In February, cancer patients received some scary news: Avastin, the world's best-selling cancer medicine, can have serious side effects. According to a new study by researchers at the Stony Brook University Cancer Center in New York, the chance of dying from side effects linked to the drug is higher than the risk for patients on chemotherapy alone.Patients currently using or considering Avastin should talk to their doctors about the risks. But what really frightens many patients - like my mother who was diagnosed with Stage IV colon cancer - is how this news will affect their access to treatment that has the potential to significantly extend the time they have left. There aren't many treatment options for terminally ill cancer patients. So, for my mother, Avastin truly is a miracle drug. While Avastin cannot cure her disease, it has eased her pain and given her time - time to spend with her daughter, her grandchildren, and the many other friends and family who love her. My mother has colon cancer, but doctors commonly prescribe Avastin for other cancers as well. Thousands of patients have benefited from Avastin and enjoyed more time with their loved ones. Now, however, the Food and Drug Administration (FDA) is considering revocation of Avastin's approval for use in treating breast cancer. The reason? An internal advisory panel of 13 experts - only two of whom are breast cancer oncologists - decided that the drug did not deliver "clinically meaningful" results, and that its side effects outweighed the benefits. In December, the FDA sided with its panel -- and started the necessary steps to withdraw Avastin for advanced breast cancer. Avastin's developer, Genentech, has appealed the decision, and the FDA will render its final judgment later this month. The new Stony Brook study would seem to buttress the panel's reasoning. Yet there is an important element strangely missing from the FDA review. It's the context in which cancer treatment with Avastin takes place. There are two simple facts that loom large in assessing treatment options. First, all drugs have side effects. Second, the side effect of untreated late-stage cancer is death. To their credit, the Stony Brook researchers recognize this context. Dr. Shenhong Wu, the study's senior author, emphasized that deaths from Avastin's side effects are rare - just 1 percent of all patients - and that the small risk should be weighed against the drug's benefits. Further complicating the results, the new study includes cancer types for which Avastin isn't approved, and in one case, a cancer - squamous cell lung cancer - for which Genentech itself says the drug should not be used. The inclusion of these cancers in the study means that the 1 percent risk is probably even smaller for the majority of patients taking Avastin. Compare these findings to the known benefits of Avastin - not just the many stories from families like mine who have seen firsthand the good it can do, but also the numerous large clinical trials demonstrating the drug's effectiveness. In these tests, nearly half of the breast cancer patients treated with Avastin saw their tumors reduced in size. More than half saw their lives extended by months. For many patients fighting late-stage breast cancer, this will not be a hard choice - a less than 1 percent chance of dying from side effects caused by their medicine versus a 100 percent chance of dying from their cancer. Their doctors are likely to make the same calculation. No matter what the FDA decides, Avastin will still be available to breast cancer patients. Doctors will continue to prescribe it on an "off-label" basis. But without the FDA's approval, many insurers will decide not to cover it, making the drug unaffordable to all but the wealthy. Women with breast cancer deserve access to every possible cancer-fighting tool. It would be a mistake to allow a small risk - however serious - to reduce the number of treatment options available to them. For some, inevitably, the treatment will be ineffective, and for a tiny fraction, the side effects may hasten the inevitable. But for others, Avastin could turn out to be the miracle drug for which they and their families were praying - just like for my mother and our family. These cancer patients deserve a choice and a chance. Holly Pitt Young, a consultant in Washington, D.C., focuses on the crossroads between policy and political engagement.
********** Published: March 10, 2011 - Volume 9 - Issue 47