<DOC>
[105 Senate Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:50025.wais]
S. Hrg. 105-861
OSTEOPOROSIS: PREVENTION, EDUCATION,
AND RESEARCH
=======================================================================
HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED FIFTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
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COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington DALE BUMPERS, Arkansas
MITCH McCONNELL, Kentucky FRANK R. LAUTENBERG, New Jersey
CONRAD BURNS, Montana TOM HARKIN, Iowa
RICHARD C. SHELBY, Alabama BARBARA A. MIKULSKI, Maryland
JUDD GREGG, New Hampshire HARRY REID, Nevada
ROBERT F. BENNETT, Utah HERB KOHL, Wisconsin
BEN NIGHTHORSE CAMPBELL, Colorado PATTY MURRAY, Washington
LARRY CRAIG, Idaho BYRON DORGAN, North Dakota
LAUCH FAIRCLOTH, North Carolina BARBARA BOXER, California
KAY BAILEY HUTCHISON, Texas
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri DANIEL K. INOUYE, Hawaii
JUDD GREGG, New Hampshire DALE BUMPERS, Arkansas
LAUCH FAIRCLOTH, North Carolina HARRY REID, Nevada
LARRY E. CRAIG, Idaho HERB KOHL, Wisconsin
KAY BAILEY HUTCHISON, Texas PATTY MURRAY, Washington
TED STEVENS, Alaska ROBERT C. BYRD, West Virginia
(Ex officio) (Ex officio)
Majority Professional Staff
Bettilou Taylor
Minority Professional Staff
Marsha Simon
Administrative Support
Jim Sourwine and Jennifer Stiefel
C O N T E N T S
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Page
Opening remarks of Senator Specter............................... 1
Statement of Dr. Stephen Katz, Director, National Institute of
Arthritis and Musculoskeletal and Skin Diseases, National
Institutes of Health, Department of Health and Human Services.. 2
Prepared statement........................................... 4
Prepared statement of Dr. Wanda K. Jones, Public Health Service,
Office on Women's Health, Department of Health and Human
Services....................................................... 11
Statement of Judy Black, member, board of trustees, National
Osteoporosis Foundation........................................ 13
Prepared statement........................................... 14
Statement of Susan Burdick, on behalf of the Osteoporosis
Foundation..................................................... 17
Prepared statement........................................... 18
Statement of Hon. Constance Morella, U.S. Representative from
Maryland....................................................... 18
Prepared statement........................................... 21
Statement of Dominic DiMaggio, member, board of directors, the
Paget Foundation............................................... 22
Prepared statement........................................... 24
Statement of Dr. Fred Singer, representing Barbara Sinatra....... 25
Prepared statement........................................... 26
Cure for osteoporosis............................................ 26
Osteoporosis gene................................................ 27
Prepared statement of Hon. Olympia Snowe, U.S. Senator from Maine 29
OSTEOPOROSIS: PREVENTION, EDUCATION, AND RESEARCH
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WEDNESDAY, MAY 20, 1998
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 12 p.m., in room SD-138, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senator Specter.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
STATEMENT OF DR. STEPHEN KATZ, DIRECTOR, NATIONAL
INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL
AND SKIN DISEASES
opening remarks of senator specter
Senator Specter. The hearing will proceed. We are on a very
tight time schedule. The Senate is considering the tobacco
bill. We may have a vote, and it is very hard to reassemble, so
I want to ask all the witnesses to come together. We
customarily have witnesses up separately, but I want Ms. Black,
Ms. Burdick, Mr. DiMaggio, and Dr. Singer to all join us at the
witness table at this time, please.
The Subcommittee on Labor, Health, and Human Services has
convened a special hearing to discuss osteoporosis and to
explore the role the Federal Government can play in increasing
research, education, and prevention efforts. Osteoporosis is a
major cause of bone fracture in older persons in general and in
women in particular. Over 28 million Americans are affected by
this disorder, and medical costs reach $13.8 million a year.
At this time there is no known cure. Recent developments
have made it possible to identify those who are at risk so that
treatment can begin to prevent bone thinning and reduce the
incidence of fractures.
We are delighted to have this very distinguished panel of
witnesses. We regret that Mrs. Barbara Sinatra could not be
with us today due to the death of Mr. Frank Sinatra over the
weekend, and there has been a state of national mourning, which
we all know about, but her testimony will be presented by Dr.
Fred Singer.
Our time is limited, so we would ask each witness to keep
within the 4-minute rule for making their opening statements,
and thank you very much, Dr. Katz, for being with us today. Dr.
Katz is the Director of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases.
You have been serving in that capacity since 1995, and we
have tried to increase the funding as much as we could. We are
going to try again this year, and we look forward to your
testimony with particular emphasis on what it will take to find
the answer.
Dr. Katz, the floor is yours.
SUMMARY STATEMENT OF DR. STEPHEN KATZ
Dr. Katz. Let me start by thanking you for all of your
efforts in past years. It is an honor and privilege to speak
with you today as director of the National Institute of
Arthritis and Musculoskeletal and Skin Diseases, and to
represent the efforts of the many NIH institutes centers and
offices and other Federal agencies that have an interest in and
support research on osteoporosis and related disorders.
Osteoporosis is the most prevalent of the bone diseases
that affects Americans. It represents a thinning of bone and
architectural abnormalities that contribute to bone fragility
and increased fracture risk. A fracture is not a benign
condition. It is not a benign event.
For example, following hip fracture, 10 to 20 percent of
patients die during the next 6 months, 50 percent of people are
unable to walk without assistance, and 25 percent require long-
term care.
Unfortunately, osteoporosis is common, particularly in
women. That means that osteoporosis is a threat to more than 28
million Americans. Although women are far more vulnerable to
osteoporosis, men are not immune. They represent 20 percent of
the affected population.
I would like to provide a brief glimpse and highlights of
how far research has brought us in understanding osteoporosis.
It is only in the last 15 years that we have come to understand
that the normal development in structure and function of bone
depends on a delicate balance between cells that build up bone
and cells that break down bone. We know that this delicate
balance depends on many factors, including genetic,
environmental, exercise, nutritional--for example, like calcium
intake and vitamin D--and hormonal factors such as estrogens,
parathyroid hormone, calcitonin, and others. When the balance
goes awry, that is when we have problems. There is a loss of
integrity in bone that results in diseases such as osteoporosis
and that makes one more vulnerable to the fractures.
Federal research efforts are multipronged and are directed
at a better understanding of the basic biology of bone.
Examples include laboratory and animal studies, genetic studies
to identify risk factors, clinical and epidemiological research
to identify better diagnostic tools and risk factors for
osteoporosis and fractures, and education research to better
understand how to translate knowledge into behavioral change.
There is a major effort to optimize calcium intake across
our Nation, including, and very importantly, in young people.
Key calcium metabolic studies are being supported by the
institute in adolescents to identify optimal daily calcium
intake. In addition long-term studies in nuns are being
conducted to see how hormones and how calcium intake alters
bone integrity.
The identification of risk factors to hip fractures is
important because preventive measures can be implemented.
Prominent and modifiable risk factors were identified in a
large cohort of female patients involved in a study of
osteoporotic fractures. These risk factors include poor visual
acuity, excessive weight loss, lack of exercise, and use of
some medications. These are all factors we can actually do
something about.
Another important ongoing effort is the development of
inexpensive and accessible tools such as quantitative
ultrasound for assessing skeletal health, because we know that
we have treatments now that really work. These treatments
include estrogens, bisphosphonates, calcitonin, as well as the
recently introduced SERM's, the selective estrogen receptor
modulators.
Prevention of osteoporosis is the goal, and it is key to
reducing fracture risk. The window of opportunity to add bone
to the skeleton is limited. This means that educational
strategies to encourage adequate calcium intake and regular
exercise, and to discourage smoking, while extremely important
at all ages, are particularly critical in children and in
adolescents.
During the past 4 years, we have supported the Osteoporosis
and Related Bone Diseases National Resource Center that is
currently operated by the National Osteoporosis Foundation in
partnership with the Paget Foundation and the Osteogenesis
Imperfecta Foundation.
Information on prevention, early detection, treatments, and
coping strategies are disseminated widely through various
media. We have also collaborated with the Public Health Service
Office on Women's Health and the National Osteoporosis
Foundation to enhance strategies to promote bone health in
women. The first focus of this collaboration will be on
adolescent teenage girls.
In closing, I hope that I have increased the committee's
awareness of the tremendous progress we have made in research
in understanding the fundamentals of bone biology and how to
prevent and treat osteoporosis. Our objective over the next
decade is to continue to promote research in all aspects of
osteoporosis and related bone diseases. The goals are to reduce
the burden of disability and enhance the lives of people who
suffer from osteoporosis, and to prevent this and other
musculoskeletal diseases in others.
PREPARED STATEMENT
I would ask that the written testimony of Dr. Wanda Jones
on behalf of the Public Health Service, Office on Women's
Health, be submitted for the record at this time, and I would
be happy to answer any questions you may have.
Senator Specter. We will accept her statement for the
record, and your full statement will be made a part of the
record.
[The statements follow:]
Prepared Statement of Dr. Stephen I. Katz
Mr. Chairman and Members of the Subcommittee, I am Dr. Stephen
Katz, Director of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS), the lead institute at the
National Institutes of Health (NIH) for research on osteoporosis and
related bone disorders. I am pleased to have this opportunity to
testify before you today to highlight recent research advances and
opportunities that relate to osteoporosis and related bone diseases and
to the enhancement of bone health in general. I would like to leave you
today with knowledge of how far research has brought us in
understanding this disease and in providing us with critical clues
about how to prevent this disease from impacting our lives and the
lives of our families and friends. Osteoporosis does not need to be a
consequence of aging. It is largely a preventable disease, and many
research opportunities exist to enhance our knowledge about how to
maintain a healthy skeleton throughout our lives.
Osteoporosis is the most prevalent of the bone diseases that affect
Americans. It results in low bone mass and architectural abnormalities
that contribute to bone fragility and increased fracture risk. Although
it is the underlying cause of most fractures in older people, the
condition is silent and undetected in most cases until a fracture
occurs. A fracture is not a benign event, particularly in older people.
The major fracture sites associated with osteoporosis are the hip, the
spine, and the wrist. Of all the injury sites, hip fractures have the
greatest morbidity and socioeconomic impact. Following a hip fracture,
there is a 10-20 percent mortality rate during the next 6 months. This
means people can and do die as a result of hip fractures. Fifty percent
of those people experiencing a hip fracture will be unable to walk
without assistance, and 25 percent will require long-term care.
Recently we gained insight into how many Americans are affected by
osteoporosis through the National Health and Nutrition Examination
Survey (NHANES). Conducted from 1988 to 1994, this survey measured the
bone mineral density of a sample population across the United States
and indicates that osteoporosis and low bone mass are common. For
women, estimates indicate that 13 to 18 percent over the age of 50 have
osteoporosis of the hip, and another 37 to 50 percent have low bone
mass placing them at increased risk for developing osteoporosis as they
age. Conservatively, this means that osteoporosis is a threat to more
than 28 million Americans. The percentage of men affected is lower but
still adds up to millions of men at risk of fractures. Although white
women account for 75 percent of the approximately $14 billion cost of
fractures in the United States, men and minority women are
substantially vulnerable. The development of prevention and therapeutic
strategies is critical given the impact of this problem in the United
States.
Women are particularly vulnerable to getting osteoporosis. In the
United States, women are four times as likely to develop osteoporosis
as men. This is attributable to two factors: women have approximately a
10 percent lower peak bone mass by maturity, and they experience an
accelerated bone loss after menopause. Although African American women
have a considerably lower rate of osteoporosis and fractures, the
NHANES data indicate that 10 percent of African American women over 50
have osteoporosis and 29 percent have low bone mass. While men are at a
lower risk for osteoporosis than women, they are not exempt from this
disease.
A great many research studies in osteoporosis and related bone
diseases are underway at the NIH. In addition to the NIAMS, 13 other
institutes, centers, and offices at the NIH are involved in research on
osteoporosis and related bone diseases ranging from very basic studies
to early intervention and prevention projects to clinical and
translational research. Studies being conducted range from
investigations of the causes and consequences of bone loss at cellular
and tissue levels to clinical trials testing strategies to maintain and
even enhance bone density. Evaluation of skeletal status is of major
concern as scientists explore the roles of such factors as hormones,
calcium, vitamin D, drugs, and exercise on bone mass. The influence of
environmental factors (e.g., cadmium, lead, and boron) is also being
examined.
Each NIH institute, center and office comes to the study of
osteoporosis and related bone diseases from the vantage point of its
individual and different mission. These efforts are both collaborative
and complementary. For example, the NIAMS supports research across the
spectrum from basic studies that are attempting to understand the
normal functions of cells that build up and break down bone to clinical
studies of the diagnosis, treatment, prevention, and epidemiology of
osteoporosis and related bone diseases. The NIAMS bone biology and bone
diseases programs not only provide improved understanding of
osteoporosis, but also of other bone diseases such as Paget's disease,
osteogenesis imperfecta, cancer metastasis to bone, and multiple
myeloma. The National Institute on Aging (NIA) has unique lines of
research that are derived from its mission to understand the aging
processes and pathological changes that cause disability and compromise
the quality of life in older people. The NIA supports a strong program
of clinical studies of age-related bone loss and fracture epidemiology,
intervention trials to prevent or reverse bone loss, and basic research
studies on bone cell biology and the role of sex steroids, cytokines,
and growth factors on bone cell function. NIA, in conjunction with the
National Institute of Nursing Research (NINR) and the NIH Office of
Research on Women's Health (ORWH) supports a large multi-ethnic
longitudinal study of women, aged 42-52 years, at five clinical field
sites to evaluate mid-life changes on bone loss and the risk of
osteoporosis as women approach and traverse the menopause. The National
Institute of Dental Research (NIDR) supports a strong basic bone
biology program with a focus on the connection between oral bone loss
and osteoporosis. The NIDR also has an intramural program that
researches normal bone growth and turnover as well as the
pathophysiological mechanisms of brittle bone diseases, including the
hereditary disease osteogenesis imperfecta. The National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) provides support for
research on nutrition and endocrinology, including the hormones
regulating bone metabolism. The National Institute of Child Health and
Human Development (NICHD) supports research to enhance understanding of
how to prevent this disease by influencing the behaviors of children in
such areas as diet and exercise, and supports studies in reproductive
endocrinology and the possible impact of hormones and reproductive
history on the etiology of osteoporosis. In addition, through the NICHD
intramural program, studies are conducted on the genetics, growth, and
rehabilitation of children with heritable disorders of connective
tissue such as osteogenesis imperfecta. The National Institute of
Environmental Health Sciences (NIEHS) research focuses on metals such
as cadmium, lead, and boron found in the environment as risk factors in
development of the disease. The NIH Office of Research on Women's
Health has made a vital contribution to osteoporosis research through
supplemental grants and the Director's leadership role in the Women's
Health Initiative (WHI). The WHI project is led by the National Heart,
Lung, and Blood Institute and coordinated with the NIAMS, the NIA, and
the National Cancer Institute. This project contains the largest test
of the effect of hormone replacement therapy and calcium and vitamin D
supplementation on osteoporosis.
Osteoporosis and related bone diseases are complex, and their study
reflects a multiplicity of interests. To provide coordination and to
enhance cooperative research and education activities across agencies,
the NIAMS launched the Federal Working Group on Bone Diseases (FWGBD)
in 1993. As Director of the NIAMS, I chair the FWGBD, whose membership
includes not only representation from the NIH institutes, centers and
offices, but also other Federal agencies including the Agency for
Health Care Policy and Research, the Department of Defense (DOD), the
National Aeronautics and Space Administration (NASA), and the Public
Health Service (PHS) Office on Women's Health. I have attached to my
statement a list of all NIH components and Federal agencies represented
on the FWGBD. The FWGBD meets regularly throughout the year and
provides a structure for information sharing, formulation of
collaborative research efforts, and coordination of osteoporosis
research across all Federal agencies with an interest in bone diseases
and bone health.
Outside of the DHHS, the NASA and the DOD have supported
osteoporosis and related bone diseases research over the past several
years. The NASA's interests relate to what happens to bone in a
reduced-gravity environment. The depletion of bone and muscle while in
space is a significant risk to astronauts. Exposure to reduced gravity
during space travel profoundly alters the load placed on bone and
muscle, and thereby has direct effects on the tissues. The DOD
initiated an osteoporosis program in 1995, and this expanded in 1997
with grants solicited in the area of mechanical stimulation of bone
growth, focussing on military preparedness in a physically active
population. The NIAMS program and review staff helped with the planning
of the solicitation of application and with their review.
With this as background on the importance of a broad multipronged
approach to targeting osteoporosis and related bone diseases, I would
like to focus my remaining testimony on research highlights, advances,
and opportunities. Specifically I will address (1) the importance of
identifying prevention, early intervention, and assessment/diagnostic
tools to reduce the prevalence of osteoporosis; (2) recent
breakthroughs in basic research leading to improved understanding of
bone formation and the role genetics in predisposing one to
osteoporosis, (3) the status of treatments for this disease; and (4) a
summary of exciting research opportunities.
importance of prevention, early intervention, and assessment tools
Prevention of Osteoporosis Through Diet and Physical Exercise
This is an exciting time for research related to osteoporosis and
bone health. There has been a revolution in thinking about osteoporosis
over the last decade. The most significant insight comes from the
recognition that osteoporosis and fractures are not a natural
consequence of aging. NIH support for clinical studies of nutrition and
physical activity interventions has provided strong evidence that
fractures can be prevented and bone loss reduced even in older
individuals. We have learned a great deal about the need to build bone
across the life span, beginning at a very young age. Most
significantly, we have learned that rapid bone acquisition occurs
before, but also at and after puberty, and this period is crucial in
skeletal development and critical for the prevention of osteoporosis
later in life.
This past August, the Institute of Medicine (IOM) completed a study
of calcium and related nutrients. The goal was to provide an update of
the dietary information published in 1989 as the Recommended Dietary
Allowances (RDA's). This IOM study follows and in many ways parallels
the successful 1994 NIH Consensus Development Conference on Optimal
Calcium Intake. Key calcium metabolic studies supported by the NIH made
it possible for the Consensus Conference and the IOM to approach the
issue of optimizing calcium intakes, not only to prevent deficiency
diseases, but to build a better skeleton and to preserve it throughout
life.
The primary data used for setting adequate intakes for children 9
through 18 years of age are derived from careful and innovative
metabolic studies estimating the intakes necessary to achieve maximal
calcium retention in the body. The NIH has supported several studies of
calcium in young girls. In one such study, young girls have attended
``Camp Calcium'' where careful calcium balance studies that require
several weeks to be completed are carried out on the Purdue University
Campus in a sorority house where the girls have fun and see how
scientists work.
Understanding the role of calcium absorption and vitamin D intake
in pre- and postmenopausal women is also extremely important to
maximizing bone health later in life. Critical long-term studies with a
major impact on the field of calcium nutritional physiology have been
conducted with NIH support that began in the late 1960's. Investigators
have followed a cohort of Catholic nuns for more than 30 years from
early premenopause up through their early seventies, thus far. Results
emanating from the ``Nuns' Study'' have described the changes in
calcium balance with age, hormone status, and vitamin D intake and have
also contributed to our understanding of calcium absorption from
different food sources (milk vs. vegetables) and from different types
of supplements. This study and others indicate that adequate calcium
intake may prevent bone loss, decrease the prevalence of osteoporosis,
and prevent fractures in the elderly.
While the progress to date has clearly been impressive, the story
is not complete. The largest study of osteoporosis and fractures ever
conducted is now underway as part of the NIH Women's Health Initiative.
Hip fractures are the most devastating consequence of osteoporosis, but
testing the effectiveness of calcium and vitamin D in preventing hip
fractures requires a large number of women over a long period of time
(8 years). This study will determine what can be achieved with calcium
and vitamin D supplements and may lead to new public health initiatives
to optimize the intake of these nutrients in the U.S. population.
Identification of Risk Factors for Hip Fractures in Women
The NIAMS and the NIA cooperatively support the Study of
Osteoporotic Fractures (SOF), a study that followed more than 9,000
women for over 10 years in order to determine what risk factors are
associated with hip fractures and especially which ones are
preventable. Results of this study have shown that one in every six
white woman will have a hip fracture in her lifetime; thus identifying
preventable risks can make an enormous impact on preventing disability
in older women. Some prominent and modifiable risk factors identified
in this study that increase the chance of hip fracture are poor visual
acuity, especially poor depth perception and contrast sensitivity;
weight loss after age 25; more than two cups of coffee a day; no
walking for exercise; being on one's feet less than 4 hours a day; and
the use of some medications such as long-acting benzodiazepines and
anticonvulsant drugs. Clearly an increase in physical activity, an eye
checkup and a review of medications can do a lot to prevent hip
fractures.
Identification of Risk Factors for Hip Fractures in Men
Although 50-year-old white men have about a 13 percent lifetime
risk of fractures of the hip, spine, or wrist, the causes of and
mechanisms involved in osteoporosis in men have received little
research attention to date. Men develop osteoporosis and osteoporotic
fractures about a decade later than women do. This has been attributed
to a higher peak bone mass at maturity and a more gradual diminution in
sex steroid influence in aging men. At each age, the rate of hip
fracture in men is about 50 percent than in women. With the decline in
premature cardiovascular mortality in men, fractures later in life are
becoming an increasingly important cause of morbidity and mortality in
older men. In a recent study, risk factors thought to affect bone
density (weight, smoking, physical activity, some drugs) as well as
factors identified as risk factors for falls (lower limb dysfunction,
psychotropic drugs) appear to be important determinants of the risk of
hip fracture in men. Physical activity may be a particularly promising
preventive measure for men and can favorably influence other chronic
diseases such as heart disease.
Assessment and Diagnostic Tools
As new treatment strategies become available, it becomes critical
to be able to assess skeletal health to identify those in need of
intervention as well as to determine the effectiveness of particular
treatments. The development of new technology to measure bone mineral
density as well as bone quality is an active focus of research.
Ultrasound technology is emerging as an alternative to bone
densitometry for some clinical applications. It is faster, cheaper, and
without the radiation exposure of conventional bone densitometry
devices. Studies are also underway to develop blood and urine tests
that may one day be used to screen for osteoporosis.
Prevention Through Public Education Campaigns
As stated many times throughout this testimony, prevention of
osteoporosis is the key to reducing the risk of this disease for men
and women in later life. Because the window of opportunity to add bone
to the skeleton is limited, educational strategies are extremely
important, for example, encouraging calcium intake by children and
adolescents at the recommended levels and encouraging regular exercise.
Likewise, strategies to encourage regular exercise, especially weight-
bearing activities, discourage smoking and limit alcohol consumption
across the life span are important to maintaining optimal bone health.
Equally important are educational strategies designed to inform those
most at risk of developing osteoporosis of the modifiable risk factors
and available diagnostic tools so that early intervention is possible.
The NIAMS supports the Osteoporosis and Related Bone Diseases--
National Resource Center (ORBD-NRC). The Center is currently operated
by the National Osteoporosis Foundation (NOF) in partnership with The
Paget Foundation and the Osteogenesis Imperfecta Foundation under a
grant from the NIAMS. The Center provides patients, health
professionals, and the public with resources and information on
osteoporosis and related bone disorders. Information on prevention,
early detection, treatments, and coping strategies is disseminated
widely through publications, online services, professional and patient
meetings, and general media outreach. The NIAMS, along with several
other NIH institutes including the NIA, the NICHD, the NIDR, the NIEHS,
and the Office of Research on Women's Health, has issued a Request for
Applications (RFA) inviting applications to continue support for such a
center.
The NIAMS has collaborated with the PHS Office on Women's Health,
the NOF through the Osteoporosis Resource Center and the Centers for
Disease Control and Prevention (CDC) to enhance the strategies to
promote bone health for women. The National Osteoporosis Education
Campaign will first focus on 9-12 year old girls, just approaching
their peak bone building years, but as the campaign develops, it will
expand to cover 13-18 year old girls. The goal is to develop strategies
for effectively reaching this age range so as to influence life-long
healthy bone behaviors.
``Milk Matters'' is another public health campaign led by the
NICHD. It is designed to increase calcium consumption among children
and teens. Studies show that most kids are not getting adequate levels
of calcium during this critical period when bones grow and incorporate
calcium most rapidly. The ``Milk Matters'' campaign works to reach
children and teens, as well as parents and health care professionals,
with the message that increased calcium and weight-bearing exercise
during the first two decades of life can be critical to good health as
an adult.
BASIC RESEARCH ADVANCES
Bone Formation and Breakdown
Treatments for osteoporosis and further information on preventive
strategies for osteoporosis and related bone diseases will come from
basic studies on understanding the genetics of bone formation and the
process of bone loss and remodeling. Bone is constantly being built up
and broken down. As evidenced by what has been learned about the role
of calcium, we try to build bone up as much as possible with calcium in
the early years because this serves as a storage bank for later years.
Enhancement of cells that build bone (osteoblasts) and interference
with cells that break down bone (osteoclasts) tend to result in
sturdier bones. All of our achievements and future progress in
osteoporosis and other bone diseases, such as Paget's disease and
osteogenesis imperfecta, are based on understanding the normal
functions of bone cells and investigating strategies to manipulate the
normal physiology of bone for therapeutic advantage. Likewise, new
insights into the control of bone remodeling by bisphosphonates
(chemicals that block resorption of bone) have led to approaches to
controlling the skeletal complications of malignancy.
Genetics of Bone Formation
In an exciting convergence of efforts by investigators around the
world, a gene essential for the formation of bone has been identified.
Researchers made two key observations: First, mice in which both copies
of the ``Cbfal'' gene have been inactivated exhibit a complete lack of
bone and bone-forming cells and die at an early age. Thus, the
``Cbfal'' protein appears to function as a ``master switch'' for bone
formation. Second, mice in which one of the two ``Cbfal'' genes was
inactivated exhibited a combination of specific skeletal defects that
closely resembled those seen in a heritable human disorder called
cleidocranial dysplasia, which is characterized by defective bone
formation. Consistent with this evidence from mice, genetic studies in
families with cleidocranial dysplasia showed that the disorder is
associated with mutations in the human ``Cbfal'' gene. Thus, in order
for normal skeletal development to occur in both mice and humans, the
``Cbfal'' protein must be present in amounts that can be provided only
by two active copies of the gene. The discovery of the critical role of
``Cbfal'' in bone formation opens a number of exciting new research
areas.
Understanding the role of genetics in predisposing one to
osteoporosis is a very important area of research. Bone mass at any
point in life represents a balance between the amount of bone
accumulated during growth and development and the amount of bone lost
with aging. Studies using families, particularly twins, indicate that
bone mass and osteoporosis may be due to an inherited trait in some
families. Resolving the genetic underpinnings of a complex trait in
humans is difficult, because human populations are genetically diverse.
Thus, current efforts include studies of the genetics of bone mass in
animals such as mice, in which selective breeding can reduce the
complexity of the problem. Because both bone metabolism and genetic
organization exhibit parallels across mammalian species, it is expected
that the results of the animal studies will provide important guidance
to further efforts in human populations.
Several human candidate genes have been examined for their
regulatory effect on bone mass including those for collagen type I,
estrogen and vitamin D. A great deal of work has focused on the vitamin
D receptor (VDR) gene, and experience with this locus will probably act
as a model for many future studies. There is increasing evidence of a
complex interaction between this gene and environmental factors in the
regulation of bone mass. Moreover, it is clear that bone mass and
density are influenced by many genes (mostly unknown) and a complex
interaction with environmental factors such as nutrition and physical
activity.
Interactions of Bone and the Hematopoietic and Immune Systems as
Consequences for Skeletal Health
Bones are not only a crucial mechanical support for our bodies,
they also enclose the bone marrow, the site of the process called
hematopoiesis, in which blood cells are produced, including the many
different cells of the immune system. Interactions among bone cells,
hematopoietic cells, immune cells, and other cells of the marrow
environment can have important consequences for skeletal health. In
August of 1997, the NIAMS and several other NIH components sponsored a
scientific workshop entitled ``Bone and the Hematopoietic and Immune
Systems'' that brought together over 200 bone biologists,
hematologists, immunologists, and physicians for 2 days of scientific
presentations and discussions. As a result, a number of areas have been
identified in which further research seems especially important. Future
efforts seem likely to be particularly rewarding if they can either
clarify the importance of specific cell types and effect or molecules
or identify previously unrecognized cellular and molecular agents that
influence bone physiology. Examples of important areas of pursuit
include (1) the determination of mechanisms that regulate the
differentiation of different bone cell types, including the nature of
stem cells and factors that govern their development, and (2) the
identification of other bone marrow cell types, such as hematopoietic
cells and stages of lymphoid and myeloid differentiation, that may
influence bone cells. The development and application of treatments for
conditions of bone loss, such as osteoporosis and for rarer conditions
of bone formation, depend upon a thorough understanding of the factors
that control the breakdown and formation of bone. It is likely that
bone cells do not function in isolation, but instead respond to a
complex mixture of influences arising in part from immune,
hematopoietic, and stromal cells. Understanding these influences may
identify targets for new bone-active agents, and may help to explain
the complex effects of agents already in use.
TREATMENTS FOR OSTEOPOROSIS
Although there is no cure for osteoporosis, there are now several
effective therapies to help stop further bone loss and potentially
prevent future fractures. Studies have shown that estrogen can prevent
the loss of bone in postmenopausal women; however, many questions
remain about the effect of estrogen on other tissues in the body. The
questions about estrogen have led to the development of a new class of
drugs called Selective Estrogen Receptor Modulators (SERM's). The hope
is to produce a drug with all the positive effects of estrogen on bone
and lipids and not to stimulate the activity of the breast or the
uterus. Tamoxifen is a SERM that has recently been shown to reduce the
risk of breast cancer in women at high risk. Another SERM, raloxifene
has recently been approved by the Food and Drug Administration (FDA)
for the prevention of osteoporosis.
Alendronate, a bisphosphonate, has recently been approved by the
FDA for treatment of postmenopausal osteoporosis. This class of drug
targets bone specifically, reducing bone breakdown and decreasing
fractures in older women. These are very promising avenues of
development and will undoubtedly lead to even more choices for
postmenopausal women.
NIH-supported studies of the underlying pathophysiologic mechanisms
of bone loss and remodeling as well as the development of animal and
cellular models, have made new drug approaches possible. These
approaches are crucial to determine the underlying mechanisms of action
of drugs and to devise alternative therapies. In recent research
results investigators have shown that estrogen induces programmed cell
death in osteoclasts which are responsible for the degradation of bone.
This discovery opens up an exciting new avenue of research
opportunities for investigators to explore whether other drugs can also
affect the programmed cell death of osteoclasts, making them
potentially useful as bone-protecting treatments.
RESEARCH OPPORTUNITIES
Numerous research opportunities exist to alter the increasing
occurrence of osteoporosis. In the past decade, there has been an
explosion of fundamental and clinical research in osteoporosis. Large
epidemiological studies have identified risk factors for low bone mass
and fractures. Clinical studies have pointed to the efficacy of calcium
and vitamin D supplementation in a subset of elderly women, and
physical activity has been associated with decreased bone loss and
improved musculoskeletal stature and balance. There are many
fundamental advances in molecular and cellular biology, immunology,
genetics, and bioengineering that have not yet been applied to skeletal
biology. Many opportunities exist to build on and expand the current
knowledge base.
Basic Research
Details are beginning to emerge about the complex network of
signaling mechanisms that control bone growth and maintain skeletal
integrity. Specific probes have made it possible to identify new
molecules responsible for the local and systemic regulation of bone
cell function, as well as the cell surface molecules and linked signal
transduction pathways that mediate their effect. Research opportunities
exist to better understand osteoclasts and osteoblasts, cells that are
essential for bone remodeling. Furthermore, the complex relationship
between the bone microenvironment and the immune system demands
attention. Evidence is accumulating to indicate that regulation of the
immune system operates on common principles and employs common
effectors.
The identification, mapping, and structural analysis of genes with
crucial functions in the regulation of bone are increasingly feasible
research goals. The use of genetically manipulated animals allows
investigators to test the effects of specific gene inactivation or
overexpression. The identification of genetic variations in the human
population that underlie different vulnerabilities to bone loss is made
possible by the increasing knowledge of the human genome and advancing
molecular screening technology. While several candidate genes have been
identified in osteoporosis, the complete picture will require both
human and population genetics and further animal studies. The study of
the genetics of osteoporosis is likely to yield insights into the
pathophysiology of the disease and clues for targeting interventions.
Behavior Modification and Education Research
Translating knowledge to behavior change is extremely difficult.
While current evidence indicates that there are effective dietary,
exercise, and lifestyle guidelines that one can follow to increase peak
bone mass and promote long-term bone health, translating this message
into changed behavior is a challenge. Research targeted at identifying
promising health education approaches that enhance awareness and
knowledge for young and adolescent females is needed. Similarly,
education messages targeted to postmenopausal women that identify risk
factors, promote regular exercise and physical activity, and discuss
intervention and treatment strategies are critical as well.
Improved Diagnostic and Assessment Tools
The establishment of new diagnostic procedures that provide insight
into the structural defects in diseased bone and allow a means to
assess bone strength is an important area of research. Currently, the
approaches to the assessment of osteoporosis are largely limited to
measurement of bone density, for example, dual energy x-ray
absorptiometry (DXA). While these methods are good predictors of future
fractures, they do have their limitations in accuracy and precision.
One significant limitation is that they do not provide insight to the
underlying abnormalities in osteoporotic bone. Bone mass and
architecture together determine the resistance of bone to fracture. New
technologies are being developed to evaluate the contribution of
architecture in vivo. These new methods may include variations of
micro-computed tomography or magnetic resonance imaging (MRI)
techniques.
One alternative diagnostic technique recently approved by the FDA
is ultrasound. With ultrasound, different properties of bone can be
measured, reflecting mechanical quality, an important determinant of
bone strength. Biochemical markers of bone turnover offer yet another
technique for assessment of osteoporosis. These measurements may add to
the ability to assess the pathophysiological basis for the disorder and
the effects of therapy. However, biological variability limits the
utility of these measures to population screening, and they are not yet
applicable to detailed evaluation of an individual patient.
New Improved Treatments
Bisphosphonates that target bone and reduce bone loss and fractures
have been approved for osteoporosis treatment and prevention. These new
agents may also have promise in reducing the skeletal complications of
malignancy. Estrogen replacement therapy has been clearly shown to
effectively retard bone loss in postmenopausal women. However, it has
effects on multiple organ systems and is not without risk. The new
selective estrogen receptor modulators that have been developed appear
to lessen bone loss in postmenopausal women without the adverse effects
on other organs. Fundamental research on estrogen receptors and their
target organs fuel the development of these new agents.
In closing, I hope that I have increased the Committee's awareness
of the tremendous progress we have made through research in
understanding the fundamentals of bone biology and how to prevent and
treat osteoporosis. Our objectives over the next decade are to
stimulate new fundamental research, to translate advances in other
fields to bone biology, to move basic/fundamental research to clinical
application, to enhance the uptake of research knowledge by the public,
especially the population most at risk of osteoporosis, and to apply
this knowledge to develop effective preventive strategies. Our goal in
osteoporosis and other musculoskeletal diseases that are our research
focus is to reduce the burden of disability and enhance the lives and
contributions of the populations who suffer from these chronic
musculoskeletal disorders.
I would be happy to answer any questions that you may have
regarding osteoporosis research.
FEDERAL WORKING GROUP ON BONE DISEASES
FEDERAL MEMBER ORGANIZATIONS
National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin
Diseases
National Institute of Child Health and Human Development
National Institute of Environmental Health Sciences
National Institute of Diabetes and Digestive and Kidney Diseases
National Cancer Institute
National Institute of Dental Research
National Institute on Aging
National Institute of Nursing Research
National Institute on Alcohol Abuse and Alcoholism
National Center for Research Resources
Office of Research on Women's Health
Other Federal Agencies
Agency for Health Care Policy and Research/Forum for Quality and
Effectiveness of Health Care
Health Care Financing Administration/Office of Research and
Demonstration
Department of Agriculture/Human Nutrition Research Center
Department of Defense/Army Operational Research Program
Centers for Disease Control and Prevention
--National Center for Chronic Disease Prevention and Health Promotion
--National Center for Health Statistics
Food and Drug Administration/Division of Metabolism and Endocrine
Drug Products
Department of Education/National Institute on Disability and
Rehabilitation Research
National Aeronautics and Space Administration/Life and Biomedical
Sciences Applications Division
Liaison Organizations/Federal and Non-Federal
NIH Office of Disease Prevention
NIH Clinical Center Nursing Department
NIH Nutrition Coordinating Committee
Department of Health and Human Services
--Office on Women's Health
--Administration on Aging
Osteoporosis and Related Bone Diseases National Resource Center
National Osteoporosis Foundation
The Paget Foundation
American Society for Bone and Mineral Research
______
Prepared Statement of Dr. Wanda K. Jones, Public Health Service, Office
on Women's Health, Department of Health and Human Services
I am delighted to have an opportunity to provide information on the
National Osteoporosis Educational Campaign; a public/private
informational campaign designed to improve the quality of life and
reduce health care costs for America's aging population.
At least 25 million Americans are afflicted with osteoporosis, most
of them women. Osteoporosis robs bones of their mineral and organic
reinforcements, decreasing bone density and increasing susceptibility
to fractures. It is a major underlying cause of bone fractures in older
women, often taking away their independence at a time they should be
enjoying life. Women with bone fractures can even die from surgery-
related complications, with a reported mortality rate of 20 percent in
the first post-surgery year for women.
We are lucky to live in a time with new medications that can help
prevent or treat osteoporosis. Even so, this disease leads to 1.5
million fractures a year, mostly in the hip, spine and wrist, and costs
$10 billion annually.
Much of the pain, suffering and costs associated with osteoporosis
could be avoided if women would take preventive measures early in life.
Current evidence indicates that young women can increase their peak
bone mass, promote long-term bone health, and reduce the risk of
disease later in life by following effective dietary, exercise, and
lifestyle practices. Yet we have so far not been able to effectively
communicate this prevention message to young women. Studies show that
less than 25 percent of adolescent females get the required daily
allowance of calcium; the prevalence of smoking among female high
school seniors now exceeds that for their male counterparts; over 18
percent of all adolescent females in a recent survey had used alcohol
in the preceding month; vigorous physical activity was significantly
less common among female high school students than among male students;
and 95 percent of anorectic and bulimic patients were adolescent
females.
In September, 1996, the U.S. Public Health Service's Office on
Women's Health (PHS OWH) convened a task force to design a blueprint
for a national osteoporosis education campaign. The Task Force
recommended that getting osteoporosis prevention messages to the 13 to
18 year old group should be a priority. These are the years appear when
girls begin making their own decisions about diet, smoking, exercise
and leisure activities, and start shifting away from their parents'
advice to their peers and the popular media. These are also the years
when girls are on the verge of accruing 90 percent of peak bone mass.
The National Osteoporosis Foundation (NOF) and the Osteoporosis and
Related Bone Diseases National Resource Center (ORBD-NRC) subsequently
recommended that girls ages 9-12 years also be included in this project
and these organizations have joined with the PHS OWH to develop this
educational initiative.
Research reveals that selecting effective health education
approaches and messages for adolescent females is far from simple. So,
prior to developing and implementing health education programs targeted
to adolescent females, the PHS OWH, NOF, ORBD-NRC, and the National
Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
felt it was necessary to conduct a study to determine how to reach
adolescent females with prevention messages. This study was designed to
identify effective health education approaches and apply the lessons of
practical experience to meet health education objectives for target
populations.
There were several key strategies used to collect data. First of
all, an exhaustive search was conducted of the published literature
using online databases such as Medline to gather findings on adolescent
females' knowledge, attitudes, and practices concerning bone health and
the prevention efforts aimed at this population. Secondly, a
questionnaire was prepared to use in interviews with representatives of
organizations that have developed messages and implemented programs for
adolescent females, including the NHLBI Education Programs Information
Center, the National Maternal and Child Health Clearinghouse for
Alcohol and Drug Information, Girl Scouts of the USA, Future Homemakers
of America, Inc., and Girls Clubs of America. Thirdly, baseline data
was gathered on adolescent females' knowledge of bone health and its
relative importance to them. And finally, adolescent and young women
representing diverse population groups ages 9 to 18 were recruited for
focus groups to solicit and explore their responses to prepared
questions concerning their knowledge of bone health and preferred
prevention messages, approaches, and channels.
The principles, patterns, and criteria for developing message
content, designing effective approaches, selecting and using channels,
and addressing adolescent populations were identified. Apparent gaps in
the knowledge base and any conflicting findings were also highlighted.
From the findings of this study, the PHS OWH is collaborating with
the Centers for Disease Control and Prevention (CDC), the National
Institutes of Health (NIH) and the NOF to establish a national
education campaign on osteoporosis to increase bone healthy behaviors
of women and their understanding of the importance of bone health.
Attention will first be placed on 9-12 year old girls, just approaching
their peak bone building years, but as the campaign develops, it will
expand to cover 13-18 year old girls. An interesting finding of this
recent study is that it is important to make efforts to change the
behaviors of parents, who are critical role models on these issues for
pre-teens. Thus, parents will also be targets of an expanded
educational program.
The PHS OWH, NIH, CDC, and NOF would like to see significant
strides made to reverse the current trend in teen health so that there
is a marked increase in physical activity, a greater consumption of
calcium among 9-18 year olds, and adoption of other healthy lifestyle
behaviors associated with bone health. We believe a long term national
campaign can help effect these changes and are committed to working
with our collaborators to ensure that this educational program can
continue past the initial year of funding provided by the PHS OWH.
In the past century, we have done much to increase the life
expectancy of women. As a result, in the next century we will see a
significant increase in the number of older women in our population. We
must use visionary, long-term strategies to ensure that these bonus
years for women are fruitful, rewarding and comfortable. Only by
preparing women in their pre-teen and teen years for a lifetime of good
health will we achieve that goal.
NONDEPARTMENTAL WITNESSES
STATEMENT OF JUDY BLACK, MEMBER, BOARD OF TRUSTEES,
NATIONAL OSTEOPOROSIS FOUNDATION
Senator Specter. I will have some questions as we move
through, but I would like to turn now to our next distinguished
witness, Ms. Judy Black, who currently serves on the board of
the National Osteoporosis Foundation, chairperson of that
group's event, America Walks For Strong Women.
She is also senior vice president for governmental
relations for Ticketmaster, and a very, very able advocate for
many causes, including osteoporosis, and the principal exponent
of this hearing.
Ms. Black, the floor is yours.
Ms. Black. Thank you, Senator, and on behalf of NOF and
millions of American women everywhere I want to thank you for
holding this important hearing on osteoporosis and other
related bone diseases.
In my written testimony I have provided several startling
statistics about this disease, including the fact that it
affects 28 million Americans, 1 out of every 2 women and 1 out
of every 8 men over the age of 50, and it costs this country,
as you said, $13.8 billion annually in medical cost.
This expenditure is projected to grow to $60 billion by the
year 2020 if steps are not taken now to stop this disease, but
you know, no dollar amount can be placed on the pain and
suffering of millions of our citizens, usually in the twilight
of their years.
The face of osteoporosis is the face of a friend of mine
who broke several bones in her feet simply walking barefoot in
the sand. It is the face of a father who stepped down one step
off his porch and snapped both of his collar bones. It is the
face of a grandmother's spine breaking vertebra by vertebra
over and over, several times, each time bringing agony and
finally resulting in the loss of several inches in height and
stooped posture, but with your help, we can stop this kind of
suffering.
Osteoporosis is a silent disease which can affect people at
all ages. Many people do not realize that it can strike young
female athletes who have trained to the point where they can no
longer menstruate. It often strikes women with breast cancer
due to chemotherapy, a cruel reward for surviving breast
cancer. It strikes asthmatics who take steroid medication in
order to help them breathe.
In fact, I could go on and on, but let me tell you that at
my age I was shocked to discover that an exoscan found that my
bones were thin. Fortunately, I am one of the lucky ones,
because I found out early, and I know how to take action and do
for myself what I can to prevent fractures.
All of this is why, Mr. Chairman, I, along with the NOF,
call for an all-out effort to combat this invisible enemy on
all fronts. We need a national osteoporosis education
prevention campaign along the lines of high blood pressure or
stroke. Everybody knows about cholesterol, but not enough
people know how to take the steps to prevent this disease.
The Office of Women's Health and the NOF call on this
education program to focus first on young people. This is
because, if people learn early enough, they can stop the
disease before it gets started. Over 90 percent of a person's
bone is developed in the teenage years. By building strong
bones early, they will avoid fractures later.
We thank you for your leadership in wanting to provide $3
million increase this year to the Office of Women's Health for
the purpose of this campaign. We also need to increase our
research efforts, and you have heard about some of those
efforts from Dr. Katz.
The National Institute for Arthritis and Musculoskeletal
and Skin Diseases, the lead institute for bone research, is one
of the smallest at NIH even though this disease affects
millions of people. It will remain one of the smallest unless
we increase it a great deal.
Another place where research is taking place right now is
the Department of Defense. This is a program we think needs to
continue. Stress fractures remain one of the most frequent
injuries of our military. Over 10 percent of women recruits
experience stress fractures during their training. Thus, we
need to continue with this program at the Department of
Defense.
PREPARED STATEMENT
In summary, this Nation needs to pay attention to building
peak bone in young people through this national education
prevention campaign. We need to focus on additional research to
find the answers to osteoporosis and related bone disease. In a
country that loves and respects all human beings, we must step
in to help millions of Americans stop this horrible disease so
that the final years of life are not a slow, painful crumbling
of their bodies.
I thank you again, Senator, and look forward to any
questions after the panel.
Senator Specter. Thank you very much, Ms. Black. We very
much appreciate your testimony and your leadership, and I would
note for the record the presence of your very distinguished
husband, Charles Black, in the hearing room.
[The statement follows:]
Prepared Statement of Judy A. Black
I am Judy Black, member of the Board of Trustees of the National
Osteoporosis Foundation. On behalf of the NOF, I want to thank you Mr.
Chairman for holding this important hearing on osteoporosis and related
bone diseases. The women of America thank you for helping to bring
attention to this serious public health threat which causes 1.5 million
fractures annually and costs this country $13.8 billion in medical
costs. Osteoporotic fractures caused one-half million hospitalizations
in 1995, along with 2.5 million visits to physicians and about 180,000
nursing home admissions. These expenditures are projected to grow to
$60 billion annually by year 2020 if steps are not taken now.
This disease affects 28 million Americans, 80 percent of whom are
women. Ten million have the disease and 18 million more are at risk due
to low bone mass. A woman's risk of a hip fracture--the most
debilitating of the osteoporotic fractures--is equal to her combined
risk of breast, uterine and ovarian cancer. One out of two women and
one out of eight men over age 50 will experience a fracture due to
osteoporosis.
Osteoporosis is a silent disease--which can affect people at all
ages. Many people do not realize that it can strike young female
athletes who have trained to the point where they no longer menstruate;
it often strikes women with breast cancer due to chemotherapy--a cruel
reward for surviving breast cancer; it strikes asthmatic men and women
who take steroids in order to help them breathe; I could go on, but let
me just tell you that, a few years ago, I was shocked to discover that
I had osteoporosis. Fortunately, I am one of the lucky ones, because I
found out early, and I knew how to take action and do for myself what I
need to do to prevent fractures.
I thought because I was an active young woman with a healthy
lifestyle, that osteoporosis was something I did not need to worry
about. How wrong I was. Everyone needs to worry about their bone
health. This is why, Mr. Chairman, I with NOF, call for an all out
effort to combat this invisible enemy.
First, as you know, we need a National Osteoporosis Education
Prevention Campaign along the lines of the High Blood Pressure Program
or the National Cholesterol Education Program. Despite the availability
of effective prevention, detection, and treatment for osteoporosis,
most women at menopause are not taking--or being advised to take--
appropriate steps to prevent, detect or treat this disease. A 1997
Roper Starch survey indicated that women 50 and older lack critical
understanding of how to maintain their bone health after menopause.
Furthermore, while one in two women 50 and over will suffer an
osteoporotic fracture, only one-third (34 percent) of women are very
concerned about the disease. During the five-seven years post
menopause, women can lose up to 20 percent of their bone--about one-
fifth of the bone they will lose in their lifetime, yet only 39 percent
of postmenopausal women cited menopause as a risk factor for
osteoporosis. Finally, nearly three-fourths (73 percent) of the
respondents believe good posture, a characteristic not at all related
to developing osteoporosis, can prevent and treat the disease.
However, in the first phase of such a prevention campaign, the
focus should be on young girls to avoid the prospect of today's youth
becoming tomorrow's generation of osteoporotics. Such a recommendation
was made by a task force convened jointly by the Public Health
Service's, Office of Women's Health and the National Osteoporosis
Foundation. By building strong bones in the early years, they will
avoid fractures in the older years. Ninety-seven percent of a young
girl's bone is laid down before the age of 18. We thank you for your
leadership in wanting to provide a $3 million increase to the Office of
Women's Health for the purpose of a National Osteoporosis Prevention
Education Campaign, and we look forward to continuing to work with you
on this issue.
Second, we need to increase our research efforts. We will hear from
Dr. Katz about some of the important progress that has been made in
osteoporosis and related bone research--and there is no question that
there have been important discoveries in the detection and treatment of
the disease. We now know how to stop bone loss in many people, but we
still do not know how to trigger new bone growth.
The first and foremost priority is an overarching recommendation to
increase clinical research. We have major gaps in our patient-oriented
research. We are simply not making the necessary translation from basic
research to benefits available to patients. Figuring out the mechanisms
of disease is very important, but once we solve the puzzle, we need to
transmit the findings to help the patient. These are some examples of
needed patient-oriented research:
We need human intervention studies to resolve unanswered clinical
questions regarding vitamin D. Our vitamin D research has been
remarkable, however, it has stopped short of translation into improved
public health. The unanswered questions regarding vitamin D are as
follows. What is the optimum vitamin D status? Will optimizing vitamin
D status reduce the fracture burden? How much vitamin D do typical
adults normally produce in their own skin every day--summer and winter?
What is the interaction between dietary calcium and vitamin D status?
Finally, we need an inexpensive, reliable, and effective vitamin D
preparation. Physicians cannot practice nutritional medicine without
this kind of information.
How Fluoride acts on bone is an another example of our lack of
knowledge. There is good reason to believe that, in an appropriate
dosage form and regimen, and with appropriate co-therapy, it could be
extremely useful, both in the management of patients who already have
osteoporosis and in the rebuilding of bone mass of individuals who are
osteopenic but have not yet fractured. But as one scientist noted,
fluoride has three drawbacks: it is old, it is cheap and it is non-
patentable. Because of the private enterprise system in the U.S., non-
patentable preparations will never elicit the necessary investment by
the pharmaceutical industry. We do not know what the right dosage is;
we do not know the right dosage form; we do not know how to monitor
therapy in terms of blood levels; and we do not know what blood levels
have to be achieved in order to be effective. Thus, a potentially
promising agent languishes.
We need human research on the incremental effectiveness and safety
of combination therapies. These combinations include simultaneous
administration of calcium, vitamin D, male and female hormones, and
bisphosphonates or other pharmaceutical agents.
We need psychosocial and quality of life studies. Osteoporosis
among older adults often involves vertebral fractures which are
responsible for substantial pain, deformity, compromised function, and
multiple social and psychological impairments. Deformity can wreck
havoc with self-esteem and mastery, but it can also cause pragmatic
problems such as finding clothes. Depression appears to be a major
problem in women with this disease. We need a better understanding the
social and psychological variables of these different quality of life
factors.
We need research on behavioral issues surrounding the widespread
lack of compliance with well-known preventive measures in osteoporosis.
We need research on methods of rehabilitation in the frail elderly
who have suffered fractures. There has been little research on how to
engage patients in physical activity when they are suffering painful
fractures, muscle weakness, and reduced endurance.
Studies should be conducted in minorities to determine the extent
of vitamin D deficiency and osteoporosis. It has been assumed, based on
genetics, that African American women are not as susceptible to
osteoporosis. Although it may be true that young adults have a higher
bone density on averaged compared to Caucasians, it is not certain that
the same could be said for women and men over the age of 50. Indeed,
one researcher's experience is that African Americans are prone to
develop osteoporosis as a result of low life-time intake of calcium and
vitamin D.
Exercise for the prevention of osteoporosis is an area that needs
further exploration. For example, what are the specific exercise needs
at each life stage to maintain optimal bone health? We lack good
controlled clinical trials which evaluate the benefits of exercise on
osteoporotic fracture outcome.
Factors that affect attainment of peak bone mass in young women
need to be looked at.
Eating disorders and exercise induced amenorrhea in young women
needs additional attention as well.
On the basic research front there is still much important research
to be done and I will just give a few example of a much larger list of
research needs:
The number one priority should be to investigate the biology of
bone adaptation to mechanical loading. The most important research to
be done in this area is on the set point mechanism which senses loading
and responds appropriately to control the skeletal adaptive response.
Genetic studies are, of course, needed in osteoporosis. Between 50
and 90 percent of variation of peak bone mass is inherited. Thus, we
need to discover the genes associated with regulation of peak bone mass
and to determine their function so that their function might be
mimicked by pharmaceutical interventions. We also need studies of the
genetic linkage to rates of bone loss.
Research is needed to understand the recently discovered
relationships between important diseases of postmenopausal women:
osteoporosis and breast cancer, depression, rheumatoid arthritis,
stroke and coronary heart disease. Do these associations provide clues
to etiology and preventive medicine?
In summary, because osteoporosis is such a young disease in terms
of research focus and public attention, the research needs are great on
multiple fronts. The National Institute for Arthritis and
Musculoskeletal and Skin Diseases (NIAMS) the lead institute for
osteoporosis and related bone diseases research is doing a important
job, but it is one of the smallest institutes at NIH. It will remain
one of the smallest institutes as long as its annual increase is based
only on a percent of its current funding. For a disease that affects
millions of Americans and costs us so much in money and suffering,
NIAMS should take a jump up to a bigger institute.
Bone disease research is also taking place at the Department of
Defense and that program must be continued. Young people, often with
sedentary lifestyles, enter the military where they as fighting men and
women are asked to perform physically. As a consequence, they develop
injuries. Stress fractures remain the one of most frequent injuries
that take men and women in the military off duty. According to the
Army, the minimum time away from significant duty for a male or female
soldier who develops a stress fracture is 6-8 weeks.
Up to 10 percent of women recruits experience stress fractures
during the 8 weeks of basic training. With the increasing number of
women in the military, the bone health of female recruits becomes a
concern of growing proportions if they are to serve at maximum
capacity. One research project among 22,000 recruits in the U.S. Marine
Corp, in San Diego, showed that as much as $4.5 million annually could
be saved by reducing stress fractures. More research is needed to
understand how to do just that.
In conclusion, this nation needs an all out effect to combat this
invisible enemy. Public education and research are the battlegrounds.
We must pay attention to building peak bone mass in young people
through a National Osteoporosis Education Prevention Campaign and we
must intensify our research effort on osteoporosis and related bone
diseases. Through these endeavors, I believe, Mr. Chairman, that we can
get our arms around this disease and eliminate it in the first part of
the 21st Century. If we fail to do so, this disease will not only
bankrupt our health care system, but also the lives of millions of
women and men.
Mr. Chairman, I thank you for the opportunity to testify and would
happy to answer any questions.
STATEMENT OF SUSAN BURDICK, ON BEHALF OF THE NATIONAL
OSTEOPOROSIS FOUNDATION
Senator Specter. We now turn to Ms. Susan Burdick,
educator, civic activist, and mother, who has campaigned to
promote osteoporosis prevention. She became involved with the
National Osteoporosis Foundation after being diagnosed after an
automobile accident.
Thank you for joining us. Ms. Burdick, the floor is yours.
Ms. Burdick. Thank you. When I heard the word osteoporosis,
7 years ago, I thought of someone much older and inactive and
stooped over, not someone like me. I was, after all, young,
physically active, and doing the right things to take care of
myself.
Then in October of that same year I broke my left leg, at
the same time fracturing all of the bones in my right foot. I
underwent surgeries and required a long hospital stay. Casts
were placed on both legs. I needed skin grafts, and screws were
placed in my leg. Through hours of physical therapy and hard
work I learned how to walk again.
I fell and broke my right ankle 3 years later. Permanent
plates and screws were put in the ankle at this time, once
again requiring hospitalization and physical therapy.
During each of these times I used wheelchairs and
eventually walkers and canes to assist me in my daily living,
making it very difficult to care for my family.
In February of this year I broke my sternum.
I have certainly learned first-hand that osteoporosis is a
disease that can affect the young as well as the old. Dealing
with the constant physical pain and its consequences is very
difficult for both myself and my family. The pain is immense.
On many days my feet and legs simply do not want to work
properly, and I must crawl through my house on my hands and
knees.
Often, I cannot exercise or function normally because of
the pain. The unpredictability of this can be frustrating. I
have little way of knowing when I will have a good day or a bad
day from a physical standpoint. I often have sleepless nights
due to pain. I try to pace myself in everything I do. I must
sit and rest my feet because my feet and legs swell so badly.
Sometimes I walk with a visible limp, and there are simply some
things that I can no longer do, or I must modify.
I now have to be careful in everything I do, asking myself,
is this safe? Will it help me or hurt me? I must be constantly
aware of falling or lifting incorrectly. Often, I have to ask
others for assistance with even the simplest of things. I find
I must be a spectator instead of a participant in some
activities now. This is hard.
I must take several medications on a daily basis. I miss
things like being able to wear a pretty shoe, or dancing on my
feet all night long. Skiing down a powdery slope is no longer
feasible, and running fast is just a memory.
PREPARED STATEMENT
I am only 39. What is my future? Mr. Chairman, please do
what you can to help educate young women about this disabling
disease and through research to find a way for me to get back
the bone that I have lost so once again I can be strong and
physically active.
Thank you. I would be happy to answer any questions.
Senator Specter. Thank you very much, Ms. Burdick.
[The statement follows:]
Prepared Statement of Susan Burdick
Seven years ago when I heard the word osteoporosis, I thought of
someone much older, inactive and stooped over, not someone like me. I
was, after all, young, physically active and doing the ``right'' things
to take care of myself.
Then, in October of that same year, I broke my left leg at the same
time fracturing all of the bones in my right foot. I underwent
surgeries and required a long hospital stay. Casts were placed on both
legs. I needed skin grafts and screws were placed in my leg. Through
hours of physical therapy and hard work I learned how to walk again.
Three years later, I fell and broke my right ankle. Permanent plates
and screws were put in the ankle at this time, once again requiring
hospitalization and physical therapy.
During each of these times I used wheelchairs and eventually
walkers and canes to assist me in my daily living--making it very
difficult to care for my three children.
In February of this year I broke my sternum. I have certainly
learned first hand that the disease can affect the young as well as the
old.
Dealing with the constant physical pain and its consequences is
very difficult for both myself and my family. The pain is immense. On
many days my feet and legs simply do not want to work properly and I
must crawl through my house on my hands and knees. Often, I cannot
exercise or function normally because of the pain. The unpredictability
of this can be frustrating. I have little way of knowing when I will
have a good or bad day from a physical standpoint.
I often have sleepless nights due to pain. I try to pace myself in
everything I do. I must sit and rest my feet because my feet and legs
swell so badly. Sometimes I walk with a visible limp and there are
simply some things I can no longer do or I must modify. I now have to
be careful in everything I do, asking myself, ``is this safe?'' Will it
help or hurt me?'' I must be constantly aware of falling or lifting
incorrectly. Often I have to ask others for assistance with even the
simplest of things.
I find I must be a spectator instead of a participant in some
activities now. This is hard. I must take several medications on a
daily basis. I miss things like being able to wear a pretty shoe, or
dancing on my feet all night long. Skiing down a powdery slope is no
longer feasible and running fast is just a memory.
I am only 39--what's my future? Mr. Chairman, please do what you
can to help educate young women about this disabling disease, and
through research to find a way for me to get back the bone I have lost
so I once again can be strong and physically active.
Thank you. I will be happy to answer any questions.
STATEMENT OF HON. CONSTANCE MORELLA, U.S.
REPRESENTATIVE FROM MARYLAND
Senator Specter. We have been joined by the distinguished
Congresswoman, Constance Morella. First elected to the House of
Representatives in 1986, she serves on the Science Committee
and chairs the Technology Subcommittee. She also serves on the
Basic Research Subcommittee.
Since taking office, she has focused on issues on
scientific research and development, the Federal work force,
the environment, and equity for women.
We welcome you here. We know you have a vote and we look
forward to your statement.
Ms. Morella. Thank you very much, Senator Specter. Thank
you for letting me join you up here for this very important
hearing.
I really do not believe in what you said to me when you
invited me here. You said, I do not want to degrade you, but I
will let you sit here with me. [Laughter.]
That was not a demotion. I thank you very much for holding
the hearing.
Senator Specter. We always try to be very polite to the
Representatives of the people's House. They consistently
exercise seniority. [Laughter.]
Ms. Morella. Senator, I thank you for providing me the
opportunity to testify at this important hearing on
osteoporosis. I want to congratulate you on your leadership in
scheduling the hearing, and I know that I speak for the
Congressional Caucus for Women's Issues when I express my
appreciation for the attention that you are devoting to this
critical women's health issue.
I realize the severe budgetary constraints under which you
must make your decisions again this year, and I know you will
develop a bill that is fair and manages to fund critical
programs despite limited funds.
I was very moved to hear Ms. Burdick's testimony, and we
know that osteoporosis is a major public health threat for 28
million Americans who either have or are at risk for the
disease. Over age 50, 1 in 2 women, and 1 in 8 men will have an
osteoporosis-related fracture.
A woman's risk of hip fractures is equal to her combined
risk of breast, uterine, and ovarian cancer, and often a hip
fracture marks the end of independent living. Many enter
nursing homes, a large percentage die within 1 year following
the fracture, and the cost incurred due to the 1.5 million
annual fractures are staggering, at $13.8 billion, or $38
million a day. Osteoporotic fractures cost the Medicare program
3 percent of its overall cost.
While much remains to be learned about osteoporosis, there
are several primary and secondary preventive health strategies
that can reduce that risk of future fractures. Research and
public education, basic and clinical research have made
important strides leading to accurate methods to measure bone
loss and biochemical markers to detect rates of bone loss.
It has further led to new drugs. We read about them every
day--new drugs to help stabilize bone loss, and even increase
bone mass. However, further clinical research is needed to
accurately identify high-risk women before irreversible damage
occurs. Basic research is needed to determine the potential for
restoring skeletal architecture to its normal state, and
thereby to reverse osteoporosis. I urge you, in your capacity
as chairman, to provide increased funding for this critical
research in the fiscal year 1999 appropriations bill.
Another key priority is the expansion of osteoporosis
prevention and public education. The Public Health Service
Office on Women's Health hopes to launch, if given adequate
resources, a national osteoporosis prevention education
campaign. Currently, this office has an unfunded mandate to
carry out such a campaign, and while Americans of all ages must
receive messages about osteoporosis relevant to their stage in
life in order to prevent costly and devastating fractures
suffered annually due to osteoporosis, a public-private task
force determined that the first target group should be young
girls.
Of particular concern is the fact that only 14 percent of
teenage girls age 12 to 19 obtain the calcium on an average
daily basis needed to reach their peak bone mass. Ninety-seven
percent of bone mass is reached by age 19. Greater bone mass
early in life means fewer fractures later in life.
To help the public obtain accurate information about
osteoporosis, Congress established an osteoporosis resource
center in the 1993 NIH Revitalization Act. The Osteoporosis and
Related Bone Diseases National Resource Center, funded by NIH
and housed at the National Osteoporosis Foundation, has been
highly successful in educating the public on a very limited
budget, $500,000 annually for 4 years. Unfortunately, due to
lack of funding, it is not able to carry out key projects to
inform the public.
Finally, while I know this issue is not within your
jurisdiction, I do want to mention the issue of insurance
coverage for bone density testing for the diagnosis and testing
of osteoporosis. Osteoporosis is largely preventable. Thousands
of fractures could be avoided if low-bone mass was detected
early and treated.
Identification of risk factors alone cannot predict how
much bone a person has, or how strong bone is. Experts estimate
that without bone density tests up to 40 percent of women with
low-bone mass could be missed.
Last year, Senator Olympia Snowe and I were successful in
obtaining coverage under Medicare for bone mass measurement
tests as part of the Balanced Budget Act of 1997. That coverage
will be effective this July 1. Since then, Senator Snowe and I
have introduced legislation to extend that same coverage to
Federal employees and retirees through the Federal Employee
Health Benefits Program. Instead of a comprehensive national
coverage policy, FEHBP, the Federal Employee Health Benefits
Program, leaves it to each of the over 400 participating plans
to decide who is eligible to receive a bone mass measurement
and what constitutes medical necessity.
A survey of the 19 top plans participating in FEHBP
indicated that many plans have no specific rules to guide
reimbursement and cover the test. They cover it on a case-by-
case basis. Several plans refuse to provide consumers
information indicating whether the plan covers the test and
when it does not. Some plans cover it only for people who
already have osteoporosis.
I urge the members of this subcommittee to cosponsor
Senator Snowe's bill on this side and join us in working to
expand the availability of this important diagnostic test.
Indeed, as a personal note, had I not had the opportunity to be
tested at an osteoporosis event which I cochaired last year, I
would not have discovered that I have osteoporosis, and so I am
now taking Fosamax, a drug that can prevent further bone loss.
So it is critical that we have improved coverage for
testing to ensure early detection and treatment.
PREPARED STATEMENT
Finally, I want to thank you again, Senator Specter, for
this hearing, and I also want to commend you on your choice of
panelists to testify. I know my husband will be thrilled to
know that Dom DiMaggio is here, Dr. Katz, and Dr. Singer, and
good friend Judy Black, and Susan Burdick, who has just given
such great personal testimony.
So I thank you and look forward to working with you.
Senator Specter. Thank you very much, Congresswoman
Morella, for your testimony. I want to make an addendum to the
record. I did not invite you here with a comment of degrade. I
invited you with a comment of demote. [Laughter.]
[The statement follows:]
Prepared Statement of Hon. Connie Morella
Mr. Chairman, thank you for providing me with the opportunity to
testify at this important hearing on osteoporosis. I congratulate you
on your leadership in scheduling this hearing, and I know that I speak
for the Congressional Caucus for Women's Issues when I express my
appreciation for the attention which you are devoting to this critical
women's health issue. I recognize the severe budgetary constraints
under which you must make your decisions again this year, and I know
that you will develop a bill that is fair and manages to fund critical
programs, despite limited funds.
Osteoporosis is a major public health threat for 28 million
Americans who either have, or are at risk for, the disease. One in two
women and one in eight men over age 50 will have an osteoporosis-
related fracture. A woman's risk of hip fracture is equal to her
combined risk of breast, uterine, and ovarian cancer. Often a hip
fracture marks the end of independent living. Many enter nursing homes
and a large percentage die within one year following the fracture. The
costs incurred due to the 1.5 million annual fractures are staggering
at $13.8 billion--or $38 million each day. Osteoporotic fractures cost
the Medicare program three percent of its overall costs.
While much remains to be learned about osteoporosis, there are
several primary and secondary preventive health strategies that can
reduce the risk of future fractures--research and public education.
Basic and clinical research have made important strides leading to
accurate methods to measure bone loss and biochemical markers to detect
rates of bone loss. It has also led to new drugs to help stabilize bone
loss and even increase bone mass. However, further clinical research is
needed to accurately identify high-risk women before irreversible
damage occurs. Basic research is needed to determine the potential for
restoring skeletal architecture to its normal state and thereby to
reverse osteoporosis. I urge you to provide increased funding for this
critical research in the fiscal year 1999 appropriations bill.
Another key priority is the expansion of osteoporosis prevention
and public education. The Public Health Service Office on Women's
Health hopes to launch, if given adequate resources, a National
Osteoporosis Prevention Education Campaign. Currently, this office has
an unfunded mandate to carry out such a campaign. While Americans of
all ages must receive messages about osteoporosis relevant to their
stage in life in order to prevent costly and devastating fractures
suffered annually due to osteoporosis, a public-private task force
determined that the first target group should be young girls. Of
particular concern is the fact that only 14 percent of teenage girls,
ages 12-19, obtain the calcium on an average daily basis needed to
reach their peak bone mass. Ninety-seven percent of bone mass is
reached by age 19; greater bone mass early in life means fewer
fractures later in life.
To help the public obtain accurate information about osteoporosis,
Congress established an osteoporosis resource center in the 1993 NIH
Revitalization Act. The Osteoporosis and Related Bone Diseases National
Resource Center, funded by NIH and housed at the National Osteoporosis
Foundation, has been highly successful in educating the public on a
very limited budget, $500,000 annually for four years. Unfortunately,
due to lack of funding, it is not able to carry out key projects to
inform the public.
Finally, while I know this issue is not within your jurisdiction, I
did want to mention the issue of insurance coverage for bone density
testing for the diagnosis and prevention of osteoporosis. Osteoporosis
is largely preventable and thousands of fractures could be avoided if
low bone mass was detected early and treated. Identification of risk
factors alone cannot predict how much bone a person has and how strong
bone is. Experts estimate that without bone density tests, up to 40
percent of women with low bone mass could be missed.
Last year, Senator Olympia Snowe and I were successful in obtaining
coverage under Medicare for bone mass measurement tests as part of the
Balanced Budget Act of 1997. That coverage will be effective on July 1.
Since then, Senator Snowe and I have introduced legislation to extend
the same coverage to federal employees and retirees through the Federal
Employee Health Benefits Program (H.R. 2699, S. 1335).
Instead of a comprehensive national coverage policy, FEHBP leaves
it to each of the over 400 participating plans to decide who is
eligible to receive a bone mass measurement and what constitutes
medical necessity. A survey of the 19 top plans participating in FEHBP
indicated that many plans have no specific rules to guide reimbursement
and cover the tests on a case-by-case basis. Several plans refuse to
provide consumers information indicating when the plan covers the test
and when it does not. Some plans cover the test only for people who
already have osteoporosis. I urge the members of this subcommittee to
cosponsor Senator Snowe's bill and join us in working to expand the
availability of this important diagnostic test. Indeed, had I not taken
the opportunity to be tested at an osteoporosis event last year, I
would not have discovered that I have osteoporosis! I am now taking
Fosamax, a drug that can prevent further bone loss. It is critical that
we have improved coverage for testing to ensure early detection and
treatment.
Mr. Chairman, I thank you for this opportunity to testify today and
I again congratulate you for holding this timely hearing. You have a
number of excellent witnesses who will be sharing their expertise with
you today. I look forward to working with you and the other members of
your subcommittee to improve our response to this serious public health
problem affecting so many women and men.
STATEMENT OF DOMINIC DiMAGGIO, MEMBER, BOARD OF
DIRECTORS, THE PAGET FOUNDATION
Senator Specter. Now I want to turn to Mr. Dominic
DiMaggio, spokesperson for the Paget Foundation.
Since being diagnosed with Paget's Disease, Mr. DiMaggio
has recorded radio and television public service announcements
to alert men and women with Paget's Disease. Also one of
baseball's greats, having spent 10 seasons and over 13 years
with the Boston Red Sox, he still holds the all-time Red Sox
record for hitting in 34 consecutive games.
I chatted with Mr. DiMaggio beforehand and commented to him
that I grew up in Kansas, where the principal activity was
reading the box scores in the days before television. I know
about his career on the Fenway Park Green, and I was not aware
of the introductory statistics which had been prepared for me
earlier, and my first question to you, Mr. DiMaggio, is, who
holds the hitting streak for most consecutive games?
[Laughter.]
Mr. DiMaggio. That is my brother Joe.
Senator Specter. And what is that record?
Mr. DiMaggio. 56.
Senator Specter. 57. [Laughter.]
Mr. DiMaggio. No; if it had been 57 he would have gotten a
contract from Heinz, 57 varieties. [Laughter.]
Senator Specter. And how many consecutive games did he hit
in following the day he missed?
Mr. DiMaggio. I think it was either 17 or 27. I know there
is a 7 behind it.
Senator Specter. Well, I think it was 14. [Laughter.]
But we can agree on most things.
Mr. DiMaggio, we welcome you here and look forward to your
testimony.
Mr. DiMaggio. Senator Specter, I, too, thank you for
holding this hearing, for your great support of all medical
research, for your interest in osteoporosis, Paget's Disease of
bone and other bone disorders, and for inviting me to be here
today.
I am here to talk about Paget's Disease of bone, the second
most prevalent bone disease after osteoporosis. Paget's Disease
is a chronic condition which may affect between 1 and 2 percent
of people over 60, or up to 1 million people in the United
States alone.
When Paget's is severe, it can cause deformity such as
bowing of the legs, fractures, hearing loss, and
osteoarthritis, and can not only be very painful but can cause
serious problems.
In my particular case, over 20 years ago, after discovering
among other things that Paget's had caused bowing of my legs,
which deprived me of much needed height, which, believe me, I
could ill afford to lose, I went to Dr. Stephen Krane at the
Massachusetts General Hospital in Boston for treatment. Almost
10 years later, he prescribed the then up-to-date treatment of
self-injecting myself three times weekly with calcitonin, to
which I rebelled.
Dr. Krane then advised me that my only alternative was to
enter the University Hospital at Leiden in the Netherlands for
treatment with a drug called pamidronate, which had not been
approved in the United States, and so I went.
The result of that treatment has been an arresting of
further deterioration of Paget's Disease. It did not cure me,
for there is no cure, but it has been arrested. I am pleased to
report that this and other effective drugs are now available in
the United States.
Since agreeing to be the spokesman for the Paget's Disease
Foundation about 10 years ago, I am pleased to say that this
organization, which is the only one in the United States that
helps patients and supports and encourages research, has done
an outstanding service in those areas.
The most important need now is for increased Federal
funding for research on Paget's Disease so that researchers can
come to understand why Paget's occurs. I will briefly discuss
three important research areas.
1. Genetics. We know that there are genetic factors in
Paget's Disease, and researchers are working on identifying one
or more genes which predispose people to Paget's Disease, but
we need to conduct wider studies.
For example, being originally from San Francisco and having
spent most of my life in the Boston-Providence-Rhode Island
area, all areas which have large Italian populations, we know
that many people of Italian descent are afflicted with Paget's
Disease, but we do not know why this is so.
2. Viruses. For many years, scientists, including Dr. Fred
Singer, who is here today, have been looking for a virus or
viruses which are thought to be a factor in Paget's Disease.
Important research funded by the National Institutes of Health
is very promising, but more studies are needed to identify the
virus or viruses and to learn about a possible connection
between viruses and genetic factors.
3. Cancer and Paget's Disease. Though fortunately less than
1 percent of people with Paget's Disease develop a form of
cancer called osteosarcoma, research in this area also funded
by the National Institutes of Health must be continued to learn
why some people develop this cancer and how this may be
connected to the genetic and viral factors in Paget's Disease.
That, Senator Specter and other members of the committee,
just about concludes the valuable time which you have given me.
Thank you for allowing me to speak today on behalf of all of
the Paget's Disease sufferers in the United States and the rest
of the world.
PREPARED STATEMENT
This committee's support of increased research for Paget's
Disease, osteoporosis, and all bone disorders will bring a more
hopeful future for the millions who are afflicted by these
serious disorders.
Senator Specter. Thank you very much, Mr. DiMaggio. We
appreciate you being here, and appreciate hearing about your
personal experiences.
[The statement follows:]
Prepared Statement of Dominic DiMaggio
Senator Specter, I want to thank you for holding this hearing, for
your great support of all medical research, for your interest in
osteoporosis, Paget's disease of bone and other bone disorders, and for
inviting me to be here today.
I am here to talk about Paget's disease of bone, the second most
prevalent bone disease after osteoporosis. Paget's disease is a chronic
condition which may affect between 1 and 2 percent of people over 60 or
up to 1,000,000 people in the U.S. When Paget's is severe, it can cause
pain, deformity such as bowing of the legs, fractures, hearing loss and
osteoarthritis.
I have known that I had Paget's disease for more than 20 years.
About 12 years ago, I went to Dr. Stephen Krane at the Massachusetts
General Hospital for treatment. He suggested calcitonin which I would
have had to self-inject 3 times each week. I rebelled and Dr. Krane
suggested that I go to the Netherlands to be treated with a drug which
was not then approved for treatment in the U.S. I was treated with that
drug, pamidronate, which, by the way, was approved in the U.S. in 1994.
Though I am not cured, since there is no cure yet, I have been in
remission since being treated in the Netherlands. I am glad to report
that other effective drugs are now approved in the U.S. and other
countries.
The most severe problems I have experienced with Paget's disease
are bowing of my legs and a regrettable loss of height. However, I
consider myself one of the luckier people with Paget's disease since
many others suffer great pain and have serious and sometimes deforming
complications.
Ten years ago I became a member of the Board and a spokesperson for
The Paget Foundation, the only organization in the U.S. which assists
Paget's disease sufferers, provides medical education and supports and
encourages increased research.
Now I want to talk about the need for increased federal funding for
Paget's disease research so that the cause or causes of this disease
can be discovered. There are three important research areas which I
will discuss briefly.
1. Genetics.--We know that there are genetic factors in Paget's
disease, and researchers are working on identifying one or more genes
which predispose people to Paget's disease, but more studies are
needed. One aspect of the genetics of Paget's disease is particularly
interesting to me. I am originally from San Francisco and have spent
most of my life in the Boston/Providence, RI area--all areas which have
large Italian populations. We know that many people of Italian descent
have Paget's disease but we don't know why this is so.
2. Viruses.--For many years scientists, including Dr. Fred Singer
who is here today, have been looking for a virus or viruses which are
thought to be a factor in Paget's disease. Important research, funded
by the National Institutes of Health (NIH), is very promising, but more
studies are needed to identify the virus or viruses and to learn about
the possible connection between viruses and genetic factors.
3. Cancer and Paget's disease.--Though it is fortunate that less
than 1 percent of people with Paget's disease develop a form of cancer
called osteosarcoma, research in this area, also funded by NIH, must be
continued to learn why some people develop this cancer and how this may
be connected to the genetic and viral factors in Paget's disease.
This concludes the valuable time you have given me. Again, Senator
Specter and other members of the committee, thank you for allowing me
to speak today on behalf of Paget's disease sufferers everywhere.
STATEMENT OF DR. FRED SINGER, REPRESENTING BARBARA
SINATRA
Senator Specter. We now turn to Dr. Fred Singer, director
of the endocrine bone disease program at the John Wayne Cancer
Institute. He is chairman of the board of directors of the
Paget Foundation and past president of the American Society for
Bone and Mineral Research.
We appreciate your being here, and we are told you are
going to present the testimony which Mrs. Frank Sinatra would
have presented. Thank you for joining us. The floor is yours.
Dr. Singer. Thank you, Senator Specter.
Mrs. Frank Sinatra was very much looking forward to
appearing before you and the subcommittee today to encourage
support for medical research directed toward the major problem
of osteoporosis. Sadly, she could not appear here today and,
therefore, asked me to convey her message to you.
In 1996, Barbara fell and fractured a vertebra. After the
considerable pain subsided, a bone density test was done for
the first time and revealed that she had severe osteoporosis, a
previously absolutely unappreciated condition. Subsequently,
she has also experienced a stress fracture of a toe.
Fortunately, at present her fractures are healed, she feels
fine, and she has been taking medications to help strengthen
her bones.
In considering why she had developed osteoporosis she
related that her intake of dairy products, i.e. calcium, was
always rather limited, particularly when she was a model and
greatly restricted her food intake. Thus, it appeared that a
low intake of calcium may have been a factor in producing her
low-bone density.
In addition, both of her parents probably experienced
fractures related to osteoporosis. Barbara has come to
appreciate that she is one of 10 million Americans with
osteoporosis, 80 percent of whom are women, and that another 18
million have low bone density and are at risk for future
problems because of osteoporosis.
She now realizes that in many individuals osteoporosis is
actually a pediatric disease with a geriatric consequence.
Growing children often do not deposit sufficient bone into
their bone bank to get them through the many bone-losing years
after age 35. This no doubt contributes to the 1\1/2\ million
fractures which occur annually in the United States.
Barbara now believes that there is a great need to focus on
the children and adolescent girls who are not getting
sufficient calcium to build up their bones to their full
potential. Surveys have shown, as already stated, that about 14
percent of young girls receive enough calcium to build strong
bones. The National Osteoporosis Foundation has already
completed research on ways to reach these youngsters which
hopefully will be translated into better bones for future
generations.
Barbara and her husband dedicated an enormous amount of
time and energy to help abused children by building and
supporting the Barbara Sinatra Children's Health Center at the
Eisenhower Medical Center in Rancho Mirage, CA. Because of Mrs.
Sinatra's personal experience with osteoporosis she can clearly
see the need to prevent abuse of the developing bones and would
like the subcommittee to help support a national effort to
teach young people about bone health and how to prevent
osteoporosis.
PREPARED STATEMENT
In addition, the millions of Americans and people of other
countries who already suffer from the complications of
osteoporosis would benefit from an increased emphasis on
medical research to find solutions to this troubling disease,
which promises to become an epidemic unless we take action now.
I thank you for allowing me to represent her views.
[The statement follows:]
Prepared Statement of Barbara Sinatra
Senator Specter, Mrs. Frank Sinatra was very much looking forward
to appearing before you and your subcommittee to encourage support for
medical research directed toward the major public health problem of
osteoporosis. Sadly, she could not appear here today and therefore
asked me to convey her message to you and the subcommittee.
In 1996 Barbara fell and fractured a vertebra. After the
considerable pain subsided a bone density test was done and revealed
she had severe osteoporosis, a previously unappreciated condition.
Subsequently, she also experienced a stress fracture of a toe. At
present her fractures are healed and she has been taking medications to
strengthen her bones. In considering why she had developed osteoporosis
she related that her intake of dairy products was always rather
limited, particularly when she was a model and greatly restricted her
food intake. Thus it appeared that a low intake of calcium may have
been a factor in producing a low bone density. In addition, both of her
parents probably experienced fractures related to osteoporosis.
Barbara has come to appreciate that she is one of 10 million
Americans with osteoporosis, 80 percent of whom are women, and that
another 18 million have low bone density and are at risk for future
problems because of osteoporosis. She now realizes that in many
individuals osteoporosis is a pediatric disease with a geriatric
consequence. Growing children often do not deposit sufficient bone into
their ``bone bank'' to get them through the many bone-losing years
after age 35. This no doubt contributes to the 1.5 million fractures
which occur annually in the United States. Barbara believes that there
is a great need to focus on the children and adolescent girls who are
not getting sufficient calcium to build up their bone mass to its full
potential. Surveys have shown that only 13 percent of young girls
receive enough calcium to build strong bones. The National Osteoporosis
Foundation has already completed research on ways to reach these
youngsters which hopefully will be translated into better bones for
future generations.
Barbara and her husband dedicated an enormous amount of time and
energy to help abused children by building and supporting the Barbara
Sinatra Children's Health Center at the Eisenhower Medical Center in
Rancho Mirage, California. Because of Mrs. Sinatra's personal
experience with osteoporosis she can clearly see the need to prevent
``abuse'' of the developing bones and would like the Subcommittee to
help support a national effort to teach young people about bone health
and how to prevent osteoporosis. In addition, the millions of Americans
and people of other countries who already suffer from the complications
of osteoporosis would benefit from an increased emphasis on medical
research to find solutions to this troubling disease which promises to
become an epidemic unless we take action now.
CURE FOR OSTEOPOROSIS
Senator Specter. Thank you very much, Dr. Singer, for
joining us.
Let me begin with you, Dr. Katz. The question of funding is
very much on my mind and the mind of this subcommittee. Last
year, the Senate passed a resolution to double NIH funding over
5 years. That would be about $2.7 billion a year. When the time
came for funding, the health account was cut by $100 million.
Senator Harkin and I joined together in a bipartisan effort
offering an amendment for $1.1 billion, because we had targeted
a more modest but we thought a more attainable 7\1/2\-percent
increase, which was $952 million. Our amendment was defeated 63
to 27. We were able to find funding by consolidating or
eliminating a number of programs.
This year, the subcommittee has funded at a level line and
again we, Senator Harkin and I, offered an amendment to add $2
billion, and that again was defeated 57 to 41.
Now, I say these things because this room is filled with
advocates for this ailment, but there has to be a concerted
effort to target those 57 Senators and their counterparts in
the House on a grassroots campaign. Tell them what you are
telling us here today.
Now, the critical question I have for you, Dr. Katz, is
what would it take to find the cure for osteoporosis, to be
able to instruct people on how to prevent it, on whatever
course of action they should take?
Dr. Katz. We appreciate your support, and have always
appreciated the support of this committee, the tremendous
support of this committee for the NIH research effort.
With regard to osteoporosis, we, as well as other
institutes and offices at the NIH, have taken a multipronged
approach to the research effort. These efforts are broadbased
and include not only prevention, but also basic and clinical
research.
OSTEOPOROSIS GENE
Senator Specter. Is there an osteoporosis gene?
Dr. Katz. That is a very good question. Is there a single
gene? Probably not. The consensus is that there is not. There
have been many candidate genes looked at.
Senator Specter. Statistically, only 27 percent of the
grant applications are awarded. That means that there are 73
doors unopened. I would like you to focus, Dr. Katz, on what
you think it would take on a time line to find the answers to
osteoporosis. That is really the critical question.
I know you cannot necessarily answer on the spur of the
moment, but I would like you to focus on that.
Let me turn to you, Ms. Black, with a question about
education. You identify yourself as one of the lucky ones. We
have very substantial funding in the educational line. The
amount of $75,000 was spent to create a focus group last year
to make decisions on what age groups to target, and it was
young girls 9 to 19, with an additional $850,000 now being
spent to develop a message, to get that message out to the
public.
I am told that approximately $3 million will be needed in
fiscal year 1999 to launch the public awareness campaign. I
would be interested in your view, and also your view, Ms.
Burdick, and not necessarily at this moment--we could start
now--as to what you think it would really take to launch that
kind of a public awareness campaign.
Ms. Black. It sounds like they are trying to build bone
right under us. [Laughter.]
Senator Specter. We have the resources, in my opinion, to
do this. We have a budget of $1,700 billion. It is a matter of
priorities, and I do not think any priority is higher than
health. I put health and education at the top of the list, and
what I would like to find the answer to is what it will take,
because I think with a sufficiently aggressive grassroots
campaign we can do it.
Ms. Black. I do, too. I think you are exactly on target,
and it is refreshing to hear you say that and push for it, and
we will help you try to continue that effort.
This is only a start, the $3 million, because as you know,
with 50 States dividing it up per citizen, it is not a lot of
money. On the other hand, we have to start crawling before we
can walk and before we can run, and so we have to start working
with Governors and the legislatures and the public awareness
program throughout the country.
So we agree with you, and we have done research on what
exactly, what reaches teenagers, because you know, they are a
different breed, and so it takes talking to them a little bit
differently, but NOF has done research, and we believe that a
lot of it is going to have to be through a mass media campaign,
and we appreciate the time lines we have today, but we will
continue working with you and with the Office of Women's Health
to accomplish that.
Senator Specter. Well, let us know as specifically as you
can what you think it would take, and also some ideas as to how
to proselytize. You are not inexperienced, nor is Charlie
Black, on how to carry the message forward.
I do not like the word lobbyist, but public persuasion.
Congresswoman Morella has other duties on the other side of
the Hill, but I wanted to give her an opportunity to make a
concluding comment.
Ms. Morella. I do. I am just so appreciative of Chairman
Specter's devotion to health. I do represent the National
Institutes of Health, and I am just so pleased with what is
being done there and at the National Osteoporosis Foundation.
And so panelists, I want to thank you on behalf of all of
the citizens of the United States, and I want to thank you,
Chairman Specter. I am excited that we have been making
strides. This issue is no longer under the carpet. We know that
people need to be measured. We know we can educate young people
to prevent it. We know that research is being done, too, and so
I thank you.
Senator Specter. Thank you very much, Congresswoman
Morella.
Ms. Burdick, would you care to make a comment about how we
carry out this public awareness campaign?
Dr. Katz has to provide the research and has to answer the
question as to what he needs for prevention and cure, and we
would like those of you like Ms. Black and Ms. Burdick to focus
on what the public education campaign should be.
Ms. Burdick. I would just like to say that before you can
solve a problem you have to be aware that there is a problem,
and I feel that we need to make our best effort to educate
people about this and bring an awareness to the public of this
dreaded disease.
Senator Specter. OK. Thank you very much.
Mr. DiMaggio is a well-known spokesman. I have his
literature, both fielding and batting. Do they still call you
the Little Professor, Mr. DiMaggio?
Mr. DiMaggio. Yes.
Senator Specter. Would you care to make a comment on what
you think it would take to have this public relations campaign?
Mr. DiMaggio. The Little Professor name came about, I
guess, because of my small stature with glasses. I looked more
like a high school student than I did a professional athlete.
That is where the Little Professor name came from.
With all due respect, Senator, I do not believe there is
enough money. I know there are so many good causes, and what I
believe is absolutely necessary, there are an awful lot of
people in this country who do not know about Paget's Disease.
They do not know it exists. I think if we could just make more
people aware of the fact that it does exist, it would be a
great benefit. Beyond that, any further help that my foundation
would care to submit I am all in favor of.
Senator Specter. Thank you very much.
Dr. Singer, would you care to make a closing comment?
Dr. Singer. Well, I think it is very important to remember
that osteoporosis is a giant problem which needs to be dealt
with with considerable funds, and that we should not forget
some of the other disorders such as Mr. DiMaggio has
experienced, because, in fact, what we have learned from the
understanding of the unusual conditions, it actually helps us
understand normal bone and osteoporosis.
I think I would like to take a global approach, of course,
emphasizing osteoporosis.
Senator Specter. Well, thank you all very much. I think
today's hearing will focus more attention, and we have the
outstanding questions, what resources do you need to find the
cause and cure, and what will it take to promote the public
relations campaign?
PREPARED STATEMENT OF SENATOR OLYMPIA SNOWE
Senator Specter. Thank you very much. We have received a
prepared statement from Senator Olympia Snowe, it will be
inserted into the record at this point.
[The statement follows:]
Prepared Statement of Senator Olympia Snowe
Mr. Chairman, I want to thank you for holding today's hearing to
bring attention to the silent killer, osteoporosis.
When I introduced the first bill on Osteoporosis back in 1985, it
was a little known disease. It was simply a silent killer that was
spreading pain and suffering among millions of older women, while it
was hiding itself in their daughters and granddaughters, waiting until
they too reached old age to strike. And it wasn't selective about who
it attacked. One out of every two women have a lifetime risk of bone
fractures due to osteoporosis, and it affects half of all women over
the age of 50 and an astounding 90 percent of women over 75.
It is the most prolific and unforgiving bone disease. Twenty eight
million Americans are afflicted with osteoporosis and each year 50,000
deaths result from this disease.
While there is no way to measure the cost of the pain and suffering
of those afflicted by this disease and their families, we do know that
osteoporosis is also a costly disease in strict monetary terms. It
costs up to $1 billion in direct medical costs for osteoporosis
fracture patients--an astounding $27 million every single day. And this
cost is projected to reach $60 billion by the year 2020 and $240
billion by the year 2040 if medical research has not discovered an
effective treatment. In fact, in a report issued by the University of
California, it is stated that Osteoporosis, along with Alzheimer's
disease are potential ``Federal Budget busters'' if interventions are
not begun immediately.
We have begun work, Mr. Chairman. We have the National Osteoporosis
Clearing House, based on legislation I authored, with an 800 number
that provides thousands more women with easy access to the most up-to-
date information available on the disease itself, the ongoing research,
where to get help and what to do to avoid becoming another statistic of
this disease.
And last year, with my former House colleague and good friend,
Congresswoman Connie Morella, we passed legislation I started
introducing almost a decade ago--the Medicare Bone Mass Measurement
Coverage Standardization Act--which will allow Medicare beneficiaries
at risk of osteoporosis to have their diagnostic tests covered under
the program as of July 1, 1998. In an effort to move toward better
access to this important test, I have introduced similar legislation to
provide coverage under the Federal Employees Health Benefit Program and
have cosponsored legislation with Senator Robert Torricelli to provide
this coverage under private insurance.
We have come a long way from 1985 when hardly anyone knew what I
was talking about when I asked them to work with me to bring this
silent killer out into the open and find a way to detect it, stop its
progress and find a cure.
Mr. Chairman you have long been a champion of federal research
funding and we need your help, again, to continue our fight against
osteoporosis. The advancements being made in research--and the recent
FDA approval of raloxifene for osteoporosis--are great news. But we
need to do more. We have made progress in terms of getting more federal
funding for research so that we can find the answers to the many
questions we still have about this disease, such as how do we build
back lost bone mass and what factors dictate a young person's reaching
peak bone mass.
I join the National Osteoporosis Foundation today in asking you and
your committee to provide a 15 percent increase in the National
Institutes of Health budget for fiscal year 1999 in order to ensure
that advances in research on ways to stop this silent killer continue.
We need to fight to find the cure and to protect our daughters and
granddaughters from this terrible disease. We need to make sure that
the only knowledge they have of osteoporosis is in the history books. I
look forward to working with you and my colleagues on the
Appropriations Committee to provide increased funding.
CONCLUSION OF HEARING
Senator Specter. Thank you all very much for being here,
that concludes our hearing. The subcommittee will stand in
recess subject to the call of the Chair.
[Whereupon, at 12:50 p.m., Wednesday, May 20, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]