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Citing Disease, F.D.A. Panel Backs Blood Donor Curbs

Citing Disease, F.D.A. Panel Backs Blood Donor Curbs

June 29, 2001 The New York Times by Raymond Hernandez

An advisory panel for the Food and Drug Administration recommended today that the agency bar blood donations from people who might have been exposed to mad cow disease while in Europe.

Experts inside and outside the F.D.A. said that they expected the agency to adopt the recommendation, a step that would almost certainly reduce the blood supply in New York City, where one in every four pints of blood is imported from Europe.

The plan could be adopted by the F.D.A. as early as next spring, according to an agency spokeswoman. It calls for excluding blood donations from anyone who has spent five years or more in Europe since 1980, or three months or more in Britain from 1980 to 1996.

The restrictions would be issued nationally, but the New York metropolitan region would be the most adversely affected because it is the only place in the country that imports blood from Europe, according to health care experts.

The panel's decision prompted protests from hospital officials in New York City, who warned that the policy would aggravate the region's blood shortage and force them to cut back on many surgical procedures. "The blood supply is already stressed," said Dr. Herbert Pardes, chief executive of New York-Presbyterian Hospital. "This kind of further cut in the blood supply creates a tremendous danger."

David P. Rosen, the president of Jamaica, Brookdale and Flushing hospitals, said: "It's going to create absolute chaos. We're not just talking about canceling elective surgery. We're talking about the need to deal with nonstop trauma cases."

The New York State health commissioner, Dr. Antonia C. Novello, added to the dismay of hospital representatives in New York today when she reiterated her support for the F.D.A.'s move to restrict donors. But even as she backed the approach, she cautioned that as many as 200 patients a day could have their surgeries or other treatments postponed if the F.D.A. moves on as quick a timetable as it is considering.

Supporters of the donor restrictions, most notably the American Red Cross, praised the panel's action, saying it was the prudent thing to do given the recent spread of mad cow disease in Europe.

"The Red Cross believes that you should not compromise blood safety for availability," said Jacquelyn Fredrick, senior vice president of the organization. "Both are our responsibility."

Even with today's action, the Red Cross, which collects and distributes half of the nation's donated blood, intends to impose an even tougher set of restrictions on donors starting in September, Ms. Fredrick said.

Medical experts point out that there is no evidence that the disease can be transmitted through a blood transfusion. But doctors believe that humans can develop a variant of the disease by eating the meat of a cow infected with mad cow disease, formally known as bovine spongiform encephalopathy. The new variant form of the disease has claimed more than 100 lives, most of them in Britain.

The panel reached its decision in a 10-to-7 vote this afternoon after hearing almost a full day's testimony from medical experts who spoke for and against several proposals to restrict blood donations from people who have either lived in Europe or traveled there.

The plan adopted is one that the F.D.A. itself had proposed, making it very likely that the agency will ultimately accept the panel's recommendation. A final decision is likely to be made in the next few months.

Dr. Novello testified before the panel today and reiterated her support for the federal agency's move toward prohibiting blood donations from anyone who might have been exposed to mad cow disease in Europe.

But in an interview afterward, she also cautioned that the agency's timetable would not give health officials in New York the time they needed to find an alternative source of blood. That timetable would cause delays and postponements in surgeries, she said.

"We need time," she said. "We need to find the blood."

The panel rejected a policy being put in place by the Red Cross, which plans to ban blood donations from anyone who has spent six months or more in Europe since 1980, or three months or more in Britain since 1980.

The ban on blood imports from Europe, experts say, could cause major problems for medical care in the region, where one in every four pints -- 145,000 pints a year -- is imported from Holland, Germany or Switzerland.

The F.D.A. is expected to issue the new restrictions as guidelines, not regulations, a tack the agency frequently takes to bring about policy changes in a quick manner. But experts say such guidance has the effect of setting the industry standard, and blood centers follow them as if they were binding.


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