An FDA advisory panel voted 12-to-1 last week to revoke the indication for advanced breast cancer for Avastin, a drug earlier approved for the treatment of advanced lung, colon and brain cancers, which was granted under the FDA s accelerated approval pathway two years ago based on a single clinical trial. Hastening the drug s approval allowed patients with life threatening breast cancer to receive potentially beneficial treatment while additional research was conducted.
The FDA s accelerated approval process is almost a reverse precautionary principle, says ACSH's Jeff Stier. Even though we may not have all the information, we often have enough preliminary evidence (i.e. biomarkers) to indicate potential efficacy, which would allow patients to gain quicker but limited access to drugs like Avastin, pending collection of more clinical efficacy data.
An editorial in today s New York Times maintains that the panel s vote was also influenced by Avastin s large price tag. The cost of Avastin has always seemed outrageously high for the medical benefits it confers. The editorial also cites Britain s National Institute for Health and Clinical Excellence (NICE) as a pace-setter in evaluating medical advances since it deemed the cost of Avastin too high for the limited and uncertain benefit it may offer patients.
Stier disagrees. The FDA must evaluate safety and efficacy, not drug costs, when considering approval. Whether or not Avastin is expensive should not be relevant to the FDA s approval decision, and The New York Times wrongly encourages the U.S. FDA to consider costs.
Unlike Britain, the U.S. government does not pay for pharmaceuticals. Apparently The Times thinks we re living in London, where cost is part of the consideration for approval, adds Stier. This demonstrates the dangers of a government-run health care system because when the government pays for medication, it could take away choices from consumers.
ACSH's Dr. Elizabeth Whelan plays devil s advocate and asks, What if Avastin were low-cost? Would it be okay to keep it on the market then?
ACSH's Dr. Gilbert Ross adds, The quick-on, quick-off market accelerated approval process worked exactly as it should in the case of Avastin for advanced breast cancer.