|Team Survivor Benefit, November 2010|
Sorry it has been a while since I've sent an update, all is well. I am back at work now and feel great. I feel very healthy and my cancer continues to be stable.
December is a big month in the world of breast cancer as it is time for the annual San Antonio Breast Cancer Symposium, which is the most prestigious convention for researchers and doctors who work in the field. I met with Dr. Rinn today and asked her if there was anything new and exciting from the conference. She was frank with me and said most of the recent research studies demonstrate how little they really know. Breast cancer is a complex disease and seems to outsmart the scientists at every turn.
On a related note, it seems we have lost the battle to keep Avastin available as a treatment in the US. The FDA officially rules tomorrow, but early press releases say they will withdraw support of this important treatment. Here is an excerpt from the Wall Street Journal update:
Yesterday the Food and Drug Administration moved to revoke its regulatory approval of Avastin for metastatic breast cancer. Withdrawing a cancer treatment is almost never done, and though the decision was expected, that does not make it any less reprehensible.
The FDA said in a statement that it is removing Avastin's breast cancer indication because the biologic does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." Ponder that "sufficient." The agency is substituting its own judgments about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.
The risks of Avastin are real, but manageable. Clinical trials do not show that the drug extends life overall in the aggregate, but they have shown that it allows women to live longer without their disease getting worse. Avastin improves progression-free survival by about four months on average. Different patients respond differently, and the drug is far more effective in some than in others, for reasons that researchers still do not understand. There aren't any perfect therapeutic options in end-stage oncology, and Avastin ought to have remained one of them.
Looking at the same data, the European Medicines Agency-the FDA's counterpart in the European Union-decided on Thursday that it would continue to approve Avastin for breast cancer in combination with chemotherapy. In October, the U.S. National Comprehensive Cancer Network-a consortium of 21 leading cancer centers that issues evidence-based medical guidelines-reaffirmed its position that Avastin is valuable in some cases.
Cancer treatment advances incrementally. Every year doctors are better able to pair medicines with the biomarkers pointing to the individuals who are most likely to respond and learn more about tumor angiogenesis, which is the process of cancer growth that Avastin helps to choke off. The FDA's assault will make it harder to conduct and enroll patients in further clinical studies, to say nothing of its message about the regulatory risk for drugs still in development.
The greatest tragedy will fall on the women who are suffering from an incurable disease and whose caregivers are trying to improve their quality of life in the months they have left. The FDA is taking away one of their only options.