Madame Chairman and members of the Committee, we are pleased
to appear before you to discuss our programs at the National
Institutes of Health.
As is described in testimony from other NIH panels, advances
in medical science and technology are occurring at breathtaking
speed. This progress in combatting disease and improving health
is accelerated through the collaborations that take place across
the borders of NIH's institutes and centers. Supporting these
collaborations and undergirding the individual research projects
funded throughout the NIH are three transcendent themes that
comprise the NIH infrastructure: sharing of resources; sharing of
information; and coordination of research activities. These
themes are a continuous refrain throughout the NIK but two NIH
components in particular, the National Center for Research
Resources (NCRR) and the National Library of Medicine (NLM),
concentrate on providing indispensable infrastructure support:
one for a variety of equipment and other resources needed by
scientists; the other for the information environment in which
biomedical scientists, health care practitioners, and students
work, learn, and ultimately transfer the fruits of research to
the patient's bedside. The infrastructure for biomedical
research is further strengthened through coordinating activities
focused in the NIH Office of the Director, covering research
interests that cut across many NIH components: disease
prevention; behavioral aspects of health and disease; women's
health; minority health; rare diseases; and studies on dietary
supplements and alternative medicine.
Sharing Research Resources
Scientists who explore disease and its remedies depend
heavily on the tools of modem science. Because the research
resources and technologies required by today's scientists are
highly sophisticated and therefore costly, it makes sense that
they be shared by many scientists. This resource sharing, in
turn, leverages precious Federal research dollars. All the NIH
institutes and centers encourage sharing of scientific resources
and create environments for such sharing. A formalized effort in
this area is focused primarily through NIH's National Center for
Research Resources (NCRR), which operates highly developed and
extensive programs for sharing precious scientific resources that
serve scientists in institutions throughout the country. These
resources include state-of-the-art instrumentation, a variety of
animal and non-animal models of human disease, repositories for
biomaterials, and specialized clinical research environments.
NCRR-supported research resources serve more than 10,000
investigators nationwide who receive more than $1.5 billion of
primary research funding from NIH's research institutes and
centers.
Research Resource Facilities
Biomedical Technology Resource Centers: These sophisticated
facilities, which offer scientific equipment and the expertise
needed to use such instrumentation, include high field nuclear
magnetic resonance (NMR) spectroscopy, intermediate voltage
electron imcroscopy, high-end mass spectrometers, and
synchrotrons. They have been invaluable in the search for
answers to medical problems. For example, x-ray technologies
have been critical in characterizing biologically important
molecules and shedding light on the causes of disorders like Lou
Gehrig's disease, atherosclerosis--the nation's number one
killer--and AIDS. Synchrotrons, which provide high-energy x-rays
for scientists to study the three-dimensional structure of
proteins, nucleic acids, and viruses, are the prime tool needed
to practice the new science of structural biology--the science we
hope will allow the design of new molecules for use in medicine.
Already, the technology shows promise in designing novel drug
therapies to combat AIDS, as is described in testimony from the
NIH infectious diseases panel. In other centralized facilities,
for example, at the Metabolic NMR Research Resource at the
University of Pennsylvania, scientists found that approximately
70 percent of breast biopsies that turn out to be benign can be
avoided by using high-resolution NM analysis. The
instrumentation is sensitive enough to distinguish benign tumors
without sacrificing capacity to detect cancer. This approach may
help reduce health care costs by eliminating unnecessary
biopsies.
The shared use of facilities like these is not only cost
effective, it also promotes collaborations across scientific
disciplines--collaborations that are highly desirable as our
understanding of biology grows more sophisticated. But NCRR
cannot support synchrotrons and other costly research Facilities
without cooperation from the broader scientific community. Both
the National Science Foundation (NSF) and Department of Energy
(DOE) provide essential funding for the four synchrotron
facilities that host NCRR- supported specially adapted beam lines
for biomedical investigators. In the United States, there has
been a progressive increase in the use of the synchrotron
facilities by biomedical investigators, more than a third of
which are funded predominantly by the NIH. As a result, NCRR is
supporting the construction of two additional beam lines at the
Advanced Photon Source, a DOE synchrotron facility at the Argonne
National Laboratory in Illinois. The NIH Director, through his
one percent transfer authority, is contributing to this effort.
NIK NSF and DOE also co-fund other biomedical technology resource
centers for studies of protein and carbohydrate structures at the
molecular level.
Another way to share scarce resources is to distribute them
widely through "smart" network-connected technologies, thereby
creating "virtual laboratories". The NCRR supports a center in
San Diego for intermediate voltage electron microscopy that
allows investigators in other geographic areas to ship tissue
samples to San Diego where the samples can be viewed via a
computer workstation that has control of the San Diego microscope
via the Internet.
Investigators can image samples in real time and reconstruct
three-dimensional images of tissues by having microscopy data
concurrently processed by the San Diego Supercomputer Center,
also supported by the NCRR and NSF. This approach is being
extended to other computer-intensive imaging and microscopy
technologies and to other biotechnology-related resources used by
scientists engaged in structure-based drug design.
Regional Primate Research Centers: The NCRR supports a
national network of seven Regional Primate Research Centers
(RPRCS) to provide models for human disease and develop clinical
applications to human health. The centers provide special
research facilities, equipment and expertise for scientists
across the country conducting studies of AIDS, arteriosclerosis,
Alzheimer's, asthma, cancer and many other diseases.
Investigators at the RPRCs discovered and characterized a
simian model of human AIDS (SAIDS). The SAIDS model in the
rhesus monkey has been invaluable in helping investigators define
the immunologic, genetic, neurologic and other consequences of
simian immunodeficiency virus (SIV) infection, a model of FUV
infection in people. The SIV model is providing insight into
vaccine development strategies that may be applicable to human
disease. Recently, investigators infected a type of macaque,
Macaca with FUV- I and HIV-2, the two known variants of the virus
that infects humans. In addition, investigators successfully
infected macaques with a hybrid virus, SFHV, a combination of
parts of SIV and FHV, to induce disease in the infected macaques.
This new hybrid virus may prove to be important in developing a
vaccine against AIDS.
Other important work at these facilities includes stem cell
research, which may hold promise for advances in a wide range of
medical fields including organ transplantation and tissue repair
as well as contribute to human gene therapy. RPRC researchers are
also focused on surfactant, a protein that is lacking in infants
with respiratory distress syndrome. They have shown that a
synthetic peptide containing surfactant is safe and effective for
nonhuman primates, providing a basis for proceeding to clinical
trials in human infants.
General Clinical Research Centers: Clinical research is
important to all the NIH institutes and centers because clinical
research is the means by which knowledge gained in laboratory
studies is translated into practical application. Clinical
studies are also important because insights gained by working
with patients can be carried back to the laboratory where
scientists can make major leaps in fundamental understanding.
Clinical research cannot be conducted in just any hospital or
clinic. Frequently, a controlled environment, staffed with
specialized paramedical personnel and equipped with sophisticated
laboratories, is required-like the Clinical Research Center on
the NIH campus in Bethesda, Maryland-or NCRR!s distributed
network of about six dozen General Clinical Research Centers
(GCRCS) at academic health centers across the country.
GCRCs provide infrastructure to academic institutions by
providing inpatient and outpatient research facilities and other
resources vital for state-of-the art patient-oriented research.
The network of GCRCs also provides an effective forum for
training and junior career development in clinical research. In
addition to NIH support, GCRC-based investigators also receive
primary research support from other sources, including the
National Aeronautics and Space Administration, Department of
Veterans Affairs, Department of Agriculture, Department of
Transportation, Food and Drug Administration, and the private
sector, including industry. In fiscal year 1994, the total
primary support to GCRC-based investigators was at least $1.17
billion from all sources.
The GCRCs enhance the research capacity for all stages of
clinical trials. Due to the negative impact of managed care on
clinical research GCRCs now provide increasing support for more
late phase 2 and phase 3 clinical trials. Many GCRCs continue to
be utilized for studies related to women's health (including the
Women's Health Initiative described later in this testimony),
AIDS clinical trials (as is described in the testimony of the NIH
infectious disease panel), heart disease, cancer, diabetes, and
osteoporosis, as well as neurodegenerative, behavioral, and rare
diseases.
An important new undertaking by NCRR in collaboration with
three other NIH institutes-the National Cancer Institute, the
National Heart, Lung, and Blood Institute, and the National
Institute of Diabetes, Digestive and Kidney Diseases, is the
establishment of three National Gene Vector Laboratories. Gene
vectors, special vehicles that scientists employ to ferry
potentially helpful genes into patients' cells, are costly and
technically difficult to develop, produce, and test for safety.
This technology limitation is seen as impeding the capacity of
clinical investigators to move the new field of human gene
therapy forward. The National Gene Vector Laboratories will
produce and safety test clinical grade gene vectors suitable for
clinical trials conducted at GCRCs and other sites. The overall
goal is to produce and distribute selected vectors to qualified
clinical investigators conducting experimental gene therapy for a
wide variety of medical conditions.
Shared Resources
Shared Instrumentation: Programs for sharing the
sophisticated, expensive instrumentation essential to modem
biomedical research are important to grantees supported by all
NIH institutes and centers. A number of institutes have programs
that encourage and support sharing of instrumentation. As an
example of one of the most significant programs, NCRR's Shared
Instrumentation Grant (SIG) program allows institutions with a
high concentration of NIHsupported investigators to purchase an
array of state-of-the-art instrumentation, including protein/DNA
sequencers, mass spectrometers and cell sorters. For instruments
that cost hundreds of thousands of dollars, 15 investigators-on
average--share each item of equipment. In FY 1994, SIG
investigators received more than $163 million in peer-reviewed
grant support from other NIH components; the total NCRR program
cost of these SIG awards was $9 minion. Thus, all research
supported by NIH benefits substantially from this cost-effective
program.
Repositories: Biomedical investigators also require a
sophisticated toolbox filled with biomaterials--ranging from
cells, genes, and tissues to mammalian and nonmammalian models of
human disease-to enable them to understand gene function and
provide models of human disease. As more of the human genome is
sequenced and specific gene abnormalities are identified, the
demand will grow for research animals that are genetically
altered-- so-called transgenics and knockouts-- that are of great
interest to the scientific community. NCRR supports a national
resource at The Jackson Laboratories, which validates, preserves,
and distributes many newly developed strains of
genetically-altered mice. This cost-effective approach to sharing
provides important animal models for research on biological
processes and diseases of interest across the NIH institutes and
centers.
Human Resources Development
Science Education: As a part of its concern about the
infrastructure of medical research, NIH has a significant
commitment to ensuring that this Nation has an adequate supply of
well-trained medical scientists for the future. The various NIH
components have programs aimed at all points along the pipeline,
from K- 1 2 to college level and from graduate school to
postdoctoral study. Today, preparation for an independent career
in science takes from 10- 1 5 years beyond the undergraduate
degree; therefore, a long-term commitment is essential on the
part of both students and institutions that support such
training. For example, NCRR has, since 1980, sponsored a program
to attract high school students to careers in biomedical research
and the health professions. This program gives thousands of
students and science teachers hands-on experience in biomedical
research laboratories each summer. Another program spurs
scientists to work with educators and other organizations to
improve student and public understanding of science and promote
interest in scientific careers. This Science Education
Partnership Award (SEPA) program developed a broad range of model
activities, including a national video education program, a
traveling ADDS exhibit, biotechnology research experiences for
students and teachers, and health promotion outreach for inner
city and rural communities.
For example, CITYLAB--A partnership of scientists, educators
and industrial development organizations--is an innovative high
school learning laboratory at the Boston University School of
Medicine that links to existing networks at the Boston University
School of Education, Boston area suburban and inner city schools,
and the biotechnology industry. CITYLAB provides high school
students and their teachers with a fully equipped regional
state-of-the-art biotechnology learning laboratory that supports
hands-on curriculum modules in biochemistry, cell and molecular
biology, immunology and microbiology. The ultimate goal of the
successful CITYLAB is to raise awareness about career and
educational opportunities in biomedical sciences, and it has now
been disseminated throughout New England and to other parts of
the country.
The quickening cadence of science relentlessly challenges the
NIH custodians of these research resources--the tools of
science--to keep pace. Thus, creation and sharing of research
resources is a dynamic enterprise: some components must be
carefully maintained, while other parts must be constantly
evaluated and adapted to today's realities and tomorrow's
opportunities.
Sharing Information
Medical research and the practice of medicine have always
required sharing of information. Science simply cannot progress
unless information is available widely.
Contemporary science and medicine rely even more heavily on
fast, reliable access to data. At NIK all components are heavily
invested in information exchange, but this emphasis is most
pointed in the National Library of Medicine (NLW, with its
mission to collect published scientific literature in medicine,
to make it accessible worldwide through a variety of
computer-based systems, and to devise new ways to apply this
rapidly growing body of medical knowledge to the benefit of
research, education, and patient care.
Over the years of its existence, NLM has continuously applied
the latest technology in developing new information service. As
a result, American health professionals today enjoy unrivaled
access to biomedical information: inunense databases accessible
from office, classroom, lab, or home; sophisticated retrieval
services on such current topics as environmental health, cancer,
ADDS, and molecular biology; a growing number of information
resources and services provided over the Internet and the World
Wide Web; and the NLM- supported National Network of Libraries of
Medicine, whose 4,500 member institutions provide interlibrary
loans and other vital services to health professionals.
Databases and Networks
The Library's major database, NEDLM, is the most-consulted
medical information database in the world, containing 8 million
references and abstracts from 4,000 journals covering 1966 to the
present. NEDLM is accessed in a variety of formats, including
online from the NLM and on commercial online vendors and CD-ROM
purveyors. The Library's round-the-clock network numbers some
140,000 users, most of them using the NLM-designed software
called "Grateful Med" as their means of easy and inexpensive
access. An extensive evaluation has shown that MEDLINE can have
an important influence on research, patient care, and education.
In the area of patient care, information from MEDLINE is
frequently critical in reaching the correct diagnosis and
developing a sound treatment plan, resulting in lives saved,
limbs spared, disease prevented, unnecessary treatment avoided,
and hospitalization reduced.
The Internet and the World Wide Web
The Internet has become extremely important in biomedical
communication. The NLM is about to announce an Internet version
of its "Grateful Med" which will permit much faster and more
flexible searching of MEDLINE. This Internet version is a
radical modification of the extremely popular Grateful Med
software that is currently used by most users of NLM's online
network to simplify the process of database searching. The
Library has been formally designated by the Administration as a
"Reinvention Laboratory," and the Internet Grateful Med is the
first tangible product of the streamlining and reinvention
effort.
The Internet, in fact, plays an increasingly central role in
how the Library makes its information available. NLM's World
Wide Web site (called "HyperDOC") is a popular destination for
those seeking health-related information. Some 40,000 users a
day visit HyperDOC and learn about the Library's many products
and services, have access to NLM databases, download the text of
NLM documents, and view a variety of visual materials. The
Internet has become so important in biomedical communication that
one of the Library's grant programs provides funds to help
medical organizations connect to the Internet, including small
hospitals, free-standing clinics, and large medical centers. The
NLM supports several ambitious projects to establish testbed
networks for health communication, ranging from citywide to
statewide to regionwide.
Another frequent stop by WWW visitors is the section of
HyperDOC where they may view selected images from the "Visible
Human." This is the project that resulted in two computer
generated cadavers, male and female, that are being used a
variety of educational, scientific, artistic, and commercial ways
(more than 400 licenses have been signed by users in 23
countries). The Visible Human Male, introduced late in 1994,
consists of NM, CT and anatomical images from a single male
cadaver. It is about 14 gigabytes in size. The dataset for the
Visible Human Female was introduced in November 1995 and has the
same basic characteristics as the male, except that the imaging
was done to a much finer detail and amounts to some 40 gigabytes.
Both male and female have received worldwide press attention.
Proposed applications include: multimedia "textbooks" for K
through 12 health education classes and for the teaching of
college and medical school anatomy; models for radiation
absorption, radiation treatment planning and surgical planning;
virtual reality games; professional surgical simulators and
endoscopy simulators; and normal reference for teaching clinical
diagnosis.
There is also a series of other databases in such specialized
areas as cancer, AIDS, and environmental health. A number of
these files contain data that may be used directly by the general
public, for example, the "PDQ" file of cancer treatment
information and the Toxic Chemical Release Inventory databases
that contain extensive data--by state, city, and
neighborhood--about harmful. chemicals that are released into the
environment by companies. Both the cancer and the environmental
health files are good examples of the extensive collaboration
between NLM and other government agencies: the National Cancer
Institute, the Environmental Protection Agency, Food and Drug
Administration, and Centers for Disease Control and Prevention.
An exciting development of the last decade or more is the
database of DNA sequences called GenBank, which contains 625,000
gene sequences from 15,000 different organisms. it is perhaps the
fastest growing of the Library's information offerings.
Previously centered at the National Institute of General Medical
Science, this databank is absolutely crucial for scientists
trying to identify new human genes, such as those responsible for
early-onset Alzheimer's disease. NLM has developed the computing
infrastructure to facilitate researchers' access to this critical
resource through the Internet. Thus, the exponential growth in
the data has been matched by similar growth in public
access--more than 25,000 searches every day by scientists around
the world. In conjunction with the GenBank data, NLM's
researchers have developed sequence comparison methods which have
become adopted worldwide as the standard for sequence searching.
The capability of doing GenBank searches has significantly
reduced the need for costly laboratory experimentation and has
accelerated the pace of gene discovery.
The National Information Infrastructure and Biomedicine
The growth of the National Information Infrastructure (NU)
and the increasing access to high speed computers and
communications by consumers, health care providers, public health
professionals, and scientists is having a fundamental impact on
health throughout the nation. As part of a multi-agency Federal
initiative to foster the rapid development of high performance
computing and communications (BPCC), the NIH is investing
resources to make use of the National Information Infrastructure.
The applications, which all involve the latest information and
communications technology, are in such areas as telemedicine (the
practice of "remote" medicine through use of electronic
technology), computer-based patient data, integrating access to
health related information, medical linguistics, and health
services research. These projects are being carried out at
universities and nonprofit research institutions throughout the
country.
The public is naturally concerned about the impact of
computer- based patient records, automated public health and
research databases, and of the use of the National Information
Infrastructure on the confidentiality of personal health data.
In addition to Federal legislation imposing penalties for misuse
of health data, consideration is now being given to setting
practical guidelines to assist those who collect and use
electronic health data in providing effective safeguards. NLM
and the NIH Clinical Research Center are funding a study on
current best practices for ensuring confidentiality while
providing effective access to electronic health data during
telemedicine conferences and while transferring patient data
within health care systems, for example.
Outreach
Recognizing that more health professionals should be using
NIH's computer-based information services, NLM has undertaken an
outreach program to scientists, health care providers, and
students. There are still far too many health professionals
throughout this country who are not aware of the NLM and the
National Network of Libraries of Medicine. Together they can
provide them with access to the most up- to-date medical
information--without regard to where they are located or to the
time of day--and make the information readily and easily
obtainable. The NLM has therefore developed a long-term, wide-
reaching effort to make health professionals across the country
more aware of the medical information resources that NLM
provides, to facilitate their access to these national resources,
to train them in the use of Grateful Med, and, whenever possible,
to link them to local library services. Close to 300 such
outreach projects, involving more than 500 institutions, have
taken place since the outreach program began. Although they have
reached out to health professionals of every sort, the projects
have a special focus on reaching those who have been
traditionally "underserved": rural practitioners and those who
serve minority populations.
Coordination of Research
Complex medical problems require many avenues of
inquiry--calling upon various scientific disciplines and
involving laboratory research, the social and behavioral
sciences, clinical studies, and epidemiologic approaches. As
technology has become more sophisticated and more
interdisciplinary approaches are required, coordination of such
diverse approaches is necessary to avoid duplication of effort
and to ensure that the most important leads are followed. Across
all of NIK such coordination is done in many different ways.
Coordinated efforts sometimes established in a very formal
manner. For example, the Office of AIDS Research (described in
testimony by the infectious diseases panel) plans and evaluates
the ADDS research programs conducted and supported by all 17 NIH
institutes. In other instances, research coordination is
practiced informally, through discussions among several
scientists or by workshops involving scientists from within and
outside of NIH. In some cases, research coordination is focused
in the Office of the NIH Director and is achieved through
specially designated offices or programs.
The Office of Disease Prevention
Maintenance of health and prevention of disease are critical
to the extension of the length and quality of life; it is
estimated that approximately 20 percent of the NIH total research
budget is spent on disease prevention activities, ranging from
studies to understand normal physiology to clinical trials on
diet modification to health education programs aimed at the
public. All of NIH's institutes and centers have programs in
prevention research, which are coordinated by the Office of
Disease Prevention in the Office of the NIH Director.
The effects of diet, physical activity, smoking, and genetic
predispositions influence the development of many diseases and
modification of these factors can alter the risk of many
diseases. Thus, it is critical scientifically for the institutes
and centers to work together on prevention issues, and there is
economic efficiency in working jointly. There are numerous
examples of cooperative prevention projects at NIK but the
Women's Health Initiative (described later in this testimony)
perhaps affords the best example. The Women's Health Initiative,
which is oriented toward preventing the major killing and
crippling disorders of older women, was originally planned by a
consortium of 12 NIH components; the content of the project
continues to evolve based on insights gained from research
supported by the individual institutes and centers, and recently
a project on cognitive changes in older women has been added.
The Office of Disease Prevention holds a series of consensus
development conferences, each developed corroboratively with one
or more of the NIH institutes and centers. These conferences
provide critical assessments of scientific knowledge about a
particular medical topic, which are summarized and presented
publicly. Most recently, a conference on the association of the
common bacterium, H. pylori, with peptic ulcers, has resulted in
a shift in prevention or therapeutic approach. Physicians have
now switched from treating ulcer patients with repeated courses
of drugs, antacids and special diets that control stomach acid
and relieve ulcer pain to prescribing a week-long course of
antibiotics instead.
All of the NIH institutes and centers are concerned with rare
diseases (defined as those diseases having a prevalence of
200,000 or fewer people in the U.S.). The Office of Rare Diseases
responds to several important needs of patients having rare
diseases and their families, for example, by providing
information about the disorder(s) and locating informed medical
investigators conducting research on these rare diseases. The
Office is collaborating with NIH institutes and centers as well
as public advocacy groups to develop a publicly available on-line
database that will provide the sources of information and of
support groups, and describe current research projects and
investigators. The investigators, in turn, hope to accrue the
numbers of patients needed to facilitate their research studies.
The Office, jointly with NIH institutes, is sponsoring a series
of 5-8 meetings each year on specific rare conditions in order to
stimulate research in these areas.
To encourage the development of a science base related to the
potential health effects of the use of dietary supplements,
including herbals and botanicals, an Office of Dietary
Supplements was established in 1995. The Office will stimulate
and coordinate research across the NIH components and will
collaborate with the NIH Office of Alternative Medicine
(described elsewhere in this testimony). Initial work will be to
develop a database of current research and published information
and to advise Federal agencies regarding the interpretation of
research findings, Collaborative partnerships with the private
sector will be sought to develop the science base and to increase
support for research.
The Office of Behavioral and Social Sciences Research
Behavioral and social factors are among the leading causes
and contributors to both illness and death in the U.S. Factors
such as smoking, dietary practices, physical activity, stress,
alcohol and drug abuse, accidents, unsafe sexual practices, and
socioeconomic status are well documented as risk factors for an
array of health problems. Indeed, these and other behavioral and
social variables account for diseases which lead to up to 50
percent of all annual deaths in the U.S. Furthermore, many
behavioral and social factors have clear effects on the central
nervous, cardiovascular, endocrine, and immune systems, and on
gene expression, as well. Interactions make it a scientific
imperative that we more fully integrate behavioral and social
sciences with the biomedical sciences across the institutes and
centers that make up the NIH.
The Office of Behavioral and Social Sciences Research (OBSSR)
was established in recognition of the substantial influence of
behavioral and social factors on health. The office, which
officially opened July 1, 1995, is located in the NIH Office of
the Director, and emphasizes the integration of knowledge from
the behavioral and social sciences with biomedical knowledge in
order to accelerate the understanding and treatment of the
physical and mental illnesses of interest to all of the NIH
institutes and centers.
More specifically, the mission of the OBSSR is to provide
leadership and direction for the development of a trans-NIH plan
to increase the scope of, and support for, behavioral and social
science research; to define an overall strategy for the
integration of these disciplines across NIH institutes and
centers; to develop initiatives to stimulate research in the
behavioral and social sciences arena; to integrate a
bio-behavioral perspective across the research areas of NIH; and
to promote studies to evaluate the contributions of behavioral,
social and lifestyle determinants to the prevention, course,
treatment, and outcome of illness and related public health
problems.
The OBSSR will focus on four areas of research that show
promise for advancing the understanding and treatment of disease
and improving the quality of life. These include:
- the identification of new behavioral and social risk
factors for disease;
- research on the interactions of biological, behavioral, and
social factors, in fields such as behavioral genetics, behavioral
neuroscience, and psychopharmacology;
- the development of new behavioral, preventative, social and
treatment approaches for health problems such as heart disease,
for which lifestyle interventions have been shown to reverse
coronary atherosclerosis, and for mental illnesses such as
anxiety and depression, for which behavioral therapy is
extraordinarily successful; and, finally,
- basic behavioral and social sciences research to accelerate
advances in such areas as learning and memory, cognition and
perceptual processes, and regarding the nature of health care
systems.
Although the office has been operating for only a short time,
a number of activities are well underway. A draft definition of
behavioral and social science has been developed that once
reviewed and refined, will be used to assess and monitor funding
in this area across NIH. In fiscal year 1996, a report will be
prepared for Congress that will provide an overview of the NIH
commitment to behavioral and social research. Also, in fiscal
year 1996, the OBSSR will develop a strategic plan, in
consultation with the scientific community, to assist in charting
the future direction of the office and establishing its
priorities. Finally, the OBSSR will continue to use a portion of
its budget to support research grants, workshops and conferences,
in consultation with the NIH institutes and centers.
The Office of Research on Women's Health
It became increasingly clear in the 1980s that women's health
issues needed and deserved greater attention across the spectrum
of NIH. Concerns had been expressed that many important research
studies had not sufficiently involved women as research subjects
and that more women scientists needed to become involved in
conducting biomedical research. Therefore, the Office of
Research on Women's Health (ORWH) was established at the NIH in
September 1990 to serve as the focal point for women's health
research across NIH. ORVM initially was charged with ensuring
that research conducted and supported by NIH appropriately
addresses issues regarding women's health and that there is
appropriate participation of women in clinical research,
especially clinical trials. The office also was given
responsibility for stimulating opportunities for women in
biomedical careers.
One of the first activities undertaken by ORWH was to develop
a comprehensive trans-NIH research agenda for women's health.
Published in 1992, that research agenda has continued to be
updated, based on new and emerging scientific findings and
addresses health issues that affect women at every stage of life,
from birth through adolescence and the reproductive years, as
well as menopause and the later years of life. A priority is the
support of studies that enhance the recruitment of females across
the lifespan, especially those traditionally underrepresented as
participants in research. Emphasis is placed on participation by
those from diverse cultures ' minority populations, the elderly,
rural and inner city women, as well as those affected by poverty
and low socioeconomic status. In order to fulfill many elements
of this agenda, the ORWH has co-funded (with NIH institutes,
centers and divisions), a number of new initiatives and provided
supplementary funds to existing NU-1 grants. New information
about gender and women's health issues continues to evolve from
these programs.
The ORWH has also undertaken activities to increase
opportunities for women in biomedical careers. The re-entry
program has encouraged fully trained women to re-enter active
research careers after interruptions caused by family
responsibilities. This initiative and other ORW-supported
collaborations are enhancing professional opportunities for women
in biomedical research.
In March 1994, the NIH Guidelines on the Inclusion of Women
and Minorities as Subjects in Clinical Research became effective
and all NIH grant and contract applications and proposals as well
as intramural projects undertaken after June 1, 1994 have been
required to comply. The ORWK for the first time, is tracking the
number of women and n-minorities in NIH-supported clinical
trials; those data, for fiscal year 1994, will be available
shortly.
The Women's Health Initiative
The Women's Health Initiative (WM), a $628 minion, 15-year
project involving 164,500 women aged 50-79, is also a trans-NIH
activity. It focuses on strategies for preventing some of the
major causes of death, disability and frailty in older women of
all races and socioeconomic backgrounds: heart disease, breast
and colorectal cancer and osteoporosis. Experts from across the
various NIH institutes, centers and divisions and from outside of
government participated in designing the WM, which is one of the
most definitive, far-reaching clinical trials of women's health
ever undertaken in the U.S.
The WHI has three major components: a randomized controlled
clinical trial of promising but unproven approaches to
prevention; an observational study to identify predictors of
disease; and a study of community approaches to developing
healthful behaviors. The first two components are being
performed at 40 clinical centers located throughout the U.S., in
order to enhance recruitment in medically underserved areas and
among minority populations. The controlled clinical trial is
evaluating three interventions: the effect of a low- fat dietary
pattern on prevention of breast and colon cancer and coronary
heart disease; the effect of hormonal replacement therapy on
prevention of coronary heart disease and osteoporotic fractures;
and the effect of calcium and vitamin D supplementation on
prevention of osteoporotic fractures and colon cancer. Women who
are ineligible or unwilling to participate in the clinical trial
will be offered the opportunity to enroll in the concurrent
long-term observational study that will delineate new risk
factors and biological markers for these diseases in women. The
third component of WFU, the community prevention study, is aimed
at evaluating strategies to achieve the adoption of health
behaviors such as improved diet, nutritional supplementation,
smoking cessation, increased physical activity, and early disease
detection. It is being conducted collaboratively with the
Centers for Disease Control and Prevention through grants to its
Community Prevention Centers.
Announced in 1991, the project is progressing well: 16
vanguard centers began recruitment of volunteer participants in
September 1993, and an additional 24 clinical centers were added
in February 1995. As of January 31, 1996, with two years to go
in recruitment efforts, the study had 45,974 women participating,
including 66.3 percent of the total goal for the hormone
replacement study, 79.6 percent of the goal for the dietary
modification study, and 81.4 percent of the goal for the
observational study. The goal for minority participants is 20
percent of the total enrollment and 17.6 percent already have
been recruited. Although the WFU is scheduled for completion in
2004, results will be published before that end point as
scientific data become available and are fully analyzed.
The Office of Research on Minority Health
Minorities at all stages of life suffer poorer health and
higher rates of premature death than do members of the majority
population. For some conditions, such as asthma and ADDS, a good
deal is known about why minority populations are the hardest hit;
less is known about how to reduce the disproportionate burden of
these illnesses. For other conditions, such as lupus and certain
cancers, it is still unclear why minorities are
disproportionately affected.
Recognizing this disparity in health status, the fact that
research has much to contribute to closing the gaps between
minority and nonuniformity populations, and the
disproportionately low number of biomedical researchers who are
minority, NIH created the Office of Research on Minority Health
(ORMH) in 1990, within the NIH Office of the Director, but with a
trans-NIH mission. The focus is twofold: to support and promote
biomedical research aimed at improving the health status of
minority Americans across the lifespan and to support and promote
programs aimed at expanding the participation of underrepresented
minorities in all aspects of biomedical and behavioral research.
The ORMH works in partnership both with grassroots organizations
in minority communities and with the scientists and program
experts in the NIH institutes, centers, and divisions (ICDs).
The office does not offer research training support directly to
the community; rather, it supports studies and programs as pilot
projects that are subject to rigorous scientific scrutiny and
ongoing assessment. It is expected that pilot projects that are
successful will ultimately become part of the research portfolios
of the ICDS, freeing ORMH funds to support new pilot projects in
other areas of need.
The Minority Health Initiative was launched in 1992 and
funded at over $55 million in fiscal year 1995. It comprises a
series of multi- year projects. The Infant Mortality component of
the MHI supports community-based epidemiologic and clinical
research to address the problem of the unacceptably high infant
mortality rate in inner cities. The Minority Children component
focuses on research on injury-related morbidity, lead poisoning,
asthma, learning disorders, and hearing and speech impairments
among minority children ages 1-9. The Minority Youth initiative
focuses on the development and evaluation of community-based
interventions for decreasing violence- related injuries and
deaths, sexually transmitted diseases and unintended pregnancies
in minority youths, aged 10-24. The Young Adult initiative
supports a variety of research projects related to the health
problems and behaviors of young minority adults. Research
projects focus on problems such as kidney disease, diabetes,
hemochromatosis, glaucoma, lupus, AIDS and alcoholism-including
risk factors for Native Americans.
The ORMH recognizes that much needs to be done to increase
minorities in research study populations; enhance the capacity of
the minority community to participate in addressing its health
problems, engender collaborative research and research training
programs between minority and majority institutions; enhance the
competitiveness and number of well-trained minority scientists
applying for NIH funding; and develop an assessment tool for
minority programs at NIH and a coordinated information system to
fink these programs.
The Office of Alternative Medicine
The Office of Alternative Medicine (OAM), located in the
Office of the NIH Director, provides a central NIH focus for a
research area relevant to all NIH components. It was created in
recognition of the fact that alternative medical practices are
becoming increasingly popular in the industrialized world and
that research might help in identifying effective approaches. In
the U.S., one out of every three Americans saw an alternative
health care practitioner in 1990, and over S 13 billion was paid
for these services. Surveys show that 50 percent of patients
with cancer use unconventional practices at some point during the
course of their illness, and over 50 percent of conventional
physicians use or refer patients for alternative medical
treatments in the U, S. Generally, alternative medicine is
defined as practices used for the prevention and treatment of
disease that are not widely accepted by physicians in medical
schools, nor generally available inside hospitals. Over 80
percent of those who used unconventional practices in 1990 used
these practices along with conventional medicine.
The purpose of the OAM is to facilitate the scientific
evaluation of alternative medical treatment modalities; to
investigate and evaluate the efficacy of alternative treatments;
to establish an information clearinghouse to provide information
to the public; and to support research training in alternative
medical practices. Funds allocated for the office were $2
million in 1992 and 1993, $3.5 million in 1994, and $5.4 million
in 1995. Across the NIK in 1993 for example, an additional $13
million was expended by the institutes for grants relating to
alternative medicine, demonstrating the trans-NIH nature of this
pursuit.
In 1995, a new director of the OAM was appointed and the
office was reorganized to better focus its activities on specific
elements of the Congressional mandate. Eight new national
research centers were funded around the country, and a technology
assessment conference was held-in conjunction with other NIH
components-on behavioral and relaxation approaches to treatment
of chronic pain.
All of these program offices within the Office of the
Director add to the ability of the NIK overall, to foster and
support its mission of research that will improve the health and
well-being of all segments of the American public. This concludes
our remarks. We would be pleased to answer any questions you may
have.
