Platelet Donor Pool Feared to Shrink

Jolie Rouge

Platelet Donor Pool Feared to Shrink
By ANDREW BRIDGES, Associated Press Writer
Fri Feb 24, 9:20 PM ET

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. 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. Patricia 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 Ericson, 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, Ericson said.

"Physicians just don't run around town for things; 911 runs around town," she said.

http://news.yahoo.com/s/ap/20060225/...ZoBHNlYwM3NTE-

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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/

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Laissez les bon temps rouler! Going to church doesn't make you a Christian any more than standing in a garage makes you a car.** a 4 day work week & sex slaves ~ I say Tyt for PRESIDENT! Not to be taken internally, literally or seriously ....Suki ebaynni IS THAT BETTER ?

Jolie Rouge

His blood, your life
Mon Apr 3, 6:53 AM ET


The nation's health depends on Americans who donate blood. More than 4.5 million patients would needlessly die each year without transfusions.

This gift of life can turn deadly, though, if the blood supply is contaminated.


That's what happened in the early 1980s, when blood banks couldn't detect the HIV virus in blood. Nearly 10,000 people contracted AIDS through tainted transfusions before the Food and Drug Administration (FDA) imposed new rules on who could donate and a new antibody test was developed.


Beginning in 1985, FDA required blood banks to screen donors by behavior. Any man who had had sexual contact with another man in the previous eight years was permanently barred from donating. This saved lives, reducing the risk of HIV transmission by 90%, FDA says.


It was a tough, smart decision. But times change. Now, 21 years later, the smart decision is to do just the opposite. So much progress has been made in screening blood that the ban is no longer medically justified. That's the view of the American Red Cross, America's Blood Centers and the American Association of Blood Banks, which collect virtually all blood nationwide. The groups recommend deferring donors who've engaged in man-to-man sex for only one year. FDA is considering revising the ban.


The chance of contracting HIV through a transfusion is now less than 1 in 2 million, according to the Centers for Disease Control and Prevention. Only three known cases of HIV can be attributed to transfusions since the late 1990s, when a new sophisticated test was implemented.


The need to increase donations, on the other hand, in indisputable.


About 38,000 pints of blood are used each day. In times of shortages, which usually occur in summer and around Christmas, donations from gay men could mean that hospitals wouldn't have to cancel elective surgery as many now do. In the event of an emergency, the same donations would save lives.


That's not likely to change. While 60% of Americans are eligible to donate blood, only 5% do on a regular basis, notes the Red Cross.


FDA is right to move cautiously before changing a policy that has worked in the past. Nonetheless, it needs to recognize that the old rules have been overtaken by medical progress, and that they now appear to be doing more harm than good. Not just for gays. But for everyone.

http://news.yahoo.com/s/usatoday/200...p2BHNlYwMxNzA0

__________________
Laissez les bon temps rouler! Going to church doesn't make you a Christian any more than standing in a garage makes you a car.** a 4 day work week & sex slaves ~ I say Tyt for PRESIDENT! Not to be taken internally, literally or seriously ....Suki ebaynni IS THAT BETTER ?