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U.S. Plan to halt blood imports worries europe

U.S. Plan to halt blood imports worries europe

July 16, 2001 The New York Times by John Tagliabue

An American proposal to ban blood imports from Europe has alarmed European suppliers, who say it would upset a decades-old trans-Atlantic system that provides blood to New York City and would cast a pall of suspicion on the safety of European blood.

The restrictions were recommended to the Food and Drug Administration last month by an advisory panel that was concerned about the spread of mad cow disease across Britain and, to a lesser degree, the rest of Europe.

Though the ban would be national, it would affect New York City in particular. Under longstanding arrangements, the city imports blood from Europe -- the only place in the United States that does. The ban would prevent hospitals from importing red blood cells, which patients receive during surgery and other procedures.

European countries that send blood to New York do so in exchange for American plasma in a program called Euroblood, and that exchange would also be upset, health officials on both sides of the Atlantic said.

"We are seriously disturbed, first of all because of the situation in New York," said Rudolf Schwabe, director of the Blood Donor Service of the Swiss Red Cross in Bern. Switzerland accounts for half the European blood that reaches New York; other supplies come from the Netherlands and Germany.

Mr. Schwabe said Switzerland relied on the New York area for plasma, which is crucial for the Swiss pharmaceutical industry. "We would not like to see those supplies stopped within six months," he said.

Officials at the Food and Drug Administration have said they expect the agency to adopt the recommendations, possibly by next spring.

Mad cow disease and new variant Creutzfeldt-Jakob disease, the human form, are both fatal. Because of the long incubation period for Creutzfeldt-Jakob in humans, the proposed guidelines would also bar the donation of blood by any American who lived in Britain for more than three months since 1980 and in Europe for more than six months.

The dispute casts light on the deep interdependency of health care systems globally. But it also highlights the nervousness about blood safety on both sides of the Atlantic. The dispute will be discussed on Tuesday, when representatives of the Swiss, Dutch and German blood banks that export to New York are to meet in Paris with a representative of the Food and Drug Administration.

European officials deny there is a need for the kind of precautions the Americans are considering. They say they have taken steps to keep mad cow disease from contaminating the blood supply.

Theo Buunen, a member of the executive board of Sanquin, a foundation affiliated with the Dutch Red Cross, said there had been no documented cases of new variant Creutzfeldt-Jakob disease being spread through blood transfusions. Dutch health officials, he added, considered mad cow disease, "at the maximum, a theoretical risk of a very small nature for the human blood supply."

The spread of mad cow disease in Europe has been attributed to cattle feed that includes tissue from sheep infected with a similar disease, rather than to blood transfusions.

The blood supplies that New York receives consist of red cells, the oxygen-bearing cells that are removed from whole blood and administered to patients who are anemic or who require blood during surgery or because of severe blood loss.

Dr. Robert L. Jones, president of the New York Blood Center, said that at the height of its dependence, the New York area imported 250,000 units a year -- each slightly less than a pint -- or 40 percent of its supplies. The amount has declined sharply in the last three years, to about 140,000 units, about one quarter of the total, as the area expanded its donor programs.

Roughly 70,000 units are from Switzerland, another 40,000 to 50,000 from the Netherlands and the rest from Germany. The New York Blood Center is the main supplier of blood for 200 hospitals in New York City, Westchester and Rockland Counties, Long Island and northern New Jersey.

Kenneth E. Raske, the president of the Greater New York Hospital Association, said that a sudden end to the European supply would create "a shortage of disastrous proportions" and that "the public health crisis would be astronomical."

Since patients rarely require all the components of whole blood, blood is typically broken down into its main components, including red cells and plasma, the protein-rich liquid portion of blood.

The Swiss pharmaceutical industry uses large quantities of plasma to make drugs used to treat various conditions, including hemophilia, so Switzerland has surplus red cells that it exports around the world. In exchange for this supply to New York, Switzerland imports plasma from the United States.

"Dollars change hands, but to cover costs, not to make money," Dr. Jones said. "We are all nonprofit organizations."

Mr. Schwabe, of the Swiss donor service, said Swiss companies would be forced to seek alternative sources of plasma if the exchange ended. Switzerland would also seek to divert supplies of red cells to countries that suffer shortages, possibly in South America and Africa, he said, though the process could be complicated if the American ban cast suspicion on the safety of European blood.

Mr. Buunen, of the Sanquin foundation, warned that the reputation of Dutch supplies was also at stake. The Netherlands, he said, regularly supplies blood banks in other countries with excess blood products, and Sanquin meets the quality criteria of the Food and Drug Administration, he added.

"There can be an image created in Europe, and the Netherlands, as if the Dutch blood supply didn't have the quality we thought it had," he said.

At the meeting on Tuesday, "the first thing we need is more information, and the background that led to the F.D.A. advisory decision," he said. "If we know more, we can better react."

The Europeans have taken various steps to keep their blood supply safe. The Netherlands, for instance, recently required the elimination of white blood cells from blood supplies because of suspicion that they could carry mad cow contagion.

About 80 percent of American blood supplies are similarly treated, according to Chris Thomas, an American Red Cross spokesman. Germany and Switzerland have followed suit, health officials in those countries said.

Moreover, Germany has banned the import of plasma from Britain, where mad cow is most prevalent, for use in pharmaceutical products, said Susanne Stocker, spokeswoman for the Paul Ehrlich Institute, which is responsible for the safety of the blood supply.

Dr. Jones, of the New York Blood Center, said a ban on imports and restrictions on donors would cost New York "all told, one-third of the supply" of blood. "New York is our most cosmopolitan city, and without European transients and immigrants, there would be a contraction of the donor base," he said, referring to the proposed residency rules.

Washington has floated a compromise plan that would delay full introduction of the restrictions until late 2002, to allow New York to develop alternative sources and to allow the city to replace European blood by importing blood from American military bases in Europe.

Lenore Gelb, an spokeswoman for the F.D.A, said, "It's always a balance between maintaining adequate blood supplies, while dealing with a theoretical risk that cannot be ruled out."

But Dr. Jones, who will attend the Paris discussions, said the compromise measures may be too little and too late for New York and the suppliers. "If the restrictions can be phased in over time," he asked, "why are they necessary at all? That is the question."


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