VA Halts Avastin For Eye Disease Over Infections
1 CommentBy Ed Silverman // September 21st, 2011 // 2:11 pm
In the latest twist in the controversy over off-label use of Avastin to treat a serious eye disease, the US Department of Veterans Affairs has suspended use of the Roche drug pending an investigation into reports of serious infections and blindness, Bloomberg News Reports.
“We’re advising physicians to consider alternate therapies. Once the investigation is complete, VA will reassess how Avastin and similar therapies may be made available for ophthalmologic use and will issue further guidance,” a VA spokeswoman tells us.
The move comes shortly after reports that at least 16 people in Florida and Tennessee suffered serious eye infections, and some were blinded, after being injected with Avastin, which is sold by the Genentech unit of Roche (see this). Many ophthalmologists use Avastin to treat wet AMD, a common cause of vision loss in the elderly, because it is much cheaper than another Roche drug called Lucentis, which is approved to treat the malady and is also sold by Genentech.
Dividing a vial of Avastin can wind up costing $50 per injection, compared with $2,000 for Lucentis which, of course, limits profits for the drugmaker. Roche has long cautioned against the dangers of off-label use, although the recent injuries apparently resulted from contamination that may have occurred during repackaging vials. To some, the implication is that the use of the medicine itself may be safe, but that the process of splitting the dosages may leave patients open to infections or worse.
For now, the move by the VA is likely to further fuel debate. By contrast, a recent report by the US Department of Health & Human Services Office of Inspector General found that Medicare could have saved more than $1 billion and Medicare patients would have saved $275 million over two years if Avastin had been used instead Lucentis (back story).
The controversy prompted the National Institutes of Health to sponsor a comparative study and the preliminary results released last spring indicated that Avastin is about as effective as Lucentis in treating the wet form of AMD (here is the abstract). The outcome spurred Genentech to quickly lobby Capitol Hill to tout the results of its own separate study that reviewed 78,000 Medicare recipients with AMD showing those given Avastin had an 11 percent higher risk of dying (back story).
To what extent, if any, the VA move will prompt a change among physicians is unclear. Meanwhile, some of the people who recently suffered infections or blindness have filed lawsuits, as reported previously.
Observer
Must have missed this the first time around.
“The outcome spurred Genentech to quickly lobby Capitol Hill to tout the results of its own separate study that reviewed 78,000 Medicare recipients with AMD showing those given AVASTIN had an 11 percent HIGHER RISK of dying.”
The aggrieved company is lobbying with stats that show if you use their own medicine - Avastin - one has a HIGHER chance of dying. What a great piece of marketing. At least that’s my observation.