    Funds would be provided on a competitive grant basis to State 
agencies, other public or private nonprofit entities capable of 
operating on a statewide basis, a political subdivision of a State that 
has a population greater than three million, or any already recognized 
State respite coordinating body. Priority would be given to applicants 
that show the greatest likelihood of implementing or enhancing lifespan 
respite care statewide.
    Coordination is also required at the Federal level between the 
administering agency, the Maternal and Child Health Bureau of the 
Health Resources and Services Administration and the following Federal 
agencies: National Family Caregiver Support Program of the 
Administration on Aging, the Administration for Children, Youth and 
Families, the Administration on Developmental Disabilities, and the 
Substance Abuse and Mental Health Services Administration.
    Funding for the bill is authorized at $90.5 million in fiscal year 
2003 and rises to $200 million in fiscal year 2007. The bill would also 
establish authority for a critically needed National Resource Center on 
Lifespan Respite Care that would assist States and local programs in 
developing and enhancing new respite services; maintain a national 
database; provide training and technical assistance, and information to 
the public on lifespan respite care.
    This legislation is timely and will help create a family caregiving 
policy in our country, not just a band-aid solution. Families are under 
greater stress than ever before and the numbers of women who will 
assume caregiving roles without adequate support in the coming decades 
are rising at an alarming rate. Respite works, respite saves money, and 
it's what families and caregivers say they want and need.
    Thank you for the opportunity to provide written testimony to the 
committee in these very important deliberations. The National Respite 
Coalition stands ready to provide assistance in rapid enactment of this 
critically important legislation.
                  Prepared Statement of Susan Scanlan
    The Women's Research and Education Institute (WREI) appreciates the 
opportunity to submit this statement to the record of the Senate 
Health, Education, Labor and Pensions Public Health Subcommittee's 
April 25, 2002 hearing on women's health. Established in 1977, WREI is 
an independent, nonprofit organization which gathers, synthesizes, and 
analyzes policy-relevant information on issues that concern or affect 
women, and serves as a resource for Federal and State policymakers, 
scholars, advocates for women, the media, and the public.
    WREI commends the subcommittee for holding this hearing and 
drafting this important piece of women's health legislation. For years, 
improving women's health has been one of WREI's high priority areas. 
Described in greater detail below, WREI's most recent project, 
Improving the Health of Midlife Women, charts a Federal health policy 
agenda for the 21st century, and serves as a blueprint highlighting 
areas where Congress can make a significant difference in promoting 
health and preventing disease. While WREI's recommendations are focused 
on mid-life women, they often apply equally well to women's health 
issues across the lifespan.
    WREI was heartened to learn that several of our highest priorities, 
such as establishing permanent offices of women's health and expanding 
the WISEWOMAN program, are already included in the bill. These 
components of the legislation would help to coordinate women's health 
programming across Federal agencies, and provide low-income and 
uninsured women with critical heart disease screening, intervention, 
and case management services. WREI is also pleased that other high-
priority recommendations, such as providing women with direct access to 
OB/GYNs, are included in pending legislation.
              wrei's high priority policy recommendations
    In addition to establishing permanent offices of women's health and 
expanding the WISEWOMAN program, WREI believes that a number of our 
high priority policy recommendations would be appropriate to include in 
the comprehensive bill. Specifically, we would like to highlight our 
recommendations to expand the National Breast and Cervical Cancer Early 
Detection Program (NBCCEDP), and for Congress to direct the Health 
Resources and Services Administration (HRSA) and the Centers for 
Disease Control and Prevention (CDC) to develop community health 
centers as sites for health promotion and disease prevention for all 
women. Both of these recommendations would improve crucial health 
promotion, screening, and treatment services for low-income, rural, and 
underserved women.
    As WREI's report points out, a number of gaps exist in midlife 
women's access to health promotion and disease prevention services. Far 
too many women, especially women with low incomes and women of color, 
are not receiving the screening services that could increase the 
likelihood of early detection and successful treatment of diseases. 
While some screening rates have improved in recent years, there is much 
more that should be done to bring the rates up.
    In the NBCCEDP, women between the ages of 40 and 64 are eligible 
for a Pap test, and women between 50 and 64 years old are eligible for 
a mammogram. Due to limited funding, however, the NBCCEDP reaches only 
15% of the eligible population. In order to provide more women with 
access to NBCCEDP education and screening services, WREI urges Congress 
to increase appropriations and expand this important program. Even a 
small expansion would be a step in the right direction.
    In addition to expanding the NBCCEDP and the WISEWOMAN programs, 
Congress could further increase access to crucial preventive and 
screening services by eliminating copayments for such services. Public 
education efforts could also encourage health care providers to adopt a 
comprehensive approach to screening women for a number of diseases, 
such as heart disease and osteoporosis.
    WREI also recommends that Congress expand community health center 
programs to provide additional services to unserved and underserved 
women, especially midlife women. Programs are needed to encourage self-
management of chronic disease, counseling on health behaviors and 
preventive health options, and screening for chronic diseases and 
conditions. Recognizing CDC's capacity in chronic disease programs in 
the States and HRSA's capacity to provide services to underserved 
women, these two agencies should be encouraged to work together to 
develop community health centers as sites for health promotion and 
disease prevention.
         wrei's report on improving the health of midlife women
    WREI undertook its latest project on midlife women's health because 
of our strong belief that a comprehensive health policy agenda aimed at 
midlife women is urgently needed. Until recently, most of the policy 
attention has focused on younger women of reproductive age and older 
women who are eligible for Medicare. However, the years between 45 and 
64 are a time when many women are at serious risk for the onset of 
chronic conditions such as heart disease, cancer, diabetes, arthritis, 
and osteoporosis. The Federal Government has an important role to play 
in educating midlife women, the public, and clinicians about women's 
health risks and in improving women's access to crucial preventive 
services.
    In January 2001, WREI brought together a broad cross-section of 
policymakers, Federal agency personnel, and representatives of advocacy 
groups and foundations for a two-day summit to identify the major gaps 
in midlife women's health and to chart a Federal health policy agenda. 
These experts identified 10 gaps in the health of midlife women and 46 
policy options to close those gaps.
    Following the summit, WREI selected 15 high-impact actions Congress 
and the Administration should take to make a significant difference in 
promoting health and preventing disease in midlife women (attached). 
The full report, Improving the Health of Midlife Women: Policy Options 
for the 21st Century, describes the gaps and policy options in detail. 
WREI would like to request that the attached summary of the 15 high-
impact recommendations be included in the hearing record.
    Similar to the bill the committee is developing, WREI's 
recommendations can be categorized into prevention, research, and 
treatment initiatives. Of the 46 recommendations, 44 fall into 
prevention, 9 into research, and 25 into the treatment category. Not 
surprisingly, the overwhelming majority of the recommendations focus on 
prevention, and many would require an additional investment of 
resources. While Congress might be hesitant to appropriate these funds, 
WREI believes that a significant investment in disease prevention and 
health promotion now would result later in improved quality of life, 
less mortality, and health care cost savings due to reduced treatment 
expenses. It is better to prevent disease in the first place than to 
treat it after it has already developed.
    As WREI's report highlighted, many women between the ages of 45 and 
64 lack access to preventive health care. Millions have no insurance 
coverage at all; millions more have private plans that require hefty 
deductibles and copayments. The development of strategies for extending 
health insurance coverage to uninsured women is urgently needed.
    Finally, the report emphasizes the need for more research on health 
promotion and disease prevention for women. A number of studies are 
currently underway at the National Institutes of Health and other 
Federal agencies. Still, we know far too little about what works in 
health promotion and disease prevention for women in midlife. We need 
additional research on what motivates women to change unhealthy 
behaviors, on barriers to change, and on how best to help women 
practice healthy behaviors. Research is also needed on the 
sociocultural and financial barriers to preventive health care, as well 
as on the factors that discourage physicians from providing 
comprehensive, preventive health care and appropriate counseling to 
women about health promotion and disease prevention.
    Much progress has occurred in recent years in improving the health 
of women, and this committee can take much of the credit for these 
improvements. In closing, in addition to the specific recommendations 
we have outlined, WREI urges the committee to examine our report and 
recommendations, and determine if any of the other provisions could be 
incorporated into your bill. WREI applauds the committee for all its 
hard work, and looks forward to continuing to work with you and your 
colleagues to improve women's health.
              Prepared Statement of Pamela Noonan-Saraceni
    Mr. Chairman, my name is Pam Noonan-Saraceni. As a breast cancer 
survivor who continues to endure the painful physical side-effects of 
silicone breast implants, I am pleased to have the opportunity to take 
part in this hearing.
    Many believe the scientific and safety debate on breast implants is 
over and are wondering why breast implants are part of today's hearing. 
You believe this issue has reached its saturation point. But, breast 
implants remain a classic example of ``what we don't know can hurt 
us.''
    Consider the number of women who have breast implants. The 
Institute of Medicine estimates that by 1997, 1.5 to 1.8 million 
American women had breast implants with nearly one third of these women 
being breast cancer survivors. In 1999 alone, nearly 83,000 women 
received implants following a mastectomy. In 2000, over 200,000 women 
received breast implants for cosmetic reasons.
    Yet, in 1999, the Institute of Medicine concluded:
     First, reoperations and local complications are frequent 
enough to be a cause for concern and to justify the conclusion that 
they are the primary safety issue with silicone breast implants;
     Second, risks accumulate over the lifetime of the implant, 
but quantitative data on this point are lacking for modern implants and 
deficient historically;
     Third, information concerning the nature and relatively 
high frequency of local complications and reoperations is an essential 
element of adequate informed consent for women undergoing breast 
implantation.
    And in 1997, the Mayo Clinic found that one in four women required 
additional surgeries within five years of implantation because of 
problems related to the implants. The rate was higher for mastectomy 
patients: one in three women.
    Despite over thirty years of use, the Food and Drug Administration 
has never approved silicone implants and just recently approved saline 
implants for the first time. Little is known about the long term 
effects of silicone and even less is known about saline. Yet their 
popularity is growing with a new generation of young women who, in 
spite of the past controversy, are being led to believe that 
improvements have been made to these implants, and therefore, they are 
now safe.
    I believe breast implants should be an option for women. But, a 
safe option. Therefore, the role of the Government cannot be 
overlooked. There are a number of measures that the Federal Government 
could implement to better protect women and preserve their health and 
their quality of life. These measures are encompassed in the 
legislation introduced by Representatives Roy Blunt and Gene Green. 
H.R. 1961, ``The Breast Implant Research and Information Act,'' calls 
upon the FDA to strengthen informed consent documents given to patients 
in clinical trials for breast implants; directs the National Institute 
of Health to conduct independent research desperately needed on breast 
implant recipients; and ensures better FDA oversight of device 
manufacturers.
    In order to better understand the need for this legislation, I 
would like to tell you a little bit about my personal experience. I was 
diagnosed with breast cancer and had a radical mastectomy in 1978. I 
was just 25 years old at the time. I waited 5 years before I decided to 
have reconstructive surgery. I was an active person. I played tennis, 
taught aerobics, and jogged. I had grown tired of the inconvenience of 
the prosthesis shifting and falling out when I perspired. I thought I 
had done my homework on breast implants prior to choosing the plastic 
surgeon to do my reconstruction. However, I was never advised of any of 
the health risks associated with the implants. In fact I was told 
repeatedly that they would ``last a lifetime'' and that 
``complications'' were rare. Within 3 months of the initial 
reconstruction, I was back in the operating room. My body had formed a 
capsule around the implant and the implant had shifted up toward the 
collarbone. My symptoms of physical illness began slowly. In the summer 
of 1990 I began to experience joint pain and chronic fatigue. This was 
six years after my being implanted. I have been to various doctors and 
specialists and have a list of various diagnoses. Before I had the 
implant removed in June of 1994 (10 years after the initial 
reconstruction), I had to wear a partial prosthesis over the implant. 
Capsular contracture had again become a problem and I was misshapen and 
lopsided. The explantation was the 5th surgery at my breast site.
    To date, my out of pocket medical expenses total almost $35,000. My 
husband and I are self-insured. The insurance policy that we took out 
in 1991 had an exclusion. I was not covered for any illness or 
disabilities related to the reconstructive surgery. Apparently, the 
insurance companies understood the health risks breast implants pose 
for women and were not willing to bear the financial costs. I believe 
there are several areas that need improvement in order to protect women 
considering breast implants. The Breast Implant Research and 
Information Act, introduced by Senator Boxer and Congressmen Gene Green 
and Roy Blunt, is a tremendous step forward to safeguarding American 
women.
              first: informed consent must be strengthened
    Insufficient and inaccurate information has posed many problems for 
women in breast implant trials. Even the Institute of Medicine 
recognized that women are not being adequately warned of rupture, 
painful local complications and multiple surgeries.
    The informed consent agreement drawn up by the breast implant 
manufacturers is the only required information women receive about the 
implants and the study prior to surgery. This document contains 
inaccurate data on rupture and contracture rates, the efficacy of the 
implants, the risks and complications, and the need for future 
reoperations. It understates the FDA's concern about the safety of 
silicone breast implants, which first led to the 1992 moratorium, and 
makes many misleading statements about the rate of complications 
following implantation.
    Furthermore, the informed consent agreement does not mention the 
effects of breast implants on future mammography. This is probably not 
a concern most cosmetic patients even consider. Yet, over 30 percent of 
the breast tissue can be obscured by the implant, which can delay the 
detection of cancer.
    Until independent research is able to answer the long-term safety 
questions surrounding breast implants, women, at the very least, need 
to be informed about what we DO know:
     chronic pain, breast hardening, infections and breast 
deformity;
     the high rate of reoperations;
     the high rate of ruptures;
     problems associated with insurance coverage;
     the fact that implants do not last a lifetime and will 
have to be replaced every 8-10 years;
     inaccurate mammography.
                 second: the need for long-term studies
    The Breast Implant Research and Information Act directs the 
National Institutes of Health to conduct the independent research that 
is so desperately needed in this area. The lack of convincing data 
submitted by the manufacturers or the plastic surgeons on the incidence 
of device failure, implant rupture or gel bleed was of concern to the 
FDA in the early 1980s--so much of a concern that an FDA panel headed 
by Dr. Norm Anderson recommended that silicone breast implants remain a 
Class III device, meaning their safety and efficacy was not proven.
    Once product liability cases involving silicone breast implants 
became more and more common, the manufacturers began to pour money into 
new scientific research on breast implant safety. Dr. Anderson implored 
the manufacturers to put their money into an independent fund so that 
impartial scientists could decide which issues should be examined. His 
wish was not granted, and the ensuing research in large part ignored 
long term outcomes, incidence of device failure, the consequences of 
implant rupture, and the causes for tissue pain.
    The latency period for breast implant complications and ruptures 
has been widely recognized in scientific circles. I had my implants for 
six years before my symptoms began to appear. But, the FDA only 
required manufacturers to follow women in saline implant trials for 
three years, and the agency recently announced that manufacturers of 
silicone breast implants will only be required to follow patients for 2 
years in order to glean data for market approval. These studies will 
not provide meaningful data on the long-term safety and efficacy of the 
implant, and will do little to protect American women in the long run.
    In its review of breast implant studies, the Institute of Medicine 
also concluded, ``risks accumulate over the lifetime of the implant, 
but quantitative data on this point are lacking for modern implants and 
are deficient historically.''
    In May of 1999, University of Florida researchers published their 
analysis of more than 35 studies, which examined more than 8,000 
implants. According to this analysis, silicone breast implant rupture 
rates were found to be 30 percent at 5 years, 50 percent at 10 years 
and 70 percent at 17 years. According to the researchers, past studies 
that have been cited in support of silicone breast implant safety have 
``paid almost no attention to the health consequences of local 
complications of pain, capsular contracture, disfigurement, chronic 
inflammation, rupture, silicone migration, and frequent surgical 
revisions.'' They conclude that the longer women have these devices in 
their bodies, the greater the risk of failure and numerous 
complications.
    This study and the IOM review reinforce the need to study women for 
a long period to accurately assess the health effects of breast 
implants.
    Furthermore, almost no research has been done to track mastectomy 
patients who suffer from local complications at a higher rate than 
other breast implant recipients.
    I hope one day there is a cure for breast cancer. But until that 
day, the National Institutes of Health should be obligated to conduct 
the independent research so badly needed on breast implants. No woman 
should be put in a position of surviving breast cancer only to 
experience chronic pain, infections, or deformities from breast 
implants.
                               conclusion
    When I opted for reconstructive surgery using breast implants, I 
thought I had made an informed decision. I asked questions of my 
doctors; I read as much information as was available in 1983. I thought 
I was making a safe choice for myself. Almost immediately, I was back 
in the operating room. It took six years before I began to experience 
unusual and chronic pain in my joints. A series of doctors diagnosed me 
with several different illnesses, and I underwent two additional 
surgeries. Finally, ten years after my initial implantation, I had the 
implants removed and my symptoms began to improve.
    Despite the breast implant manufacturers advertisements, breast 
reconstruction is not an essential part of the recovery process; being 
cancer free and feeling physically well enough to return to a normal 
life is. Had I known the additional physical, emotional and financial 
hurdles I would have to overcome due to breast implants, I would have 
made a different decision. I would have never chosen implants.
    My personal story and what I've learned from the experiences of 
women like me across the country and around the world is my only breast 
implant expertise. I feel a tremendous responsibility to increase 
awareness about the unanswered safety questions that still surround 
breast implants. My hope is that other women, when faced with the same 
choices, can make their decisions based upon better informed consent 
and independent research. Please support the passage of S.1961, the 
Breast Implant Research and Information Act.
                    Prepared Statement of Esta Soler
    Chairman Kennedy, Ranking Member Frist and members of the 
subcommittee, my name is Esta Soler and I am the President of the 
Family Violence Prevention Fund. The Fund is a national nonprofit 
advocacy organization dedicated to ending domestic violence through 
prevention, public education and advocacy for victims and their 
children. I would like to thank you for the opportunity to address this 
committee with regard to the urgent need for the health care system to 
do more to prevent family violence and assist families facing abuse.
              prevalence and health consequences of abuse
    Domestic violence is a health care problem of epidemic proportions. 
Experts estimate that 25 to 31 percent of women in the United States 
have been abused by an intimate partner at some point in their lives. 
In addition to the immediate trauma and injury caused by abuse, 
domestic violence can cause serious physical and mental health problems 
that last a lifetime. It contributes to chronic conditions including 
neck, back and pelvic pain, ulcers, migraines and arthritis, and 
victims of domestic violence suffer from higher rates of mental health 
problems including depression, anxiety, post-traumatic stress disorder 
and suicide attempts. Patients experiencing abuse also are more likely 
to have adverse health risk behaviors such as smoking, substance/
alcohol abuse and poor diet.
    Battered women can have great difficulty accessing health care. The 
control exercised by batterers--and the isolation that results--often 
mean that battered women are less likely to engage in preventative 
health behaviors and to make or keep well woman/well child 
appointments, have mammograms and access early pre-natal care. Managing 
chronic illnesses such as asthma, diabetes and hypertension may also be 
problematic for abused women because batterers frequently deny them 
access to money and transportation and prevent them from keeping 
medical appointments or getting medicine.
    In particular, pregnant women are at a risk. Some 240,000 pregnant 
women each year are abused by their partners. A recent study showed 
that homicide, including intimate partner homicide, is the leading 
cause of death for pregnant women. Abused pregnant women are also 
significantly more likely to experience complications of pregnancy 
including low weight gain, anemia, infections and first and second 
trimester bleeding. Victims of domestic violence are more likely to 
have gynecological problems during pregnancy than women who are not 
abused. In addition, battered women have higher rates of sexually 
transmitted infections including HIV, as well as depression, suicide 
attempts, and tobacco, alcohol and illicit drug use.
    Children can also suffer greatly when they are exposed to domestic 
violence. Three to ten million children witness domestic violence each 
year in the United States. The greatest immediate risk for children who 
live in violent homes is that they will be physically abused. In 30 to 
60 percent of families experiencing intimate partner violence, children 
also are abused. Children who are exposed to violence are more likely 
to become both perpetrators and victims of domestic violence. They 
often show symptoms associated with posttraumatic stress disorder and 
they are more likely to have cognitive and behavioral problems 
including depression, anxiety and violence towards peers. They are more 
likely to attempt suicide, abuse drugs and alcohol, run away from home, 
engage in teenage prostitution and commit sexual assault. Fortunately, 
children can often overcome the harm caused by witnessing abuse with 
interventions and developmentally appropriate mental health services. 
However, without these interventions, the impact of childhood exposure 
to violence often lasts a lifetime. Adults who experienced adverse 
childhood experiences, including domestic violence, are more likely 
than other adults to smoke, abuse drugs or alcohol, and suffer from 
depression and obesity. They are also at significantly higher risk for 
health problems associated with those poor health behaviors, including 
cardiopulmonary disease, heart disease, diabetes and suicide attempts.
                     role of the health care system
    The health care system often plays an important role in identifying 
and preventing serious public health problems, and we believe the 
health care system can play a unique and pivotal role in domestic 
violence prevention and intervention. Virtually every American woman 
interacts with the health care system at some point in her life--
whether it is for routine care, pregnancy, childbirth, illness, injury 
or to seek care for her child. Women who are abused also frequently 
seek health care for illnesses and injuries resulting from the violence 
they face. In fact, a November 1998 report of the National Institute of 
Justice and the Centers for Disease Control and Prevention found that 
women make 693,933 visits to health care providers per year as a result 
of injuries resulting from physical assault. The majority of these 
visits are for treatment of injuries that were inflicted by intimate 
partners. This study only measured the impact of specific injuries 
directly related to physical assault; experts believe the numbers would 
be significantly higher if it had examined visits for other health 
problems related to domestic violence and how abuse affects the 
management of other illnesses.
             an urgent need for screening and intervention
    We are convinced that the models developed to prevent other chronic 
health problems can be effectively applied to domestic violence. Recent 
experience with AIDS, smoking, breast cancer and cardiovascular disease 
support the efficacy of screening as a tool to identify health problems 
and intervene effectively. Domestic violence is more prevalent than 
diabetes and breast and cervical cancer--conditions that health care 
professionals screen for on a routine basis--yet screening for domestic 
violence is much more rare.
    By not screening for domestic violence and inquiring about abuse, 
health care providers often fail to recognize or address the underlying 
cause of battered women's health problems. Even when domestic violence 
results in injuries that were clearly inflicted by another person, 
health care providers too often treat and record the injuries without 
inquiring about the cause.
    Providers also miss opportunities to intervene early, before a 
woman is injured, by not routinely screening for violence. A study 
published in the Journal of the American Medical Association in August 
1999 found that less than ten percent of primary care physicians 
routinely screen for domestic violence during regular office visits. 
These wasted opportunities literally cost battered women their lives.
    Fortunately, that practice is beginning to change. For almost two 
decades, a host of national health care organizations and experts have 
called for programs that educate health care providers about intimate 
partner violence and promote routine screening and intervention. The 
American Medical Association, American Nurses Association, American 
Psychological Association, American College of Obstetricians and 
Gynecologists, American Academy of Pediatrics and, most recently, the 
Institute of Medicine have all developed guidelines or recommendations 
for improving providers' response to family violence. In addition, the 
Family Violence Prevention Fund's ``national screening for intimate 
partner violence consensus guidelines'' are widely used.
    Routine screening, with its focus on early identification and its 
capacity to reach patients whether or not symptoms are immediately 
apparent, is the starting point to improve medical practice for 
domestic violence. Routine and multiple face-to-face screenings by 
skilled health care providers can markedly increase the identification 
of domestic violence. Routine--rather than indicator-based--screening 
increases opportunities to identify and intervene with patients who 
present with symptoms not generally associated with domestic violence. 
Several studies demonstrate the importance of conducting inquiries in 
private settings and using straightforward, nonjudgmental questions, 
preferably asked verbally by a health care practitioner.
    This kind of screening gives women a valuable opportunity to tell 
their providers about their experiences with abuse, and battered women 
report that one of the most important parts of their interactions with 
their physicians is being listened to about their abuse. When victims 
of domestic violence or those at risk for abuse are identified early, 
providers can help them understand their options, live more safely 
within the relationship or safely leave the relationship. In one study, 
a ten minute intervention was proven highly effective in increasing the 
safety of women abused during pregnancy. All these interventions can 
lead to reduced morbidity and mortality.
    This work is being successfully tested. The Family Violence 
Prevention Fund is working in 15 States to improve the health care 
response to domestic violence. These State-based programs are 
demonstrating that improved collaboration and coordination between 
battered women's advocates, health care leaders, policy makers and 
public health officials can strengthen health care services to victims 
of domestic violence.
    Due in part to these efforts, screening and intervention is 
becoming the standard of care. More than 20 States now have laws 
addressing the health care system's response to domestic violence. The 
Joint Commission on the Accreditation of Health Care Organizations 
developed standards for emergency departments about how to respond to 
abuse, and has now expanded those guidelines for all departments in 
hospitals. The coding clinic guidelines issued by the American Medical 
Association, the American Hospital Association and the American Health 
Information Management Association also require coding domestic 
violence in medical records.
    Finally, research shows that patients support screening practices. 
In fact, in four different studies of survivors of abuse, 70 to 81 
percent of the patients asked said that they would like their health 
care providers to ask them privately about intimate partner violence.
                        recommended legislation
    Because domestic violence is so prevalent and has such detrimental 
health, social and economic consequences, there is an urgent need for 
more serious and ongoing attention from the health care system and from 
our elected officials.
    We are heartened, however, by the actions of this committee and 
efforts of many Senators here on behalf of battered women and their 
children. Senator Wellstone's Screening and Services Act will make a 
tremendous difference to abused women and their children. By funding 
demonstration projects to improve collaboration between the health care 
system and advocates for victims of abuse, this legislation will help 
ensure that women are treated appropriately and that a full system of 
care and services will be available to them. This bill will lead to 
more effective interventions, more coordinated systems of care, greater 
resources to educate health care providers and, ultimately, more women 
disclosing abuse and receiving help. In addition, providers who can 
recognize abuse in their patients will more effectively address the 
health implications of the violence their patients are experiencing. 
Without resources to promote this collaboration, efforts may be 
duplicative and health systems will struggle with the grave 
consequences of their failure to effectively help patients experiencing 
domestic violence for years to come.
    The legislation also targets specific funds to federally qualified 
health centers and requires providers participating in the National 
Health Service Corps to be trained in the dynamics of domestic 
violence. Local community health centers deal with family violence 
every day, and many are doing an excellent job of identifying, treating 
and referring patients, when appropriate. However, much more work needs 
to be done to ensure that providers throughout the nation have the 
knowledge and specific training necessary to intervene appropriately.
                   training of health care providers
    Other legislative proposals being addressed during this hearing are 
critical to a strengthened health care response to domestic violence. 
Health care providers should be trained early in their professional 
careers. Medical and nursing schools, as well as dental and physician 
assistant programs, need to teach their students in a substantive way 
about domestic violence. Providers often report that they don't view 
domestic violence as a health issue, but rather as a social problem, 
and one that they're not equipped to handle in our current health care 
environment. If we train physicians and other providers early about the 
health care implications of domestic violence, we will have greater 
success in making preventive screening routine.
    Senator Boxer's bill, S. 518, The Domestic Violence Identification 
and Referral Act, will encourage schools that train health 
professionals to give their students the education necessary to 
properly screen for, identify and treat victims of domestic violence. 
Its approach of providing preference in Federal funding to programs 
that do provide ``significant training'' also will have no budget 
implications, since it will only address the awarding of grants that 
have already been funded.
                            research needed
    In addition, we need funding to improve the research around family 
violence and the quality of the training for health care providers and 
researchers. Senators Durbin and Collins are sponsoring S. 2009, the 
Family Violence Prevention Act, to provide much needed funding for 
research. Based on a recent report from the Institute of Medicine, this 
legislation will support research in medical education and effective 
interventions to address family violence. Specifically, we applaud the 
bill's focus on outcomes-based research and effective interventions as 
they relate to women's safety and the impact of witnessing violence on 
children. Their bill targets areas where new research needs to be 
focused, including:
     Patterns of health care utilization by victims of family 
violence, the effects that family violence has on victims' health 
status, and the health care costs attributable to family violence;
     The effects of family violence on other health conditions 
and preventive health behaviors;
     The relationship between childhood exposure to domestic 
violence and child and adult health and safety;
     Effective interventions for children exposed to violence;
     Strategies to inform and mobilize public action for 
prevention; and
     The effects of mandatory reporting requirements on 
victims' safety and likelihood of receiving appropriate care and 
services.
    We are particularly appreciative of their efforts to include 
domestic violence experts as members of a team that will review the 
types of research funded, further building the bridge between the 
research and advocacy communities.
                     mental health services wanted
    Finally, we see great hope in the two bills introduced by Senator 
Edwards to improve mental health services for victims of domestic 
violence. While not all battered women experience mental health or 
substance abuse problems, many women and their children do need and 
request services to deal with the effects of the violence. The 
consequences of not receiving help can be severe. Twenty-nine percent 
of all women who attempt suicide are battered, 37 percent of battered 
women have symptoms of depression, 46 percent have symptoms of anxiety 
disorder, and 45 percent experience post-traumatic stress disorder. 
Children who witness domestic violence are more likely to exhibit 
behavioral and physical health problems including depression, anxiety 
and violence towards peers. As noted earlier, they are also more likely 
to engage in a host of harmful behaviors.
    Unfortunately, many of the women who need mental health services 
for themselves or their families often lack the resources to access 
services in their communities or live in communities where services 
simply are not available. The Counseling in Shelters Act and the Women 
in Trauma Act would give women and their children access to needed 
mental health services in a safe and caring setting. Importantly, they 
would also improve coordination between and support cross-training for 
domestic violence advocates and mental health providers. This 
legislation would fill a critical void in our efforts to help battered 
women and their children repair their lives.
    Again, Mr. Chairman and members of the committee, I would like to 
thank you for holding this hearing and for your efforts on behalf of 
the nation's battered women and their children. These pieces of 
legislation to improve the health care system's response to domestic 
violence and provide resources for victims are greatly needed. Your 
efforts will help the health care system to take its rightful place on 
the frontlines of America's effort to end domestic violence and help 
victims.

    [Whereupon, at 3:45 p.m., the subcommittee was adjourned.]