http://www.denverpost.com/Stories/0,1413,36%257E53%257E836403%257E,00.html#
Denver Post
FDA OKs rare use of synthetic blood
Springs woman's faith prevented her getting ordinary transfusion
By Karen Auge
Denver Post Medical Writer
Wednesday, September 04, 2002 - A 38-year-old Colorado Springs woman whose religious beliefs forbid her from receiving human blood has received a rare emergency transfusion of an experimental, synthetic blood at Denver Health Medical Center.
Some half-dozen companies have been working on blood substitutes, or synthetic blood, for years. But nearly all have hit snags - some serious - and none of the blood substitutes has been approved for use in this country.
But last week, the Food and Drug Administration gave permission to use one - PolyHeme - in this particular case, said Dr. Ernest E. Moore, chief of Denver Health's surgery department.
Once the FDA gave permission, the synthetic blood was flown here from Illinois, where it is made, as Sheryl Padilla was driven by ambulance to Denver Health. She got the transfusion Thursday and was in serious condition Tuesday in the hospital's intensive care unit, Denver Health spokeswoman Sara Spaulding said.
Padilla is probably the fourth person in Colorado to get PolyHeme in an emergency, with the FDA's permission, Moore estimated.
In the early 1990s, dozens of companies were scrambling to find a safe alternative to donated blood, in response to fears of HIV and Hepatitis C being passed through donated blood.
By the mid-'90s, Baxter Healthcare appeared to be ahead in the race to get a substitute onto the market. But trials of that company's product were abruptly halted when 24 of 52 patients who got it died.
Since then, the FDA has been proceeding with caution before approving synthetic blood trials. Of some half a dozen companies now working on blood substitutes, many have butted heads with FDA regulators.
But now, with concerns about so-called mad cow disease and West Nile virus being spread through transfusions, Moore hopes there will be renewed urgency to perfect a blood substitute.
Artificial blood being developed now isn't expected to replace the stuff that Bonfils Blood Centers, the Red Cross and others pull out of donors' arms.
Instead, it is hoped the synthetic can serve as a "bridge," as Moore put it, until the right whole blood can be found, or until a patient can get to a hospital that has the right kind of blood. One advantage of synthetic blood such as PolyHeme, Moore said, is that it can be stored up to 100 days. Donated blood has a shelf life less than half that long.
Denver Health was one of 20 sites across the country conducting clinical trials of PolyHeme, the only blood substitute currently being evaluated in trauma situations, said Dr. Stephen Gould, president of Northfield Labs, which makes PolyHeme. The others have been tested in elective surgeries.
Last year, after nine years of clinical trials, the company applied for permission to market PolyHeme, Gould said.
In November, the FDA rejected the application.
But Gould said he is "engaged in a productive dialogue" with the agency.
In the meantime, "I get calls every week, sometimes every day from patients who have a life-threatening anemia or for whom blood cannot be used," Gould said. "In each case we have to make a decision about whether we think it's an appropriate use. If so, I call the FDA and try to get authorization."
He estimated that two-thirds of the calls are about patients who, like Padilla, are followers of the Jehovah's Witness faith, whose beliefs prohibit blood transfusion.
Padilla was seven months pregnant with her fifth child when she started having contractions last week, said her mother, Lois Wagner.
She went to Memorial Hospital in Colorado Springs, where doctors discovered that the baby, a boy, had died.
"After the delivery, she started having problems," Wagner said, including massive bleeding. "She lost a lot of blood very quickly."
Doctors there told her that without a blood transfusion Padilla would die, Wagner said.
"They said, 'Call all the family, they should be here."'
Wagner said that as her daughter grew weaker, her resolve and her faith never wavered.
Like some half million Jehovah's Witnesses across the country, Padilla and her family believe it is a sin to receive a transfusion of whole blood or plasma. The belief is based on the Witnesses' interpretation of several Bible verses that caution against ingestion of blood.
However, according to watchtower.org, the faith's official website, "Witnesses' religious understanding does not absolutely prohibit the use of (blood) components ... each witness must decide individually if he can accept these."
Wagner said she and her daughter had never heard of PolyHeme, and were only vaguely aware that anyone was even trying to perfect blood substitutes. But a fellow Jehovah's Witness knew about it, and started making calls.
Wagner said she's convinced those calls saved her daughter's life. Otherwise, "I don't think we'd be here talking now with this happy outlook," she said.