Hope, science and the FDA
Avastin is displayed in a Cambridge, Massachusetts pharmacy. Credit: Getty Images
The Food and Drug Administration's decision to withdraw its approval of Avastin to treat advanced breast cancer will crush the hopes of some with the disease. But the agency reviewed four clinical studies before concluding, with disappointment, that the drug was not shown to be safe and effective for that use.
That kind of hard-eyed analysis is ultimately best for those with breast cancer. They need expert help to weigh the benefit versus risk of any treatment. Their lives depend on it.
Avastin in combination with chemotherapy won accelerated approval in 2008 in a process that allows patients early access to promising drugs while more clinical trials are conducted. Those trials have now been done and none demonstrated that breast cancer patients using Avastin lived longer, or that the disease progression was slowed enough to outweigh the risk of heart attack, hemorrhage and stomach and intestine perforation. Avastin maker Genentech will appeal.
In any case, the drug won't disappear from the market. It's approved for colon, kidney, brain and lung cancers and that hasn't changed. So patients and doctors who think the decision about Avastin for breast cancer should be up to them can still use it, though insurers may not pay the $88,000 a year tab.
Hope is a precious commodity for the sick. But the FDA's job is to temper hope with science. hN
