Curbs on Blood Threaten Stocks For the Region

Curbs on Blood Threaten Stocks For the Region

June 27, 2001 New York Times by Raymond Hernandez

The New York City region, already desperately short of blood, stands to lose at least a quarter of its potential blood supply as the Food and Drug Administration moves toward restricting donations from people who may have been exposed to mad cow disease in Europe.

While the restrictions would be issued nationally, the New York area would be the most affected, largely because it is the only place in the country that imports blood from Europe, health care experts say.

Hospital representatives and blood bank officials in the region warn that the donor restrictions would force hospitals to cut back on a host of surgical procedures, including hip replacement and heart bypass surgery.

"It will cripple the hospitals," said Dr. Robert L. Jones, the president of the New York Blood Center, the main supplier of blood for 200 hospitals in New York's five boroughs, Westchester and Rockland Counties, Long Island and northern New Jersey.

The restrictions, the subject of an F.D.A. advisory panel meeting on Thursday, would be issued as guidelines, a tack the agency frequently takes to bring about policy changes quicker.

Experts inside and outside the F.D.A. said that such guidance, as the agency calls it, had the effect of setting the industry standard, meaning blood centers follow them as if they were binding.

"The practical impact of it is that we have to follow it," Mr. Jones said. "They use guidance to get people into compliance because regulations take longer to get done."

Lawrence Bachorik, a spokesman for the F.D.A., would not directly address the concerns raised by medical officials in New York, saying only, "The F.D.A. will carefully consider the arguments and data presented at the meeting as we revise our guidelines."

Those who support such donor restrictions, including the American Red Cross, say it is better to err on the side of caution, given the spread of mad cow disease in Europe. And regardless of what the F.D.A. does, the Red Cross, which collects and distributes half of the nation's donated blood, has already decided to implement similar restrictions in screening its donors.

The other half of the nation's blood is collected by America's Blood Centers, which is composed of independent blood banks, including the New York Blood Center. Dr. Celso Bianco, the executive vice president of the national organization, opposes the donor restriction as unnecessary. He said there had been no documented case of the human form of mad cow disease, called Creutzfeldt-Jakob disease, being spread through blood transfusions.

Dr. Bianco said the measure would also force the New York region to tap into the national blood supply to make up for the losses. "The national supply is already strained," he said. "This complicates the situation."

The restrictions on donors is contained in two different proposals that the F.D.A. is considering, as concerns over tainted blood have risen in recent months with the spread of mad cow disease across Britain and, to a lesser extent, the rest of Europe.

One of the proposals under consideration is identical to the one the Red Cross will enact in September. It recommends banning blood donations from anyone who has spent six months or more in Europe since 1980, eliminating a host of potential donors throughout the United States, including recent immigrants and business travelers. It also bans donations from people who have spent three months or more in Britain since 1980.

The second proposal is one that the F.D.A. itself has offered and considers a viable option. It would not go as far as the Red Cross plan, instead seeking to exclude blood donations from anyone who has spent five years or more in Europe since 1980. It would also seek to prevent donations from anyone who has spent three months or more in Britain from 1980 to 1996.

In either case, the result would be a ban on blood imports from Europe, potentially causing major disruptions in medical care in the New York region, where one in every four pints -- or a total of 145,000 pints a year -- is imported from Holland, Germany and Switzerland, according to blood center officials.

The proposals are being reviewed by a federal advisory panel that is expected to give its recommendations to the F.D.A. as early as Thursday, when it meets. The F.D.A. is not bound by the recommendation, though it frequently follows them. A decision is likely in a few months.

A third proposal, which has fewer restrictions on donors, is also on the table, but experts said it had little chance of being adopted, particularly because the F.D.A. did not do so when it was proposed in January.

The situation has prompted deep concerns among medical experts in New York, who said the approaches suggested by the F.D.A. and the Red Cross were an overreaction. "To blindly adopt this policy," said Kenneth E. Raske, president of the Greater New York Hospital Association, "is to impose a death sentence on hospitalized patients in the New York metropolitan area."

The proposals are being considered by the F.D.A. as the New York Blood Center is appealing for more donations to make up for the region's shortage. It says the worst shortages were for O-positive blood, the most common type; O-negative, which can be given to anyone in an emergency; and the rarer B-negative, which has been in short supply since the beginning of the year. The shortages have become so bad that the blood bank cut Type O deliveries to hospitals by about 25 percent six weeks ago.

The F.D.A. is apparently aware of the situation in New York. In a briefing paper that the agency prepared on the subject, it noted that blood donations from Europe account for 25 percent of the blood supply in the New York region. It also noted that the restrictions would reduce the blood supply in New York by an additional 10 percent because of the loss of donors who travel frequently to Europe.

Dr. Jones of the New York Blood Center said he did not know where the center would get enough blood to make up for the potential loss, given the national crunch.

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