Blood Supply Should Be Filtered, Federal Panel Says
The government should require that white blood cells be filtered out of all donated blood, a federal advisory panel recommended Friday--a change that could make transfusions less risky for some people but cost the nation $500 million annually.
The Food and Drug Administration will have to decide whether to order the filtering and, if so, how soon, but officials indicated they support the change.
At issue are white blood cells called leukocytes. Removing most of them from a unit of transfusable blood is called leukoreduction.
Leukocytes are important infection fighters, but people who need transfusions need red cells or other blood components, not someone else’s leukocytes. In fact, leukocytes are a main reason some people suffer post-transfusion fever and chills. And some patients--premature infants, cancer or AIDS patients and those who need repeated transfusions--today are given leukoreduced blood because they are at risk for a virus that can hide in white cells. They are also at risk for an anti-leukocyte reaction that also can reduce the effectiveness of future transfusions.
About 20% to 40% of the blood supply already is leukoreduced so those patients can get the specially filtered blood.
The question is whether every American needs filtered blood.
It has sparked a furious controversy among transfusion experts and blood banks, partly fueled by filter makers hoping to increase sales.
Some scientists call leukoreduced blood purer and thus better. Others say there’s no evidence expensive filtered blood benefits the average transfusion recipient. They say the money, about an extra $40 per transfused blood unit, should be used to fight real blood risks.
Wading into the controversy Friday, the Department of Health and Human Services’ blood-safety advisory committee voted, 11 to 2, to recommend that the FDA mandate leukoreduction for everyone “as soon as feasible.”
The main reason the advisors cited: Some people, such as cancer patients who need filtered blood, accidentally get regular transfusions, particularly when they go to smaller hospitals that don’t have transfusion experts. If only filtered blood were sold, that problem would be solved.
“To not vote for universal leukoreduction would be a giant mistake,” Dr. Ronald Gilcher of the Oklahoma Blood Institute told fellow panelists. “This process . . . improves the quality” of blood. The institute uses only filtered blood.
Also, proponents added, leukoreduction might benefit more people than believed. Some studies suggest, but do not prove, that transfusions might subtly weaken the immune system and that filtering might counter that by decreasing hospital infections.
But critics argued that there’s no proof filtered blood will benefit anyone except high-risk patients who already should be getting it. Worse, filtering can lose about 10% of red cells, at a time when the nation already is experiencing blood shortages.
Also, the blood of healthy people who carry the sickle cell disease gene doesn’t filter well, meaning many black blood donors might be rejected.
“We don’t need to rush headlong into this decision. This is not an epidemic,” said Dr. Jane Piliavin of the University of Wisconsin, urging fellow panelists against mandatory filtering.
But when asked if they would prefer filtered blood if they were in the emergency room, most panelists said they would.
“Why can’t you provide that to communities if you believe it yourselves?” asked panelist Dr. John Penner of Michigan State University.
The panel cautioned that the FDA should mandate filtering gradually, in a way that would minimize blood shortages. They also urged federal health officials and Congress to find a way to pay for the filtering. Currently, neither Medicare nor most insurance companies reimburse hospitals for the more expensive blood.
