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Friday, January 05, 2001
 David Zimmerman's newsletter on science, media, policy and health

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David R. Zimmerman,

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Don't Ask, Don't Tell . . .

When a volunteer comes to donate blood, blood banks don't ask if he or she has hemochromatosis. Neither do they test the blood for iron overload - although the test exists, and could easily be done.

Even if he or she has diagnosed hemochromatosis, the donor doesn't volunteer that information. The payoff:

The donor gets a free phlebotomy. The blood center gets to keep and use for transfusion a unit of blood they would otherwise have to down label and discard. Also, many volunteer blood donors who have hemochromatosis are never diagnosed, so their condition is not adequately treated.

Hematologist Herbert says changing the rules, to remove the taint from their blood, will serve all parties: By testing all donors' blood, those who need periodic bleeding will be identified. The blood banks will have more usable blood, and also a list of needy and eligible donors to call in when shortages arise.

Hemochromatosis Patients Describe Their Plight

Before Brian Jarvis of Portland, Oregon was diagnosed with HH hemochromatosis in 1993, he says, he donated blood infrequently. After the diagnosis, "I gave on a regular basis - every 60 days - from 1995 to 1997, in order to maintain my blood iron at a normal level."

Jarvis says that when he went public with the fact that he was an HH person, the American Red Cross declared him "an unacceptable donor," and cancelled his donor eligibility.

His blood is now discarded.

Randy Alexander, a hemochromatosis sufferer, and founder of the Iron Disorders Institute in Greenville, South Carolina, said at the U.S. Public Health Service's advisory meeting last April: "I have experienced firsthand the frustrations of having to have blood drawn, at a cost of over $800 a month - and it was to save my life. I had few alternatives because I was unable to work for long periods of time . . . .

"Hemochromatosis patients do not understand why this blood cannot be used . . . . If some people are paying $300 for a pint of blood, and it puts them in financial ruin, what options do they have? We have an opportunity, a resource of blood from people with hemochromatosis. They feel they can help somebody else. When they have blood drawn, and then see a biohazard sticker put on that bag, that does not set well with them."

Alexander told PROBE by phone that internist Herbert, in the Bronx, has been "one of the main drummers in this fight." He's a doctor and a lawyer, Alexander points out.

"He yells and screams at the FDA and the blood banks - but not without merit. It took knocking down their doors to get these organizations to where they are now - investigating why this blood isn't being used!"

Blood Shortage Remedy Is Found, But Blood Banks and Fed Resist It

February, 2000, New York, NY

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."


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