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

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.