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Testimony on Revitalization of the NIH by Harold Varmus, M.D.
Director, National Institutes of Health
U.S. Department of Health and Human Services

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

I am Harold Varmus, Director of the National Institutes of Health (NIH), and I am pleased to appear before you to discuss the revitalization of the NIH.

Organization and Purpose of the NIH

The NIH is a confederacy of twenty four organization units that seeks to expand fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to improve the health of human beings. The research undertaken by the NIH assumes many forms, occurs in many places, and employs many techniques. Some research is confined to the laboratory, and often attempts to understand complex biological systems by examining individual molecules, cells, or tissues; some addresses normal human biology and disease in the context of living subjects; and some is based on the study of human populations. About ten percent of NIH-funded research takes place in the NIH intramural program; the rest is conducted at nearly 2000 institutions which receive grants, contracts, and cooperative agreements awarded by the NIH after competitive expert review. Both intramural and extramural research activities address a wide spectrum of biological questions with methods that range from structural analysis of macromolecules to clinical trials to behavioral studies. In addition, the NIH takes responsibility for the training of new medical scientists through programs designed to assist undergraduates, graduate, and post-graduate students in both extramural and intramural settings.

These several genres of research activity are supported by funds allocated to twenty one Institutes and Centers (IC's), each of which has authorities defined by earlier legislation. Seven IC's address specific health problems: the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Four IC's are organized around biological systems: the National Heart, Lung, and Blood Institute, the National Eye Institute, the National Institute on Deafness and Other Communication Disorders and the National Institute of Dental Research. Two IC's focus on stages of human development: the National Institute of Child Health and Human Development and the National Institute on Aging. Five other IC's study particular aspects of human health or area of science: the National Institute of Mental Health, the National Institute of Environmental Health Sciences, the National Institute of General Medical Sciences, the National Institute for Nursing Research, and the National Center for Human Genome Research.

Other IC's provide research infrastructure. The National Center for Research Resources supports research infrastructure including shared instrumentation programs and centers for clinical research located across the Nation; the Fogarty International Center fosters international scientific collaborations; and the National Library of Medicine collects, disseminates, and exchanges biomedical information. The NIH organization also includes three independent Divisions without budgetary authority. The Division of Computer Research and Technology and the Division of Research Grants carry out research management functions involved in review of grant applications and maintenance of our information infrastructure; while the NIH Clinical Center supports nearly 50 percent of all the federally-funded clinical research beds in the Nation and helps translate basic science discoveries of intramural and extramural investigators into clinical applications that advance human health.

A Seamless NIH

Although each of the IC's has a specific research orientation, there are many commonalities. Most obvious are the shared technical approaches to medical research and the common locations for research within the intramural and extramural programs. In addition, IC's often address different aspects of the major health problems faced by our citizens. This feature requires close interactions among the IC's; these may be informal, or they may be guided by inter-IC committees or by NIH-wide coordinating offices, some of which are located within the Office of the Director, NIH. This rich matrix of research activity requires collegial relations among the IC's and thrives in an atmosphere that maximizes flexibility in the management of research programs. A major objective of my administration at the NIH has been the enrichment of these interactions and a strengthening of the sense of unified purpose.

My colleagues and I will attempt to display these attributes of the NIH in the presentations to be made by each of the five panels that will testify during the remainder of this hearing. The Committee will hear about four important problems in medical science --- cancer, degenerative diseases, neuroscience, and infectious diseases --- and will learn about the physical and intellectual infrastructure that supports our work. In each presentation, we will emphasize the multidisciplinary approach that is undertaken by IC's working collaboratively to address the Nation's health.

An Illustrative Example

I will begin with an illustration of how the NIH does research, describing a common condition that almost everyone in our country worries about --- obesity. To some, obesity may appear to be a simple problem: too much fat in a body that ingests too much food. But, in fact, obesity is a problem with complex origins and complex manifestations; as a result, it engages the energies of many of our IC's, as well as other government agencies, and demands a wide variety of technical approaches.

At least six major issues need to be confronted (Chart 1): the definition and prevalence of obesity; the factors that contribute to its cause; the other medical conditions to which it predisposes; and the preventive and therapeutic strategies that can be used to control it. At the NIH, the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) leads the efforts to confront most of these issues, both by supporting a great deal of research on obesity and diabetes and by housing several organizations --- the National Task Force on Prevention and Treatment of Obesity, the Weight-Control Information Network, and the Office of Nutrition--that help to coordinate research activities and interpret and disseminate the findings. But at least ten other IC's support studies of obesity and its complications and participate in the coordinating functions. In addition, several program offices in the Office of the Director, NIH --- the Office of Research on Minority Health, the Office of Research on Women's Health, the Office of Disease Prevention, and the Office of Behavioral and Social Sciences Research --- help to guide obesity research in the areas of their expertise.

Largely through the work of the National Health and Nutrition Examination Surveys, conducted by our sister agency, the Centers for Disease Control and Prevention, we know that obesity, as currently defined, afflicts about 50 million adults, roughly one third of the population over 30 years of age. The condition disproportionately affects women, minorities, and the poor. Unlike most other risk factors for cardiovascular disease, such as smoking, hypertension, and blood lipid levels, obesity has become substantially more common in the past decade, especially among children and adolescents.

The importance of obesity as a subject for research by the NIH is underscored by its impact on the morbidity and mortality of our citizens (Chart 2). Obesity is second only to tobacco as a risk factor for disease, accountable for about 300,000 deaths per year and an economic cost of between 50 to 100 billion dollars. Of the diseases promoted by obesity, cardiovascular disorders and diabetes (non-insulin dependent diabetes mellitus NIDDM ) are probably best known; but obesity also increases the likelihood of several cancers, stroke, gall bladder disease, gout, and osteoarthritis, and is associated with eating, sleep, and mood disorders. For these reasons, obesity is studied from many vantage points by a large number of the organization units at the NIH.

The rising prevalence of obesity attests to our inability to control it effectively, despite the fact that at any one time about one third of our adult population claims to be engaged in weight control activities --- dietary, pharmaceutical, and behavioral modification programs. A recent NIH Consensus Conference, organized by the Office for Disease Prevention in collaboration with the White House Council on Physical Fitness, strongly recommended greater attention to increased physical activity as a means to control weight, in part because it provides health benefits even in the presence of obesity. In addition, behavioral research shows long-term benefits to obese children receiving family-based therapies. But, in general, weight loss is transient with the methods now in widespread use, and the dangers of frequent cycles of weight gain and loss have not been fully assessed.

In the long run, the best prospects for control of obesity reside in a better understanding of its origins. Many factors are now known to contribute to obesity (Chart 3). Several of these (such as gender or socioeconomic status) are difficult or impossible to alter, but others (such as dietary habits and physical activity) should be amenable to change through instruction. The difficulty in achieving long-term behavioral changes accounts in part for the public excitement about some remarkable recent discoveries of genetic factors controlling obesity and obesity-associated NIDDM in animals.

Mice and rats with certain inherited mutations that predispose to obesity and NIDDM (Chart 4) are now known to lack a hormonal mechanism for maintaining healthy patterns of eating and activity. Through this mechanism, the animals --- and, presumably, human beings-- regulate diet and exercise through the brain's response to a hormone, called leptin, that is produced by fat cells. Although it appears unlikely that this hormone is itself deficient in a significant number of obese people, the isolation of the genes for leptin and the leptin receptor has already deepened our understanding of metabolism and stimulated additional fundamental research. Furthermore, applied studies already underway in the private sector may yield more potent ways to control body fat and thereby prevent NIDDM and other complications of obesity.

Challenges to the Continued Productivity of American Medical Research

Throughout the course of these hearings, we will present many examples of excellence in NIH-supported research programs, the basis for our Nation's uncontested role as the world leader in medical research. But to remain strong, the NIH --- and the American research enterprise generally --- must be capable of adapting to very substantial demographic, economic, and other changes in our society. These changes are already beginning to affect the kinds of problems we study, the way we finance medical research, and the recruitment and training of new scientists.

Demographic changes and disease incidence. Although public health has improved dramatically over the past half-century, due in large part to NIH-supported biomedical research, current demographic trends are creating new health problems. The aging of the U.S. population, for example, is leading to an increase in chronic and degenerative diseases, as will be presented by one of tomorrow's panels. More people are surviving acute illnesses and injuries that were once invariably fatal. As the number of minorities in the U.S. grows, diseases such as diabetes mellitus, which disproportionately affects members of some minority populations, will become more prevalent. These changes and many others that affect the distribution of illness must inevitably affect the emphasis we place on the study of various diseases. They also demand that we have the flexibility to respond as an institution to new health threats and to recurrences of old ones. Current concerns about emerging and re-emerging infections, as discussed by another of tomorrow's panels. illustrate this problem well.

Changes in health care delivery and clinical research. Systemic changes in the financing and delivery of health care also may be producing substantial effects on the Nation's biomedical research capacity. Most NIH-supported medical research, especially clinical investigation, is conducted at academic health centers. During the 1980s, these centers began to rely heavily on clinical revenues to subsidize the costs of both teaching and research. As more patients enroll in managed care organizations, however, referrals to the centers could decline, because their multiple missions drive up service costs. As a result, less clinical revenue may be available to support biomedical research. In addition, managed care providers are reluctant to support the costs of clinical research by covering hospitalization and other health care needs for patients enrolled in clinical trials.

These changes will affect the capacity of some academic medical centers to conduct research, particularly patient-oriented research. They may also affect the availability of research subjects for clinical trials. In addition. as the States increasingly adopt managed care plans under their Medicaid Programs, recruitment of minorities and underserved populations into clinical trials may be more difficult. These trends could slow the discovery of new treatments for many diseases.

The NIH is attempting to respond to these changes by providing better oversight of clinical research in both the extramural and intramural sectors. The NIH Director's Clinical Research Panel is seeking new sources of funds to support clinical research, evaluating the programs for recruitment and training of clinical investigators, and determining where clinical research can be most effectively conducted. The NIH Clinical Center is also undergoing major changes in governance, financing, and daily function, as a result of a recent REGO II evaluation, and it has strengthened its training programs in clinical research.

Yesterday, the NIH and Department of Defense announced a demonstration project that we believe could serve as a model for future partnerships in health care between the health insurance industry and medical research community. The National Cancer Institute and the DoD signed an agreement that formalizes the process by which patients who are beneficiaries of DoD's health benefits program can participate in NCI-sponsored clinical trials.

Changes in the recruitment of new scientists. The number of scientists working in fields supported by the NIH has increased in the past decade. As a result, research scientists face more competition for jobs, especially in the academic sector; a lower likelihood of success when applying for NIH grants; longer periods of graduate and post-doctoral training; and considerable and justifiable anxiety about their long-term productivity and career prospects. These problems have been offset somewhat by increased hiring in medical research industries-including biotechnology, research supplies, and pharmaceutical companies. In addition, new Ph.D.s and M.D.s have pursued new career options, including patent law, science policy, journalism and business.

The need for research in the health sciences is unlikely to diminish in the decades ahead. Our ability to maintain the momentum of recent scientific progress and our international leadership in medical research depends on the continued production of new, highly trained investigators. We do not plan to reduce our efforts to recruit new investigators, especially from under-represented sectors of the population, or to curtail our training programs for graduate and post-graduate students. We do, however, agree with a recent report from the National Research Council that argues that trainees should be better acquainted with the wide variety of new career opportunities that have been created by the remarkable success of medical science.

Proposed Authorization Legislation

I support the authorization process. and am pleased the Committee has undertaken these hearings. Authorization can play a strong role in facilitating NIH's ability to conduct research. NIH has been working with the Department to develop authorization proposals that will help NIH advance scientific excellence in basic and clinical research. We look forward to sending the Committee a letter from Secretary Shalala outlining these authorization proposals in the coming weeks.

Our proposals will likely fall into four broad areas: research training; improving NIH' s administrative efficiency and flexibility, ensuring that all of NIH's Institutes, Centers, and Divisions, including the National Center for Human Genome Research, possess similar authorities; and extending the authorization of the NIH Office of AIDS Research. Each of the authorization proposals HHS submits to the Congress will help NIH capitalize on new areas of scientific opportunity. Extending the authorization of the Office of AIDS Research, which plans, coordinates, and funds all NIH AIDS research, will guarantee that NIH has the flexibility to respond immediately to the many promising new avenues of research that will help us fight AIDS. Central to this flexibility is retention of the Office of AIDS Research's budgetary authority.


When I first appeared before this Committee on November 2, 1993, as part of the process leading to my confirmation as Director of the NIH, I pledged to remain firmly committed to scientific excellence, to defend open-ended basic science, and to encourage the extension of discoveries to clinical settings. I believe that you will see many examples of the fruits of that pledge in the course of our testimony over the next two days. I hope we will convince you that the NIH continues to thrive and that its reauthorization is richly deserved.

I look forward to working with the Committee on the reauthorization of NIH and would be pleased to answer any questions you may have.

**Attached are 3 charts.

Chart 1

Obesity Issues



Causative Factors

Associated conditions



Chart 2

Conditions Associated with Obesity

Obesity is in the middle with the following conditions pointing to and from it.

  • Hypertension
  • Stroke
  • Heart Disease
  • Hyperlipidemia
  • Non-Insulin dependent Diabetes Mellitus
  • Osteroarthritis
  • Mood Disorders
  • Sleep Disorders
  • Eating Disorders
  • Gout
  • Gall Bladder Disease
  • Some Cancers

Chart 3

Causative Factors

Obesity is in the middle with the following conditions pointing to and from it.

  • Nutrition
  • Smoking Cessation
  • Gender
  • Race
  • Socio-economic Status
  • Age
  • Genetic Factors
  • Metabolic and Endocrine Status
  • Pregnancy
  • Activity Level

Chart 4
is omitted from this version.

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