Blood Substitutes Linked to Deaths
Safety Data Hidden From Public, Researchers Say
April 28, 2008 -- Patients treated with experimental blood substitutes were
30% more likely to die and more than twice as likely to have heart attacks as
patients who did not get the blood substitute products, a pooled analysis of
the research reveals.
Combined results from 13 published and three unpublished industry-sponsored
trials showed the increase in risk for all the hemoglobin-based blood
substitute products tested and for all populations studied, including trauma
patients and those having heart, vascular, or elective surgery.
The study, conducted by researchers from the National Institutes of Health
(NIH) and the consumer advocacy group Public Citizen, is scheduled for
publication in the May 21 issue of The Journal of the American Medical
But the findings were made public online Monday, the day before a planned
two-day FDA-sponsored workshop examining the safety of the blood
NIH researcher Charles Natanson, MD, says the analysis makes it clear that
the products are too dangerous for use in human clinical trials.
One of the blood substitutes, Biopure Corp.'s Hemopure, is approved for use
in humans in South Africa. None is approved for human use in the U.S., but
there are five ongoing clinical trials involving the blood substitutes,
"I don't believe this research should go forward in humans until these
products have been reformulated and animal studies show them to be less
toxic," he tells WebMD.