http://www.nytimes.com/2002/04/02/health/02BLOO.html
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For extra safety, Cerus and Vitex require users to remove the chemicals from the blood before it is transfused.
"The only thing we want to add back to a patient is a red cell," said Dr. Bernadette L. Alford, executive vice president of Vitex.
Cerus's platelet process uses a chain of three transparent plastic bags connected by tubes. The donated platelets are put into the first bag, where they comes in contact with the psoralen. They drip into the second bag, which is placed in a machine that looks like a photocopier to expose the platelets to light for about three minutes. The platelets then drip into the third bag, where an absorbent material removes the psoralen.
The companies will also have to show their processes do not harm the ability of the blood cells to do their jobs.
Cerus's clinical trial showed that some platelets were lost in the treatment and that the ones that were transfused did not last as long in the patient as untreated platelets. But while that meant more platelets were used and transfusions were done more frequently, it did not affect the health of the patients, said Dr. Jeffrey McCullough, a professor at the University of Minnesota, who led the clinical trials and is on Cerus's scientific advisory board.
Cerus's process has so far been tested only on platelets collected by a machine made by Baxter, its partner. The company plans to move quickly, however, to prove it works for all platelets.
The technique is expected to add about $50 to $100 to the cost of a unit of blood. Platelets now cost from $200 to $600 and red cells $100 to $200.
Hospital blood centers are already struggling to keep pace with increases in the cost of blood because of new tests and a new technique for filtering out white blood cells, which can cause problems in some transfusion recipients.
Scientists say the technique will clearly improve the safety of platelets, which are stored at room temperature and therefore are prone to bacterial contamination.
Such bacteria kill about 8 to 12 people a year, according to F.D.A. statistics.
Red blood cells are refrigerated so that bacteria are less of a problem. Still, numerous other possible infections exist. These include hepatitis B and other forms of hepatitis. Chagas' disease, which is widespread in Latin America, can fatally damage the heart after many years. Babesiosis, a sometimes fatal tick-borne infection, is found in southern New England and has symptoms similar to malaria. But it is unclear how often such infections are spread through blood transfusion, and many people can fight off the infections.
The biggest benefit of pathogen inactivation may be the insurance it provides against a new pathogen that could appear as H.I.V. did.
"I can tell you as I sit here today that if an agent like H.I.V. emerged next week, we would not be in any better position to deal with it now than we were in 1982," said Dr. Harvey G. Klein, head of the department of transfusion medicine at the National Institutes of Health.
So far, he and others said, the American public has been willing to spend whatever it takes to eliminate even marginal risks of infection. That factor, plus fear of being sued, make it highly likely that pathogen inactivation will be widely adopted.
"I think from a public policy point of view," said Dr. McCullough of Minnesota, "it's almost impossible to be the leader of a major blood program and face the cameras and face the public and say, `I intentionally made a decision to allow people to be infected by blood transfusions because I didn't want to spend the money to prevent it.' "
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