Study warns of increased risks in blood substitutes
Study: FDA should not have allowed trials after 2000
By Bruce Japsen
Tribune reporter
April 29, 2008
In another potential blow to the development of blood substitutes, new research published Monday warned of an increased risk of heart attack and death from use of such products and criticized the U.S. Food and Drug Administration for allowing certain clinical trials beyond 2000.
The study, published online by the Journal of the American Medical Association, comes a day before a two-day FDA workshop on blood substitute-related issues. One such product under FDA review is PolyHeme, developed by Evanston-based Northfield Laboratories Inc.
The study, which involved a pooled analysis of more than a dozen studies that included research on PolyHeme, found a 30 percent increased risk of death for patients treated with blood substitutes and a nearly threefold increase in heart attacks.
"Randomized controlled trials completed as early as 1996 have raised questions about the safety of these products and have failed to demonstrate clinical benefit," the authors wrote in the study.
Had the FDA done a more prompt review of pooled results, or so-called meta-analysis, the agency would have uncovered "significant risks by 2000" and some deaths and adverse events may have been averted, said the study's authors, who included Dr. Charles Natanson of the National Institutes of Health and researchers from the consumer group Public Citizen.
"Had the agency placed a moratorium on trials at that point, product-related deaths and [heart attacks] in subsequent trials most likely would have been prevented," the authors wrote. "However, such data were not available to scientists, the public, institutional review boards, or competing [blood substitute] manufacturers."
For decades, researchers have tried to develop a safe substitute for blood that has a long shelf-life and does not require refrigeration. Not only would it have life-saving potential, some researchers believe it also could reduce the risk of infection, unlike donated blood.
But several companies have failed to win U.S. approval, including Deerfield-based medical product giant Baxter International Inc., which stopped research on a blood substitute a decade ago because of an increased risk of heart attacks and death in its trials. The data evaluated in the JAMA study also included research from Baxter's clinical trials of its HemAssist.
Northfield discounted the analysis in the JAMA article. Such meta-analyses are "not designed to provide answers about specific products or to examine fully the risk-benefit ratio of any particular product," said Dr. Steven Gould, Northfield chairman and chief executive. "Rather, that is the role of clinical trials that are focused on a particular product and are conducted to assess the safety and efficacy of the product in relation to a proposed indication."
FDA officials said they carefully evaluated safety before allowing additional trials. The agency weighed the balance between risks and benefits, particularly blood substitutes, with the potential to treat "unmet medical needs," said Dr. Jay Epstein, of the FDA's office of blood research and review.
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