Off-Label Avastin Use Tied To Eye Injuries
8 CommentsBy Ed Silverman // December 19th, 2008 // 5:30 pm
The biotech gets a chance to say ‘I told you so.’ A letter posted on its web site and addressed to healthcare professionals says there 36 reports of off-label use in Canada last month that resulted in adverse events, 32 of which were serious. Genentech goes on to make the point that its Avastin cancer med, which was being used to treat wet maculer degeneration, was not approved for “use…in the ophthalmology setting.”
The disclosure comes a year after controversy erupted when Genentech yanked distribution of Avastin to compounding pharmacies, which were repackaging and selling the drug to opthalmologists for treating wet macular degeneration. Unlike Avastin, Genentech’s similar, but newer Lucentis drug was approved two years ago to treat the malady, but at $2,000 a dose, it costs about 40 times as much.
After outcries and bad publicity, the biotech eventually struck a deal with opthalmologists to loosen the restrictions, but not before entering into a dispute with the FDA over its original move, which also prompted an invstigation by the US Special Senate Committee On Aging into Medicare expenditures for Avastin (back story). The NIH, meanwhile, is conducting a head-to-head clinical trial in which both drugs will be tested for treating the eye disease (look here).
Justice in Michigan
Does anyone know whether Genentech had specifically warned about the kinds of eye issues showing up? And what they were?
Following Ed’s link, I see that Genentech raised questions about contamination before the NIH head-to-head trial. Do we know whether that figured into a significant number of the cases at issue?
pharma pr hack
I can’t get over 25 adverse events in one lot of avastin.. that seems incredibly high which despite their assertions to the contrary that the lot was okay.. Given how readily Genentech publicized this issue — and how readily they would have had there been a number of adverse events in the US around the start of the NIH trial and how long avastin has been used this way it really makes you wonder why there are only so many adverse events in Canada?
Irv Arons
According to several retinal specialists that I checked with, this seems to be a one-time occurrence, and probably related to the one batch of Avastin supplied by Roche, and/or the way it was handled by the compounding pharmacy.
The adverse events only caused blurriness of vision, which cleared up within a few days.
There have been essentially no occurrences in the U.S.using Avastin and only a few occurrences with Lucentis.
A task force of retinal specialists have been consulting with their Canadian brethern about this.
As one specialist told me, “It is a non-event!” (Unless Genentech wants to make a big deal about it in its fight to stop the use of Avastin for wet-AMD by ophthalmologists.)
Irv Arons
Barry Wheeler
I wrote about this on my website Macular Degeneration Support Canada. It was isolated to a specific lot of Avastin. They are investigating why there was a difference now.
I’m sure Health Canada wiill find out what was the cause.
TD
Pretty matter-of-fact comment by Irv..I guess you can call it a non-event when it doesn’t happen directly to you. Aren’t you the same individual that was aggressively asserting (as you did again just now) Genentech’s motivation for raising the issue was purely finanical vs patient consideration? If I remember correctly, one major assertion from Genentech was the issue with the risk of contamination via the compounding pharmacies and folks like yourself said this was a non-issue and more about $…regardless of the issue since it is unknown to date maybe you should at least operate with some degree of transparency since patients’ health is involved. Folks may even end up taking your perspective seriously.
billybob
no need for nasty. I agree with Irv.
maybe, just perhaps a few RS in teaching hospitals across Canada are involved in a common study were controls regarding the ‘mixing’ of the drug in a non-sterile environment and non-sterile techniques to acommplish this? I’m sure Health Canada will find out what was the cause. lol
betty
My ophthalmologist wants to inject Avastin into a pterygium in my eye. Is there any research where it has been used in this way?
WEL
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