Chicago Tribune - July 20, 2001
Evan Osnos, Tribune staff reporter

New restrictions urged last month by a U.S. Food and Drug Administration panel are designed to avert a theoretical spread of mad cow disease by banning the use of blood from Europe and limiting donations from those who spent considerable time in Europe.

The new rules are expected to cut donations by 5 percent nationally, which would be the largest single drop on record. Supporters, including the American Red Cross, say the plan might prevent what happened in the early 1980s when hemophiliacs and other patients received HIV-tainted blood.

But others, noting that the human form of mad cow disease never has been shown to be spread by blood, call it an overreaction that will aggravate the shortage.

Parts of the country already are suffering their worst blood shortage in 20 years, forcing doctors to postpone some surgeries and cancer treatments. Before an uptick in blood donations this month, Chicago hospitals suffered a critical shortage but stopped short of postponing surgeries, according to hospital officials.

Though the stricter guidelines are not expected to take effect until next spring, the Red Cross, collector of half the nation's blood supply, plans to adopt similar rules in September.

"We feel it is prudent and aggressive in dealing with this disease," said Dr. Jerry Squires, the organization's chief scientific officer. "No one quibbles with being aggressive. The only concern is, Will there be enough blood?"

Squires believes a donor recruitment campaign and better collection practices will allow the Red Cross to offset the expected drop in supply, but others are less optimistic.

"This is the tightest blood supply I've seen in the more than 25 years I've been involved in blood transfusions," said Dr. Harvey Klein, president of the American Association of Blood Banks, the industry's leading professional association.

"We worry about mad cow disease, and you have to be aware of the potential risk. ... On the other hand, if you show up at the hospital and they say you need six units and we have four, that is a safety issue here and now."

The plan faces its fiercest opposition from the doctors who rely on blood reserves daily.

"Countless lives will be lost" if the new rules are allowed to reduce blood supplies further, argued Dr. Geoffrey Doughlin, chairman of emergency medicine at Jamaica Hospital in New York, in comments to the FDA panel. On June 28, the board endorsed the plan 10-7.

Nowhere will the restrictions be felt more severely than in the New York area, the only region in the country that imports European blood products. In addition to imports, which make one-quarter of total reserves, the New York Blood Center also projects up to 10 percent more would be lost with the exclusion of previous donors.

Compound factors

Both sides agree the mad cow threat could not have come at a more difficult time. An aging population and the growth of more sophisticated transplants and cancer treatments have fueled a steady rise in national blood usage since 1994, according to the National Blood Data Resource Center.

Supply has not risen as fast, due in part to generally smaller workplaces--frequent sites of blood drives--and the gradual shift of the World War II generation from blood donors to users. In 1989, the nation's blood supply exceeded demand by 1.87 million units; by 1999 that figure had declined 35.7 percent to 1.20 million, resource center figures show. A unit is equal to one donation, or roughly a pint.

"I think about it day and night," said Dr. Janice Nelson, medical director of the blood bank at Los Angeles County + USC Medical Center.

As in many hospitals, Nelson's greatest shortages are in Type O, the most versatile type of blood. Two shelves she regularly devotes to O-positive have been virtually empty for weeks.

"We get by with basically nickel and diming units of blood and negotiating with doctors," she said of the constant shuffling of treatment schedules and blood supplies. "It is blind luck that, as far as I know, no one has been harmed yet."

Delays in surgeries

Several non-emergency heart surgeries at Harbor-UCLA Medical Center in Torrance, Calif., have been delayed recently for lack of blood. Meanwhile, doctors in Phoenix have been allocating the same blood to two patients and then hoping one does not need it, according to United Blood Services of Arizona.

In all, at least 26 cities and regions from Florida to Montana to Texas have seen critical appeals for blood donors in May and June, according to media reports compiled by America's Blood Centers.

At its center, the problem is that 60 percent of Americans are eligible, but only 5 percent of that group donate blood. The FDA plan would reduce the pool by excluding donors who have spent a total of five years in Europe since 1980, or three months in the United Kingdom between 1980 and 1996.

Mad cow disease, the vernacular for bovine spongiform encephalopathy, has been linked to a lethal brain-wasting disorder in humans who ate infected meat. First identified in Britain, mad cow disease has been found in recent months elsewhere in Europe.

Dr. Michael Busch, a professor of laboratory medicine at the University of California-San Francisco, has studied the threats of HIV and mad cow disease to blood. In testimony to the FDA panel, he argued against broad restrictions, saying research on mad cow is persuasive that transfusions are not at risk.

Arthur Caplan, a bioethicist at the University of Pennsylvania, says he believes the Red Cross and FDA policies unduly reflect the scars of broad criticism that the blood community was slow to address the spread of HIV.

"If we had not been through the HIV crisis, we would not be handling [mad cow] this way," said Caplan, who heads a blood safety panel for the Health & Human Services Department.

Influence of HIV

"We would be saying the risks are low, the challenge to the supply is great, and we would not take the policy decisions we have taken," Caplan said.

Nevertheless, FDA position papers call the existing mad cow research "limited," and the Red Cross believes it is short of conclusive.

"There is so much scientific uncertainty as to how it is transmitted," said Squires of the Red Cross. "It is very important to us to say for sure, [so] we don't run the risk of sacrificing safety in the name of availability."
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