Testimony of SHARE Leaders on Removal of Avastin's Breast Cancer Indication
Helen Schiff presented this testimony before the FDA on June 28, 2011.
My name is Helen Schiff and I am speaking on behalf of SHARE Leaders, a group of breast cancer advocates who meet monthly to discuss and debate controversial issues in breast cancer. We are affiliated with SHARE, a breast and ovarian support organization as well as graduates from the National Breast Cancer Coalition's advocacy training program, Project LEAD.
When we started to discuss Avastin several years ago the overwhelming majority of SHARE Leaders supported granting Avastin accelerated approval status for first line metastatic breast cancer. Now it is just the opposite. The overwhelming majority think that Avastin should not remain on the market for this indication. Here are the five reasons for this dramatic reversal of opinion.
1) Progression free survival is an endpoint that benefits women with metastatic breast cancer only if it predicts overall survival or demonstrates improved quality of life. Avastin has done neither. What use is there for a drug, that in this population doesn't extend life and has more toxicities than the present standard of care.
2) It is absolutely essential that biomarkers be developed before a drug comes on the market, not after. If Avastin does work for a subset of women we need to know who they are. True compassion prevails only when drug companies are motivated to identify the group of patients who actually might benefit from their drugs, thus sparing others, who will not benefit, serious and life-threatening toxicities.
3) It is one thing to give access to a promising drug, however, if it does not fulfill that promise, it exposes more and more patients to unnecessary harm and needs to be removed from the market immediately.
4) It starts us down a slippery slope at the bottom of which there is no drug regulatory approval process at all -- putting a drug on the market before you know if it works and for whom.
5) However, we do feel that the FDA should follow the same policy it did with the lung cancer drug Iressa, which would allow women already responding to Avastin-containing regimes to stay on them.
Like everyone else, we wanted Avastin to succeed in metastatic breast cancer. We are honest enough to admit that it has not. But we have seen success before with targeted drugs like Herceptin and Tamoxifen that have saved or extended lives of hundreds of thousands of women. We will not settle for less.
Posted June 30, 2011.
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