Developing a product that could be used as a blood substitute — one that has a long-shelf life and doesn’t require refrigeration or cross-matching — would be a great medical advance. Imagine the use of it in battlefield M.A.S.H. units or in times of natural or man-made disasters. But a new study by researchers from Public Citizen and the National Institutes of Health raises some serious concerns about the rush to bring these blood substitutes to the market. The study found that patients in clinical trials treated with blood substitutes faced a 30 percent greater risk of death and a 177 greater risk of a heart attack than those treated conventionally. The study was posted online today on the Journal of the American Medical Association website.
The study levels some criticism at the Food and Drug Administration for continuing to allow clinical trials, despite the evidence that the blood substitutes were putting patients at risk.
Carla K. Johnson’s story, “Study says FDA allowed risky tests of blood substitutes,” in the AP, questioned whether companies are intentionally withholding important information from the FDA.
Dr. William Hoffman, former chief medical officer at Biopure, left the company in 2000 after management prevented him from telling the FDA that he believed one of the company’s studies should be stopped. Hoffman said Biopure management has changed since then.
“The FDA knows more than anyone at any of the individual companies, but they may not know the whole story,” Hoffman said. “There may be information withheld from the FDA.”
Most developers of blood substitutes are one-product companies, and their existence depends on the fate of the product, said Hoffman, now director of cardiac-surgery critical care at Massachusetts General Hospital in Boston.
“Drug development is expensive. In order to get a drug to market you have to keep good news coming out so the value of the company remains high,” Hoffman said.
Perhaps more importantly, some of the people who were enrolled in the clinical trials were apparently not told of the increased risk of death and heart attacks, as Robert Davis writes in his story, “Study: Blood substitutes increase risk of death,” in USA Today:
“This is the race for the Holy Grail,” says Dean Fergusson, of the Ottawa Health Research Institute, who co-authored an editorial on the topic. “Maybe we were a bit too rushed. We have to go back to the drawing board and see exactly where we are.”
Specifically, he says, more research needs to be performed to understand why the blood substitutes seem to cause heart attacks. In animal studies, he says, blood substitutes caused blood vessels to constrict, which could be part of the problem. But some of the risks were hidden and downplayed by blood substitute manufacturers, he says.
” People were enrolled into trials where the risk was not portrayed to them,” Fergusson says.