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Several independent patient advocacy organizations and consumer groups have submitted letters to the FDA for its March 13 meeting of the Oncologic Drugs Advisory Committee to consider additional issues of risk and benefit in the use of ESAs to treat chemotherapy-induced anemia. Reading these letters provides useful insight into the issues of importance to patients and also some good ideas to consider going forward.

C3 Colorectal Cancer Coalition submitted the letter you can read here: http://www.fightcolorectalcancer.org/news/C3%20ODAC%20Comments%20final.pdf. For additional information on issues related to colorectal cancer see their excellent website here: www.FightColorectalCancer.org.

Breast Cancer Action submitted this letter to the FDA: http://bcation.org/index.php?page=fda-letter-february-27-2008-2. They also have a website that is an excellent source of information and perspective: http://www.bcaction.org/.

We will add links to additional letters as we receive permission from their authors. Stay tuned. . .

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.

Two recently published meta-analyses offer two different anwers to the question about help or harm. The reality is that ESAs do both–they help some patients and they harm others. In some cases they may both help and harm the same patient.

Meta-analyses are helpful in gaining a broad overview of the evidence, but they have limitations. One important limitation is the fact that the conclusions suggested by any given meta-analysis can be significantly influenced by which studies are included and which are left out.

Read the plain language summary of the Cochrane Collaboration meta-analysis of drugs used to treat cancer-related anemia at the following link. This study concludes that ESAs provide a quality of life benefit to cancer patients.  http://www.cochrane.org/reviews/en/ab006704.html

A meta-analysis published in the Journal of the American Medical Association concludes that ESAs are harmful to cancer patients. Read a summary of that analysis here: http://jama.ama-assn.org/cgi/content/abstract/299/8/914.

By the way, given the public health importance of both of these studies, it would be nice to make the full text available to the public at no charge. Perhaps both organizations are willing to grant us permission to do so. If we receive the green light, we will be glad to provide a link to the full text or enable downloading of the PDFs we have of these papers.

Visit us here for the latest updates and commentary on the information you can find at ESAFacts.Org.