- The Washington Times - Wednesday, April 11, 2001

South Africa has become the first country to approve a substitute blood product for use in humans.

Called Hemopure, the solution is created from purified cow blood and is designed to carry oxygen to tissues. It can replace blood in transfusions but has medical limitations and does not eliminate the need for Red Cross blood drives.

"Every unit of blood you get is different, whereas ours is a consistent, reproducible, pharmaceutical-grade product," said Carl Rausch, chief executive officer of Biopure, the Cambridge, Mass., biotechnology company that has developed the blood substitute.

Mr. Rausch, speaking in Johannesburg, did not say how much his company would charge for the product, but indicated that wealthier countries could expect to pay more than poorer nations.

South Africa's Medicines Control Council approved Hemopure's use Monday, becoming the first country to permit its use in humans.

U.S. medical specialists said the product is an important breakthrough but will not replace the need for blood donors.

"We will still be knocking on your door asking you to give blood," Dr. Rebecca Haley, chief medical officer of the Red Cross, said yesterday. "I think something like this will be approved for the U.S. I think it will be a niche product."

Dr. Haley said the Red Cross collects some 6.3 million pints of blood a year. The average cost per unit is $130, but that does not cover the entire cost of collecting and preserving the blood.

"[Hemopure] is fairly safe. It wouldn't surprise me to see it approved in the United States within two years," said Dr. Barbara Alving, a hematologist and director of blood diseases at the National Institutes of Health.

The Jehovah's Witnesses, which has a religious prohibition against using blood for transfusions even if it is used to save a life last year approved Hemopure for its members to use in emergencies.

Hemopure is made using hemoglobin from cow's blood, taken at a Pennsylvania abattoir. The cows, which are raised and monitored from birth in controlled conditions, are raised for food. At the slaughterhouse, the animals are butchered for hamburgers and steaks, while the blood is removed to make Hemopure.

The raw blood is stripped of all its proteins and then purified. The process eliminates the possibility of passing diseases like bovine spongiform encephalopathy to humans, Hazel Forney of Biopure said yesterday. BSE, also called mad cow disease, is caused by a mutated protein.

Biopure will file an application by the end of this year to sell and use Hemopure in the United States and anticipates selling the product for worldwide use, Miss Forney said.

The U.S. Food and Drug Administration had no comment on Hemopure yesterday.

Dr. Alving said the product has been "extensively studied," undergoing at least nine human trials in the United States. She said it has been approved for study in non-cardiac surgeries and in trials for elective orthopedic surgeries in the United States.

"If I were an ambassador in a country with a questionable blood supply, it would make me feel much better to have this around," said Dr. Alving. "If someone had a car accident, they could be transfused with this and evacuated by air for further care."

According to Biopure company literature, Hemopure can be used by patients with any blood type. Biopure claims the product eliminates the risk of transmitting infectious diseases, like HIV/AIDS and hepatitis, in blood transfusions. While blood collected at Red Cross drives has a shelf life of just 42 days, Hemopure can be stored at room temperature for two years.

But Dr. Alving said a solution such as Hemopure that carries oxygen costs five times what normal blood costs and has a half-life of just 20 hours, which means that after it is infused in the body, half of it is gone within 20 hours.

"They have all kinds of uses, in severe anemia, an ambulance could carry this to a crash victim, in emergency rooms. The army has long been interested in something like this for their field hospitals," she said.

Those who receive Hemopure transfusions are at a slightly increased risk of nausea, stomach pain, jaundice and hypertension, but no greater than with normal blood transfusions, its makers say.

Biopure, started in 1984, has had a nearly identical product to Hemopure on the market in the United States since 1998 for dogs.

• This article is based in part on wire service reports.

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