Revoking FDA Approval: Right or Wrong? - Part VIII

The case of the FDA revoking approval of Avastin for the treatment of breast cancer is complicated by the urgency of the need for better therapies. We’re not talking about treatments to decrease the sniffles of the common head cold. At issue is a drug to help patients who are suffering -- and dying -- from metastatic breast cancer.

For patients who are doing well on Avastin, the FDA revocation of approval may feel like having the plug pulled from their life support. The notion that the risks outweigh the benefits may seem irrelevant. Having proven they tolerate Avastin, they may feel at lower risk than patients who are considering the drug and don't know if they will develop side effects.

In addition, these patients may fear stopping Avastin will unleash their cancer, a terrifying risk that outweighs any risk of side effects.

These arguments are weak if serious side effects can first develop months or longer after patients begin treatment and if the side effects can be as life-threatening as progressive cancer.

It's the same old problem of uncertainty. Physicians choose treatment for the unique patient in front of them based on data from groups of past patients with similar problems. Researchers are striving to find ways to determine ahead of time which therapies will work well for an individual patient and which will cause serious side effects. We're not there yet.

Next: Why not, at least, make Avastin available to breast cancer patients who are doing well on it?