Earlier today, Dr. Margaret A. Hamburg, the commissioner of the U.S. Food and Drug Administration revoked Avastin’s approval as a treatment for breast cancer. The ruling follows the recommendation of the FDA Oncologic Drugs Advisory Committee, which voted 12-1 in August 2010 in support of the FDA revoking approval of Avastin for breast cancer. This decision was based on data from research studies that showed the level of improvement in women who received chemotherapy and Avastin was not significantly better than that of women who received chemotherapy alone. The new studies also showed that the women who took Avastin experienced more serious side effects, including bleeding, blood clots and gastrointestinal perforations. Today’s New York Times has a full story on the decision.
As I have noted previously, the FDA advisory panel’s recommendations do not stem from some evil desire to keep women from getting effective treatments, or from an insurance company’s desire to keep expensive drugs out of patient’s hands. They are based on what the data show. We conduct clinical trials to get this data, and it makes no sense to do studies if we don’t pay attention to the findings. Revoking approval for Avastin for breast cancer is not going to cause more women to die or to die more quickly because there is no difference between taking paclitaxel and Avastin than taking paclitaxel alone. Furthermore, treatment with only paclitaxel results in fewer serious side effects.
I wish that wasn’t the case. But it is and wishing won’t change the situation. We need treatments that work not drugs that we wished worked!
You can read Commissioner Hamburg’s statement on her decision.