March 8, 2004
As the largest national organization serving the bleeding disorders community, the National Hemophilia Foundation (NHF) is acutely aware of the impact of and challenges presented by the hepatitis C virus (HCV) to persons with hemophilia and other bleeding disorders. We are committed to addressing the needs and interests of HCV-affected individuals through the Foundation’s advocacy, education, and research programs.
Nearly four million people in the United States are infected with HCV, with blood transfusions accounting for 10 percent of these cases. Prior to 1990, there was no HCV test for donated blood and plasma. During this time, the risk of HCV infection from a blood transfusion was between 8 and 10 percent. This risk was amplified for persons with bleeding disorders as, at the time, plasma pools used to manufacture clotting factor contained blood from 60,000 to 400,000 donors. Since testing was implemented in 1992, the risk of HCV has become negligible, although transmissions have and continue to occur. The risk today of transfusion-associated HCV is less than one per million transfused units of blood.
HCV, however, continues to take a heavy toll on the bleeding disorders community. Overall, an estimated 6,200 persons with bleeding disorders are affected by HCV, representing 44 percent of all persons with hemophilia and five percent of all persons with von Willebrand disease. As expected, persons above the age of 21 have the highest rates of infection.
Current Activities Supporting Research and Improved Treatment
NHF has been at the forefront of encouraging and ensuring access to improved treatment for HCV-affected individuals in the bleeding disorders community. NHF’s efforts over the last 15 years have focused on blood product safety as well as improved diagnosis and treatment of HCV, including non-invasive mechanisms for liver biopsy, access to HCV clinical trials, and increased Federal funding for HCV disease research.
NHF has worked closely with the National Institutes of Health (NIH) to ensure HCV programs and clinical trials are accessible to persons with bleeding disorders. To date, the National Institutes of Health (NIH) has funded 64 HCV clinical trials, with 35 of these trials currently recruiting patients. NIH also currently funds seven hemophilia-specific research studies on HCV. Four of these studies address co-infection issues and seek to better understand the differences in immune response between co-infected persons and persons with HCV only.
On the legislative front, NHF has endorsed the Hepatitis C Epidemic Control and Prevention Act (S. 1143/H.R. 3539). This legislation mandates additional resources and a more coordinated Federal approach for improving HCV prevention, treatment, and disease management. This bill is sponsored in the Senate by Senators Kay Bailey Hutchison (R-TX) and Edward Kennedy (D-MA) and in the House by Congresswoman Heather Wilson (R-NM) and Congressman Ed Towns (D-NY).
Internationally, three countries have compensated or plan to compensate for HCV infection as a result of the receipt of a contaminated blood transfusion or blood product.
• In Ireland, a tribunal was established by the Irish government for compensation.
• In Canada, a settlement agreement was reached between the Canadian federal, provincial, and territorial governments and lawyers for class action plaintiffs. This program compensates those individuals who were infected with hepatitis C through the Canadian blood system between January 1, 1986, and July 1, 1990.
• In England, the British government announced on August 29, 2003 that it would proceed with establishing a compensation mechanism for persons infected with HCV as a result of contaminated blood products and transfusions. An estimated 3,000 to 5,000 people are believed to be eligible for the program, which would provide 20,000 British Pounds for persons with HCV infection and 45,000 British Pounds for persons with liver damage.
Furthermore, at its 2003 meeting, the World Federation of Hemophilia approved a resolution endorsing compensation for persons who had contracted HCV through blood products. The resolution states:
“The World Federation of Hemophilia recognizes the pain and suffering caused to people with hemophilia and related bleeding disorders by iatrogenic infection with the hepatitis C virus. WFH calls on all governments to make available suitable recompense to all those infected and their families.”
In the United States, most activities to date have consisted of individual or class action law suits on behalf of affected individuals. Information regarding worldwide compensation for HCV, when available to NHF, has been reported to the community via HemAware magazine, eNotes (NHF’s electronic newsletter) and on the NHF Web site, www.hemophilia.org.
NHF is aware of and respects the recent efforts of affected individuals in the bleeding disorders community in pursuing introduction of legislation that would provide Federal compensation for their HCV. However, similar to the community’s successful campaign to achieve passage and funding for the Ricky Ray Hemophilia Relief Fund Act, we believe significant groundwork must be completed prior to the consideration of Federal compensation. The findings regarding the Federal government role in the spread of HCV have not been documented in an authoritative manner nor have the results of various litigated court cases provided a strong base of advocacy on this issue. Introduction of legislation without a strong substantive foundation leaves the community vulnerable to failure and dims prospects for future Congressional consideration.
To this end, NHF is committed to seeking support for an independent review of the Federal government’s responsibility in the spread of HCV through blood and blood products. As many of you recall, the Institute of Medicine’s report on HIV and the blood supply provided needed information for the community’s HIV compensation campaign. An independent review is a first and necessary step towards any future Federal HCV compensation effort.
NHF is committed to working with bleeding disorders and the larger HCV community in continuing to provide strong advocacy and education on HCV prevention, research and treatment and in exploring the potential for achieving Federal compensation.