The FDA attempt to de-label Avastin for breast cancer patients is the first skirmish of the rationing wars. The battle must be fought and won. This isn’t an issue of government paying the cost of these late stage drugs. This is an issue of the government manipulating data to deny care to late stage cancer patients–even those with private insurance.
The issue at hand is whether or not the drug Avastin should be used to treat late stage terminal cancer patients. The FDA is seeking to de-label Avastin for breast cancer patients. Labeling is the FDA’s method of approval for using certain drugs for certain illnesses. Like Medicare, private insurance companies use these labels to determine whether or not they will cover the use of that drug to treat a certain illness.
Fair enough, right? But what’s particularly scurrilous about the FDA’s attempted actions with Avastin is not that they are attempting to de-label it for use with late stage breast cancer patients its how and why they are doing it.
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 meaningful”–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 “meaningful” 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 ‘meaningful’. 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.
As tragic as it is for breast cancer patients today, this arbitrary shift is a preview of one of the tools in the government health care rationing toolbox. The government is not just saying outright that they won’t cover the cost of this, they are hiding their financial decisions behind language like “clinically meaningful” to lead people to believe the drug doesn’t work. The Avantis case is setting the precedent for the government to arbitrarily deny coverage to millions of American’s based on cost alone.
This battle will be repeated time and time again over the next few years. Life extending drugs for the sick and elderly will be made harder to obtain in order to limit the costs of health care. Treatments to extend life will be denied over and over — if we let them.