Platelet Donor Pool Feared to Shrink

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Platelet Donor Pool Feared to Shrink

By ANDREW BRIDGES, Associated Press Writer 29 minutes ago

That sticky, colorless stuff in blood that makes it clot could become

scarcer for chemotherapy, radiation and transplant patients who need

regular transfusions.

The federal government wants to overhaul the guidelines for platelet

donations to ensure donors are protected. Donation center officials

say the changes could have an unintended consequence: as much as a 50

percent reduction in the supply.

They have flooded the Food and Drug Administration with letters of

opposition, some running dozens of pages.

The government wants to limit annual platelet donations to 24 pints

per donor. Now, the limit is on how often someone can donate — 24

times a year. That could equal 72 pints a year since donors can give

up to three pints at a time.

Platelets, with just a five-day shelf life, are transfused almost

immediately. They are chronically scarce.

The blood officials fear the changes to the 18-year-old guidelines

would mean a 10 percent to 50 percent drop in the volume of donated

platelets, which are vital for patients who can't make them on their

own. During chemotherapy, cancer patients can require six pints to

eight pints of transfused platelets a day for weeks.

" It's something they need a continuous, reliable supply of, " said Doug

Delhay, who has donated more than six gallons of platelets since 1998.

" To me, life is a gift we receive and it's a gift we can give, " said

Delhay, 52, a maintenance supervisor for an electric utility in the

Lincoln., Neb., area.

The FDA's rationale and timing are coming under question.

" At a time when the supply is tight and for what reason? The FDA did

not provide us with the information that tells us why, " said Dr. Louis

Katz, executive vice president for medical affairs at the Mississippi

Valley Regional Blood Center in Davenport, Iowa.

Dr. Jay Epstein, director of the FDA's Office of Blood Research and

Review, said the proposal is intended as a recommendation. But

donation officials said they would view it as a requirement.

" There were audible gasps all across the country at blood centers, "

said Katz, a member of the FDA advisory committee.

In addition to volume restrictions, FDA is proposing that a doctor be

present or within 15 minutes of a donation center while platelets are

being drawn and that people who take aspirin and medications such as

Ibuprofen wait several days longer before giving platelets.

Epstein said 1988 was the last time the FDA's guidelines for platelet

donations were overhauled.

He said there have been no reports from donors about significant

problems stemming from giving platelets. He added, however, that there

isn't enough information to assess whether current practices are safe.

" It's not really surprising that (the blood donation) industry has

expressed concerns because we are suggesting there are things that

have come into current practice that may not be for the best, " Epstein

said.

An FDA advisory committee plans to consider the proposal March 9.

Most platelet donation is done through a process called apheresis,

which involves drawing whole blood from a donor's arm and running it

through a centrifuge to separate out the platelets. Red blood cells,

white bloods cells and plasma are returned through the other arm. This

reduces the impact on donors and allows them to give as many as three

pints in a one- to two-hour session.

Platelets also can be culled from donated whole blood, but it can take

six pints to produce the one that a single apheresis donor can give.

In letters sent to the agency since September, nervous blood donation

officials said people have safely have made double and triple

donations for years.

Dr. Joy L. Fridey and Mark Kaniewski of the City of Hope National

Medical Center in Duarte, Calif., said the changes could cause

shortfalls in the availability of platelets.

" We are not at all confident that nearly enough donors could be

recruited to make up for the platelet losses that would occur should

this proposal be formalized. Thus, we are fearful that the platelet

supply will be severely inadequate to meet transfusion needs, " the two

cancer hospital officials wrote.

City of Hope said it would face a 15 percent deficit if the guidelines

went into effect. Others predict more serious shortages.

" We would lose 50 percent of the platelets we collect and that is a

conservative estimate. We would probably lose more than that, " said

Dr. Kopko, medical director of BloodSource, a blood bank in

Sacramento, Calif.

The American Red Cross estimated it would lose 65,000 pints of

platelets a year, slightly more than 10 percent of the 638,971 pints

the charity collected in 2004.

Phyllis son, chief executive officer of the Community Blood Bank

in Lincoln, Neb., where Delhay donates, said the requirement to have a

doctor nearby would be restrictive and costly. Calling paramedics for

an emergency is a better solution, son said.

" Physicians just don't run around town for things; 911 runs around

town, " she said.

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On the Net:

Food and Drug Administration: http://www.fda.gov

America's Blood Centers: http://www.americasblood.org/

American Red Cross: http://www.redcross.org/