http://www.nytimes.com/aponline/health/AP-Blood-Battle.html
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January 24, 2002 Senators to Probe Blood Safety
By THE ASSOCIATED PRESS
Filed at 6:34 p.m. ET WASHINGTON (AP) -- The American Red Cross recalled thousands of pints of
blood products shipped to hospitals in 2000, federal documents show, and some
possibly hazardous blood was transfused into patients before word reached
doctors not to use it. Recalls were up 18-fold from 12 years earlier. Consumer advocates cited the 641 recalls -- and federal documents
suggesting it's unclear whether anyone has gotten sick from tainted blood --
in urging Congress Thursday to investigate the safety of blood provided by
the Red Cross. Senate Majority Leader Tom Daschle and Sen. Edward Kennedy called the
allegations serious, and Kennedy agreed to look into them. ``The disclosures ... raise serious questions about the ability of the
American Red Cross to ensure the safety of its blood supply,'' said Kennedy,
D-Mass. ``Congress needs to deal with these questions, too, and take whatever
steps are necessary to guarantee the safety of the blood supply.'' None of the recalls were Class 1, FDA's designation for the most dangerous
type. Most were Class 2 recalls, meaning there was a small risk that patients
could be harmed. It is the latest black eye for the Red Cross, which provides 45 percent of
the nation's blood and is fighting government regulators in federal court
over this very issue. The Food and Drug Administration has accused the Red Cross of repeated and
serious violations of blood safety regulations, including shipping
contaminated blood, despite a 1993 court order mandating improvements. Last
month, the FDA has asked a federal judge to hold the charity in contempt of
court and allow the government to levy millions of dollars in fines for
continuing violations. That court fight promises to last months. The consumer group Public
Citizen wrote Daschle and Kennedy Thursday that congressional intervention
would speed solutions. ``Force the Red Cross to improve its public health-threatening record,''
the group wrote. The Red Cross argues it has spent millions improving its blood business
and that the blood supply is safer than ever. ``It is unfortunate the Public Citizen is creating unnecessary fear and
alarm about the safety of the blood supply,'' said Red Cross interim general
counsel Larry Moore. ``The chief priority of the Red Cross is to ensure that
patients who depend upon blood receive the safest possible products.'' FDA court documents say Red Cross recalls of blood jumped from 36 in 1988
to 641 in 2000. Those latest recalls totaled 12,701 units of blood products,
including red blood cells and platelets. One example involves cytomegalovirus, which doesn't harm most healthy
adults but can kill or seriously injure the ill or newborns. In October 2000,
the Red Cross recalled four units of blood labeled CMV-free when in fact they
hadn't been tested -- and three already had been transfused, say the FDA
documents. The Red Cross argues that no one has been found to have been harmed by its
mistakes. That is ``a notoriously dangerous assumption to make,'' FDA blood chief
Dr. Jay Epstein said in court documents. It is very hard to detect
transfusion-caused illnesses because some infections lie dormant for a long
time and doctors aren't required to report suspicious infections to the
government, he said. Thursday's allegations are the latest public blow to the Red Cross. It had
to backtrack from a sharply criticized plan to divert to other uses some of
the half-billion dollars donated to help victims of the Sept. 11 terrorist
attacks. And the Red Cross provoked tension with other blood banks seeking massive
donations following Sept. 11, even after it became clear supplies were
sufficient. The Red Cross wound up discarding 49,000 units of donated red
cells. |
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