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