Death Panels Exposed

Over at Big Government, Capitol Confidential has exposed the "government's rationing toolbox". At issue is a cancer drug, Avastin, which the FDA is seeking to de-label for breast cancer treatment. From Big Government:

No one disputes that the drug helps extends life for terminal patients.

The National Cancer Institute on E2100, the initial trial to test Avastin:

The results of E2100 had not shown an increase in overall survival

It turns out the actual issue is a new metric being considered for oncology trials, progression-free survival (PFS). The standard metric is overall survival (OS).

The difference between PFS and OS is that PFS measures the time from a patient's random assignment to one treatment arm or another until the patient's cancer begins to grow again or the patient dies from their cancer; whereas OS measures the time from randomization until death from any cause.

 If you follow the link, it is actually a fascinating look at the complexities of the metrics used for oncology research. Near the end of the article, there is a good quote from Dr. Richard Pazdur, the director of the FDA Office of Oncology Drug Products:

I have no problem accepting that, in a lethal disease such as metastatic cancer, delaying progression is a clinical benefit in itself, provided that the magnitude of the benefit is sufficient and the side-effect profile acceptable.

In other words, there is a risk-benefit analysis that must be performed. No one wants an extra month before the cancer begins to grow if it means that they have to endure a horrible side effect during that month. Note that this is a risk-benefit analysis, not a cost-benefit analysis. On Avastin, Dr. Pazdur notes:

Because treatment with Avastin is associated with considerable toxicity, the magnitude of PFS improvement—especially if not supported by an improvement in overall survival—should be substantial, clinically meaningful, and be able to be replicated in additional trials.

By a vote of 12-1, a review by a panel of 13 medical professionals found Avastin to fail this risk-benefit analysis. Or, as Capitol Confidential puts it:

The Avantis case is setting the precedent for the government to arbitrarily deny coverage to millions of American’s based on cost alone.

If Capitol Confidential believes that the decision to de-label Avastin was based "on cost alone", he (she?) must be outraged at the composition of the panel that made the decision. There is not a single economist (PDF) on the Oncologic Drugs Advisory Committee! The members all have irrelevant degrees, like M.D., Pharm.D., Ph.D., RN, M.S., F.A.C.P., and D.O. This is the true outrage!