Bad Blood
A decade later, improved tests have reduced the risk of getting HIV from an average four-unit transfusion to between 1 in 11,000 and 1 in 59,000; the risk for hepatitis C is now about 1 in 900. And just last week, scientists announced a discovery that may reduce the need for transfusions. Researchers isolated thrombopoietin--a protein crucial to the formation of platelets, which in turn are fundamental to clotting. Researchers at Genentech Inc. in San Francisco and Zymogenetics Inc. of Seattle reported in the journal Nature that the protein must now undergo clinical trials. Cancer patients may be the first to benefit, since therapy often destroys platelets, requiring transfusions from many donors.
Blood banks get virtually all of their blood from volunteers--although plasma centers, which save just the plasma from donors and reinject the red cells, still pay donors $10 to $15 per visit. The plasma--the amber, liquid portion of blood--is usually used to make drugs like immune globulin that are heated or otherwise treated to kill viruses.
Despite safety advances, slip-ups still occur. They are committed by doctors, nurses and blood bank technicians coping with increasingly sophisticated tests and by volunteers who screen donors. And one bad unit can create several victims, since whole blood is routinely split into components such as red cells, plasma and platelets. Since 1989, reported mistakes have soared. The FDA logged about 1,000 blood bank errors and accidents in the year ended Sept. 30, 1989. Three years later the number had shot up to 10,456, and the year after that the total was nearly 9,000. There has been no improvement since. Through March 1994, halfway through the current reporting year, the mistake toll stood at 4,615. Since the beginning of 1990, 29,586 mishaps have been reported.
Urgent plea. One factor behind the increase may have been a March 1991 letter from the FDA scolding blood banks for being lax in reporting errors and accidents. But public health officials attribute the jump more directly to the failure of some blood banks to safeguard the blood supply. In an internal memo sent last September to Health and Human Services Secretary Donna Shalala, Philip Lee, head of the Public Health Service, called the surge in errors "increasing evidence" of safety problems. At least a fourth of all major blood banks, he said--and up to a third of those run by the Red Cross--violate federal safety standards. "These compliance problems ... need to be addressed urgently if FDA is to ensure the safety of the nation's blood supply," he wrote.
The most worrisome offender may be the American Red Cross. Numerous safety slip-ups in the 1980s led to a 1988 "voluntary agreement" with the FDA. Yet by 1991, the FDA had threatened to close Red Cross centers in Albany, N.Y., Charleston, S.C., and Portland, Ore., for transgressions from botched tests to bags of blood labeled with the wrong blood type. Between 1988 and 1993, the FDA documented more than 2,500 safety violations at Red Cross blood banks. Finally, in May of 1993, the FDA brokered a consent decree in U.S. District Court in Washington, D.C., to raise the Red Cross's standards according to a timetable.
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