My name is Christine Brunswick. I am Vice President of the National Breast Cancer Coalition. I was diagnosed with breast cancer 20 years ago and can personally attest to how devastating this disease is. NBCC, along with thousands of advocates, is dedicated to Breast Cancer Deadline 2020® to refocus research on preventing breast cancer and preventing metastasis by January 1, 2020. We look to the FDA to help us achieve that goal.
I am here on behalf of NBCC to support FDA’s decision to remove breast cancer as an indication for the drug Avastin®. Avastin® has been shown to be unsafe and ineffective for breast cancer patients.
The FDA’s decision on Avastin® must be based on scientific evidence from well done trials and cannot be based on any one individual’s story no matter how compelling. This decision cannot be driven by anecdotes. It must be driven by science.
This decision must be made for the greater good and on a public health basis. The addition of Avastin® failed to demonstrate a significant improvement in overall survival. This may not be what many of us wanted to hear but we must accept and act on evidence or we will never make the needed progress in this disease.
In 2008, NBCC expressed concern about the accelerated approval of Avastin®. We now know that women died because of the drug. We know the follow-up studies confirmed that the drug is not effective for breast cancer patients and that it increases serious adverse effects.
Women deserve access to treatments that scientific evidence proves are effective. Avastin® does not meet that standard. We fully understand how painful it is that we do not yet know how to cure metastatic disease. But we need to focus on doing more good than harm. The FDA’s decision to withdraw the indication supports that approach.
This decision must be about one investment only, the investment in saving lives. What we are currently engaged in propels us backwards – spending enormous resources defending a drug that does not live up to any of its promises. It does not improve the quality of life, it does not significantly keep the disease at bay, it surely is not a cure, and it does not extend life. The drug does raise false expectations and does detract from focusing on other research that may produce effective life-saving drugs.
Should we be defending and promoting a drug that fails patients in every way? Should we spend time and lives on drugs like Avastin® that do nothing to save women from the devastation of breast cancer? We really do deserve more. The data show that Avastin® should no longer be used in the treatment of this disease and the FDA’s decision to rescind should stand.
We applaud the FDA for responding to this scientific evidence in the face of significant political and public pressure. We applaud the FDA for not lowering the bar on the public’s health and for living up to its role in assuring patients’ access to effective treatment. The FDA’s decision further emphasizes the urgency of NBCC’s Breast Cancer Deadline 2020®, which raises the bar as it aims to harness and refocus breast cancer resources toward ending this disease by January 1, 2020. This is what we deserve. Let's change the conversation.