I received a Press Release today from HemoPure and also viewed an
AP article that also reported on the approval of HemoPure for use
in humans in the country of South Africa.
In very short order, Jehovah's Witnesses in South Africa will begin
using this form of highly purified cow's blood.
BioPure will apply for final FDA approval later this year in the U.S.
This product, if widely accepted by the JW community will save
hundreds of lives each year.
This is a very promising development.
José Orduño lay dying. Doctors grumbled about their lack of options. And Orduño's sister, Angelica, wondered how she would tell their frail mother that he had refused lifesaving blood transfusions because of his faith.
"You walk around with your arms tied behind your back," said Mercy San Juan Hospital trauma surgeon Leon Owens. "It's torture."
But Orduño didn't die. After two weeks in the hospital, breathing through a tube in his throat, the baby-faced 34-year-old was offered a long shot: an experimental therapy made from the blood of cattle.
Before sunup July 21, Orduño was nearing the end of his 40-minute bike ride to McDonald's on Madison Avenue near Sunrise Boulevard, where he worked making salads, when he was hit by a car. He remembers nothing of the accident, but learned later that he was thrown about 90 feet, and that the driver of the car that hit him fled.
Orduño arrived at Mercy San Juan with a gash to the back of his head, bruised lungs and several broken ribs, including the bone under the collar, which is not easy to break.
"It's like a wooden doughnut," said Owens. "When it's broken, a little light goes on: This guy has really had a beating."
Orduño was losing blood, which was filling his chest cavity. That led to dangerously low levels of hemoglobin, the protein molecule that carries oxygen in the red blood cells to the heart, brain, kidneys and other vital organs. Without oxygen, tissue dies.
Owens ordered a blood transfusion.
After Orduño had received two units of a donor's blood, he awoke to tell the doctors and nurses surrounding him that he didn't want any more.
The transfusion was halted.
Although Orduño never officially has been baptized a Jehovah's Witness, he would explain later that he subscribes to the denomination's doctrine and is well-versed in its practices. "I know in the text where it mentions that we should not receive blood by mouth or by transfusion," he said.
His belief is based on several Biblical passages, including Leviticus 17:12-14: "No soul of you shall eat blood ... whosoever eateth it shall be cut off."
The faith's prohibition against transfusions has inspired debates within the medical and religious communities: Should a person's freedom to worship overrule a doctor's oath to do everything possible to save that person's life?
Even among Jehovah's Witnesses, the blood policy is controversial. A group calling itself the Associated Jehovah's Witnesses for Reform on Blood maintains a Web site dedicated to analyzing the no-blood doctrine.
Owens said he had to respect Orduño's wishes. But he did so grudgingly.
"You have a lot of margin of error with blood," he said. "With this guy, every drop you lose is lost."
A local representative from the Jehovah's Witnesses Hospital Liaison Committee was summoned. Owens told him that Orduño would die without more blood. Already, the patient's hemoglobin levels measured just 3 grams per 100 ccs of blood; a normal level is 12 grams. Owens had never seen anyone live with less than 2 grams.
"We discussed his vital signs, his fluid output, his hemoglobin, his respiration," said Gregory Brown, the representative. Brown suggested ways to manage the patient without more blood, but would not yield on the transfusion.
Owens couldn't perform surgery to stanch the bleeding without further blood loss. So he tried other innovative procedures.
He gave Orduño nitric oxide for more than a week, using the treatment as part of a clinical trial. Researchers have found that the gas helps the blood vessels pull oxygen across membranes that have bruised and swelled, as had happened in Orduño's case.
At the same time, Owens tried to stimulate Orduño's bone marrow to generate more hemoglobin using a drug called Epogen. But Epogen takes weeks to work, time that Orduño likely didn't have.
Meanwhile, Orduño's sister Angelica had arrived from her home in Guanajuato, Mexico. Doctors told her of his decision and, not being a Jehovah's Witness, it deeply disturbed her.
She spent days at his bedside. When the nurses kicked her out at 4:30 a.m., she slept in a lobby chair. She couldn't talk to José, who was heavily medicated and hooked up to a ventilator.
"I was scared," she said, turning to shield her eyes as they filled with tears. "I couldn't do anything."
Angelica stayed in touch with their sisters and brothers back home, but kept the news from their ailing mother, who, she said, wouldn't be able to cope if she knew of her son's impending death.
Orduño was barely hanging on, already showing signs of heart failure and vulnerability to deadly infection. "Every day we thought, this is the day," said Robynn Gough-Smith, the trauma program manager.
About two weeks into the ordeal, Dr. Roy Semlacher, a plastic surgeon, overheard another doctor discussing the case. "I know exactly what to use," he told them.
Semlacher knew of a Cambridge, Mass., company called Biopure that had developed an alternative therapy for situations in which patients can't -- or won't -- accept blood transfusions.
A case in which the drug had been used had been published in the June 1 edition of the New England Journal of Medicine. The article described how the therapy had saved the life of a young woman whose own immune system was destroying her red blood cells.
Semlacher called Biopure. Dr. Edward Jacobs, senior vice president of medical affairs for the company, said Orduño sounded like a good candidate for their drug Hemopure. Jacobs quickly got approval from the Food and Drug Administration to provide the drug on a compassionate-use basis.
The hospital called Brown to discuss whether Hemopure would be an acceptable alternative to whole blood. Brown agreed that the substance did not constitute a major blood component, as would plasma or red blood cells, which would be prohibited.
"Medicine has found ways of breaking down the components into many tiny pieces," he said. "We are saying, that becomes a matter of conscience because the Bible doesn't really address that."
Hemopure is made from cattle red blood cells that have been ultra-purified, processed and mixed with a salt solution. It can be given to anyone, regardless of blood type, said Jacobs. The drug is being tested in several clinical trials, and the company hopes to apply for permission to market it next year.
Packets of Hemopure arrived within two days of Semlacher's call. After getting the drug intravenously over three or four days, Orduño's hemoglobin level shot up, reviving his body's ability to produce new oxygen-carrying red blood cells.
When Orduño woke up from his drug-induced slumber, about a month after the ordeal began, Angelica was there. Seeing her face, he didn't know if he was in Mexico or the United States, where he has lived since 1997.
His sister told him about the accident and how he almost died, and about the drug made from cow blood that had saved his life.
He told his sister he didn't remember refusing the transfusion and never knew his life was in danger. But he said he agreed with his own dazed decision.
The doctors and nurses, the drug maker, the Jehovah's Witnesses -- everyone involved -- were elated at Orduño's recovery.
Orduño left the hospital on Sept. 10. His breathing is still labored and his right arm difficult to move after six weeks motionless and tethered to a hospital bed.
But he is eager to work again in his adopted homeland. Angelica, meanwhile, plans to return home to Mexico where she can deliver the good news to their mother.
NEW YORK (CNNfn) - The first regulatory approval for an oxygen therapeutic for human use has been awarded to two South African hospital groups Tuesday.
Netcare and Community Health Care hospitals have won the approval of South Africa's Medicines Control Council to import Biopure Corp.'s (BPUR: Research, Estimates) Hemopure, which treats acute anemia and avoidance of blood cells in adult surgery patients.
Hemopure is the first product approved for human use in a new class of intravenously administered drugs, called oxygen therapeutics, that are used to deliver oxygen to the body's tissues as a safe alternative to red blood cell transfusion.
"This could profoundly impact public health issues in Africa as the product's purity, compatibility with all blood types and two-year room temperature stability address many of the medical and logistical problems surrounding the treatment of anemia with red blood cells," said Dr. Richard Friedland, chief operating officer of Netcare.
Hemopure is licensed in South Africa to Tshepo Pharmaceuticals Ltd., a joint subsidiary of Netcare and Community Healthcare. Tshepo will launch the product nationally in the first half of 2002 following's completion of its Cambridge, Mass. manufacturing facility.
Thanks for letting us know, Lee.
And thank you, S, for posting the articles here.
PS How many on the board will now buy stock in oxygen therapeutics?
I want to express my gratitude for such posts.
After having followed the long debate on the BMJ...excellent
by any standard, these kind of informations should be shared
I'll keep you informed if anything moves here in Europe...
it should at anytime now!
Thanks LeeElder for your " labor " in behalf of the friends
and all those in need of such informations.
Agape to you all, J.C.MacHislopp
if you go to the bio pure website you can sign up for email updates... there is also the press conference on real player......
Perhaps its just me..but red blood cells is red blood cells blood... this comes from animals and its ok with the JWS?
I'm confused, witnesses can accept cow's blood but not human blood. If taking a criminal's blood can make you a criminal, can taking cow's blood make you act like a cow?
I am looking forward to hearing moooooving experiences about this.
Is it cow's blood or just bull?
Udder destruction can't be far behind.
i am having a big glass of cat's blood
but don't worry god said it's ok
the ideas and opinions expressed in this post do not necessiarly represent those of the WTB&TS inc. or any of it's subsidiary corporations.
I must say... quite some EXCELLENT udderenaces!