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Alan Brownstein

President/CEO, The American Liver Foundation
Statement on Hepatitis C

  • 25,000,000 Americans - or 1 in every 10 - are or have been afflicted with liver, bile duct or gallbladder disease. These diseases represent the seventh leading cause of death in the United States.
  • There are an estimated 3.9 million people infected with hepatitis C, with more than 5% of them expected to develop long-term liver diseases, cirrhosis or liver cancer. Since acute hepatitis C infections are typically mild, it is often not diagnosed and may be recognized only in its chronic state many years later. CDC has projected that deaths due to hepatitis C will more than triple by the year 2010 to more than 25,000 per year.
  • Liver transplantation at a cost of approximately $250,000 often becomes the only therapeutic option for those with chronic liver disease. Last year there were approximately 9,323 people on the UNOS list waiting for liver transplants (and 55,994 people on the list for all organs), and only 4,058 individuals actually received liver transplants. There are nearly 1,000 deaths each year among those waiting for a liver transplant.
  • With regard to hepatitis B, current estimates suggest that there are nearly 150,000 new infections annually, and there are about 1.2 million individuals with chronic hepatitis B in the United States. Severe manifestations of chronic hepatitis B infection include scarring of the liver (cirrhosis) and liver cancer which usually occurs decades later. Each year 5,000 people die due to HBV infection.
  • 22,000 pregnant women in the United States each year are estimated to be carriers of the HBV virus, an increase from the estimated 17,000 in 1991. Up to 90% of their newborns will become infected with hepatitis B unless detected and treated. In the future, vaccination of newborns would prevent them from becoming infected as they grow older.
  • Two chronic and life threatening liver diseases, primary biliary cirrhosis (PBC) and autoimmune hepatitis, disproportionately affect women. Women are 10 times more frequently affected by PBC than are men and 70% of the cases of autoimmune hepatitis are women.
  • People with chronic HBV infections have a 100 times greater chance of developing liver cancer than those not infected.

The research recommendations of the hepatitis C Consensus Development Conference and the implementation of the Research Action Plan for Liver Disease, soon to be delivered to the Committee, provide important benchmarks for continued progress to find cures, prevention and better treatments for liver disease.

HEPATITIS C CONSENSUS DEVELOPMENT CONFERENCE MAKES SIGNIFICANT NEW RESEARCH RECOMMENDATIONS

In March 1997, the NIH convened a HCV Consensus Development Conference which assembled the best and brightest scientific minds from across the country to ascertain the best diagnostic and treatment protocols and to identify additional research most urgently needed to address the HCV health threat. Both the scientific and popular press covered the conference extensively and perhaps two headlines from the Washington Post capture the sense of urgency that emerged from the conference. On March 25 1997, the Washington Post ran a story with the headline "Researchers Fear That Hepatitis C Epidemic Looms;" and, on March 27, 1997, the Washington Post reported on the Consensus Conference with a story that included the following headline: "Death Toll From Hepatitis C May Triple in U.S."

The sense of urgency is due to the fact that over the past 30 years, about 4 million Americans have contracted chronic hepatitis C and the health outcome of these people - 1.8 percent of the Nation's population - is an unanswered question. HCV rarely causes immediate illness, is often diagnosed by chance years or even decades after a person contracts it, and about 85% of the people develop "chronic" infections. Without significant additional research and medical intervention, the medical system may be increasingly overcome with people chronically ill from hepatitis C. Already hepatitis C is the leading reason for liver transplants in the United States and transplantation becomes the only remaining medical option at the end stages of the disease.

The ALF, therefore, strongly recommends full implementation of the Consensus Conference research and public health education recommendations. The ALF's prestigious Hepatitis Council is comprised of specialists in hematology and infectious disease who are involved in both the practice of medicine and biomedical research. The ALF Hepatitis Council's review of

the Consensus Conference recommendations has resulted in translating the broad recommendations of the Conference into specific research strategies. The ALF recommends that to adequately fund the HCV research opportunities an additional $56 million will be required in the first year with research efforts sustained over a 7 year period supported with incremental funding totaling $404 million over a 7 year period. Attached to this testimony is a summary of the ALF recommended research initiatives. We will also make available to the Committee the ALF document, "A Research Agenda for 4 Million Americans," that provides the supporting discussion and justification for the research initiatives needed to implement the Consensus Conference recommendations.

INCREASING THE SUPPLY OF ORGANS FOR DONATION

We applaud the Committee's leadership in the Fiscal Year 1998 appropriations bill to include an increase of $500,000 for the HRSA Division of Transplantation for a Public Awareness Program to increase the rate of organ donation. As the Subcommittee knows, the need to increase the rate of organ donation is critical. Today there are more than 55,990 people on the UNOS list waiting for a donated liver, kidney, heart, lung or other organ. In contrast to the numbers on the waiting list - and about 500 people are added to the list each month - only slightly more than 19,400 Americans each year receive an organ transplant. As a result, about 4,000 people die in the U.S. each year. About 10 people die each day while waiting for an organ. Last year for example, nearly 1000 people died waiting for a liver. Last year the Administration recognized the shortage problem and requested a $1.6 million funding increase to launch an expanded Public Awareness Program. In December, 1997 the White House announced a series of new initiatives to focus on known barriers to donation. In order to have the impact that is needed, we believe that an increase of $5 million should be provided to the HRSA Division of Transplantation.

RESEARCH ACTION PLAN FOR LIVER DISEASE

In response to the Committee's guidance, the NIH is preparing a Research Action Plan for Liver Disease that will be submitted to the Committee along with the Fiscal Year 1999 budget proposal. With the Committee's leadership, funding for