The National Hemophilia Foundation (NHF) enjoys a long and respected reputation as a vigilant advocate and protector of the nation's blood supply and blood product safety. Following is a history of blood-borne infectious disease in the US hemophilia community and NHF's pivotal role in ensuring future safety for all Americans.
Throughout their lives, people with hemophilia and other bleeding disorders are dependent on blood clotting factor products to supply a missing protein needed for normal clotting. The development of effective medications (clotting factor concentrates) and the introduction of comprehensive care in the 1960s and 1970s dramatically improved life for persons with hemophilia, thus eliminating the need for frequent and costly hospitalizations. This also ensured that even those with severe hemophilia were able to attend school, obtain employment, and enjoy a greatly increased life expectancy. Unfortunately, this promise of a better life quickly deteriorated in the early 1980s, when the nation's blood supply became contaminated with HIV. More than half of the 17,000 people with hemophilia and 80% of those with severe hemophilia were infected with HIV, a large percentage of whom subsequently died. The national tragedy of HIV/AIDS in the hemophilia community was recognized by the Federal government in 1998 with passage of the Ricky Ray Hemophilia Relief Fund Act. The Act provided compassionate payments to persons with hemophilia who contracted HIV through the use of contaminated blood products.
BLOOD SAFETY AS THE PRIORITY
The tragedy of HIV catapulted NHF into the spotlight as the prime advocate for a safer blood supply and blood products. In 1992 NHF worked with Congress to request an Institute of Medicine (IOM) report on HIV and the blood supply. The report, issued in 1995, contained 14 specific recommendations that set the stage for NHF's blood safety initiatives. As a result of NHF's aggressive advocacy, today, many of the IOM recommendations have been implemented. Blood and blood product safety have now been dramatically improved. The Food and Drug Administration (FDA) has an improved response protocol to potential adverse incidents and is more diligent in the inspection and enforcement of good manufacturing practices at blood collection and manufacturing facilities. Blood screening, testing, viral inactivation and removal methods have been refined. Communications with consumers, the medical community and the public has been enhanced.
THE NEED TO REMAIN VIGILANT
Despite the implementation of safety advances, the risk remains for known and unknown potential infectious agents and pathogens to threaten the blood supply and blood products. In recent years, these threats have included West Nile Virus; Creutzfeldt-Jakob Disease and its variant, Mad Cow Disease; and Parvovirus B19. In each instance, NHF has worked with the FDA, the Centers for Disease Control and Prevention, manufacturers and the medical and consumer communities to assess risk and communicate information. Further, NHF is well positioned to influence public policy decisions in Congress and by active participation on key Federal committees. The hemophilia community is now represented on the Health and Human Services Advisory Committee on Blood Safety and Availability and the FDA's Blood Products Advisory Committee and Transmissible Spongiform Encephalopathies Advisory Committee.
Throughout its work on blood safety, NHF's stance has never wavered. Today NHF's commitment to blood product safety drives a strong nationwide research effort into improved treatments, including improved protein-free recombinant clotting factor products and gene therapy. Blood safety must and will always be a top NHF priority.