BREAST CANCER – A SECOND AVASTIN OPINION
- JULY 23, 2011
Oncologists vs. the FDA on the breast cancer drug.
- The humanitarians urging the Food and Drug Administration to withdraw Avastin for women with terminal breast cancer claim there is no other choice: The evidence shows Avastin doesn’t work, so too bad. But how to square that view with the highly respected medical group that—reading the same evidence—recommends preserving Avastin as a treatment option?
The National Comprehensive Cancer Network is a consortium of 21 leading U.S. oncology programs that issues practice guidelines on the basis of “sound, evaluative clinical information,” according to its mission statement. Last week, the NCCN’s breast cancer panel reaffirmed its position that Avastin is “an appropriate therapeutic option” for some patients in combination with chemotherapy. The vote was 24 in favor, with one abstention. No members were opposed.
The FDA’s expert panels have now reviewed Avastin three times. All three have rejected it, though the first vote was overruled by the FDA leadership in 2008 to give the biologic drug provisional approval. Cancer division chief Richard Pazdur moved to revoke approval last year after a negative re-review of the evidence, and a final decision is now pending following an unprecedented appeal hearing last month by Avastin’s maker, the Roche subsidiary Genentech.
Yet the NCCN has now reviewed Avastin for breast cancer four times since adding it to the compendium in 2005, and each time it has reaffirmed its support. One reason for the group’s divergence with government is that it fields practicing oncologists from institutions like Dana-Farber/Brigham and Women’s Cancer Center at Massachusetts General Hospital, the University of Texas’s M.D. Anderson and Memorial Sloan-Kettering in New York. They understand the benefits that Avastin can provide to some (but not all) women in controlling their disease, and the NCCN’s advice is appropriately qualified.
The FDA, by contrast, favors statistical purists who think in the abstractions of controlled trials, and its conflict-of-interest rules are meant to exclude doctors who have experience treating specific cancers in the real world. For the FDA, believe it or not, being an expert in breast cancer fatally compromises your objectivity in ruling on a breast cancer drug. The oncologists also don’t carry Dr. Pazdur’s political agenda to increase his agency’s power over cancer drug approvals.
Genentech is merely asking for Avastin to remain available for metastatic breast cancer while it conducts an additional trial to add to the evidence about which patients Avastin does help. FDA Commissioner Margaret Hamburg hasn’t said when she’ll make a final decision. If you were a patient, would you rather trust a federal regulator or some of the best cancer doctors in the country?
