The FDA did the right thing last week when it removed its seal of approval from the use of Avastin in treating advanced breast cancer. The decision is a long time coming, given that its own expert panel recommended against approval in the first place, and that another panel recommended removing the breast cancer indication nearly a year and a half ago.
Still, this is an important and courageous move for the FDA: important because it implicitly acknowledges the FDA's duty to only approve drugs that are safe and effective; courageous because the agency will undoubtedly be raked over the coals for the decision. Members of the breast cancer advocacy community, like most other people, have a bias toward preferring action over inaction. Their frustration is understandable, as advanced breast cancer is a terrible diagnosis. For advocates of evidence-based medicine, however, it's time to stand behind the FDA. They're doing their job, and doing it well.
Several other blogs have made important points about the decision. The Incidental Economist provided an excellent list of all the things the FDA didn't do, including:
- "Pulling Avastin from the market;
- Banning use of Avastin for metastatic breast cancer;
- Punishing doctors who use it off-label;
- Banning reimbursement for off-label use; or
- Making a death panel decision based on inadequate scientific evidence."
Of course, the FDA can't do many of these things, but many advocates seem to forget that Avastin is still available, and it will surely still be used off-label. But at least oncologists and patients will be on notice that the risks of the drug are not worth taking, at least for most, perhaps even all patients. (There might be a small sub-population of women who benefit from the drug -- and maybe not. Genentech, the manufacturer, would have to do further study to identify those women.) We echo the Incidental Economist's exhortation to journalists: please don't make these mistakes again. Don't even imply them. No excuses.
GoozNews also pointed out that insurers are unlikely to drop coverage of Avastin for breast cancer, even without the FDA's word:
"most insurance companies and Medicare will continue to follow the National Comprehensive Cancer Network guidelines. NCCN’s guideline writing committee, a third of whom have financial ties to Roche/Genentech, has said it will not withdraw Avastin’s use in metastatic patients." (emphasis added)