FDA panel recommends some additional blood donation restrictions

Broad ban on donors who visited Western Europe rejected

By Elizabeth Cohen
CNN Medical Correspondent

BETHESDA, Maryland (CNN) -- People who have spent more than ten years in France, Portugal, or Ireland since 1980 would be banned from giving blood if the U.S. Food and Drug Administration adopts a recommendation by its advisory committee on mad cow disease. The recommendation was spurred by fears of possibly transmitting the human form of mad cow disease through blood products.

While mad cow disease first showed up in Great Britain, there have since been reports of hundreds of infected cows in France, Ireland, and Portugal and infected people in France and Ireland.

People who spent more than six months in Great Britain from 1980-1996 are already banned from giving blood in the United States, Canada, New Zealand, and Australia.

However, the FDA's Transmissable Spongiform Encephalopathies Advisory Committee overwhelmingly turned down a recommendation by the American Red Cross to ban blood donations from people who had spent an unspecified period of time in any part of Western Europe since 1980. The vote was 13-3.

Jackie Fredrick, executive vice president of biomedical services for the American Red Cross, said the organization was "encouraged by the expansion of the donor criteria."

But, she added, her organization has not made a final decision on additional restrictions. "The Red Cross will review the testimony with all of our experts, scientists and doctors, but we are prepared to expand the deferral criteria to safeguard the blood supply and the availibilty of the blood supply," she said.

The FDA usually adopts recommendations from its advisory committees but is free not to.

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Members of the advisory committee did not give reasons for turning down the Red Cross recommendation, but experts have said it is unknown whether mad cow disease, properly known as bovine spongiform encephalopathy, can be spread through blood in the first place.

In addition, experts pointed out that some 200,000 cows have been infected with the disease in Great Britain, while there have been less than a thousand infected cows in the rest of Western Europe.

In the past three years, 174 cows in France, 390 cows in Portugal and 231 in Ireland have been found to be infected with mad cow disease, according to the World Organization for Animal Health.

Through the end of November, there were 87 definite or probable cases of variant Creutzfeld-Jakob Disease (vCJD), the human form of mad cow disease, in the United Kingdom, two confirmed cases and one probable case in France, and one confirmed case in Ireland, according to a recently published report by Dr. Paul Brown, head of the FDA advisory committee.

However, there is no evidence to date that CJD can be transmitted through blood transfusions, and no cases of mad cow disease have been found in the United States.

A spokesman for a group representing blood collection programs said he agreed with the ban for visitors to France, but expressed concern that it could hurt the nation's blood supply at a time when there's already a shortage.

"When you get into a shortage situation there's always a risk. We hear about more elective surgeries being cancelled. What about the losses of organs because we can't do transplant surgeries because the blood isn't there?" said Jim McPherson, president of America's Blood Centers, a group that represents programs that together collect about half of the nation's blood supply.

But he added that he understood why the committee wanted to be extra careful about vCJD.

"This is potentially the most devastating epidemic of our time," McPherson said. "Conservatives say the epidemic has been contained, but others say there may be tens of thousands, or hundreds of thousands of people who are infected."

There is no diagnostic test for mad cow disease in animals or humans. In humans, it takes five to 20 years before symptoms show up, leading some experts to wonder whether people in the United States are infected now and don't know it.

"I think it's inevitable because it's a global world and you can't say that what happens in Britain, France, then Italy and Portugal is not going to happen here," McPherson said. "It's a question of where it will come from, whether it will be from someone who lived in Britain for a long time, or perhaps a military person who ate British beef while stationed in Japan in the 1980s."

The FDA advisory committee also plans to decide Thursday whether certain people should be banned from donating tissues based on their potential exposure to mad cow disease.

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