1. Introduction

Diabetes is a major public health problem. Approximately 5.5 million Americans have been diagnosed as diabetic. An estimated 4.5 million additional persons have undiagnosed diabetes. This year 500,000 new cases of diabetes will be diagnosed. Some 150,000 people will die from diabetes and its complications.

People with diabetes face a shortened lifespan and are subject to a number of long-term complications, including heart attacks, strokes, kidney failure, blindness, premature atherosclerosis, neurological disorders, and amputation of the lower limbs. Uncontrolled diabetes also results in the acute complication of diabetic ketoacidosis, a condition that can lead to coma and death. In addition, women with diabetes have a significantly increased risk of miscarriage and other obstetrical complications, and their babies have a higher incidence of birth defects, early mortality, and illness requiring intensive medical care in the early days of life.

The economic burden of diabetes is enormous and continues to rise because of increasing medical costs and an aging population. Each year, chronic and acute complications of diabetes contribute to 24 million days in the hospital and cost at least $7.4 billion in direct medical care. Additional indirect costs to our economy from disability and premature death total more than $6.3 billion each year. The costs of diabetes are reflected in higher health insurance premiums paid by employers, unions, and private citizens. In addition, a major portion of the economic burden of diabetes falls directly on the Federal Government and ultimately on the individual taxpayer through Medicare, Medicaid, and the health care responsibilities of the Public Health Service, the Veterans Administration, the Indian Health Service (IHS), and the Department of Defense. For example:

• About 25 percent of all cases of end-stage renal failure are attributable to diabetes. The annual cost of care for diabetic patients under the Medicare-funded End-Stage Renal Disease Program is currently about $200 million per year and is growing rapidly.

• About 5,000 new cases of diabetes-related blindness occur each year. Diabetic retinopathy is the leading cause of blindness among middle-aged Americans. Federal and state disability payments, benefits, and rehabilitation services total approxi

mately $60 million annually. This amount does not include the cost of medical services, loss of income, and other related expenses, nor does it reflect the reduced quality of life resulting from loss of vision.

• About 40,000 amputations are performed annually because of diabetes-related complications of the feet and legs. This number represents about one-half of all nontraumatic amputations in this country. Hospital costs for amputations related to diabetes exceed $350 million. The additional costs of physician services, disability and unemployment pay, and rehabilitation programs are several times higher. A major share of these expenses are borne by Federal health care programs.

• Diabetes is a major risk factor in complications associated with pregnancy. Approximately 14,000 babies are born each year to diabetic women, and an additional 90,000 babies are born to women who develop diabetes during pregnancy (gestational diabetes). Infants of diabetic mothers experience high rates of perinatal mortality (a total of 4,000 to 4,500 deaths per year), congenital malformations and anomalies, respiratory distress, prematurity, and other serious medical problems. Estimated costs of these perinatal complications range from $10,000 for a week of care in a neonatal intensive care nursery to $1 million for the lifetime care of a person handicapped by birth defects.

Major advances in biomedical research have greatly expanded our understanding of the pathogenesis of diabetes. Our ability to treat the disease and to prevent or reduce the severity of some of its complications has improved markedly. Major efforts to communicate these advances to health practitioners are being made in the Diabetes Research and Training Centers and through diabetes control programs in several states. However, current treatment advances, valuable as they are, do not cure the basic underlying disease, nor do they prevent the most serious complications. Preventing diabetes and reducing the severity of its complications would result in enormous savings in medical care, hospitalization costs, rehabilitation services, and

economic losses due to shortened lifespans and lost days of work. Therefore, continued support and expansion of diabetes-related biomedical research is a prerequisite to reducing the economic and social impact of diabetes. In addition, we must continue to improve our ability to communicate these results to the practicing community. Diabetes control programs also must be expanded to facilitate the effective application of currently available treatment information.

Recognizing the serious impact of diabetes and the need to develop effective strategies for its prevention and control, Congress established the National Commission on Diabetes in 1974 to prepare a Long-Range Plan to Combat Diabetes. As a result of the Commission's recommendations, the National Diabetes Advisory Board was established in 1976 to monitor the plan and to report on its progress annually to the Congress and the Secretary of Health and Human Services. The

plan specifically recommended a major expansion of the national research effort in diabetes, the establishment of Diabetes Research and Training Centers, and the initiation of diabetes control programs to facilitate the beneficial application of research advances to the patient. Federal diabetes-related programs were expanded during the latter half of the 1970's in response to the plan. This initial impetus, however, was not maintained into the 1980's.

This seventh annual report of the National Diabetes Advisory Board provides highlights of recent advances in diabetes research and control. Included is an analysis of current and recommended appropriations for the major Federal agencies responsible for implementing the plan. The needs and opportunities summarized in this report justify a strengthened and expanded Federal diabetes program.

Over the past 5 years, funding for the agencies with the greatest responsibility and the greatest opportunities for progress toward the eventual prevention of diabetes and its complications has not kept pace with inflation. For example, the increased costs of research have exceeded the rate of increase in the appropriations for the National Institutes of Health (NIH). As a result, the percentage of approved grants that could be funded has declined steadily, from 45 percent a few years ago to approximately 30 percent in 1984. This reduction would have been even greater if individual research grant budgets had not been administratively reduced in recent years below the funding levels recommended by the NIH peer review process. The decline also can be measured in the priority scores of funded grants. A priority of 100 represents the highest possible rating (on a scale of 100 to 500). Although it is generally agreed that a score of 225 or better represents excellent quality, most NIH Institutes have been unable to fund grants with scores above 190 in the past 4 years.

Congress attempted to correct this decline in fiscal year 1985, when it appropriated funds for NIH to support 6,500 new and competing grants. Under that appropriation, approximately 39 percent of approved grants would have been funded, to a priority score of approximately 170. However, there is some uncertainty at the present time whether the funds provided will be used to support the full number of 6,500 awards. The administration has proposed that only 5,000 new and competing grants be funded in 1985, some on a multiyear basis. The administration also has proposed that 5,000 grants be awarded in fiscal year 1986.

Although the Board is aware of the administration's efforts to reduce the Federal deficit, the Board nevertheless is committed to the strongest possible support for diabetes research throughout NIH. If NIH awards only 5,000 new and competing research grants in fiscal year 1985 or 1986, the priority score cutoff could be as low as 150 to 160 in many Institutes, the lowest level in the history of NIH. Such action would affect a large number of very high-quality research projects. Bright young trainees also would be discouraged from pursuing research careers, thus compromising our ability to conduct research in future years.

The increasing economic burden of diabetes directly

increases Federal expenditures for health care. Therefore, the Board recommends that the NIH fiscal year 1985 budget be used to fund the 6,500 new and competing grants provided by Congress and that additional funds be provided in 1986 to permit a modest increase for high-priority projects.

The National Institute of Arthritis, Diabetes, and Digestive and Kidney Diseases (NIADDK) is the lead agency for diabetes-related research. The Board recommends a budget for NIADDK of $640 million in fiscal year 1986, an increase of $95 million over the original 1985 congressional appropriation. This budget will enable grants to be funded at recommended levels to a priority score of approximately 180, permit funding of the Diabetes Control and Complications Trial, maintain support for the diabetes centers, and restore manpower development awards to the 1985 level.

Comparable increases are recommended for the other NIH Institutes and Divisions that support diabetes-related research, including the National Heart, Lung, and Blood Institute (cardiovascular consequences of diabetes), National Eye Institute (ocular complications of diabetes), National Institute of Child Health and Human Development (effects of diabetes on pregnancy and infants), National Institute of Allergy and Infectious Diseases (infections and immunogenetic factors in diabetes), National Institute of Neurological and Communicative Disorders and Stroke (neurological complications of diabetes), National Institute on Aging (interrelationships between diabetes and aging), National Institute of Environmental Health Sciences (relationship between environmental agents and pancreatic structure and function), and National Institute of General Medical Sciences (noncategorical research and the training of physician-scientists).

In addition, the Division of Research Resources (DRR) provides a critical resource that has direct application to diabetes research. The General Clinical Research Center (GCRC) program, funded by DRR, supports noncategorical clinical research facilities at academic institutions. The vast majority of all clinical investigations related to diabetes are conducted in these facilities. The budget for this important program has not kept pace with inflation in recent years, leading to a decline in the number of centers and the number of beds. This program should receive increased sup