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.
