And they were right!
Appologies to the Blogfather.
Standard practice for evaluating drugs is to use data-driven objective endpoints to evaluate effectiveness and safety. In the case of Avastin, the FDA has arbitrarily and unilaterally stopped using this objective criterion and are applying a highly subjective criterion of “clinically significant”—to cut costs.
No one disputes that the drug helps extends life for terminal patients. The FDA is arguing that it just doesn’t do it for long enough to be worth the cost. So now the FDA is deciding how much life is “significant” and what it is worth? This should be a decision for patients, doctors and family members and the FDA should not be replacing their own value judgments about how much time is significant. While six months might not be significant to a statistician or a bureaucrat, for the families of a loved one or a dying patient, it’s a lifetime.
Emphasis added. The FDA is no longer content with determining if a drug is safe, now they want to know if it's "cost effective." Oh the dark irony of "Free" Healthcare being even more bottom-line oriented, then again it's also more expensive and tyranical, so dark irony abounds.