Panel sees risks in Amgen, J&J anemia drugs

Use of anemia drugs made by Amgen and Johnson & Johnson at high levels likely worsens heart problems and possibly chances for survival in kidney patients, a U.S. Medicare advisory panel said yesterday.

During the hearing, outside experts on the panel told CMS that they were confident that use of erythropoiesis-stimulating agents (ESAs) in chronic kidney disease patients could cause harm, according to Reuters. Currently, Medicare has no formal reimbursement policy for use of Amgen's Aranesp and Epogen and J&J's Procrit in kidney patients. Reimbursements thus vary from region to region. If it were to formulate a nationwide policy, analysts say, CMS is likely to push for less use of the drugs. 

In the fall of 2006 through winter 2007, published reports highlighted the dangers--including increased mortality--associated with ESA use. These findings, based on the results of clinical trials, were followed by a series of changes including boxed warnings in the FDA approved labeling for ESAs and a "Dear Doctor Letter" regarding concerns about the safety of the products, according to the CMS.

In a series of votes, most panelists said there was enough data to draw those conclusions about increased heart risks. At the same time, evidence also showed ESAs could improve patients' quality of life and help them be active. Amgen Executive Medical Director Reshma Kewalramani said "the totality of the evidence" supported the current guidelines "consistent with product labeling." And J&J's Scott McKenzie, who oversees economic and outcomes research at its Ortho Biotech Products unit, said despite concerns "studies show increases in quality of life," according to Reuters.

- see the Reuters coverage