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Last Updated: Jun 30, 2008 - 11:14:37 AM |
MONDAY April 28, 2008 (Foodconsumer.org) -- A study report says the Food and Drug Administration ignored the fact that experimental blood substitutes raised risk of heart attack and death and forged ahead to allow the products to be tested in humans, ABC News reported today.
The news report, citing the study, says that the federal agency knew the increased risk as early as 2000, but chose not to make the data available to the public.
The study renewed clinical trial data on five different artificial blood products and found patients given blood substitutes were 30 percent more likely to die and 171 percent more likely to suffer heart attack compared to those receiving conventional treatment.
The authors, from the National institutes of Health and Public Citizen, criticized the FDA for not stopping the experiments, according to the news report.
The FDA was cited as contending that the agency did not release the data to the public because of trade secret issues.
The ABC News says it has early reported that the experiment product known as polyheme was given patients who were seriously injured in accidents in 27 cities across the U.S. without their knowledge or consent. The experimental blood was used even if the real blood became available at the emergency room.
Results from the trial of polyheme released by the maker, Northfield Labs, last year showed those who were given experimental product were died at an 11.1 percent rate compared to 9.1 percent for the control.
Serious adverse effects were found in 40 percent of those who received the artificial blood compared to 35 percent in the control group.
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