WSJ: Breast Cancer and the FDA

WSJ, 12/17/2010 - Breast Cancer and the FDA: The agency's Avastin decision is a tragedy for desperately ill women.

Yesterday the Food and Drug Administration moved to revoke its regulatory approval of Avastin for metastatic breast cancer. Withdrawing a cancer treatment is almost never done, and though the decision was expected, that does not make it any less reprehensible.

The FDA said in a statement that it is removing Avastin's breast cancer indication because the biologic does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." Ponder that "sufficient." The agency is substituting its own judgments about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients. Read more at Wall Street Journal/Opinion...