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Science Forum Index » Medicine - Cancer Forum » Anemia drugs up death risk in cancer patients: study
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| Roman Bystrianyk |
 Posted: Wed Feb 27, 2008 12:13 am |
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Guest
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Julie Steenhuysen, "Anemia drugs up death risk in cancer patients:
study", Reuters, February 26, 2008,
Link: http://www.reuters.com/article/topNews/idUSWNAS246120080227
Treating cancer patients with anemia drugs increases their risk of
blood clots and death, U.S. researchers said on Tuesday, confirming
concerns about these widely used drugs.
Researchers said the drugs, including Amgen Inc's Aranesp and Johnson
& Johnson's Procrit, raised the risk of death by 10 percent in
patients who took them, a finding that could not be explained by the
higher blood clot risk alone.
"Our findings, in conjunction with basic science studies, raise the
concern that the drug may be stimulating cancer and shortening cancer
patients' survival," Dr. Charles Bennett of Northwestern University in
Chicago said in a statement.
The study, which appears in the Journal of the American Medical
Association, sent shares of both companies lower in extended-hours
trading on Monday.
"The findings of mortality are new and are different from prior
reports," Bennett said in a telephone interview. He said the drugs,
erythropoiesis-stimulating agents (ESAs), also increased the risk of
blood clots in the lungs and legs by 57 percent in cancer patients,
confirming other findings.
An advisory panel to the U.S. Food and Drug Administration is due to
discuss safety concerns about the drugs on March 13.
Eric Snyder, an analyst at Mehta Partners, said most investors
expected the FDA panel meeting to result in tighter restrictions on
the use of anemia drugs.
Worldwide sales of Aranesp fell 12 percent to $3.6 billion in 2007
compared with 2006, while sales of Procrit fell 9.4 percent to $2.9
billion over the same period.
Last March, the FDA warned of an increased risk of serious and life-
threatening side effects in a public health advisory on ESAs. And last
fall, the U.S. Centers for Medicare and Medicaid Services tightened
its reimbursement policy for elderly cancer patients on ESAs.
The drugs generated up to $6 billion in cancer-anemia related sales
last year for drug companies and represented Medicare's largest drug
expenditure, Bennett said.
Anemia is a common complication of cancer treatment. Millions of
cancer and kidney disease patients take ESAs, man-made versions of a
human hormone that stimulate production of oxygen-carrying red blood
cells.
Amgen spokeswoman Ashleigh Koss said the study does not define any new
risks associated with ESAs, and the blood clot risk is included in
current labeling.
She said doctors and patients need to weigh the drugs' benefit
(avoiding a blood transfusion) and risks and use them appropriately.
J&J said in a statement the study's conclusions "do not provide an
accurate reflection of the safety profile" of ESAs when used to treat
chemotherapy-induced anemia.
"When used according to product labeling, ESAs remain safe and
effective and are the only proven treatment alternative to blood
transfusions for patients with chemotherapy-induced anemia," the
company said.
Known as a meta-analysis, the study culled data from 51 clinical
trials with 13,611 patients treated with ESAs or a placebo. It updates
a 2006 report from the Cochrane Collaboration, which studies health-
care issues, with additional data on 5,000 patients from 13 clinical
trials, many of which addressed the issue of survival. The 2006 report
did not show an increased risk of death.
The study is an update of a presentation Bennett made to the American
Society of Clinical Oncology in June and includes data through January
17, 2008.
The drugs were approved by the FDA as a treatment for anemic cancer
patients to avoid blood transfusions.
"The current FDA recommendation is these drugs are safe for cancer
patients as long their hemoglobin levels aren't raised too high. Our
data do not support that," Bennett said in a statement.
Dr. Michael Henke of the University of Freiburg, Germany, who worked
on the latest analysis, said the study would likely affect treatment
guidelines, and that more research was needed to understand the
effects of the drugs on cancer patients.
"We suspect that ESAs activate survival pathways in cancer cells,"
Henke said.
J&J's shares fell 1.5 percent to $62.76 in after-hours trading, while
shares of Amgen fell 1.9 percent to $46.90. |
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