Artificial blood was originally created to offset any shortages of fresh blood that could be used in an emergency or for wounded soldiers. It does not need refrigeration, has a long shelf life and does not need to be matched to an individual’s blood type.
But a published study casts doubt on whether the FDA has been upfront on the risks involved to patients enrolled in medical trials on fake blood.
The findings, published in the Journal of the American Medical Association (JAMA), find that artificial blood has led to a 30 percent increase in the risk of death and in a three-fold risk of heart attacks.
The JAMA review of 16 clinical trials that involved five hemoglobin-based blood substitutes, concludes that manufacturers downplayed the risks of blood substitutes and kept enrolling thousands of patients without informed consent.
For example, data from clinical trials of Hemopure, completed in 2000, only became public after Public Citizen sued the FDA and the FDA called an advisory committee meeting in December 2006.
Data from two additional trials had not been published, even though the studies were terminated for safety reasons.
The lead researcher, Charles Natanson from the National Institutes of Health (NIH), says the dangers should have been clear in 2000 before 1,000 unsuspecting patients were enrolled in trials.
Still, the FDA did not intervene to stop a blood substitute trial even after patients were being injured, he said.
The medical trials are supposed to be closely watched by independent medical boards and their ethics panel known as Institutional Review Board (IRB).
Natanson reports that communities were not told about the risks because the risks were not reported by sponsors to the FDA in a timely manner.
"We need change in regulations such that there can't be secret science," Natanson says. "The only way that IRBs can make informed decisions is if they know what the previous risks have been."
"Openness and full disclosure is one of our best defenses for protecting patients."
Despite the warning signs, South Africa has approved the use of artificial blood for the treatment of acute anemia in adults.
Five human studies are underway in eight countries with one planned for the U.S.
Critics believe human trials should be halted and returned to animal testing before further human trials are allowed to proceed. They also call on Congress to open the doors to review information from studies during a product development process, not have to wait until a product is approved.
Public Citizen's Dr. Sydney Wolfe and NIH's Charles Natanson will make their findings public Tuesday and Wednesday at a workshop on the safety of artificial blood.
The FDA’s director of blood research, Jay Epstein, defends the FDA concerning human testing and the risks. There are enough differences in individual products to allow some studies to continue, he says. #