Blood banks fear proposal would make platelets less plentiful
Patients who need transfusions require reliable supply
WASHINGTON -- 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 that 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 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. Patricia Kopko, medical director of BloodSource, a blood bank in Sacramento, Calif.