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Government says use of breast cancer drug should be discontinued
By Catholic Online (NEWS CONSORTIUM)
November 22nd, 2011
Catholic Online (www.catholic.org)
November 22nd, 2011
Catholic Online (www.catholic.org)
Avastin, a last-ditch drug prescribed to patients who suffer from breast cancer has been denounced by the Food and Drug Administration. The government agency says there is no solid proof that the drug extends lives and has life threatening side effects, internal bleeding just one of many.
LOS ANGELES, CA (Catholic Online) - The ruling had been long expected. The decision was sure to disappoint women who say they've run out of other options as breast cancer takes its toll through their bodies. Many impassioned patients are asking the FDA to give Avastin another shot."This was a difficult decision," FDA Commissioner Margaret Hamburg said. Hamburg added that "it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, which would justify those risks."
Among the many side effects linked to Avastin use is severe high blood pressure, massive bleeding, heart attack or heart failure and perforations in parts of the body such as the stomach and intestines.
The world's best-selling cancer drug, Avastin is also used to treat certain forms of colon, lung, kidney and brain cancers. So even though FDA formally revoked its approval of the drug to treat breast cancer, doctors still could prescribe it - but insurers may not pay for it. A year's treatment with Avastin could cost as much as $100,000.
Some insurers already had quit covering the drug's use in breast cancer after FDA's advisers twice, once last year and once last summer, urged revoking the approval. Medicare says it will keep paying Avastin for the time being.
"Medicare will continue to cover Avastin," Don McLeod, spokesman for the Centers for Medicare and Medicaid, or CMS said.
"CMS will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies."
"We are disappointed with this outcome," Charlotte Arnold, a spokeswoman for Genentech, a unit of Roche said. "We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment."
She said Roche will pursue a new Phase III study of Avastin in combination with the chemotherapy drug paclitaxel in previously untreated metastatic breast cancer.
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