esafacts.org

As analysis of, and debate about, the safety of ESA products administered to cancer patients continues, it is worth considering the safety of blood transfusion as the alternative. Because ESAs were approved by the FDA for cancer patients on the basis of demonstrated reduction in the need for blood transfusion by patients receiving ESA therapy, it makes sense to evaluate the risks and benefits of these products in the context of ESA clinical trial data and also information about the current status of the national blood supply.

Clearly the blood supply is safer now than it was two decades ago, but how safe is it and how safe should it be?

On February 6, 2008 the FDA issued an Adverse Determination Letter to the American Red Cross. This letter includes notification of a fine of $4,649,000 and documents numerous incidents of failure to comply with safety commitments described in the Consent Decree established between the US Government and the American Red Cross in 2003. The full text of the letter from the FDA, with the attachments, is available at this link: http://www.fda.gov/ora/frequent/letters/ARC_20080206_AD_letter.pdf.

For an interesting discussion of problems the American Red Cross has encountered in recent years in maintaining necessary standards for blood safety, read this article: http://www.msnbc.msn.com/id/23047936/.

If you are interested in some details of the American Red Cross fiscal year 2007 revenue of $3.2 billion, the expenditures they made in providing services, and their lobbying payments of $981,713, take a look at their 2007 tax return and Form 990 at this link: http://www.redcross.org/static/file_cont7537_lang0_3150.pdf.

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