Healthy Skepticism Library item: 5493
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Publication type: news
Bridges A.
Substitute blood development suffers blow
Associated Press 2006 Jul 13
http://seattlepi.nwsource.com/health/1500AP_Substitute_Blood.html
Full text:
Substitute blood development suffers blow
By ANDREW BRIDGES, Associated Press Writer2 hours, 21 minutes ago
The effort to develop substitutes for human blood, for use in emergencies from highways to battlefields, suffered a setback Thursday.
In response to a lawsuit, the Food and Drug Administration canceled what was to have been a closed-door meeting Friday to discuss the U.S. Navy’s proposed experiment using a product derived from cow blood on as many as 1,000 unsuspecting civilian trauma victims.
If the experimental trial is ultimately approved, the product from Biopure Corp., called Hemopure, would join another blood substitute already being tested on patients who have lost dangerous amounts of blood. Researchers hope the substitutes one day could step in to perform one of the vital roles of the real stuff: carry oxygen from the lungs throughout the body.
The substitutes would be given to patients only when and where donor blood was unavailable. They also would replace the saline fluids typically now given to bleeding victims in the field or on the way to the hospital. That salt water can counter a dangerous drop in blood pressure but cannot carry oxygen.
A lasting and constant font of donor blood would be ideal. The problem with using real blood, the gift of life, is that it doesn’t last a lifetime. Its 42-day shelf life, along with the scarcity of donors, difficulty in matching blood types between donors and recipients and perennial concerns about the transmission of disease also are problems.
The solution, researchers hope, could be the blood substitutes that can be churned out regardless of donor availability. They also could last for years and then be used without concern for infection or blood type.
The development and testing of experimental blood substitutes has been problematic: Baxter International Inc. stopped research on one such product in 1998 when more than 20 patients given the substitute died.
A second company, Northfield Laboratories Inc., is wrapping up clinical trials begun in 2004 of another product, called Polyheme, amid ongoing ethical concerns. Polyheme is being given to trauma patients without their consent as they’re being whisked to – and later, at – more than 20 hospitals around the country.
Now, Biopure, together with the Navy and backed by military funding, seeks FDA permission to begin trials of Hemopure, on 900 to 1,000 civilian trauma victims.
Hemopure is made from oxygen-carrying hemoglobin derived from cow blood. Biopure previously won FDA approval to sell a similar product to treat anemia in dogs.
Under the proposed trial, Hemopure, like Polyheme, would be given without patient consent, but only en route to the hospital.
Still, the lack of consent angers ethicists. Northfield previously has brushed off concerns about its Polyheme trials, which are subject to review by independent monitors.
“You have to go the extra mile to make the case. It isn’t enough to say giving salt water is a poor treatment – it’s true. But before you can experiment on people without their permission, you have to make sure that you have turned over every stone to find out whether you could get surrogate consent or prior consent,” said Arthur Caplan, a University of Pennsylvania medical ethicist.
On three previous occasions since June 2005, the FDA has blocked Hemopure trials from starting. Each time, it has cited safety concerns. Biopure, based in Cambridge, Mass., contends the benefits of Hemopure outweigh its risks.
The FDA recently relented, and agreed to refer the application to an outside panel of advisers. The agency isn’t required to follow the advice of its advisory committees but usually does. That panel was to have met behind closed doors Friday, but a last-minute lawsuit filed by the watchdog group Public Citizen led the FDA to cancel the meeting.
“Obviously, something is wrong. If it weren’t wrong, they wouldn’t have three times denied it,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.
The FDA now plans an open meeting to discuss Hemopure, agency spokeswoman Susan Bro said. The date has not been set.
It was not immediately clear who sought to keep the advisory meeting closed.
Bro said Biopure asked that it be closed. That appeared to contradict a published comment made by Biopure Chairman and Chief Executive Officer Zafiris Zafirelis, who in a July 11 article in The Wall Street Journal was quoted as saying the company had “no objection” to holding an open hearing. However, in a statement released late Wednesday, the company said it had not signed a waiver that would let the FDA open the meeting since it “could have significantly delayed the meeting.”
A Biopure spokesman declined to comment.
Both time and Hemopure appear key for Biopure, which has lost money each year since its founding in 1984 and as of April 30 had an accumulated deficit of nearly $513 million, according to recent Securities and Exchange Commission filings. Failure to win approval for Hemopure could have “severe negative consequences,” the company warned.
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On the Net:
Biopure Corp.: http://www.biopure.com/
Food and Drug Administration: http://www.fda.gov/
