June 2, 2007
An updated analysis of data from studies of anemia drugs used with cancer treatments showed that they increase risk of death and blood clots.
The findings showed that use of the drugs, which include Amgen Inc.'s Aranesp and Epogen as well as Johnson & Johnson's Procrit, increased risk of death by 11 percent and risk of blood clot by 59 percent when compared with oncology patients who did not use the drugs, according to the Cancer Letter.
The results, culled from a collection of randomized trials reported since 2003, were an update and reinterpretation of Cochrane Collaboration reports on the drugs and will be presented at the American Society of Clinical Oncology on Sunday.
Tom Lillie, Amgen's medical director for Aranesp, said the results were the same as prior findings from Cochrane, which showed that overall survival is neutral.
"The overall conclusion here is still that the jury is out," said Lillie, who added that a few neutral studies have come out in the last year.
Lillie said all of the studies with bad outcomes have come out since 2003. There were a number of large studies before 2003 improved patients, he said.
The drugs, known as erythropoiesis stimulating agents, are often used to help cancer patients combat chemotherapy-related anemia.
The U.S. Medicare health insurance program proposed limiting payments for Amgen and J&J's anemia drugs last month in response to safety concerns.
Morgan Stanley analyst Steven Harr said the new findings from the Cochrane Collaboration, an academic consortium that crunches data from multiple studies, creates more bad news for Amgen.
The so-called meta-analysis is not considered as persuasive as a randomly controlled clinical trial, but the companies have used a similar pooled-study approach to defend the use of the drugs.
"Given the heightened publicity around negative safety signals in this class, this analysis could continue to pressure both demand and reimbursement" as the U.S. Food and Drug Administration and The Centers for Medicare and Medicaid Services mull the future of the drugs, Harr said.
Source: health.yahoo.com |
