Stopping
the flow of tainted blood - FDA files suit against Red Cross
In November 1989, 60-year-old carpenter Robert Jones
was rushed to the emergency room of the Mount Hood Medical Center
outside Portland, Ore., with an aneurism in his aorta. Ten days
later he left the hospital, recovering from a three-hour operation
that he thought had saved his life.
But four months later, the regional director of the Portland
Red Cross called Jones with chilling news: The donor who
had supplied the blood that Jones received during his operation
had the human immunodeficiency virus, or HIV, which causes AIDS.
One month later, Jones tested positive for AIDS.
"I never thought I could get AIDS, that only drug addicts
and homo-sexuals got it" he says. "They told me and
my family that the blood supply was safe and not to worry."
Jones's case raises alarming questions about the
safety of the blood supply in America today -- as does a lawsuit
filed against the American Red Cross in federal court in May by
the Department of Justice on behalf of the Food and Drug Administration.
The FDA, which is responsible for regulating the blood industry
and for determining that blood products are safe and effective,
presented evidence in May before a federal judge in U.S. District
Court for the District of Columbia that the Red Cross continues
to violate blood safety laws and regulations -- despite a voluntary
agreement it made in 1988 with the FDA and a $140 million program
to correct violations that the FDA discovered before 1988.
Jones sued the Red Cross, which provides half the
nation's blood supply, for $10 million, and in May he agreed to
an undisclosed settlement, though the Red Cross admitted no negligence,
attorneys said.
The blood donor, a married man, apparently was infected with
the virus by a prostitute one month before giving blood at the
Red Cross donor center in Portland -- a center that the FDA cited
in federal court as one of the four worst violators of federal
regulations on blood safety.
Jones's donor stated in a deposition that if he had been aware
he was at risk of carrying the virus that causes AIDS, he would
not have given blood.
At the time, however, the Red Cross did not ask donors directly
about sexual activities and drug use.
According to the Red Cross, the donor who infected Jones fell
into the "window period," in which HIV-infected people
who have not yet developed HIV antibodies test negative for the
virus -- though they are infected and contagious.
It can take several months before an HIV-infected person develops
the antibodies. A definitive test that identifies HIV before the
antibodies develop is available, but is too expensive for large-scale
use, say blood bank company and health care officials.
Nevertheless, officials say, the blood supply is not dangerous.
Fred Kyle, senior vice president of biomedical services at the
Red Cross's national headquarters in Washington, said in a recent
statement, "Our blood services operations are safer than
ever."
"Safer than ever" is evidently not safe enough: The
FDA sued the American Red Cross "to ensure that the American
people ... have access to a blood supply that is as safe as possible,"
said FDA Commissioner Dr. David A. Kessler in a statement on May
7, the day the lawsuit was filed.
The most recent official statistics from the federal Centers
for Disease Control show a total of 52,506 cases of HIV infection.
(Other blood-borne diseases that can be contracted through transfusion
include AIDS-related complex, hepatitis A, hepatitis B, hepatitis
C + and syphilis.)
The CDC estimated that from 1981 to August 1992, 4,658 people
had developed AIDS after contracting HIV from transfusions of
whole blood or blood components or from tissue transplants. (One
unit of whole blood can be broken down into component units --
three of the most common are platelet, plasma and red cells. Therefore,
one unit of infected whole blood, when broken down, can be transfused
into as many as three people.)
The CDC has documented only 21 of these transfusion cases since
1985, when blood banks began testing potential donors for HIV
antibodies.
"That is 21 cases in about 28 million transfusions during
that time," says Dr. Arthur Silvergleid, president of the
American Association of Blood Banks.
Now, he says, the "best guess" at the odds of acquiring
the infection through a window transfusion are about 1 in 225,000.
"The risks of dying in normal childbirth are 1 in 10,000,"
Silvergleid says.
Why then, if the blood supply is so safe, is the Red Cross under
close scrutiny from the FDA? Joleen Ottosen, author of The Blood
Conspiracy, published in April, believes that the CDC's statistics
are misleading, since the 21 cases documented include only cases
of full-blown AIDS. In truth, 158 cases of AIDS acquired through
transfusions have been reported to the CDC since 1985, Dr. Scott
Holmberg and Lois Conley of the CDC wrote in a letter published
in the New England Journal of Medicine last year.
"Very few of the AIDS given via blood transfusion ever get
into CDC statistics as AIDS cases," reported Warren Epstein
on June 15 in the Colorado Springs, Colo., Gazette Telegraph.
"Dr Holmberg said that when today's transfusion AIDS risks
are quoted, they are for each unit of blood transfused and are
only based on the HIV test's inadequacies. They do not include
the human and computer errors that blood banks frequently make.".....Continued
