August 20, 2015

The Real Story


The Real Story

Editorial by
Dan Roberts
An August 13 news release from the Perelman School of Medicine at the University of Pennsylvania announced results from their recent study of the safety of Avastin (bevacizumab). The study was intended to address the FDA’s restriction of ophthalmic use of Avastin to a five-day period following the repackaging of the drug by compounding pharmacies.
The media headlines have, however, missed that point. We have known for a while now that Avastin is safe for off-label treatment of wet macular degeneration, but some news writers seem to think that was the main finding of the Perelman research. The findings do further confirm that the drug is safe for ophthalmic use, but it has nothing to do with the inherent quality of the drug. The FDA’s quick response to dangerous mishandling of Avastin back in 2011 deserves the credit for its safety. Lack of caution back then by a couple of pharmacies was responsible for several cases of severe eye infection in three states, leading to tighter restrictions on the industry. Now the American Academy of Ophthalmology is lobbying to block the new restriction limiting the time period between acquisition and use.
According to the study’s senior author Brian L. VanderBeek, MD, MPH, the FDA’s recent action would “effectively prevent most ophthalmic use of Avastin, since compounding pharmacies require 14 days after repackaging just for sterility testing.” His concern is that ophthalmologists will lose confidence in the safety of the drug without that step and resort to using the more expensive Lucentis (ranibizumab).
That is the real story, and it deserves to stand on its own without dredging up an old debate about which of the two drugs is better and safer. Let’s trust that the FDA will understand the problem with a five-day limit and reconsider the additional restriction.

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