Usually government regulation is about money, not safety. I wonder how the smell of money caused this off FDA regualtion!
Blood banks fear FDA plan would cut platelet-donor pool
Andrew Bridges Associated Press Feb. 25, 2006 12:00 AM
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 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.
The limit now is 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 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 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 6 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.
In Arizona, United Blood Services collected platelets from 2,719 donors last year, with an average of 4.6 donations per donor.
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's advisory committee.
In addition to volume restrictions, the 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 before giving platelets.
Epstein said 1988 was the last time the FDA's guidelines for platelet donations were overhauled.
Reporter Kerry Fehr-Snyder contributed to this article.