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Drug for anemic cancer patients raises risk of death
Date:2/26/2008

e cells increased their ability to migrate or invade. Our basic science findings and the clinical trial results suggest that giving cancer patients 'epo' for their anemia may actually cause their tumors to progress."

Lai's basic science study is part of a growing body of studies that demonstrate erythropoietin expression and function in a variety of human cancers as presented at a National Cancer Institute workshop on erythropoietin and tumor progression December 2007 in Bethesda, Md.

The FDA approved the ESAs erythropoietin and darbepoetin in 2003 as a treatment for anemic cancer patients to avoid blood transfusions. However, evidence linking these drugs to a higher risk of death has been mounting. In March 2007, the FDA issued a public health advisory on EPAs, warning of an increased risk of serious and life-threatening side effects.

Ironically, Bennett noted, "The later clinical trials were conducted to see if these drugs help people live longer. But, it turns out, this is not the case."

ESAs produced up to $6 billion in cancer-anemia related sales last year for pharmaceutical firms, Bennett said, and represented Medicare's largest pharmaceutical expenditure.

Bennett began investigating these drugs when the study's senior author, Michael Henke, M.D., professor of medicine in radiation oncology at the University of Freiburg in Germany, first raised an alarm in 2003. For the new study, Bennett and his co-authors updated a 2006 analysis by the Cochrane Collaboration with more recent statistics from 13 additional Phase III trials. The 2006 Cochrane study did not show an increased risk of death, Bennett said.

"This is why it's important to continuously look at the data," Bennett said. "You can't let it fall by the wayside. Just a year out of date is not acceptable. Importantly, the more recent clinical studies were larger and addressed the issue of survival."

The Northwestern study also confirmed
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Contact: Marla Paul
Marla-Paul@northwestern.edu
312-503-8928
Northwestern University
Source:Eurekalert

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