DHHS Eagle graphic
ASL Header
Mission Nav Button Division Nav Button Grants Nav Button Testimony Nav Button Other Links Nav Button ASL Home Nav Button
US Capitol Building
HHS Home
Contact Us
dot graphic Testimony bar

This is an archive page. The links are no longer being updated.

Testimony on NIH Infrastructure by
Judith Vaitukaitis, M.D. Director, National Center for Research Resources Donald Lindberg, M.D. Director, National Library of Medicine Ruth Kirschstein, M.D. Deputy Director, National Institutes of Health
U.S. Department of Health and Human Services

Before the Senate Committee on Labor and Human Resources
March 6-7, 1996

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.


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.

Privacy Notice (www.hhs.gov/Privacy.html) | FOIA (www.hhs.gov/foia/) | What's New (www.hhs.gov/about/index.html#topiclist) | FAQs (answers.hhs.gov) | Reading Room (www.hhs.gov/read/) | Site Info (www.hhs.gov/SiteMap.html)