Are PROCRIT (Epoetin alfa) and Aranesp(R) (Darbepoietin Alpha) Safe for Cancer Patients?
by Rob Lester
PROCRIT and Aranesp are drugs in the category known as ESAs, or Erythropoiesis Stimulating Agents. Both products are manufactured versions of a natural human protein, a growth factor called Erythropoietin, which stimulates the bone marrow to produce red blood cells. ESAs have been on the market for many years, and have primarily been administered to patients undergoing kidney dialysis, and to patients undergoing cancer treatment. PROCRIT is sold by the Ortho Biotech Products division of Johnson & Johnson and Aranesp is sold by Amgen. Both drugs are available by presciption only and are given by subcutaneous (under the skin) injection. Many years of clinical use has proven that ESAs are effective in stimulating the production of red blood cells, and they are widely accepted by many patients and oncologists as a standard part of many cancer treatment regimens.
Unfortunately, over the last few years a significant body of evidence has accumulated that raises doubts about the safety of ESAs when given to cancer patients. During 2007, the FDA added new safety warnings to the detailed package inserts for ESAs, and the Centers for Medicare and Medicaid Services radically reduced the cancer treatment situations in which it will pay for use of these products. As of December, 2007 new negative data have been reported from clinical trials of breast cancer patients and cervical cancer patients that further raise concern about safety.A point of debate among many medical professionals is whether or not the use of ESAs contributes to an improvement of the quality of life of cancer patients, and whether or not ESAs reduce the fatigue that is commonly experienced by people with cancer.
ESAs were heavily marketed and promoted, even directly to consumers, on the basis of a positive effect on reducing fatigue, but according to the FDA, the data is not convincing and the companies who sell these products are no longer allowed to market them on that basis. There also appear to be little data supporting the theory that use of ESAs increase the effectiveness of cancer therapy, although there may be certain situations in which effective treatment is more likely to be completed if a person receives the red blood cell-boosting effect of an ESA product. However, for many patients, the question will be--Is the benefit worth the risk?
The questions that remain to be answered about safety and benefit of ESA products are complex.
One website that seems to provide balanced and objective information in a single location is esafacts.org. General information on ESA products is available from many cancer treatment information sites, but the most complete information on risks and benefits is available from the FDA. Links to FDA documents and to the FDA website, www.FDA.org are available at www.esafacts.org, along with other useful links to information and opinion.
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