A Washington Post story about the U.S. Food and Drug Administrationâ€™s review of its advisoryâ€™s panelâ€™s recommendation to revoke approval of Avastin (bevacizumab) for the treatment of advanced breast cancer has resulted in a whole lot of blog postings and readersâ€™ comments about death panels and the evils of â€œObamacare.â€Â So, I think itâ€™s important to take the time to look closely at what this decision is really all about.
Last month, the FDA Oncologic Drugs Advisory Committee voted 12-1 to recommend that the agency revoke approval of Avastin.Â This decision was the result of findings from two new studies which showed that 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.
Avastin received â€œaccelerated approvalâ€ in 2008 for the treatment of patients who have not yet received chemotherapy for metastatic HER2-negative breast cancer. The FDA can grant accelerated approval for therapies for cancer and other life-threatening diseases when initial clinical data is positive. In this case, the preliminary date came from a Phase III study that showed that the combination of Avastin and paclitaxel extended progression-free survival by 5.5 months when compared with paclitaxel alone. (This accelerated approval was also controversial, as drug makers are usually required to show that a cancer drug extends overall survival, which the study did not show.)
Since then, about 17,500 women a year have been prescribed Avastin, which costs about $8,000 a month. But while these women were taking Avastin, clinical trials continued. Thatâ€™s because after a drug has received accelerated approval its manufacturer must submit more data from studies that have followed patients longer to receive full approval. The new studies showed that the drug only extended progression-free survival by, at most, 2.9 months and had no effect on overall survival. And remember, extending survival does not mean that you are symptom-free. It means that you might live 2-3 months longer than the women not taking it.
Not surprisingly, the drugâ€™s manufacturers are arguing that the FDA should not revoke the drugâ€™s approval and that it should remain an option for women with advanced breast cancer. But all I can say to that is: Why? Have we learned nothing from the debacle of high dose chemotherapy and stem cell rescue? Women sued their insurance companies to get this treatment after being sold magic by doctors and hospitals and when the dust settled and the studies were done it was found to be no better than standard chemotherapyâ€”and with many more significant and sometimes fatal side effects!
The FDA advisoryâ€™s panelâ€™s recommendations do not stem from some evil desire to keep women from getting effective treatments, or from an insurance companyâ€™s desire to keep expensive drugs out of patientâ€™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 donâ€™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.Â Furthermore, treatment with only paclitaxel results in fewer serious side effects.
I wish that wasnâ€™t the case. But it isâ€”and wishing wonâ€™t change the situation. We need treatments that work not drugs that we wished worked!