FDA advisory committee recommends new restrictions on blood donors

Friday, June 29th 2001, 12:00 am

By: News On 6

BETHESDA, Md. (AP) _ New restrictions on blood donors who have lived or traveled in Europe are needed to help protect the U.S. blood supply from mad cow disease, a federal advisory panel says.

The 17-member Food and Drug Administration committee approved the restrictions Thursday despite warnings that they could further reduce already short supplies of blood for medical treatments.

The new restrictions were in a proposal the FDA presented to the panel. Agency officials said the changes could go into effect in about a year.

As a result of the new requirements, the FDA estimated that available blood donors in the United States would be reduced by about 5.3 percent, and the risk of mad cow disease entering the blood supply would be reduced by about 91 percent.

There have been no identified cases of mad cow disease in American cattle. A human form of the disease, called new variant Creutzfeldt-Jakob disease, has claimed victims in Britain and other European countries, but has not been reported in the United States.

There is no evidence that the human variety can be spread through blood transfusions, but the FDA urged the restrictions on donors because of a theoretical risk.

The vote came after the American Red Cross had announced plans to institute even tighter restrictions in September. The Red Cross collects about half of the 14 million units of blood donated in the United States annually.

Earlier, a New York surgeon warned the panel that ``countless lives will be lost'' if blood supplies are cut further in the nation's most populous city.

``We already are dealing with a dwindling supply,'' said Dr. Jeffrey Doughlin, who works at Jamaica Hospital in Queens.

The proposal, which the committee approved by a 10-7 vote, recommends the exclusion of donors who have spent a cumulative three months or more in Britain from 1980 through the end of 1996. It also would bar donors who have had a cumulative time of travel or residence of five years or more in any other European country.

Additionally, the proposal recommends that American military personnel or dependents who have spent six months or more on a base in Europe from 1980 through the end of 1996 be excluded from blood donation.

Also excluded would be people who have received blood transfusions in Britain any time from 1980 to the present.

Acknowledging concerns about the effect on the blood supply, the committee added an amendment that calls for a national donor recruitment campaign.

FDA officials are concerned that people who have traveled or lived in Europe, particularly Britain, may have eaten beef contaminated by bovine spongiform encephalopathy, or mad cow disease. Studies have shown that the disease can be transmitted to humans in meat and, years later, cause new variant Creutzfeldt-Jakob disease, or vCJD, a lethal brain disease.

Although it has not been proved, some health experts fear that people who have eaten contaminated beef might transmit the disease through donated blood.

Current regulations forbid collecting blood from donors who have lived in Britain for six months or in some European countries for 10 years.

The Red Cross plan, scheduled to go into effect in September, could reduce the number of blood donors in the United States by up to 9 percent, the FDA estimated. East Coast areas would be hardest hit, with the blood supply cut by up to 35 percent in New York City, officials said.

Part of the New York impact would come from a plan to reject some 145,000 blood units that the state now receives from Europe.

The Red Cross plans to reject donors who have a cumulative time in Europe of six months from 1980 to the present, or three months in Britain.

``We believe our donor deferral plan is cautious and prudent,'' said Jacquelyn Frederick, a Red Cross vice president. She said the Red Cross would start an aggressive drive to recruit donors to replace those excluded under the new rules.

The FDA now forbids donations from people who've spent a total of six months or more in Britain between 1980 and 1996. Britain was the center of an outbreak of Mad Cow disease and about 100 people there have developed vCJD, which rots holes in the brain.

Mad cow disease is caused by an abnormal protein, called a prion, which can cause changes in normal proteins and result in deep lesions in the brain. The same type of prion has been found in the brains of victims of the new variant CJD and has been traced to beef from infected animals. There are American cases of Creutzfeldt-Jakob disease, but it is a type of the disease that has not been linked to food.