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The Avastin Travesty

A cancer-fighting drug vs. an out-of-control federal agency.

by
Thomas Bowden

Bio

December 12, 2010 - 12:00 am
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Avastin is a cancer-fighting drug that works by starving tumors of vital nutrients and oxygen. Although Avastin doesn’t cure cancer, it can improve quality of life by slowing the disease’s spread. The Food and Drug Administration approved its use for colon cancer (2004), lung cancer (2006), and advanced breast cancer (2008).

But now the FDA is on the brink of rescinding that last approval, relegating breast cancer to the category of an “off-label” use. In our semi-socialized health care system, that’s significant because government-funded insurance plans (such as Medicare, Medicaid, and Tricare, which serves the military) refuse to reimburse off-label prescriptions, and private insurers generally follow their lead.

Since an Avastin breast cancer regimen costs as much as $88,000 annually, withdrawal of FDA approval would, in effect, lock the medicine cabinet and throw the key onto a high shelf, unreachable by many desperately sick patients.

The FDA is slated to decide whether to follow the advice of its own Oncologic Drugs Advisory Committee, which back in July voted 12-1 that Avastin does not “represent a favorable risk/benefit analysis.” Does that mean the drug fails to help any woman more than it hurts her? Not at all — many individual women benefit from the drug. But the FDA regards such facts as sentimental distractions, to be deliberately ignored when deciding the fate of a drug like Avastin. The FDA’s idea of a risk/benefit analysis deals with health in the aggregate, as revealed in statistics involving large populations, not with the health of individuals.

But can risks and benefits really be weighed at the level of society as a whole? A society is only a collection of individuals. A society doesn’t enjoy life, or suffer — only individuals do. Metaphors aside, a society doesn’t get sick and die — only individuals do. To appreciate the difference, consider how a rational patient with breast cancer decides whether to undergo drug treatment.

Such a patient weighs (among other things) the statistical likelihood of a favorable result against the statistical likelihood of painful side effects. At all times, her judgment is individual and personal: How will my life improve if these tumors temporarily stop growing? How might side-effects interfere with my enjoyment of life? How much better will I feel if the results are above average — or how much worse, if the results are below average? How much is an additional year, month, or week of relatively normal life worth to me?

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