Concerns about anemia medications for cancer patients

Based on mounting concerns about the safety of certain anemia medications on cancer patients, the FDA recommended the discontinuation of their use for patients with breast, head, and neck cancer.

According to FDA briefing documents filed this week, there are now a total of eight clinical trials that suggest these widely used medications, sold as Epogen and Aranesp by Amgen Inc. and as Procrit by Johnson & Johnson, actually speed the growth of tumors and shorten the lives of cancer victims. Known as erythropoiesis-stimulating agents (ESAs), they work by stimulating red blood cell production.

The decision has had mixed reviews in the business community, with the brunt of the decision falling on hardest on Amgen and Johnson and Johnson. The companies said the drugs' benefits outweighed risks for chemotherapy patients when used appropriately. The new votes are the latest setback for the drugs, which have seen sales drop significantly in the wake of a tough "black box" safety warning added last March, and updated repeatedly, as well as limits on cancer-patient reimbursement, set last summer by Medicare officials.

Although the decision has hurt both Johnson & Johnson and Amgen, the two companies avoided the outcome they most feared: a recommendation that the drugs not be used by any cancer patients. That probably would have meant the loss of at least $1 billion in sales for each company.

“They dodged the really big bullet, but they still took some damage,” said Geoffrey C. Porges, a biotechnology analyst at Sanford C. Bernstein & Company.

The companies said the drugs' benefits outweighed risks for chemotherapy patients when used appropriately.

Each of the eight studies cited by FDA staff involved high doses to drive blood hemoglobin above levels now recommended.

FDA staff said for most cancers there was "insufficient" data to rule out a risk of deaths or tumor growth when the drugs are used at recommended doses, and new results may not be available for years.

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