Posted on 02/27/2008 12:32:13 AM PST by neverdem
Widely used anemia drugs sold by Amgen and Johnson & Johnson raise the risk of death among cancer patients by about 10 percent, according to a new analysis of previous clinical trials that is to be published Wednesday.
The study is the first compilation of clinical trial data — called a meta-analysis — to show a statistically significant increase in the risk of death from the drugs, said Dr. Charles L. Bennett, a professor at Northwestern University and its lead author.
The Food and Drug Administration is planning to convene an advisory committee on March 13 to discuss whether to impose further restrictions on the use of the drugs, Aranesp from Amgen and Procrit from Johnson & Johnson, with cancer patients.
The Amgen drug Epogen, which is the same as Procrit but is aimed at kidney dialysis patients, will not be directly affected by the discussions.
Amgen said the study, being published in The Journal of the American Medical Association, provided little new information. “What he observes is the risks that we’ve already talked about that are in the label,” said Roger Perlmutter, Amgen’s executive vice president...
--snip--
A meta-analysis published in 2004 by the Cochrane Collaboration, an international research group, found that patients who were given the drugs tended to live longer.
But in recent years, some new clinical trials, aimed at showing that using the drugs at higher doses than indicated on the label would improve survival, found the opposite. As those studies were added to the compilations, the safety balance appeared to shift.
A meta-analysis published in 2006 by the Cochrane Collaboration found an 8 percent higher risk of death among users of the drugs, but the result just missed being statistically significant. The analysis being published Wednesday adds some more recent studies and reaches statistical significance...
(Excerpt) Read more at nytimes.com ...
“Didn’t they discredit this type of study several years ago?”
I was taught in college that meta-anaylsis is useless. You can’t compare apples and oranges to determine that bananas are yellow.
Meta analysis is the heart of modern medicine
“Meta analysis is the heart of modern medicine”
LOL. In that case I hope that teacher didn’t know what she was talking about!
Has the feel of a great tag line.
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