Study Finds Heart Risks in Blood Substitutes

A meta-analysis of studies on five blood substitute products by researchers at the National Institutes of Health has revealed that these experimental blood substitutes can increase the risk of heart attack and sudden death by a long way. Based on the findings, the researchers are calling for health regulators to control experiments on the products and raise safety standards.

The unique study was a joint effort between health advocates and federal government researchers. Led by Dr. Charles Natanson, the study team looked at data from 16 trials involving five products and 3,711 patients. All the products use haemoglobin, the molecule that gives red blood its ability to transport oxygen.

The study revealed that the five products increased risk of death by 30% and that of heart attack by 2.7 times. Already reported in the Journal of the American Medical Association, the researchers now plan to put their findings before an FDA public workshop on the safety of the products to be held this week. By doing so, they plan to not only pitch for getting the trials of blood replacement products halted, but also demand for an overhaul of the FDA’s requirement to keep corporate secrets confidential.

“The case study detailed here underscores both the scientific inefficiency and the real risks to patients of the current failure to report data promptly,” Dr. Natanson and colleagues said. “When ‘secret science’ is allowed, scientists are unable to build on the successes or failures of other researchers testing similar products, and patients can be repeatedly exposed to risks unnecessarily.”

“One straightforward solution to these problems would be for Congress to reverse the FDA’s policy of treating as confidential all corporate materials submitted during the product development process, including the investigational new drug application,” they added.

Defending its stand on corporate confidentiality, Dr. Jay Epstein, director of FDA’s office of blood research said they are aware of the safety issues. “There is a major unmet medical need,” he said and added, “Independent of this recent meta-analysis, FDA had already, based on our own analysis, identified concerns about an increasing body of data that has emerged about the safety of (haemoglobin based blood substitutes).”

Refuting the FDA’s claim, the researchers said that if the FDA had actually done an analysis the risks involved with the products would have become apparent as early as 2000. “Had the agency placed a moratorium on trials at that point, product-related deaths and MIs (heart attacks) in subsequent trials most likely would have been prevented," they argued.

Disagreeing with the researchers, Dr. Epstein stated that the FDA was aware of “certain signals” and hence only a few trials of the products had been allowed to go ahead. At the same time, Dr. Epstein upheld the teams findings that the products affect a molecule called nitric oxide and confirmed that the products might lead to inflammation and also affect blood pressure and blood flow.

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