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Article Last Updated: Saturday, March 08, 2003 - 9:25:38 PM PST
Church lets faithful opt for PolyHeme
Blood substitute's use an individual's choice
By ANNETTE WELLS, Staff Writer
Webster's defines faith as a belief in the traditional doctrines of a religion.
The rules of the Watch Tower which guides Jehovah's Witnesses forbid members to consume their own or others' blood.
This religious conviction, based on three passages from the Bible, applies to whole blood, packed red blood cells, white blood cells, plasma and platelets, said L.C. Cotton, associate director of Jehovah's Witnesses hospital information services.
"We feel that the Bible clearly indicates that blood is sacred and it is not to be used for human consumption,' he said. "Though it doesn't discuss it in medical terms, Jehovah's Witnesses feel that would preclude the acceptance of it in a blood transfusion.'
Violation could lead to loss of eternal life, the Watch Tower suggests.
"We're not anti-life,' said Jose Urbina of Pasadena, whose father, a Rialto resident also named Jose, and other family members have undergone surgery without the use of blood.
"As Jehovah's Witnesses, we love life, the former San Bernardino resident said. "But the issue of blood is a major thing that we have to adhere to.'
The younger Urbina continued, "We don't want to violate Jehovah.'
However, in January, Urbina's father became one of two patients in Orange County who have received the chemically modified hemoglobin, PolyHeme.
Though it is not whole blood, it is derived from it.
The question now is it still blood?
Cotton could not answer that question but said individuals must decide whether to accept the product.
"When blood is fractionated beyond those primary components and other blood derivatives, we feel that it is an individual decision,' he said. "If an individual's conscience will allow him to accept the product, then that would be up to that individual. That is between himself and his God.'
As far as other Jehovah's Witnesses possibly ostracizing those who do accept hemoglobin substitutes, Cotton said it would never happen.
"The understanding is that each person stands before God and is judged according to his own conscience,' he said. "The other Witnesses would not criticize any decisions he makes.'
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http://www.sbsun.com/Stories/0,1413,208~12588~1230929,00.html
Article Last Updated: Saturday, March 08, 2003 - 9:48:41 PM PST
Blood substitute is surgical solution for church member Doctors use alternative on Rialto Jehovah's Witness By ANNETTE WELLS, Staff Writer
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| | Steven Lewis | | Jose Luis Urbina listens to his daughter Ruth from a hospital bed on Friday in Santa Ana. Urbina, a Jehovah’s Witness, was bleeding internaly and near death recently but his faith prevented him from accepting a blood transfusion. His family located a hospital in Orange County where a bloodless surgery was performed. |
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RIALTO - Blood is sacred.
Blood should not be eaten, and if removed from the body should be disposed of, not reused or given to someone else.
That's the belief of Jose Urbina and other Jehovah's Witnesses.
In January, the 56-year-old Rialto man's beliefs were tested as he nearly died because of gastrointestinal bleeding. The man's hemoglobin had dropped below critical levels, doctors said.
Surgery to locate and treat the bleeding likely would have required a blood transfusion.
Unable to breathe on his own, Urbina was at a crossroads.
To his right, religion. Faith. A wife and three children.
To his left, Urbina's physician at Community Hospital of San Bernardino. His life.
"I told them no blood,' he said, speaking Spanish through a translator at Fountain Valley Regional Medical Center, where was transferred for a special procdure. "They knew why.'
As a result, Urbina became one of two patients in Orange County to receive the chemically modified hemoglobin, PolyHeme.
PolyHeme, developed by Evanston, Ill.-based Northfield Laboratories Inc., is basically recycled blood.
Though used on a case-by-case basis depending on emergency need, PolyHeme has not been approved by the federal Food and Drug Administration, said Jason Shane, manager of Fountain Valley Regional Medical Center's Bloodless Medicine and Surgery Program.
The program was started about 20 years ago as an alternative approach to treating patients who refused blood products. Most of the program's patients are Jehovah's Witnesses, Shane said. The others fear blood transfusions because of the potential risk of acquiring a disease from a donor.
"The FDA knows about PolyHeme. It is currently in Phase III, the final phase, of testing,' Shane said. "But it is being used all over the country and world.'
Dr. Vinod Melhotra, medical director of bloodless medical programs at Fountain Valley Regional Medical Center, said that before Urbina came to the Fountain Valley hospital, he was given NovoSeven, a new drug with the capability of stopping internal bleeding.
"We needed to get the bleeding to stop or his hemoglobin levels would have dropped till he died,' Melhotra said. "Without a blood transfusion and no ability to make it, your brain cannot function.'
Hemoglobin is the oxygen-carrying component of red blood cells.
When Urbina got to Fountain Valley on Jan. 14, his hemoglobin level had dropped below 3. A level of 14 is considered normal, Melhotra said.
"That's near fatal,' Shane said. "By this time, it is so low, you can't do surgery. And because he (was) anemic, he was not getting enough oxygen and had to be placed on a breathing machine.'
Melhotra said, "We did not think he was going to make it.'
PolyHeme was the only solution.
What is PolyHeme?
Northfield Laboratories began developing the product in 1985, said Dr. Steven Gould, the company's chief executive officer.
To produce PolyHeme, researchers separate, filter and chemically modify blood purchased from the American Red Cross and Blood Centers of America.
First, hemoglobin is separated from red blood cells and is filtered to remove impurities. The purified hemoglobin is then chemically modified using a multi-step process to create a polymerized form of hemoglobin.
The modified hemoglobin is mixed into a solution and given to the patient as it would be done during a blood transfusion.
"It looks like blood,' Melhotra said. "It comes in a plastic bag and is pre-mixed. It doesn't have any cells, and because the body doesn't react to it, it can be given to all blood types.'
One unit of PolyHeme contains 50 grams of modified hemoglobin or the same amount of hemoglobin delivered by one unit of transfused blood.
"We are in late-stage product development now,' Gould said. "We have data most of it has been published showing the life sustainability of our product. This data is based on cases where a person has virtually lost all of their own blood and was given our product.'
Who qualifies
Because PolyHeme has not received FDA approval, and it is only used as a substitute for blood in extreme acute blood-loss situations, obtaining it is a tedious task, Melhotra said.
"Prior to product approval we have to comply with all FDA's laws,' Gould said. "We have to get authorization to use it on a case-by-case basis. If the FDA approves the individual use, it is because the individual is in a life-threatening situation.'
In Urbina's case, a "compassionate use' approval was given because of his perilous condition and his inability to breathe on his own, Shane said.
Urbina's approval though, took about 48 hours. "It's a great deal of work, but obviously it's worth it,' Gould said.
After receiving approval from both Northfield and the FDA, 12 units of PolyHeme were delivered to Fountain Valley Regional for Urbina.
He was given five units over three days.
His hemoglobin levels gradually built back up to 10 within those days, and Urbina was weaned off PolyHeme.
Urbina's family members said they were glad someone knew about their options.
"They have a reputation for treating Jehovah's Witnesses with alternative blood products,' Urbina's son, also known as Jose, said about Fountain Valley Regional.
"I have nothing but respect for the people here and the respect they had for our father's beliefs,' he said. "From the time he was in San Bernardino until he got here, my father did a complete 180.'
Melhotra said Urbina was given other medication such as a bone marrow stimulant and folic acid.
About two weeks later, he was transferred to a Santa Ana rehabilitation center to recover.
"PolyHeme saved his life,' Melhotra said.
Benefits
So far, PolyHeme has only been used twice at Fountain Valley Regional, Melhotra said.
Before Urbina, a man had arrived at the hospital with advanced leukemia and received the solution. But the man's illness was too far advanced and he died, Melhotra said.
"PolyHeme provides a tremendous boon to patients during traumatic situations where they need blood in a hurry,' Melhotra said. "Especially when there isn't that much blood available today.'
The one major benefit of it is that it eliminates disease transmission.
Diseases such as AIDS and hepatitis are known to have been transmitted through blood transfusions, Shane said.
Another benefit of PolyHeme is that it has universal compatibility. It doesn't require blood typing so it can be used immediately.
"You don't have to cross type it,' Melhotra said. "You don't have to be part of any particular blood group to receive it.'
PolyHeme also has an extended shelf life.
Northfield Laboratories Inc. estimates that PolyHeme has a shelf life of about one year if refrigerated. Human blood has a shelf life of about 42 days, health officials say.
Dr. Arthur Silvergleid, medical director and chief executive officer of the Blood Bank of San Bernardino and Riverside Counties, said hemoglobin substitutes will not likely replace blood transfusions.
He said there are a selected group of professions, such as the military, that could benefit from the products.
"If we are in a combat situation, and soldiers have lost blood and need it quickly, hemoglobin substitutes would be helpful,' Silvergleid said. "But we're not concerned about going out of business.'
Silvergleid said hemoglobin substitutes were looked at in the mid 1970s, and at the time, researchers said they were just a "few years away.'
"On paper they do fine,' he said, "but they haven't completely been able to satisfy everyone.'
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For Witness faithful, it's all in the blood Many physicians seek to accommodate their patients' beliefs By ANNETTE WELLS, Staff Writer
Physicians face a unique challenge when treating Jehovah's Witnesses.
Members of the denomination an estimated 2 million in the United States do not accept blood, and are reluctant to undergo any organ transplants requiring blood transfusion.
According to information on the Web site for the faith ( http://www.watchtower.org/ , their religious convictions are based on the belief that all of a person's traits, including impulses to commit a crime, are contained in blood.
If that's the case, what are hospitals left to do?
L.C. Cotton, associate director of hospital information services for Jehovah's Witnesses, said physicians across the world, and especially here in the United States, have made efforts to accommodate their beliefs.
In this country, there are more than 82 bloodless medicine and surgery centers and more than 30,000 physicians capable of treating patients without the use of blood products, Cotton said.
In the world, there are more than 100,000 physicians, he said.
"I think at one point, there was a time when doctors were more paternalistic in their view,' he said. "It was more of, 'I will tell you what you need and you don't question me.'
"Today, more doctors want the patient to have a say in what is done to his body. The patient has a right to bodily self-determination.'
Dr. Julius Ibanez, medical director of the emergency room department at Community Hospital of San Bernardino, and Dr. James Killeen, vice chairman of the department of surgery at Loma Linda University Medical Center, say blood isn't always needed.
"There are very few surgical procedures where 100 percent of the time you need a blood transfusion,' Killeen said. "If somebody wanted a liver transplant without blood, that could be done.'
In fact, in the last 20 years, a number of products have been developed for physicians to treat patients who refuse blood.
Those products include fluids that can be used to maintain blood volume, drugs that can stimulate the production of red blood cells, blood salvaging machines and pads that can stop bleeding.
During blood loss, a patient's blood pressure drops and the heart rate goes up, Ibanez said.
When this occurs, and the patient refuses a blood transfusion, he or she can be given saline solutions or plasma volume expanders to replace the fluid that has been lost in arteries and veins.
"Saline solutions and volume expanders also keep the patient's blood pressure down,' Ibanez said. "However, they are not replacements for blood.'
Ibanez said that Community Hospital does not offer hemoglobin substitutes such as PolyHeme or Hemopure. PolyHeme, which is manufactured by Evanston,Ill.-based Northfield Laboratories Inc., is modified hemoglobin.
Manufactured by Cambridge, Mass.-based Biopure Corp., Hemopure is purified oxygen-carrying hemoglobin solution made from cow blood.
In addition, surgeons have tools, and the capability of performing procedures without the use of blood products, said Shane Jason, manager of the Bloodless Medicine and Surgery Program at Fountain Valley Regional Medical Center.
"Even blood tests, which usually require a certain amount of blood, can be done with very small amounts here,' he said. "Instead of one full vile, we only need two or three drops.'
Started in the early 1980s, Fountain Valley Regional's bloodless program is one of the oldest in the country, he said.
"Back then, people kind of looked at us like, 'Are you nuts?' Now there are more than 200 similar programs across the country,' he said.
Dr. Vinod Melhotra, director of the bloodless program at Fountain Valley Regional, said about 95 percent of the patients receiving treatment there are Jehovah's Witnesses.
The other 5 percent fear disease transmittal.
"Unless they are in dire need of surgery, we wait,' Melhotra said. "If a patient is anemic, then we would postpone surgery so that they can build up their blood count.'
Though Loma Linda University Medical Center doesn't have a bloodless program, Killeen said surgeons there likely wouldn't have a conflict if a patient wanted such a procedure.
However, the decision to perform the procedure would be dependent upon the degree of the medical problem, he said.
"If the job entailed a very complicated procedure, some surgeons might not be too comfortable, especially if they had a feeling the patient would not survive,' he said.
Ibanez said the idea is to know things in advance so that appropriate measures can be taken.
"The first thing we do is try to identity if a patient is a Jehovah's Witness,' he said. "That way, if the patient needs blood, we know that we can not give it to them.'
If the patient's condition is too serious for bloodless products, then there is a little bit of pleading done, he said.
"We explain the gravity and severity of their disease and we plead with them to make an exception in this case which is very, very rare,' Ibanez said.
"Secondly, we do as much as we can with what we have.'
