Blood substitute is surgical solution for church member

Doctors use alternative on Rialto Jehovah's Witness

San Bernadino Sun/March 8, 2003
By Annette Wells

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.'