Growing Blood Clot: New Mad-Cow Rules Cause Big Shortage

Growing Blood Clot: New Mad-Cow Rules Cause Big Shortage

August 20, 2001 New York Observer by Josh Benson

Some of New York's top medical officials fear that a last-ditch effort to avert a catastrophic blood shortage has failed, as the federal government and the American Red Cross prepare to implement new blood-donation guidelines that could eliminate up to a third of the metropolitan area's blood supply.

At a hastily organized meeting in Washington, D.C., on the afternoon of Aug. 10, a handful of clinicians, medical officials and representatives from the offices of Governor George Pataki and Senator Charles Schumer lobbied officials from the Food and Drug Administration to postpone or alter new guidelines that they say will precipitate a deadly blood shortage. The meeting was arranged at the behest of Mr. Schumer during a phone conversation with Health and Human Services Secretary Tommy Thompson.

According to several people who attended the meeting, the F.D.A. officials indicated that they could introduce the new guidelines -- which would ban blood imported from Europe and blood donated by many Americans who have traveled there -- as soon as next month, and they told New York -- area hospitals to prepare for a potential emergency. The New Yorkers at the meeting had a warning of their own. "We wanted to make sure that [the F.D.A. officials] knew what a disaster they were going to have on their hands," said Greater New York Hospital Association president Kenneth Raske. "We told them that their good effort to increase the safety of the blood supply was going to end up causing patient death and suffering, but I don't think we made any progress. They just told us to come up with a disaster plan."

The new restrictions are designed to guard against a human version of mad-cow disease, known as variant Creutzfeldt-Jakob Disease. The rules would not only eliminate many eligible voluntary donors, but would effectively destroy a blood-importation program upon which New York has become dependent. Faced with the imminent prospect of losing so much of their available blood supply, area hospital officials are blaming not only the F.D.A., but also one of the country's most prestigious institutions, the American Red Cross. The critics say that Red Cross officials have forced the F.D.A. to follow their lead as they rushed to place tougher restrictions on sources of donated blood over the past several months. The Red Cross, which supplies about half of the nation's donated blood from its collection centers across the country, has no official power to create mandatory national guidelines, but its rules effectively attain the weight of law by dint of its reputation.

New York hospital officials are now preparing for a disaster that, they say, could have been averted. "You can speculate that this disease can be transmitted through blood -- I don't think there's a case for it -- but either way, it's a possible problem in the future, whereas the restrictions will be a real problem for God knows how many people," said Herbert Pardes, president of New York-Presbyterian Hospital. "If there were a cut in blood supply, my hospital would be hamstrung in terms of the procedures we have to do. We do a lot of very special procedures; we take care of babies, heart disease and high-end people with very complicated health-care problems. And how would you tell cancer patients that they have to wait for exploratory surgery? This whole thing is a judgment call, but Jesus Christ -- first make sure you have a plan before you start constricting the blood supply."

There are no documented cases in the world of variant Creutzfeldt-Jakob Disease being transmitted through blood transfusions. But the Red Cross is taking a conservative approach to the still-mysterious illness -- an attitude that seems to have inspired the federal government to adopt similar measures. "It appears that the proposal for [blood] policy from the American Red Cross is what's driving everything else at this point," said David Wuest, the chief of Blood Bank and Hemotology Laboratory Services at the Memorial Sloan-Kettering Cancer Center, who was also present at the F.D.A. meeting.

"The F.D.A. has stated that they can't stand by while the Red Cross is producing a standard that, on the surface, is safer for the blood supply -- even when that standard is not based on science, and when it devastates blood supply in the New York area," added Robert Jones, president of the New York Blood Center, the nation's largest independent blood-distribution organization. Mr. Jones made a presentation to the F.D.A. officials outlining New York's contingency plan for dealing with the new regulations. The New York area would be disproportionately hard-hit, since it currently relies on European blood to cover its chronic shortage of locally donated blood.

A spokeswoman for the F.D.A., Lenore Gelb, said that there were no new developments to report on the planned guidelines, but that the F.D.A. would continue to "look at ways to try to ease the situation in New York."

Under previous leadership, the Red Cross was on the receiving end of humiliating public criticism from the federal government and in the press for failing to screen H.I.V.-infected blood that was provided to hospitals. At the heart of many of the current complaints about the blood policy is a contention that the Red Cross, under the leadership of the telegenic former Republican Senate candidate Bernadine Healy, is now engaged in a politically motivated image-mending by positioning itself as the undisputed guardian of the nation's blood supply.

The recommendations that the Red Cross plans to enact next month will ban donations from anyone who has spent at least six months in Europe or at least three months in Britain since 1980. The vast number of New Yorkers who are immigrants or who travel frequently would be eliminated from the donor pool.

Some critics suggest that the Red Cross' push for tight regulations is based not on science, but on self-interest. A nonprofit organization, the Red Cross is perennially strapped for cash -- it is currently in debt to the tune of $339 million -- and critics point out that the Red Cross' efforts to set the agenda on the blood supply would have the convenient consequence of reducing that debt while expanding market share.

A Rare Commodity?

"The Red Cross has been losing money for years," said Celso Bianco, executive vice president of America's Blood Centers, a national network of independently run blood banks. "I believe they now want to change blood from a common commodity to a rare product that would increase the value of that product. They also have a desire to be the national blood service, and if New York fails in providing blood as a result [of the Red Cross regulations], it would give them a chance to acquire the New York Blood Center, or to supply hospitals through a blood center of their own."

Howard Berliner, an associate professor of the health-services management program at the New School University, also believes that the Red Cross' recommendations on blood policy are motivated, at least in part, by self-interest. "This is not just about the fact that the Red Cross is hurting really badly for money, but also the fact that they were burned really badly for being so slow to implement changes to deal with the H.I.V. virus," he said. "Now they're erring on the side of caution and doing well by doing good."

The Red Cross is, to some extent, caught in a no-win situation. Though officials are being criticized for taking a conservative, geographically based approach to donor selection, it can also be argued that the risk of a mad-cow infection of the American blood supply does exist. Officials point out, for example, that their critics can label the risk of variant Creutzfeldt-Jakob infection through transfusions as "hypothetical" in part because no blood test yet exists that would detect the disease with certainty. They say that similar restrictions have been placed on donated blood in places like Japan and Canada. And, they say, the New York area should have had a contingency plan in place long ago to replace the imported European blood with a more reliable local donor base. (Approximately 2 percent of New Yorkers donate blood; the national average is closer to 5 percent.)

"The people from New York are criticizing us -- maybe because we're an easy target -- instead of talking about ways to expand their own donor base," said Christopher Thomas, a Red Cross spokesman. "We've made an offer to help New York. The Red Cross offered to support New York blood needs if the [new guidelines] affect the supply."

Mr. Thomas also said that the H.I.V. crisis had, if anything, better equipped the Red Cross to deal with new problems. "Absolutely, we have to recognize our past and our response to the H.I.V. epidemic, and it should inform our response to this new threat. But this was a thoughtful decision, based on the same data that the F.D.A. uses, to deal with the safety and availability of the blood supply."

Dr. Jones and Dr. Wuest stressed in interviews that they were already seeking ways to expand their donor base to make up for any possible shortfall, but they seem convinced that the task would be difficult -- at least in the short term -- once the new restrictions are in place.

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