Breast Cancer Action Applauds Anemia Drugs Warning; Questions Pharma Influence on FDA

For Immediate Release

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Contact: Mary DeLucco
Breast Cancer Action
415.243.9301 xt 16

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San Francisco, CA—Breast Cancer Action said that today’s action by the U.S. Food & Drug Administration warning about the risks that certain anemia drugs pose to cancer patients was delayed by the influence of drug manufacturers on the drug approval process.

Breast Cancer Action (BCA) is calling for a decrease in the entanglement of the FDA with the pharmaceutical industry.

There has been controversy since 2004 over the safety and appropriate dosage of these drugs—which were approved by the FDA and promoted by the drug companies through direct-to-consumer advertising—without sufficient evidence of benefits outweighing risks.

Epogen, Procrit and Aranesp have been used to treat breast cancer patients with anemia caused by chemotherapy. The FDA says the new warnings address the potential risks of these drugs, which are called erythropoiesis-stimulating agents (ESAs). The new boxed warnings emphasize that excessive doses of ESAs can cause tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer.

The labeling changes include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in cancer patients who are treated with ESAs. The new boxed warning also clarifies that ESAs should only be used in cancer patients whose anemia is specifically caused by chemotherapy. Moreover, it states that ESAs should be discontinued once the patient’s chemotherapy course has been completed.

“The medical and scientific communities have known for a long time that these drugs pose risks to cancer patients,” says BCA Executive Director Barbara A. Brenner. “These warnings are long overdue, and might well have been issued sooner if the pharmaceutical companies had less influence on the FDA’s decision-making process.”

Brenner added that, “Today’s action by the FDA should finally help patients decide whether the dubious benefits of these drugs are worth the risks. The questions of how the FDA makes decisions, and who influences those decisions, still need to be addressed.”

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This entry was posted in Press Releases.

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