STATEMENT OF THELMA KING THIEL, PRESIDENT AND CHIEF OPERATING OFFICER, AMERICAN LIVER FOUNDATION, AND CHAIRMAN, DIGESTIVE DISEASE NATIONAL COALITION

Mr. Chairman and members of the Subcommittee, I'm honored to be here and to call attention to some remarkable advances in Ilver research and some critical areas that need exploration.

Twenty years ago when I lost my Infant son, who was diagnosed with cirrhosis of the liver at two weeks of age, there was no hope. The prognosis for most victims of liver disease at that time was doom and gloom. Dr. Farrar has just told you about some of the miracles made possible through research; Ilver transplants; band-aid surgery for removal of gallbladders; advances in the treatment of hepatitis B and C; vaccines to prevent hepatitis B and one on the way for hepatitis A, to mention a few.

As recently as a year ago, if you received a blood transfusion, you had a 5-10% chance of being Infected with hepatitis C. A new test for this virus enables blood banks to identify this treacherous virus in about 50% of the blood donated. There still remains a chance of transmitting hepatitis C through blood transfusions.

Researchers have made the first glant step in solving this problem.

The next step

to Improve this test and make the blood supply totally safe depends on the skills and Investment of researchers' time. An Investment In this project alone could prevent an estimated 100,000 hepatitis C cases each year.

As you know hepatitis C can lead to cirrhosis and we are all aware of the high cost of treating this disease medically or by liver transplantation.

Cirrhosis is scar tissue that replaces damaged liver cells and goes all through the liver like the gristle in meat. In essence, the virus kills off employees In your Internal chemical power plant. As the Infection progresses you have

and

fewer and fewer employees in your liver to keep you alive and alert one day, without much warning, your power plant will shut down. That can be the end of the story for you or a loved one.

One of the vital functions the liver performs is the production and excretion of cholesterol. A lot of folks worry about those globs of cholesterol building up in their blood vessels. Maybe you do.

Within our grasp are the elusive answers to "why" cholesterol is a bad guy In some people and a good guy in others. If we had that answer we would not only prevent many heart attacks but we would also be able to prevent gallstones from forming circumventing the need for a half million gallbladder surgeries each year.

If we could stop, or even reverse, the development of cirrhosis, which is a fatal complication caused by many liver diseases including hepatitis, billary atresla, Iron overload, PBC, and Wilsons disease, and substance abuse, such as alcohol, we could reduce the high cost of end-stage liver diseases which Is often associated with life-threatening hemorrhages, requiring multiple hospitalizations and large amounts of blood. Currently, liver transplants are the only treatment available for thousands of patients with liver disease. Prevention of liver diseases and less costly, less traumatic and more effective treatments will only be found if the highly trained, brilliant reseachers we have in this country receive the support they need to make miracles become a reality.

The liver is its own worst enemy. It's a non-complaining organ not letting you know it's in serious trouble until it's almost at the point of no return.

The American Liver Foundation is the "voice of the liver" that needs to be heard and given the attention is justly deserves. The payoff In Ilves saved

and reduced health care costs is an Investment we can't afford to miss.

Mr. Chairman, thank you for giving me this opportunity to share this Information with you. I'd be happy to respond to any questions you might have.

STATEMENT OF THE NATIONAL DIGESTIVE DISEASES
ADVISORY BOARD

I am Dr. Harold J. Fallon, Chairman, Department of Medicine. Medical College of Virginia, and Chairman of the National Digestive Diseases Advisory Board. The National Digestive Diseases Advisory Board was established by Congress to review Federal digestive diseases programs and make recommendations for future directions Our 1991 annual report has been provided to this Subcommittee.

These

The numerous disorders known as digestive diseases include serious and potentially life-threatening illnesses such as cirrhosis of the liver, inflammatory bowel disease, hepatitis, cancer, ulcers, and gallstones. acute and chronic disorders have one common element they all affect the digestive tract, which includes the esophagus, stomach, liver, pancreas, small and large intestines, and anorectum. Digestive diseases are responsible for approximately 13 percent of all admissions to general hospitals in the United States and 10 percent of all surgical procedures.

Clinical Trials in Digestive Diseases (NIDDK)

The Board's recent reports have highlighted the need for a clinical trials program in digestive diseases. Carefully controlled trials are an essential component of the research continuum from the laboratory to patient Without clinical trials, many critical research questions remain unanswered, and potential treatments cannot be evaluated.

treatment.

Two years ago, the Board recommended that additional funds be appropriated to initiate new trials. Congress subsequently requested that NIDDK examine the need for trials and provide a report to Congress. That report highlighted areas considered by the Institute to be compelling because of public health needs, scientific opportunity, and/or technical feasibility, including primary biliary cirrhosis, inflammatory bowel disease, gallstones, and peptic ulcers.

The Board recently reviewed three NIDDK initiatives designed to strengthen the Institute's ability to foster and support priority trials: Planning grants. The NIDDK has issued a program announcement for 1year awards to support the design of improved clinical trials. Administrative guidelines. The NIDDK will issue guidelines in 1991 to establish a uniform process for design, submission, review, award, and monitoring of clinical trials.

Program office for clinical trials. The NIDDK has approved the
establishment of a program office for clinical trials in digestive
diseases to coordinate and expand staff support for this activity.

The NIDDK has allocated funds from its FY 1991 budget to support a limited number of planning grants. However, trials that are designed during the planning period cannot be initiated within existing NIDDK resources. Additional funds must be provided in FY 1992 to support these trials.

The Board urges Congress to provide an additional $7.5 million to the National Institute of Diabetes and Digestive and Kidney Diseases in FY 1992 to support clinical trials in digestive diseases.

It is the Board's unanimous opinion that substantial increases are required for all research programs of the National Institutes of Health in general and particularly for NIDDK. The current fiscal climate prevents investigators from initiating research in promising areas and deters future scientists from entering research careers. Additional funds are urgently required if we wish to reduce the impact of digestive diseases in the future.

The Board recommends that the total appropriation for the National Institute of Diabetes and Digestive and Kidney Diseases be increased to $721 million in FY 1992. This recommendation includes $7.5 million for the clinical trials initiative and necessary funds to support current research project and research center grants.

Elimination of Hepatitis B Transmission (Centers for Disease Control)

Hepatitis B is a major public health problem. Each year, 5,000 to 6,000 deaths occur from acute and chronic hepatitis B-associated liver disease. Next to alcohol abuse, hepatitis B appears to be the major cause of cirrhosis of the liver and liver cancer. Although a highly effective vaccine against hepatitis B became available in 1982, the incidence of the disease continues to rise because the vaccine is not reaching those individuals who are at greatest risk of infection.

During 1990, the Board has continued to review efforts to implement hepatitis B immunization programs. Based on information received from expert consultants and representatives of the Federal Government, the Board recommends the full implementation of the comprehensive national prevention program designed by the Centers for Disease Control (CDC) to eliminate transmission of this disease. The Board has transmitted this recommendation directly to the Secretary of Health and Human Services. Congress appropriated $16 million to CDC in FY 1991 to implement the first part of this prevention program. These funds will be used to prevent perinatal hepatitis transmission from mother to child among pregnant women who obtain their health care in the public sector (approximately 50 percent of all births). An additional $10 million is required in FY 1992 to initiate the second phase of this program:

· The universal immunization of infants born to first generation immigrant mothers who come from those parts of the world with high rates of hepatitis B (Asia, Africa, and parts of Eastern Europe).

The development of the public health infrastructure required to
integrate routing hepatitis B vaccination of infants into current
immunization programs.

Funds for all phases of the hepatitis elimination program should be included in the administration's budget for FY 1993 and later years.

The Board recommends that Congress provide an additional $10 million to the Centers for Disease Control in FY 1992 to initiate the second phase of the national program to eliminate hepatitis B transmission.

STATEMENT OF THE NATIONAL DIABETES ADVISORY BOARD

I am Dr Jerrold M Olefsky, Professor of Medicine, Division of Endocrinology and Metabolism at the San Diego School of Medicine, University of California, and Chairman of the National Diabetes Advisory Board. The National Diabetes Advisory Board was established by Congress to review Federal diabetes programs and make recommendations for future directions. Our 1991 annual report has been provided to this Subcommittee.

Diabetes and its complications are among the leading causes of death, disability, and associated medical expenses in this country. The true cost of diabetes includes premature heart disease, stroke, blindness, renal failure. amputation of extremities, and babies born with birth defects. A major portion of the economic burden of diabetes is paid by Medicare and Medicaid.

In 1987, the Board updated the national long-range plan that is designed to reduce the medical, economic, and human impact of diabetes and its complications. Unfortunately, most of those recommendations still have not been implemented because of inadequate Federal appropriations. Many promising research initiatives cannot be undertaken because of fiscal constraints placed on the National Institutes of Health (NIH) in general and in particular on the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Current funding levels are seriously impairing established research programs, discouraging investigators from embarking on new research initiatives, and deterring future scientists from entering the field.

Search for the Diabetes Genes. In the past decade, we have witnessed an explosion in our ability to isolate genes responsible for a few human diseases, such as cystic fibrosis. Diabetes is a genetic disease with environmental determinants. The term diabetes, however, encompasses a number of different diseases; hence, a number of different genes may be involved. Therefore, the attempt to isolate diabetes genes will be complex. However, geneticists already are developing the research tools and techniques to solve the difficult problems of diabetes.

Within the past 2 years, a dramatic discovery has uncovered a diabetes susceptibility gene in insulin-dependent diabetes that appears necessary, but not completely sufficient, to cause the disease. There is an urgent need to search for other contributing genes in insulin-dependent and noninsulindependent diabetes. A broad-based research effort in this area should be initiated. An additional appropriation must be provided to enable NIDDK to implement this important program.

The Board recommends that Congress appropriate an additional $50 million to support activities related to the search for the diabetes genes.

Atherosclerotic Cardiovascular Disease is the major cause of morbidity and mortality in people with diabetes. During the past decade there has been an explosion of knowledge about the cellular and molecular biology of atherosclerosis and the genesis of the disease. In contrast, there is a paucity of basic research information about how diabetes affects this process and how these effects might be modified. There is an urgent need to conduct additional basic research to identify the causative factors and mechanisms that lead to increased atherosclerosis and cardiovascular mortality among people with diabetes.