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titis patients with alpha interferon, the only substance found to inhibit a particularly severe form of viral hepatitis. Investigators are also studying the effects of combining alpha and gamma interferons to treat this disease.

Anorectal disorders

Anorectal disorders such as hemorrhoids and incontinence do not always kill, but the disability and economic loss associated with these diseases are significant among elderly patients. In acute care facilities, fecal incontinence occurs in 26 percent of cases. The National Center for Health Statistics reports over 200,000 hospital admissions per year for hemorrhoid treatments, with a cost over $196,000,000. The Committee recommends that the Digestive Diseases Advisory Board formulate a long-range plan for studying the causes and treatment of anorectal disease. As well, adequate resources should be targeted toward funding research projects, and consideration should be given to establishing adequate epidemiologic data studies to document statistics and information on anorectal disease.

Digestive disease researchers

As requested by the Committee in last year's report, the Institute developed a document outlining the serious shortage of young investigators entering the field of digestive disease research. Funding for career development awards and other mechanisms through the Institute were revealed to be inadequate. The Committee urges that every attempt be made by the Institute to implement the recommendations made by this important document. An adequate level of funding has been provided by the Committee for this purpose.

Diabetes

Diabetes is one of the Nation's most serious health problems, affecting 11 million Americans at an annual cost of $14,000,000,000. Recent research into the causes of juvenile-onset (type I) diabetes points to a multigene defect in which two genes may act together to destroy the insulin-producing cells of the pancreas. As a future therapy for type I diabetes, pancreatic transplantation shows promise; current research in this area is revealing new ways to prevent organ rejection.

Adult-onset (type II) diabetes occurs when cells are unresponsive to insulin, often caused by defects in the cell's insulin receptors. The recent cloning of the insulin receptor is enabling researchers to study the interaction of insulin with its receptor and the importance of this interaction in adult-onset diabetes.

Both forms of diabetes can lead to many debilitating and life-threatening complications such as kidney failure, blindness, and limb amputation. The diabetes control and complications trial, which tests the ability of heightened glucose control to alter the course of complications in type I diabetes, is in the full-scale stage with about 1,400 volunteers.

The Institute supports ongoing research and is stimulating new research initiatives on the special health problems of minorities, especially in the area of diabetes research.

The Committee is aware that the National Diabetes Advisory Board's "National Long-Range Plan to Combat Diabetes, 1987" contains recommendations for two major new programs designed to enhance diabetes research and to improve translation of research results to clinical care. These recommended programs include: the establishment of eight diabetes interdisciplinary research programs to integrate the most modern scientific techiques into diabetes research; and establishment of a Diabetes Translation Center at the Centers for Disease Control to plan, conduct, and coordinate national efforts to transfer research advances into community level preventive health services. The Committee urges favorable consideration of these new initiatives as an expansion of the NIDDK research effort.

The Committee notes with great concern that the largest single cause of renal disease is diabetes mellitus. Expert testimony before the Committee warned that within the next decade the number of patients entering end stage renal disease [ESRD] will increase form 30 percent to 50 percent.

These expert witnesses informed the Committee, "The field of kidney disease of diabetes mellitus is poised on the threshold of an important new era which may ultimately lead to a significant reduction in the morbidity and mortality of the renal complications of diabetes mellitus." They cited the need for additional research on the effects of antihypertensive agents and glycemic control on the progression of kidney disease in patients with diabetes mellitus and studies in the epidemiology of kidney disease of diabetes mellitus in groups with a known predisposition to diabetes.

The Committee, therefore, urges the National Institute of Diabetes, Digestive and Kidney Diseases [NIDDK] to undertake new kidney diabetes mellitus research initiatives with the funds provided for fiscal year 1988.

Urology and diabetes

While research is advancing rapidly in the area of diabetes, it is becoming increasingly clear that research is needed in the areas where diabetes presents major urological problems. Impotence and neurogenic bladder are diseases often resulting from diabetes, and these areas have had little research in the past. The Committee believes that increased research is needed in this area.

Kidney and urologic diseases

More than 13 million Americans suffer from kidney and urinary tract diseases. Treating the more than 80,000 patients with end-stage renal disease [ESRD], who require dialysis and kidney transplantation, costs nearly $3,000,000,000 annually. Diabetics are not only the largest segment of the ESRD population, but have excessively high mortality rates at much younger ages, making this complication of diabetes especially tragic. To arrest the rapidly expanding numbers of diabetics with ESRD, NIDDK is beginning a multifaceted research initiative to slow or prevent the progression of diabetes-related kidney disease. Intramural

studies are now under way, and the diabetes control and complications trial will track the natural history of the disease. The Institute is strongly encouraging the origination of new research efforts and the recruitment of new investigators to interlink the many scientific disciplines needed to understand diabetes-related kidney disease.

A new method to measure kidney filtration rate, developed by Institute researchers, is aiding in evaluating new therapies that can arrest or reverse some types of renal disease. Lowering blood pressure is one promising way to halt kidney injury in people whose kidney function is compromised. The establishment of the ESRD data system will meet a need to document the effectiveness of various ESRD treatments, characterize the ESRD patient population, and identify areas of future research.

NIDDK is stimulating research on determining optimal regimens for children receiving kidney transplants. Also in the area of transplantation, NIDDK researchers found that combining immunosuppressants improves kidney transplant outcomes; this regimen also benefits patients with lupus nephritis.

The diet study is a 4-year clinical trial designed to determine if dietary factors can alter the progression of kidney disease. Ten new participating institutions are being added as the study enters its full-scale phase.

Research on kidney stones reveals that potassium citrate greatly reduces kidney stone formation. By dramatically reducing the need for surgery, this treatment has potential for multimillion dollar savings.

Benign prostate growth affects over 50 percent of men over age 50. NIDDK researchers recently found the first prostate-specific growth factor, a breakthrough in understanding prostatic growth.

NIDDK is establishing a congressionally mandated program of kidney and urologic research centers. Six centers will be established this year to inaugurate the new program, which will expand research into the causes, disease processes, and therapies for ESRD and benign prostatic hyperplasia.

Interstitial cystitis

The Committee heard testimony on interstitial cystitis, a painful and debilitating condition which is often undiagnosed or misdiagnosed and for which no satisfactory treatment or cure is known. The Committee is pleased that NIDDK is conducting a workshop on interstitial cystitis and has also interested the research community in this disease by issuing a request for proposals on basic bladder physiology including states such as interstitial cystitis.

The Committee believes that the Institute should continue to solicit research proposals on the etiology and treatment of interstitial cystitis and should give such proposals high priority, special consideration, and support. The Committee strongly encourages the allocation of supplementary funds to conduct basic research on interstitial cystitis at the established kidney and urologic diseases research centers.

Urologic research investigators

The Committee learned that many areas of urologic research now show considerable promise, but there seems to be a shortage of qualified urologic research investigators.

The Committee believes that a report should be developed on the needs in urologic research training, including a projection of the needs for manpower and the required levels of funding and the grant mechanisms to meet those needs. This report should be made available to the Committee by January 1, 1988.

Metabolic diseases

Institute investigators are locating and cloning the missing or defective genes that cause metabolic diseases, which are mostly rare orphan diseases. These studies are generating new therapies, such as administering genetically engineered enzymes or dietary factors that compensate for defective cell metabolism.

Two exciting breakthroughs in cystic fibrosis recently narrowed the location of the defective gene to a small portion of chromosome 7 and produced strong evidence that the primary biologic defect in the disease is the cell's inability to conduct chloride. Intramural researchers are exploring the use of a new test for early detection and monitoring of cystic fibrosis.

The success of existing centers and other research center programs supported by the Cystic Fibrosis Foundation has proven the vitality of the multidisciplinary approach such centers can bring to the research problems that surround cystic fibrosis. In view of the medical burden caused by cystic fibrosis and recent encouraging research progress, the Committee has provided up to $3,000,000 to fund cystic fibrosis research centers selected through the normal competitive process. Of this total, up to $500,000 has been provided within the budget of the National Heart, Lung, and Blood Institute.

Hematology

NIDDK researchers contributed to cloning the gene for the hormone erythropoietin, a regulator of red blood cell production. This landmark in blood research allows the hormone to be commercially produced for use in treating anemia. A clinical trial in patients with ESRD-associated anemia is producing overwhelmingly positive results of erythropoietin therapy.

A newly developed laser technology is enabling intramural researchers to study blood flow patterns in sickle cell patients. This technique can be used to detect blood flow changes that precede clinical crises and evaluate treatments in sickle cell patients.

Endocrinology

Last year, research in endocrinology yielded an amazing number of newly discovered hormones, meriting several Nobel prizes. Scientists are defining the roles of hormones in diseases as diverse as osteoporosis, Alzheimer's disease, and kidney disease and are exploring their connection with the immune system.

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The discovery of a new family of hormones is giving insights into reproduction that may have applications to fertility and contraception. NIDDK and NICHD are jointly funding a long-term epidemiologic study of recipients of human growth hormone from the National Hormone and Pituitary Program to determine any possible association between the use of human growth hormone and Creutzfeldt-Jakob disease.

Nutrition

The Institute's nutrition program integrates diverse areas of investigation, such as nutrient metabolism, intravenously administered diets, and obesity. The increased risk of the obese to many health problems is a major concern. NIDDK researchers have increased understanding of metabolic mechanisms, the role of body fat distribution, and the identification of the markers that predispose people to obesity. Participating in the explosion of interest in omega-3 fatty acids, NIDDK researchers found evidence that omega-3 fatty acids are essential to the normal function and development of the brain and retina.

NATIONAL INSTITUTE OF NEUROLOGICAL AND COMMUNICATIVE DISORDERS AND
STROKE

1987 comparable appropriation

1988 appropriation request..

House allowance1

Committee recommendation..

This does not include $12,755,000 provided for AIDS in another section.

$490,553,000

433,005,000

554,039,000

550,172,000

The Committee recommends an appropriation of $550,172,000 for the National Institute of Neurological and Communicative Disorders and Stroke [NINCDS]. This is $117,167,000 more than the administration request, $59,619,000 more than the fiscal year 1987 appropriation of $490,553,000, and $3,867,000 less than the House allowance.

The NINCDS conducts and supports research and research training on the cause, prevention, diagnosis, and treatment of literally hundreds of neurological and communicative disorders. This effort requires a careful balancing of basic research, which is fundamental to understanding the mechanisms of the brain and nervous system, and clinical research, which provides more immediate benefits for the health of the Nation. Spinal cord injury

The number of spinal-cord-injured people in the United States is estimated to be between 250,000 and 500,000. Although the lives of more and more accident victims are being saved today because of improved emergency medical and surgical services, survivors who are paralyzed still face a lifetime of difficulty. After initial injury, the spinal cord reacts to trauma with a complex series of changes. The body releases a number of substances to control pain, swelling, and bleeding. Some of these substances, however, may contribute to subsequent damage within the spinal cord and to ultimate loss of function. Scientists are trying to identify these secondary events and develop forms of intervention that will prevent or lessen the resulting damage and improve the patient's chances for a favorable recovery.

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