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Opinion

Breast Cancer Survivor Decries Removal of Treatment Drug


web posted May 20, 2011

Dear Editor:

As a breast cancer survivor, I have closely followed any developments in the diagnosis and treatment of the disease. Currently there is a battle with the FDA over the use of Avastin for the treatment of incurable metastatic breast cancer. Avastin is the only approved antiangiogenic drug for MBC, meaning that the drug interferes with blood flow, essentially starving tumors of their life-line. In addition, the drug is at least as effective and shows fewer side effects than other drugs approved by the FDA.

An estimated 17,500 breast cancer patients are taking the drug in the United States.  Some of these women are super-responders, who would normally not be expected to live much longer without Avastin.  But the FDA has chosen to ignore these women and to only concentrate on statistics and average results in their decision to de-label the drug for breast cancer treatments after initially giving Avastin approval under their fast track provision.

As a result, Medicare and private insurance companies will most likely discontinue coverage for Avastin, which for most patients is unaffordable.  Genentech, the manufacturer of Avastin, has a compassion fund to help the truly needy, but the FDA has adapted new policies whereby drug companies could face liabilities for donating a drug off-label.

Ironically, the European Medicines Agency voted for use of Avastin with certain chemotherapy. The FDA and EMA evaluated the same trials data, but reached different decisions. So, a drug developed in San Francisco gets approval for MBC in other countries, but not in America.

Genentech has been granted an appeal hearing by the FDA June 28-29.  This is the last chance to prolong the lives of many advanced breast cancer patients. 

For more information, to sign the petition, or to sign up to protest at the FDA HQ, please visit www.fameds.org.

Tracy Walsh
Merriwether







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