New Blood Donor Rules Target ‘Mad Cow’ Risk

Increasingly worried about protecting the nation’s blood supply from “mad cow” disease, the Food and Drug Administration on Monday further tightened restrictions on blood donors who have lived or traveled abroad.

The new rules affect those who have traveled to Europe since 1980, when mad cow disease--bovine spongiform encephalopathy, or BSE--began showing up in British cattle herds.

The rules will forbid donations from anyone who spent three or more cumulative months in Britain from 1980 to 1996 and those who have spent five or more years in France since 1980. The disease, which originated in Britain, spread first to France.

The current restrictions are for those who spent six or more cumulative months in Britain from 1980 to 1996.

The rules also will bar donations from anyone who received a blood transfusion in Britain since 1980 and from American military personnel who spent six or more months on a European base from 1980 to 1996, when British beef was sold to bases there.

The agency called its action “prudent” until more is known about the disease or until a donor screening test can be developed.

“FDA’s goal is to strike a careful balance between increasing the safety of the blood supply while ensuring that life-saving blood and blood products remain available when needed,” acting FDA Commissioner Bernard A. Schwetz said.

The devastating disorder in humans, believed to be a variant of Creutzfeldt-Jakob disease, is a degenerative neurological ailment that is carried within the body for years before it attacks and destroys the brain, usually causing rapid deterioration and death within a year.

While the disease has been recognized for generations, its cause was only recently identified: a highly resistant, infectious protein called a prion. It is thus far undetectable and survives routine sterilization.

Currently, mad cow disease is not known to have been transmitted by blood transfusion, “but animal models suggest that transmission by blood products may be possible,” the FDA said.

Also, human cases continue to increase in Britain, and mad cow disease in cattle has become widespread in Europe, where many herds have been slaughtered. Nearly 100 people are known to have died from the disease, presumably from eating infected meat.

The tightening of blood donor rules reflects a growing concern within the Bush administration, which last week announced it would expand a research program to address mad cow disease.

Mindful of the bitter lessons learned during the early days of the AIDS epidemic--when blood officials resisted the possibility that the disease was transmitted by blood and were slow to act--the FDA decided to impose the new rules before problems arose.

Under the rules, which will be phased in next year from May to October, “about 95% of those currently eligible to donate blood would remain eligible, yet the risk of possible exposure . . . would be reduced by approximately 90%,” said Dr. Jay Epstein, the FDA’s director of the office of blood research and review.

The 5% drop in the nation’s eligible blood donors likely will hit the East Coast harder than the West Coast because of the former’s large number of travelers to Europe, immigrants and retired military personnel. However, major urban areas on both coasts are expected to have a 50% higher donation refusal rate than the rest of the nation, the FDA said.

Also, New York City, which depends upon blood imported from Europe for about 20% of its blood supply, “will be particularly affected,” the agency said.

The FDA said the phase-in dates were established to allow more time to increase local recruitment efforts to replace lost donors and establish alternate sources.

“In order to accomplish this, it is important that blood centers avoid implementing the [plan] more quickly than recommended,” the agency said.

The American Red Cross, which supplies about half the nation’s blood supply, will implement its own regulations starting Sept. 17, which are a little stricter than the government’s.

It will refuse donations from anyone who spent three months in Britain or six months anywhere in Europe since 1980. It also will bar anyone who received a blood transfusion in Britain since 1980.

While some have estimated the Red Cross’ action will eliminate 9% of its donors, the organization estimates it will lose 4% of its donors.