FDA could OK costly blood standards
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November 29, 1999 12:00 AM

FDA could OK costly blood standards

An expert says that like chicken soup, removal of white cells from blood supply can't hurt

Scott Hensley
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    Blood costs soon could soar by more than $30 per unit if the Food and Drug Administration orders the nation's blood banks to remove white cells from the most common blood components used by hospitals. Only about 20% of blood is treated this way today.

    When white cells, or leukocytes, are removed from blood before transfusion, it reduces side effects such as temporary suppression of the immune system, infection and serious fever, according to some researchers. In recent years many countries, including Canada, France and Switzerland, began requiring that all transfused blood and platelets be stripped of white cells, or leukoreduced.

    Some blood specialists caution that the purported clinical benefits from using this leukoreduced blood for all patients have not been proved conclusively. Everyone agrees, however, that there are no clinical drawbacks to the process-except for its cost.

    "It's sort of like chicken soup," said James MacPherson, executive director of America's Blood Centers, Washington. "It wouldn't hurt." But he warned that the cost increase would be substantial.

    Filtration would add between $30 and $40 to the cost of each unit of red cells and platelets bought by hospitals, which now average about $80 and $45, respectively. All told, the tab for the improved blood could add at least $300 million to the more than $2 billion spent on blood products annually.

    Earlier this month, eight Tenet Healthcare Corp. hospitals in South Florida sued their local blood bank for switching to leukoreduced blood (Nov. 8, p. 4).

    In December the FDA will hold public meetings on the safety of the blood supply. Testimony at the meetings will address a requirement that standard processing include the removal of white cells from blood. An expert advisory committee to the FDA recommended last year that the agency require leukoreduction. Though not bound by the recommendation, the agency usually follows such panels' advice.

    An FDA decision could come as early as at the meeting itself, although a gradual phase-in is likely.

    Blood banks already provide leukoreduced blood products for some high-risk patients, such as those undergoing certain cancer treatments, transplants and some surgeries.

    But there is no consensus on whether doctors should use the improved blood for all patients.

    "We don't feel that there are enough data to support universal leukoreduction," said D. Michael Strong, director of operations at Puget Sound Blood Center in Seattle, which serves 22 hospitals.

    As more countries switch to 100% filtered blood, however, the pressure builds for U.S. regulators to follow suit.

    "It will happen-it's just a matter of when," predicted Darrell Triulzi, M.D., medical director of the Institute for Transfusion Medicine in Pittsburgh.

    "It's predominantly a cost issue, because there's not a medical downside to it," he said.

    Already the American Red Cross, the largest single supplier of blood to hospitals, has committed to universal leukoreduction, in the belief that all patients stand to benefit.

    "Evidence is accumulating that by avoiding immune suppression, length of hospital stay is reduced," said Richard Davey, M.D., chief medical officer for the Red Cross, Washington.

    Carraway Methodist Medical Center, Birmingham, Ala., is a trailblazer that switched to 100% leukoreduced blood in April 1998. Length of stay dropped by half a day for patients who received leukoreduced blood, and total treatment costs per case declined by $1,859, said Cindy Williams, administrator at 383-bed Carraway.

    "When you reduce complications you reduce costs associated with taking care of them," she said.

    Hospitals in Amarillo, Texas, worked with Coffey Memorial Blood Center, their local supplier, to switch completely to filtered blood products this summer.

    "It costs you a little bit more to have leukoreduced blood," said James Hamous, M.D., chairman of the transfusion committee at 345-bed Northwest Texas Healthcare System. "But the hospital and the patients do better."

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