Health World — 20 November 2011
Mother and daughter holding sign in front of US Capitol

In this June 28, 2011 photo provided by Terry Kalley, Arlene Kalley and her daughter Leila hold a pro-Avastin banner outside the U.S. Capitol.

The Food and Drug Administration’s ruling that the blockbuster drug Avastin should no longer be used to treat breast cancer is being condemned by some patients and their families — who say “women will die” because they no longer have access to the drug.

“This vote is highly disappointing,” said Terry Kalley, whose wife Arlene has late stage breast cancer. “It wasn’t unexpected, given the FDA’s continued, closed-minded opposition to the continued use of Avastin for treatment of metastatic breast cancer.”

The FDA’s ruling was expected, but is sure to disappoint women who say they’ve run out of options. FDA Commissioner Dr. Margaret Hamburg called the decision difficult but said patients must have confidence that drugs sold for their condition are safe and effective

“After reviewing the available studies 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 that would justify those risks,” saidHamburg. “Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”

Avastin’s risks include high blood pressure; bleeding and hemorrhaging; heart attack or heart failure.

“The Commissioner lacked the courage to make a decision for the benefit of American women,” said Kalley, who founded the group Freedom of Access to Medicines. “Instead she caved in to the internal pressure within the FDA. It is impossible to see how the health care of Americans is improved by limiting their choices.”

Kalley says women undergoing treatment for breast cancer inJapanandEuropewill continue to have access to Avastin, while American women will not.

“Is this the newAmericawhere the critically ill are denied care and coverage?” said Kalley. “The wealthy will find ways to obtain Avastin, while the rest will be rationed according to their health insurance coverage.”

Avastin will still be available to treat colon, lung, kidney and brain cancers, but the FDA decision is expected to influence insurance coverage. Medicare will continue to cover Avastin while it evaluates whether a change is needed. Avastin was the first drug approved by the FDA designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor.



About Author

Pat Anson, Editor

Pat is Editor in Chief of American News Report. He is a veteran journalist and a former correspondent and producer for HealthWeek (PBS), Nightly Business Report (PBS) and other nationally syndicated shows. Pat has won numerous journalism awards, including a Golden Mike award for investigative reporting.

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