By Jean E. Herskowitz
This year, America will end up a quarter million one-pint units of
blood short of the amount Americans will need. This estimate is from the
nonprofit National Blood Data Resource Center in Bethesda, Md., which says
that about the same amount of blood is imported from abroad each year to
fill Americans' needs.
As in the past, the new millennial year started with acute holiday
shortages of donor blood in California and other parts of the nation
(including New York), as Dan Rather reported on CBS. Blood was rationed;
elective surgery curtailed.
Astonishingly, however, hematologists have discovered a way to end
America's perennial blood shortage forever! But: It's not being used.
It is an untapped source: people whose blood contains excess iron. They
are sufferers of hemochromatosis, iron overload disease. In this genetic
disorder, the red cells absorb too much iron. Hematologist Victor Herbert,
M.D., of the Veterans Affairs Medical Center in the Bronx, N.Y., an
affiliate of Mount Sinai Medical Center, says:
"For genetic reasons, 12% of all Americans - including about one in
five Irish-Americans and one in three African-Americans - have too much
body iron."
Many Are Afflicted
People with moderate iron overload - heterozygotes (H) - absorb fifty
percent more iron from their food than people without the disease, Herbert
explains. People with homozygous hemochromatosis (HH) - the more serious
form of the disease - can absorb up to three hundred percent more iron
than normal. If untreated, they may suffer multiple-organ damage
(including pancreas, liver and heart) - and death.
Treatment for this condition has been basically the same since the
1950s. It is called therapeutic phlebotomy - in essence, blood-letting.
"On average," writes hematologist Nancy C. Andrews, M.D., of Children's
Hospital, Boston, in a December 23 review article in the New England
Journal of Medicine, "men require phlebotomy three to four times per year,
and women require it one to two times per year. When phlebotomy is
instituted before endstage organ damage has occurred, patients can have a
normal life expectancy and quality of life."
What, then, happens to the thousands of gallons of blood from
hemochromatosis patients?
Value Is Perceived
For years, it's been poured down the drain, and most of it still is.
U.S. Food and Drug Administration (FDA) regulations have required that
this blood be stigmatized by labeling it "thera-peutic phlebotomy -
patient has iron overload." As the result, most of it is thrown out,
thereby perpetuating blood shortages and the importation of foreign blood.
Herbert, who is a nutritionist as well as a hematologist, has long
believed this blood is a valuable resource being wasted. While iron
overload is dangerous, a rare or occasional pint of this blood, diluted
1:10 in an adult recipient's circulation, is no risk at all, Herbert says.
In fact, many transfusion recipients are anemic, and for them the bit of
extra iron is a plus rather than a minus. What is more, hemochromatosis
sufferers, with their iron-rich blood, are less likely than others to need
transfusions. So, they are less likely to be infected with hepatitis and
other transfusion-related microbes.
Several years ago, Herbert and his Mount Sinai associates reexamined
the blood-dumping practice.
"I have lived through many blood shortages, including one this past
summer," said Mount Sinai's blood bank chief, Morton Spivack, M.D. "The
use of blood drawn from the many otherwise healthy patients with
hemochromatosis would go a long way toward alleviating these recurrent
shortages."
He and Herbert and several colleagues filed a petition with the FDA in
1996, to destigmatize hemochromatotic blood. In June, 1997, the FDA
rejected the petition, saying there was not enough evidence to support the
idea. Then, last April, Herbert was invited to present his case to a U.S.
Public Health Service's advisory committee meeting on blood.
The result of that two-day meeting was passage of a unanimous
resolution:
The committee finds that blood products obtained from persons with
hemochromatosis carry no known increased risk to recipients attributable
to hemochromatosis, per se, and therefore may be a valuable resource to
augment the diminishing blood supply.
End of story? Unfortunately, no. The FDA and the national blood
organizations still have not lifted their ban on using iron-heavy blood
for transfusions.
"The government cannot in one day, on its own initiative, do something
completely different than it did yesterday," explains internist Stephen D.
Nightingale, M.D., a blood resources expert in the Department of Health
and Human Services. Meanwhile, he told PROBE, "The FDA is preparing, for
release this spring, a blood industry guidance that will state how blood
banks can gain exemption from the current law, which still says 'no' to
using the blood."
This despite the fact that "[n]o knowledgeable person believes [the
blood] is intrinsically dangerous," complained Vincent Felitti, M.D., of
the Southern California Permanente Medical Group, in San Diego, at the
Public Health Service conference last year. "Indeed, [this blood] has been
transfused in Sweden for thirty years without a problem, and in Canada for
almost a decade."
Money Counts in the Equation
One reason for the foot-dragging, Herbert asserts, is money: the fees
blood banks charge hemochromatosis patients to draw their blood. Plus, the
costs recipients incur for transfusions. The blood-letting fees paid by
hemochromatosis patients typically range between $50 and $200. This is
essentially pure profit, since the blood is discarded, and doesn't need to
be typed or tested.
"Blood banks currently gross $200 million a year charging
hemochromatosis patients for phlebotomies," says Herbert. Not an easy
thing to give up.
The reform proposal would redefine the hemochromatosis patients as
blood donors. They no longer would have to pay to be bled.
Proposal Issued
These considerations led FDA last year to issue an interim waiver
procedure that says:
"If blood establishments [blood banks and hospitals] can
verify that therapeutic phlebotomy for hemochromatosis is
performed at no expense to the patient, the FDA will consider
case-by-case exemptions to [the] existing regulations" [emphasis added].
To start using the iron-rich blood for transfusions, the hospital or
blood bank must ask FDA for a variance from the current rules. The request
submitted by Mount Sinai in New York, and accepted by FDA, says:
"We . . . will no[t] . . . charge any hemochromatosis donor who
qualifies as a routine blood donor. We will perform all required viral
marker studies on these units [of blood] and will provide FDA with any
data" on problems that may arise.
An FDA director responded by granting the hospital the right to collect
blood from hereditary hemochromatosis donors, without the special
labeling.
The FDA still has not come up with a proposal to fully legitimize the
iron-rich blood.
Blood Bankers Demur
The American Association of Blood Banks (AABB), which represents a
majority of the blood collecting agencies in the country, is also dragging
its feet. In a memo to member blood banks, it stated that its standards
currently prevent hemochromatosis patients from donating. The memo went on
to state that blood facilities could get an exemption from the AABB
regulations.
"Those facilities that apply to the FDA for a variance from their
requirements should probably apply to the FDA for a variance from our
standards at the same time" [emphasis added].
However, an AABB official said by e-mail, "We are not currently
granting variances from . . . the standard that prohibits . . . donations
from hemochromatotic individuals."
According to Herbert, Mount Sinai's Spivack, an AABB member, hasn't
asked the organization's approval. Mount Sinai is operating, with no
problems, under the FDA waiver alone, he says.
Mechanisms Not Known
Some blood banks may not know of the FDA's exemption to the
restrictions on using hemochromatotic blood. A doctor at New York
Hospital's blood bank told PROBE by phone:
"I was aware that the process was in place. But we have not yet taken
advantage of it. I didn't know the exact mechanism of how it was going to
be done."
He added, later, that the exemption didn't really apply to New York
Hospital, as it performs phlebotomies, but does not
operate as a blood donor center. New York Hospital continues to charge
about $200 per phlebotomy, and then tosses the blood.
No one knows exactly how much blood would actually be added to the
nation's blood supply if hemochromatosis blood is finally destigmatized.
Herbert estimates that re-using the blood from just one of the four
phlebotomies that male hemochromatosis patients need each year would
provide about 31 million units. He says:
"Using this blood would keep the patients healthy, and would forever
end blood shortages!"
PROBE phoned several blood banks across the
country to see if they knew of the FDA exemption. If so, were they
using it to collect hemochromatosis patients' blood for transfusion?
Here's what they said:
Sacramento Blood Center, California:
People at this blood bank are aware of the exemption, but are not yet
applying for it, explained blood banker Leonor Fernando, M.D.
"The exemption application process is a challenging one," a colleague,
Chris Gresens, M.D., added: "To apply for this exemption we'd have to
commit at least several hundred hours of work," at a cost of "thousands of
dollars . . . . Labeling and tracking these units would present additional
challenges."
American Red Cross - New England Region:
The policy of the American Red Cross (ARC), which accounts for about
half of the blood supply nationwide, is to not use the blood. "Our
national headquarters is evaluating the recent FDA announcement," said
Stephanie Millian, ARC spokesperson for the New England Region. "But for
now the current procedure remains in place. We don't accept
hemochromatosis patients for transfusion."
Meanwhile, the New England ARC phlebotomizes 7,000 patients a year. The
average cost is $32, according to Millian, which covers the staff's time
and the blood bag.
What does she think of the discard policy?
"It boils down to what our national headquarters tell us to do with the
blood," she said. Meanwhile, New England is experiencing shortages of O+
and O-, but, Millian says:
"We need blood of all types. Flu has had an impact on
our supply; many donors have canceled. We're not in an emergency
situation, but we're monitoring the supply on a daily basis."
Blood Centers of the Pacific, San Francisco:
Until two years ago this blood bank used hemochromatosis blood. Now
they've stopped. "The AABB came out with regulations against using it,"
explains Danna Sorenson, Director of Donor Collections. "And now the one
hospital that our blood center used won't accept it . . .
"We drew blood from those patients for 20 years . . . . We didn't kill
anybody by using it. What made it okay one day, and not okay the next day
is beyond me!"
New York Blood Center:
Currently does not have a waiver. But hematologist Robert Reiss, M.D.,
says they are in the process of getting one.
He said that once they "apply for the FDA waiver, we have protocols in
place that would enable us to [use the blood for donor purposes]. We have
to show how we'll collect data. We also have to apply for a New York State
waiver and one from the AABB."
-J.E.H.
