[Senate Hearing 105-861]
[From the U.S. Government Publishing Office]


                                                        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

                                 ______

                    U.S. GOVERNMENT PRINTING OFFICE
50-025 cc                   WASHINGTON : 1999

_______________________________________________________________________
            For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 
                                 20402
                           ISBN 0-16-058110-9





                      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

                              ----------                              
                                                                   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

                              ----------                              


                        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.]

                                    
