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Community Oncology Explores Pitched Debate Over Anemia-Fighting Drugs

June 27, 2007

The June issue of Elsevier's Community Oncology takes an in-depth look at the charge that ESAs, generally considered vital to cancer patients' quality of life, are overprescribed for profit. Scientists, oncologists, and critics of oncologists are in a heated debate now over the use of ESAs, or erythropoiesis-stimulating agents-drugs that fight anemia by boosting levels of oxygen-carrying red blood cells and the protein hemoglobin.

Many cancer patients, suffering from fatigue and symptomatic anemia as side effects of their disease and its treatment, are prescribed ESAs-also known as EPO (epoetin alfa, or Procrit) and DARB (darbepoetin alfa, or Aranesp). New data-mostly from studies of off-label uses-on potentially dangerous side effects such as blood clots, and on survival rates, are prompting some scientists to recommend that the US Food and Drug Administration effectively curtail the use of ESAs. Adding fuel to this debate is the fact that the drugs are costly, and some critics have accused oncologists of overprescribing them, swayed by drug company rebates.

"The question is whether trained oncologists will be allowed to make the best clinical decision for each patient, or whether rationing-which isn't based on scientific evidence but on an economic policy tug-of-war-becomes the standard," says Lee S. Schwartzberg, MD, Editor-in-Chief of Community Oncology. "The current issue of the journal puts the debate in clear focus."

ESAs are intensively studied medications. "After 15 years of well-designed clinical trials, we know that ESAs decrease the need for blood transfusions in cancer patients, increase hemoglobin, and improve quality of life in most patients with chemotherapy-induced anemia," says David H. Henry, MD, an editor of Community Oncology. He adds, "It's clear that these drugs cost too much and that any profit from reimbursement should be corrected. But when used on-label, ESAs are safe. Still, the recent studies give us pause. They suggest we need to review all the data in a fair and balanced way. There has been too much emotional distraction."

The June issue of Community Oncology, which serves private practice-based clinicians, contains a point-counterpoint debate, an economic analysis of the cost of ESAs to practices, a report on toxicities from the RADAR project (Research on Adverse Drug Events And Reports) which closely monitors reports to the FDA on drug side effects, a review of ESA clinical studies, the point of view of a payer who plays a key role in ESA prescribing patterns, and a community oncology advocate who says that if insurers jump the gun on policy, both patients and practices could suffer. "It's not an exaggeration to say that this controversy has serious implications for the future of cancer care in the United States," notes Dr. Schwartzberg.

Elsevier