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Study Links Artificial Blood To Higher Death Rate

Researchers criticize FDA's 'secret science' policy

April 29, 2008

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Investigators working at the National Institutes of Health have concluded that artificial blood is too risky for further testing, because patients who receive it have a 30 percent increased chance of dying.

While the idea of a blood substitute that doesn't need refrigeration or cross-matching and has a long shelf life would be an exciting scientific advance, the study concludes these products significantly increase the risk of heart attacks and death.

The authors also raise serious questions about the role of the U.S. Food and Drug Administration in continuing to allow human trials of these products, despite evidence from past clinical trials that found patients given these hemoglobin-based blood substitutes face a 30 percent greater risk of death and a 171 percent increased risk of heart attack than those treated conventionally.

Currently, such blood substitutes are not approved for use in the U.S., although at least one product is approved for use outside the U.S. and new clinical trials are being conducted worldwide.

The findings appear in the online edition of the Journal of the American Medical Association. The authors include Peter Lurie, M.D. and Sidney Wolfe, M.D., from the Health Research Group at Public Citizen, and Charles Natanson, M.D., Steve Kern, B.S., and the late Steven Banks, Ph.D, from the National Institutes of Health.

In the JAMA article analysis, the authors identified 16 different trials of five different blood substitutes. The studies were combined by the authors using a statistical technique called meta-analysis.

Of those trials, 13 were published in medical literature, sometimes years after they were completed, while others were never published at all. In some cases, the only information available came from company news releases.

The authors complain that the FDA does not make much of the research into these blood substitutes available for review even though companies are required by law to report such data to the agency.

"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 increased risks unnecessarily," the authors wrote.

They add that studies available to the FDA, but not always to the scientific community at-large, would have made it clear by 2000 that these hemoglobin-based blood substitutes posed a significant risk to patients. By that point there was already a 27 percent greater risk of death and a 177 percent greater risk of heart attacks based on trials of four products.

"Had the agency placed a moratorium on trials at that point, product-related deaths and [heart attacks] in subsequent trials most likely would have been prevented," the authors wrote.

The authors recommend that the FDA require new and existing blood substitutes to be tested in animals before any further human trials are allowed. They also called on Congress to make it easier for independent researchers to review information and studies submitted to the FDA during the product development process, either through changing FDA policy or amending the Freedom of Information Act.

Several previous studies have suggested that statins may have an effect on blood pressure, particularly in patients with hypertension (high blood pressure). Statins may activate compounds that widen blood vessels and improve their function.

Researchers at the University of California, San Diego, La Jolla compared statins with placebo in 973 individuals who did not have diabetes or cardiovascular disease. For six months between 2000 and 2004, 322 participants were assigned to take 20 milligrams of simvastatin, 323 to take 40 milligrams of pravastatin (doses frequently prescribed for cholesterol-lowering purposes) and 328 to take placebo.

Blood pressure was measured at the beginning of the study, at one and six months during treatment, and again two months after ending treatment (eight months after the beginning of the study).

Among those assigned to take statins, systolic [top number] blood pressure decreased by an average of 2.2 milligrams of mercury and diastolic [bottom number] blood pressure decreased by an average of 2.4 milligrams of mercury.

“Blood pressure reductions ranged from 2.4 to 2.8 milligrams of mercury for both systolic blood pressure and diastolic blood pressure with both simvastatin and pravastatin, in those subjects with full follow-up and without potential for influence by blood pressure medications (i.e., neither receiving nor meriting blood pressure medications),” the authors write.

The effect of statins on blood pressure was not evident at one month of treatment, was significant at six months of treatment and dissipated two months after treatment ended.

“This study adds to our understanding of the effects of statins, currently the best-selling prescription drugs in the world,” the authors write. “The reduction in blood pressure seen with statins may contribute -- among other identified factors -- to some of the ‘rapid’ cardiovascular benefits of statins, arising too swiftly to be explained by effects of statins on plaque accumulation.”

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