Report blasts blood studies

CHICAGO -- Experimental blood substitutes raised the risk of heart attack and death, yet U.S. regulators allowed human testing to continue -- including at Duke University Medical Center -- despite warning signs, says a scathing new report.

The U.S. Food and Drug Administration fell short, the report contends, even as red flags popped up during studies by five biotech companies. Rules barred the agency from releasing company trade secrets, and that kept some information hidden and may have led to unnecessary heart attacks and deaths, wrote the authors.

The report, published online Monday by the Journal of the American Medical Association, is the latest analysis of the risks of blood substitutes.

It was written by scientists with the National Institutes of Health Clinical Center and advocates with the watchdog group Public Citizen.

A safe replacement for blood would be a breakthrough for medicine and a big money-maker for companies that produce it. Unlike ordinary blood, it could, theoretically, be stored for years without refrigeration. It also would work with any blood type and would not carry infections like hepatitis or the AIDS virus.

By the end of 2000, a dozen studies of blood substitutes had been completed. By then, FDA officials would have known enough about cumulative risks to put a halt on further experiments, the JAMA report contends.

But the FDA looked at each product and each use separately -- in surgery, in trauma, in stroke patients -- rather than pooling the results to get a fuller picture of the risk, said Dr. Charles Natanson, lead author of the report.

Dr. Jay Epstein, director of the FDA's office of blood research and review, defended the agency's decisions about human testing of the products. The agency has found enough differences among the individual products and their intended uses to allow some studies to proceed, Epstein said Friday.