05 | 6 | 2008 Posted By Regan Zambri & Long

Experimental Blood Substitutes Linked to Heart Attack, Death: New Study

New hemoglobin-based artificial blood -- still unapproved for use in the U.S., but heavily studied -- appears to raise a patient's risk of heart attack and death according to an exhaustive review of clinical research data.  This latest research was published in a recent edition of the Journal of the American Medical Association (JAMA).  The findings have spurred critics to allege that the U.S. Food and Drug Administration (FDA) put clinical trial participants in imminent danger by failing to detect or act on research data illustrating significant increases in the rates of heart attack and death reported in trials of these blood substitutes.

The research review focused on data from 16 trials of 5 different experimental artificial blood products, involving nearly 4,000 patients.  Overall, the artificial blood products were associated with a 30% increased risk of death and a tripled risk of heart attack for patients receiving the products in lieu of actual human blood.

According to the consumer advocacy group Public Citizen, the results of 13 of the 16 product trials were published in medical journals years after the completion of the research -- and the results of other trials were simply not ever published.  The group maintains that for years, patients have been put at risk by a system of medical research that forces manufacturers to report research data to the FDA, but never compels the FDA to make the data available for scientific review.  In these cases, specifically, the group alleges, the FDA repeatedly and continually repressed clinical trial data that clearly illustrated the serious danger faced by people who volunteered to participate in clinical research.

Authors of the study note that laboratory-created hemoglobin-based blood substitutes are currently approved for use in South Africa and Russia, and that the release of this latest new report may affect the drug's approval in those countries.

A safe blood substitute has been sought by medical device manufacturers and doctors for years as a safe emergency treatment with a longer shelf life than human blood.

Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:

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