BLOOD-SCRUBBING: FDA Approves New Technique
The Food and Drug Administration yesterday approved a new "blood-scrubbing" technology allowing "scientists to wash out of plasma certain viruses, including the AIDS virus." The AP/Philadelphia Inquirer reports that the approval comes a week after the Justice Department began an antitrust investigation of the American Red Cross' exclusive contract for this new technology "on concern that the arrangement created a monopoly."
A Thorough Cleanup
The AP/Inquirer reports that "the first batches of new plasma will be ready to ship to interested hospitals in two weeks." Solvent-detergent plasma, or SD plasma, "will replace some of the 2.5 million units of plasma ... used by tens of thousands of Americans to treat certain diseases," although it does not cleanse red blood cells used in transfusions (Neergaard, 5/7). The treatment dissolves the lipid coating of certain viruses in the blood while leaving plasma proteins intact, which reduces the chances of developing lipid-enveloping viruses such as HIV. "The American Red Cross is continually researching, developing and implementing new testing and treatment methods to ensure the greatest possible protection of our nation's blood supply," said organization President Elizabeth Dole. She added that the Red Cross is "proud to introduce an added layer of protection with" SD plasma (release, 5/6).
Not The Only Solution
Dr. Paul Holland of the Sacramento Blood Center called the new technique "a step forward." "It ... should make plasma even safer," he said (Chicago Tribune News Services, 5/7). However, one "downside" of the new plasma-washing technique is that it can be used "only if donations from about 2,000 people are pooled," and "if a virus that doesn't respond to the washing technique ... slips in, many more people would be exposed." Because of the risk of some unknown pathogen entering the blood supply, "doctors today often prefer to use plasma packaged from one donor." Holland noted that his facility "is seeking FDA approval for an alternative safer plasma" (AP/Inquirer, 5/7). The center plans to "individually package each donor's plasma, freeze it for 90 days, then retest the donor." Dr. Harvey Klein, transfusion chief at the National Institutes of Health, said, "This virtually eliminates today's blood-testing drawback that an occasional donor is so newly infected that tests don't immediately spot infection" (Neergaard, AP/Atlanta Journal-Constitution, 5/7).