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Congress Investigates Procrit, Epogen and Aranesp Marketing

Apr 2, 2008 | Parker Waichman Alonso LLP

Two members of Congress are looking into to allegations that the marketing of Procrit, Aranesp and Epogen encouraged overuse of the anemia drugs, placing some patients in danger.  Reps. John Dingell and Bart Stupak, both Michigan Democrats, sent letters to Amgen and Johnson & Johnson on Monday, suggesting their marketing campaigns for Procrit, Aranesp and Epogen convinced physicians to prescribe the drugs at unsafe dosages.

Procrit, Aranesp and Epogen are known as an erythropoiesis-stimulating agent (ESA).  All are made by Amgen, but Procrit is sold by Johnson & Johnson subsidiary Ortho Biotech under a licensing agreement. ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. Procrit, Aranesp and Epogen have been touted as  treatments to lessen fatigue and improve quality of life among cancer and HIV patients with anemia. But since then the drugs has been forced to undergo five label changes, and the labels now state that there was no evidence to back that claim. Rather, the drugs are only approved to raise red blood cell counts high enough to avoid transfusions.

Last March, the Food & Drug Administration (FDA) added a black box warning to the drugs’ labels cautioning doctors that the medications should be administered at the lowest dose possible in order to bring red blood cell counts to the lowest level necessary to avoid transfusions. This past November, that black box warning was modified to include more specific dosing information.

Last month, Amgen and Johnson & Johnson announced that they would be including another black box warning on the drug’s labels.  The latest black box warned of the medications’ association with increased tumor growth and shortened survival time in some cancer patients.  A week after those warnings were added, the FDA cancer-drugs advisory committee voted 13 to 1 in favor of allowing the continued sale of the ESAs for use in cancer patients undergoing chemotherapy. However, the panel voted 11 to 2 in recommending that the drugs not be used in cancer patients who are likely to be cured from their treatments.  The panel also voted 9 to 5 that the shouldn’t be used in patients with breast cancer as well as patients with head and neck cancer. The FDA is not bound by the recommendations of its advisory panels, however, it usually does follow them.

Reps. Dingell and Stupak want Johnson & Johnson to turn over information regarding its promotion of Procrit. Some of the company's television advertisements suggested Procrit improved quality of life by showing patients who appeared healthy and active.  The Congressmen said such promotions encouraged "excessive and dangerous off-label use of the drug." Prior to last year's warnings on dosage, many doctors would prescribe unapproved high doses of the drugs.  Johnson & Johnson stopped direct-to-consumer Procrit ads in 2005.

For its part, Amgen never engaged in direct-to-consumer marketing of Aranesp or Epogen. However, the Congressmen's letter questioned whether the company's practice of granting  higher rebates  to doctors who ordered more vials of Amgen drugs might have led to overuse.