By Jan Hamilton, Executive Director
Hemophilia Federation of America

Hemophilia Federation of America (HFA) is a national non-profit organization that exists for the sole purpose of serving its constituents as a patient advocate for, but not limited to product safety, treatment, insurance, and quality of life issues in a positive and pro-active manner. Our mission is to serve the needs of all persons with coagulation disorders and complications of treatment such as HIV.

All issues related to blood safety have been uppermost on our agenda and a major cornerstone of our mission. We have followed all of the developments in the area of safety of blood collection and processing and have been extremely vocal on the national level on issues from blood donor screening to nucleic acid testing, deferral of British donors, a waiting period for new donors and last, but far from least, leukocyte reduction. We have always asked for more purity, more safety and more efficacy in our blood supply while keeping in mind good manufacturing processes.

In September of 1998, I made a presentation on behalf of HFA at a meeting of the FDA’s Blood Products Advisory Committee regarding our concerns regarding “the lack of pre-storage filtration as a mandate in US blood centers and hospitals.” At that time, there were six other countries including the tiny country of Malta that had mandated this procedure.

At that time, we complimented Dr. Lorna Williamson of the United Kingdom on its move to act rather than wait for 100% evidence which seemed to be in direct opposition to the United States’ perspective of waiting to see how severe the problem is and then offering corrective action.

We are quite aware of the cost of pre-storage filtration and urge Pall Corporation to continue to make every effort to streamline the manufacturing process and continue making strides toward a more compact and even less expensive technology. This would make the leukocyte reduction process more affordable to a wide range of blood banks and hospitals.

It is our understanding that leukocyte reduction:

• Reduces transfusion-associated immune suppression
• Helps to protect patients from post surgical infections
• Reduces morbidity and mortality rates
• Helps reduce length of hospital stay
• Reduces hospital costs.

Each of these points fit right into our plea for purity, safety and efficacy in our blood supply. We have always been advocates for empowering patients to know more about what constitutes good care for the hemophilia patient and to speak up for better conditions and safer, more efficacious treatment. It only makes sense that a procedure that can reduce so many problems that can arise in a blood transfusion should become the “rule of thumb” as opposed to an option.

While our blood supply is safer today than ever before, there are new pathogens that become a threat as time goes by. Even today, there are such pathogens as TTV (Transfusion Transmitted Virus), Hepatitis G, Human Herpes Virus 8 and Parvo B19. Each of these appear quite frequently in the blood supply and yet there are no known screening tests developed to protect our citizens against them.

With the advent of leukocyte reduction and the addition of VITEX and Pall’s process of INACTINE™ under development, new levels of blood safety may be achieved in the future. While this process may be expensive, so is the loss of life due to pathogens yet undetectable. Hopefully, we are at a point in the advent of blood safety in the United States, that we can be pro-active as opposed to reactive in this area so important to the health of so many.

We urge third-party payers to be pro-active in this area as well. It is not feasible to institute these important measures without the support of the third-party payers.

In summation, we once again ask for more purity, more safety and more efficacy in our blood supply coupled with good manufacturing practices.